Cancer Drug Shortages Continue in the US, Survey Finds

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Changed
Wed, 07/03/2024 - 09:52

Results from the latest survey by the National Comprehensive Cancer Network (NCCN) showed that numerous critical systemic anticancer therapies, primarily generic drugs, are currently in shortage.

Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.

“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.

The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.

“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.

However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.

“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.

In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.

Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).

In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.

In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.

Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.

How are centers dealing with ongoing supply issues?

Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.

“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.

Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.

The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.

“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”

A version of this article appeared on Medscape.com.

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Results from the latest survey by the National Comprehensive Cancer Network (NCCN) showed that numerous critical systemic anticancer therapies, primarily generic drugs, are currently in shortage.

Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.

“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.

The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.

“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.

However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.

“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.

In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.

Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).

In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.

In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.

Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.

How are centers dealing with ongoing supply issues?

Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.

“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.

Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.

The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.

“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”

A version of this article appeared on Medscape.com.

Results from the latest survey by the National Comprehensive Cancer Network (NCCN) showed that numerous critical systemic anticancer therapies, primarily generic drugs, are currently in shortage.

Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.

“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.

The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.

“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.

However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.

“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.

In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.

Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).

In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.

In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.

Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.

How are centers dealing with ongoing supply issues?

Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.

“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.

Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.

The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.

“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”

A version of this article appeared on Medscape.com.

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Denlinger, MD, said in an interview.<br/><br/>The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/992943">shortage in 2023</a></span>, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.<br/><br/>“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.<br/><br/>However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.<br/><br/>“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.<br/><br/>In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.<br/><br/>Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).<br/><br/>In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.<br/><br/>In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.<br/><br/>Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.<br/><br/>How are centers dealing with ongoing supply issues?<br/><br/>Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.<br/><br/>“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.<br/><br/>Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.<br/><br/>The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.<br/><br/>“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/cancer-drug-shortages-continue-us-survey-finds-2024a1000bz8">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Benzos Are Hard on the Brain, But Do They Raise Dementia Risk?

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Changed
Tue, 07/02/2024 - 12:20

New research supports current guidelines cautioning against long-term use of benzodiazepines.

The study of more than 5000 older adults found that benzodiazepine use was associated with an accelerated reduction in the volume of the hippocampus and amygdala — brain regions involved in memory and mood regulation. However, benzodiazepine use overall was not associated with an increased risk for dementia.

The findings suggest that benzodiazepine use “may have subtle, long-term impact on brain health,” lead investigator Frank Wolters, MD, PhD, with Erasmus University Medical Center, Rotterdam, the Netherlands, and colleagues wrote.

The study was published online in BMC Medicine.
 

Conflicting Evidence 

Benzodiazepines are commonly prescribed in older adults for anxiety and sleep disorders. Though the short-term cognitive side effects are well documented, the long-term impact on neurodegeneration and dementia risk remains unclear. Some studies have linked benzodiazepine use to an increased risk for dementia, whereas others have not.

Dr. Wolters and colleagues assessed the effect of benzodiazepine use on long-term dementia risk and on imaging markers of neurodegeneration in 5443 cognitively healthy adults (mean age, 71 years; 57% women) from the population-based Rotterdam Study. 

Benzodiazepine use between 1991 and 2008 was determined using pharmacy dispensing records, and dementia incidence was determined from medical records. 

Half of the participants had used benzodiazepines at any time in the 15 years before baseline (2005-2008); 47% used anxiolytics, 20% used sedative-hypnotics, 34% used both, and 13% were still using the drugs at the baseline assessment. 

During an average follow-up of 11 years, 13% of participants developed dementia. 

Overall, use of benzodiazepines was not associated with dementia risk, compared with never-use (hazard ratio [HR], 1.06), irrespective of cumulative dose. 

The risk for dementia was somewhat higher with any use of anxiolytics than with sedative-hypnotics (HR, 1.17 vs HR, 0.92), although neither was statistically significant. The highest risk estimates were observed for high cumulative dose of anxiolytics (HR, 1.33). 

Sensitivity analyses of the two most commonly used anxiolytics found no differences in risk between use of short half-life oxazepam and long half-life diazepam (HR, 1.01 and HR, 1.06, respectively, for ever-use, compared with never-use for oxazepam and diazepam).
 

Brain Atrophy

The researchers investigated potential associations between benzodiazepine use and brain volumes using brain MRI imaging from 4836 participants.

They found that current use of a benzodiazepine at baseline was significantly associated with lower total brain volume — as well as lower hippocampus, amygdala, and thalamus volume cross-sectionally — and with accelerated volume loss of the hippocampus and, to a lesser extent, amygdala longitudinally. 

Imaging findings did not differ by type of benzodiazepine used or cumulative dose. 

“Given the availability of effective alternative pharmacological and nonpharmacological treatments for anxiety and sleep problems, it is important to carefully consider the necessity of prolonged benzodiazepine use in light of potential detrimental effects on brain health,” the authors wrote. 
 

Risks Go Beyond the Brain

Commenting on the study, Shaheen Lakhan, MD, PhD, a neurologist and researcher based in Miami, Florida, noted that “chronic benzodiazepine use may reduce neuroplasticity, potentially interfering with the brain’s ability to form new connections and adapt.

“Long-term use can lead to down-regulation of GABA receptors, altering the brain’s natural inhibitory mechanisms and potentially contributing to tolerance and withdrawal symptoms. Prolonged use can also disrupt the balance of various neurotransmitter systems beyond just GABA, potentially affecting mood, cognition, and overall brain function,” said Dr. Lakhan, who was not involved in the study. 

“While the literature is mixed on chronic benzodiazepine use and dementia risk, prolonged use has consistently been associated with accelerated volume loss in certain brain regions, particularly the hippocampus and amygdala,” which are responsible for memory, learning, and emotional regulation, he noted. 

“Beyond cognitive impairments and brain volume loss, chronic benzodiazepine use is associated with tolerance and dependence, potential for abuse, interactions with other drugs, and increased fall risk, especially in older adults,” Dr. Lakhan added.

Current guidelines discourage long-term use of benzodiazepines because of risk for psychological and physical dependence; falls; and cognitive impairment, especially in older adults. Nevertheless, research shows that 30%-40% of older benzodiazepine users stay on the medication beyond the recommended period of several weeks.

Donovan T. Maust, MD, Department of Psychiatry, University of Michigan Medical School, Ann Arbor, said in an interview these new findings are consistent with other recently published observational research that suggest benzodiazepine use is not linked to dementia risk. 

“I realize that such meta-analyses that find a positive relationship between benzodiazepines and dementia are out there, but they include older, less rigorous studies,” said Dr. Maust, who was not part of the new study. “In my opinion, the jury is not still out on this topic. However, there are plenty of other reasons to avoid them — and in particular, starting them — in older adults, most notably the increased risk of fall injury as well as increased overdose risk when taken along with opioids.”

A version of this article first appeared on Medscape.com.

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New research supports current guidelines cautioning against long-term use of benzodiazepines.

The study of more than 5000 older adults found that benzodiazepine use was associated with an accelerated reduction in the volume of the hippocampus and amygdala — brain regions involved in memory and mood regulation. However, benzodiazepine use overall was not associated with an increased risk for dementia.

The findings suggest that benzodiazepine use “may have subtle, long-term impact on brain health,” lead investigator Frank Wolters, MD, PhD, with Erasmus University Medical Center, Rotterdam, the Netherlands, and colleagues wrote.

The study was published online in BMC Medicine.
 

Conflicting Evidence 

Benzodiazepines are commonly prescribed in older adults for anxiety and sleep disorders. Though the short-term cognitive side effects are well documented, the long-term impact on neurodegeneration and dementia risk remains unclear. Some studies have linked benzodiazepine use to an increased risk for dementia, whereas others have not.

Dr. Wolters and colleagues assessed the effect of benzodiazepine use on long-term dementia risk and on imaging markers of neurodegeneration in 5443 cognitively healthy adults (mean age, 71 years; 57% women) from the population-based Rotterdam Study. 

Benzodiazepine use between 1991 and 2008 was determined using pharmacy dispensing records, and dementia incidence was determined from medical records. 

Half of the participants had used benzodiazepines at any time in the 15 years before baseline (2005-2008); 47% used anxiolytics, 20% used sedative-hypnotics, 34% used both, and 13% were still using the drugs at the baseline assessment. 

During an average follow-up of 11 years, 13% of participants developed dementia. 

Overall, use of benzodiazepines was not associated with dementia risk, compared with never-use (hazard ratio [HR], 1.06), irrespective of cumulative dose. 

The risk for dementia was somewhat higher with any use of anxiolytics than with sedative-hypnotics (HR, 1.17 vs HR, 0.92), although neither was statistically significant. The highest risk estimates were observed for high cumulative dose of anxiolytics (HR, 1.33). 

Sensitivity analyses of the two most commonly used anxiolytics found no differences in risk between use of short half-life oxazepam and long half-life diazepam (HR, 1.01 and HR, 1.06, respectively, for ever-use, compared with never-use for oxazepam and diazepam).
 

Brain Atrophy

The researchers investigated potential associations between benzodiazepine use and brain volumes using brain MRI imaging from 4836 participants.

They found that current use of a benzodiazepine at baseline was significantly associated with lower total brain volume — as well as lower hippocampus, amygdala, and thalamus volume cross-sectionally — and with accelerated volume loss of the hippocampus and, to a lesser extent, amygdala longitudinally. 

Imaging findings did not differ by type of benzodiazepine used or cumulative dose. 

“Given the availability of effective alternative pharmacological and nonpharmacological treatments for anxiety and sleep problems, it is important to carefully consider the necessity of prolonged benzodiazepine use in light of potential detrimental effects on brain health,” the authors wrote. 
 

Risks Go Beyond the Brain

Commenting on the study, Shaheen Lakhan, MD, PhD, a neurologist and researcher based in Miami, Florida, noted that “chronic benzodiazepine use may reduce neuroplasticity, potentially interfering with the brain’s ability to form new connections and adapt.

“Long-term use can lead to down-regulation of GABA receptors, altering the brain’s natural inhibitory mechanisms and potentially contributing to tolerance and withdrawal symptoms. Prolonged use can also disrupt the balance of various neurotransmitter systems beyond just GABA, potentially affecting mood, cognition, and overall brain function,” said Dr. Lakhan, who was not involved in the study. 

“While the literature is mixed on chronic benzodiazepine use and dementia risk, prolonged use has consistently been associated with accelerated volume loss in certain brain regions, particularly the hippocampus and amygdala,” which are responsible for memory, learning, and emotional regulation, he noted. 

“Beyond cognitive impairments and brain volume loss, chronic benzodiazepine use is associated with tolerance and dependence, potential for abuse, interactions with other drugs, and increased fall risk, especially in older adults,” Dr. Lakhan added.

Current guidelines discourage long-term use of benzodiazepines because of risk for psychological and physical dependence; falls; and cognitive impairment, especially in older adults. Nevertheless, research shows that 30%-40% of older benzodiazepine users stay on the medication beyond the recommended period of several weeks.

Donovan T. Maust, MD, Department of Psychiatry, University of Michigan Medical School, Ann Arbor, said in an interview these new findings are consistent with other recently published observational research that suggest benzodiazepine use is not linked to dementia risk. 

“I realize that such meta-analyses that find a positive relationship between benzodiazepines and dementia are out there, but they include older, less rigorous studies,” said Dr. Maust, who was not part of the new study. “In my opinion, the jury is not still out on this topic. However, there are plenty of other reasons to avoid them — and in particular, starting them — in older adults, most notably the increased risk of fall injury as well as increased overdose risk when taken along with opioids.”

A version of this article first appeared on Medscape.com.

New research supports current guidelines cautioning against long-term use of benzodiazepines.

The study of more than 5000 older adults found that benzodiazepine use was associated with an accelerated reduction in the volume of the hippocampus and amygdala — brain regions involved in memory and mood regulation. However, benzodiazepine use overall was not associated with an increased risk for dementia.

The findings suggest that benzodiazepine use “may have subtle, long-term impact on brain health,” lead investigator Frank Wolters, MD, PhD, with Erasmus University Medical Center, Rotterdam, the Netherlands, and colleagues wrote.

The study was published online in BMC Medicine.
 

Conflicting Evidence 

Benzodiazepines are commonly prescribed in older adults for anxiety and sleep disorders. Though the short-term cognitive side effects are well documented, the long-term impact on neurodegeneration and dementia risk remains unclear. Some studies have linked benzodiazepine use to an increased risk for dementia, whereas others have not.

Dr. Wolters and colleagues assessed the effect of benzodiazepine use on long-term dementia risk and on imaging markers of neurodegeneration in 5443 cognitively healthy adults (mean age, 71 years; 57% women) from the population-based Rotterdam Study. 

Benzodiazepine use between 1991 and 2008 was determined using pharmacy dispensing records, and dementia incidence was determined from medical records. 

Half of the participants had used benzodiazepines at any time in the 15 years before baseline (2005-2008); 47% used anxiolytics, 20% used sedative-hypnotics, 34% used both, and 13% were still using the drugs at the baseline assessment. 

During an average follow-up of 11 years, 13% of participants developed dementia. 

Overall, use of benzodiazepines was not associated with dementia risk, compared with never-use (hazard ratio [HR], 1.06), irrespective of cumulative dose. 

The risk for dementia was somewhat higher with any use of anxiolytics than with sedative-hypnotics (HR, 1.17 vs HR, 0.92), although neither was statistically significant. The highest risk estimates were observed for high cumulative dose of anxiolytics (HR, 1.33). 

Sensitivity analyses of the two most commonly used anxiolytics found no differences in risk between use of short half-life oxazepam and long half-life diazepam (HR, 1.01 and HR, 1.06, respectively, for ever-use, compared with never-use for oxazepam and diazepam).
 

Brain Atrophy

The researchers investigated potential associations between benzodiazepine use and brain volumes using brain MRI imaging from 4836 participants.

They found that current use of a benzodiazepine at baseline was significantly associated with lower total brain volume — as well as lower hippocampus, amygdala, and thalamus volume cross-sectionally — and with accelerated volume loss of the hippocampus and, to a lesser extent, amygdala longitudinally. 

Imaging findings did not differ by type of benzodiazepine used or cumulative dose. 

“Given the availability of effective alternative pharmacological and nonpharmacological treatments for anxiety and sleep problems, it is important to carefully consider the necessity of prolonged benzodiazepine use in light of potential detrimental effects on brain health,” the authors wrote. 
 

Risks Go Beyond the Brain

Commenting on the study, Shaheen Lakhan, MD, PhD, a neurologist and researcher based in Miami, Florida, noted that “chronic benzodiazepine use may reduce neuroplasticity, potentially interfering with the brain’s ability to form new connections and adapt.

“Long-term use can lead to down-regulation of GABA receptors, altering the brain’s natural inhibitory mechanisms and potentially contributing to tolerance and withdrawal symptoms. Prolonged use can also disrupt the balance of various neurotransmitter systems beyond just GABA, potentially affecting mood, cognition, and overall brain function,” said Dr. Lakhan, who was not involved in the study. 

“While the literature is mixed on chronic benzodiazepine use and dementia risk, prolonged use has consistently been associated with accelerated volume loss in certain brain regions, particularly the hippocampus and amygdala,” which are responsible for memory, learning, and emotional regulation, he noted. 

“Beyond cognitive impairments and brain volume loss, chronic benzodiazepine use is associated with tolerance and dependence, potential for abuse, interactions with other drugs, and increased fall risk, especially in older adults,” Dr. Lakhan added.

Current guidelines discourage long-term use of benzodiazepines because of risk for psychological and physical dependence; falls; and cognitive impairment, especially in older adults. Nevertheless, research shows that 30%-40% of older benzodiazepine users stay on the medication beyond the recommended period of several weeks.

Donovan T. Maust, MD, Department of Psychiatry, University of Michigan Medical School, Ann Arbor, said in an interview these new findings are consistent with other recently published observational research that suggest benzodiazepine use is not linked to dementia risk. 

“I realize that such meta-analyses that find a positive relationship between benzodiazepines and dementia are out there, but they include older, less rigorous studies,” said Dr. Maust, who was not part of the new study. “In my opinion, the jury is not still out on this topic. However, there are plenty of other reasons to avoid them — and in particular, starting them — in older adults, most notably the increased risk of fall injury as well as increased overdose risk when taken along with opioids.”

A version of this article first appeared on Medscape.com.

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All rights reserved. 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However, benzodiazepine use overall was not associated with an increased risk for dementia.<br/><br/>The findings suggest that benzodiazepine use “may have subtle, long-term impact on brain health,” lead investigator Frank Wolters, MD, PhD, with Erasmus University Medical Center, Rotterdam, the Netherlands, and colleagues wrote.<br/><br/>The study was <span class="Hyperlink"><a href="https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03437-5">published online</a></span> in <em>BMC Medicine</em>.<br/><br/></p> <h2>Conflicting Evidence </h2> <p>Benzodiazepines are commonly prescribed in older adults for anxiety and sleep disorders. Though the short-term cognitive side effects are well documented, the long-term impact on neurodegeneration and dementia risk remains unclear. Some studies have linked benzodiazepine use to an <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/acps.12909">increased risk</a> for dementia, whereas others <a href="https://ajp.psychiatryonline.org/doi/full/10.1176/appi.ajp.2019.19030315">have not</a>.</p> <p>Dr. Wolters and colleagues assessed the effect of benzodiazepine use on long-term dementia risk and on imaging markers of neurodegeneration in 5443 cognitively healthy adults (mean age, 71 years; 57% women) from the population-based Rotterdam Study. <br/><br/>Benzodiazepine use between 1991 and 2008 was determined using pharmacy dispensing records, and dementia incidence was determined from medical records. <br/><br/>Half of the participants had used benzodiazepines at any time in the 15 years before baseline (2005-2008); 47% used anxiolytics, 20% used sedative-hypnotics, 34% used both, and 13% were still using the drugs at the baseline assessment. <br/><br/>During an average follow-up of 11 years, 13% of participants developed dementia. <br/><br/>Overall, use of benzodiazepines was not associated with dementia risk, compared with never-use (hazard ratio [HR], 1.06), irrespective of cumulative dose. <br/><br/>The risk for dementia was somewhat higher with any use of anxiolytics than with sedative-hypnotics (HR, 1.17 vs HR, 0.92), although neither was statistically significant. The highest risk estimates were observed for high cumulative dose of anxiolytics (HR, 1.33). <br/><br/>Sensitivity analyses of the two most commonly used anxiolytics found no differences in risk between use of short half-life oxazepam and long half-life diazepam (HR, 1.01 and HR, 1.06, respectively, for ever-use, compared with never-use for oxazepam and diazepam).<br/><br/></p> <h2>Brain Atrophy</h2> <p>The researchers investigated potential associations between benzodiazepine use and brain volumes using brain MRI imaging from 4836 participants.</p> <p>They found that current use of a benzodiazepine at baseline was significantly associated with lower total brain volume — as well as lower hippocampus, amygdala, and thalamus volume cross-sectionally — and with accelerated volume loss of the hippocampus and, to a lesser extent, amygdala longitudinally. <br/><br/>Imaging findings did not differ by type of benzodiazepine used or cumulative dose. <br/><br/>“Given the availability of effective alternative pharmacological and nonpharmacological treatments for anxiety and sleep problems, it is important to carefully consider the necessity of prolonged benzodiazepine use in light of potential detrimental effects on brain health,” the authors wrote. <br/><br/></p> <h2>Risks Go Beyond the Brain</h2> <p>Commenting on the study, Shaheen Lakhan, MD, PhD, a neurologist and researcher based in Miami, Florida, noted that “chronic benzodiazepine use may reduce neuroplasticity, potentially interfering with the brain’s ability to form new connections and adapt.<br/><br/>“Long-term use can lead to down-regulation of GABA receptors, altering the brain’s natural inhibitory mechanisms and potentially contributing to tolerance and withdrawal symptoms. Prolonged use can also disrupt the balance of various neurotransmitter systems beyond just GABA, potentially affecting mood, cognition, and overall brain function,” said Dr. Lakhan, who was not involved in the study. </p> <p>“While the literature is mixed on chronic benzodiazepine use and dementia risk, prolonged use has consistently been associated with accelerated volume loss in certain brain regions, particularly the hippocampus and amygdala,” which are responsible for memory, learning, and emotional regulation, he noted. <br/><br/>“Beyond cognitive impairments and brain volume loss, chronic benzodiazepine use is associated with tolerance and dependence, potential for abuse, interactions with other drugs, and increased fall risk, especially in older adults,” Dr. Lakhan added.<br/><br/>Current guidelines discourage long-term use of benzodiazepines because of risk for psychological and physical dependence; falls; and cognitive impairment, especially in older adults. Nevertheless, research shows that 30%-40% of older benzodiazepine users stay on the medication beyond the recommended period of several weeks.<br/><br/>Donovan T. Maust, MD, Department of Psychiatry, University of Michigan Medical School, Ann Arbor, said in an interview these new findings are consistent with other recently published observational research that suggest benzodiazepine use is not linked to dementia risk. <br/><br/>“I realize that such meta-analyses that find a positive relationship between benzodiazepines and dementia are out there, but they include older, less rigorous studies,” said Dr. Maust, who was not part of the new study. “In my opinion, the jury is not still out on this topic. However, there are plenty of other reasons to avoid them — and in particular, starting them — in older adults, most notably the increased risk of fall injury as well as increased overdose risk when taken along with opioids.”<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/benzos-hard-brain-do-they-raise-dementia-risk-2024a1000c75">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Revised Criteria for Alzheimer’s Diagnosis, Staging Released

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Mon, 07/01/2024 - 15:15

A work group convened by the Alzheimer’s Association has released revised biology-based criteria for the diagnosis and staging of Alzheimer’s disease, including a new biomarker classification system that incorporates fluid and imaging biomarkers as well as an updated disease staging system. 

“Plasma markers are here now, and it’s very important to incorporate them into the criteria for diagnosis,” said senior author Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer and medical affairs lead. 

The revised criteria are the first updates since 2018.

“Defining diseases biologically, rather than based on syndromic presentation, has long been standard in many areas of medicine — including cancer, heart disease, and diabetes — and is becoming a unifying concept common to all neurodegenerative diseases,” lead author Clifford Jack Jr, MD, with Mayo Clinic, Rochester, Minnesota, said in a news release from the Alzheimer’s Association. 

“These updates to the diagnostic criteria are needed now because we know more about the underlying biology of Alzheimer’s and we are able to measure those changes,” Dr. Jack added. 

The 2024 revised criteria for diagnosis and staging of Alzheimer’s disease were published online in Alzheimer’s & Dementia
 

Core Biomarkers Defined

The revised criteria define Alzheimer’s disease as a biologic process that begins with the appearance of Alzheimer’s disease neuropathologic change (ADNPC) in the absence of symptoms. Progression of the neuropathologic burden leads to the later appearance and progression of clinical symptoms.

The work group organized Alzheimer’s disease biomarkers into three broad categories: (1) core biomarkers of ADNPC, (2) nonspecific biomarkers that are important in Alzheimer’s disease but are also involved in other brain diseases, and (3) biomarkers of diseases or conditions that commonly coexist with Alzheimer’s disease.

Core Alzheimer’s biomarkers are subdivided into Core 1 and Core 2. 

Core 1 biomarkers become abnormal early in the disease course and directly measure either amyloid plaques or phosphorylated tau (p-tau). They include amyloid PET; cerebrospinal fluid (CSF) amyloid beta 42/40 ratio, CSF p-tau181/amyloid beta 42 ratio, and CSF total (t)-tau/amyloid beta 42 ratio; and “accurate” plasma biomarkers, such as p-tau217. 

“An abnormal Core 1 biomarker result is sufficient to establish a diagnosis of Alzheimer’s disease and to inform clinical decision making [sic] throughout the disease continuum,” the work group wrote. 

Core 2 biomarkers become abnormal later in the disease process and are more closely linked with the onset of symptoms. Core 2 biomarkers include tau PET and certain soluble tau fragments associated with tau proteinopathy (eg, MTBR-tau243) but also pT205 and nonphosphorylated mid-region tau fragments. 

Core 2 biomarkers, when combined with Core 1, may be used to stage biologic disease severity; abnormal Core 2 biomarkers “increase confidence that Alzheimer’s disease is contributing to symptoms,” the work group noted. 

The revised criteria give clinicians “the flexibility to use plasma or PET scans or CSF,” Dr. Carrillo said. “They will have several tools that they can choose from and offer this variety of tools to their patients. We need different tools for different individuals. There will be differences in coverage and access to these diagnostics.” 

The revised criteria also include an integrated biologic and clinical staging scheme that acknowledges the fact that common co-pathologies, cognitive reserve, and resistance may modify relationships between clinical and biologic Alzheimer’s disease stages. 
 

 

 

Formal Guidelines to Come 

The work group noted that currently, the clinical use of Alzheimer’s disease biomarkers is intended for the evaluation of symptomatic patients, not cognitively unimpaired individuals.

Disease-targeted therapies have not yet been approved for cognitively unimpaired individuals. For this reason, the work group currently recommends against diagnostic testing in cognitively unimpaired individuals outside the context of observational or therapeutic research studies. 

This recommendation would change in the future if disease-targeted therapies that are currently being evaluated in trials demonstrate a benefit in preventing cognitive decline and are approved for use in preclinical Alzheimer’s disease, they wrote. 

They emphasize that the revised criteria are not intended to provide step-by-step clinical practice guidelines for clinicians. Rather, they provide general principles to inform diagnosis and staging of Alzheimer’s disease that reflect current science.

“This is just the beginning,” said Dr. Carrillo. “This is a gathering of the evidence to date and putting it in one place so we can have a consensus and actually a way to test it and make it better as we add new science.”

This also serves as a “springboard” for the Alzheimer’s Association to create formal clinical guidelines. “That will come, hopefully, over the next 12 months. We’ll be working on it, and we hope to have that in 2025,” Dr. Carrillo said. 

The revised criteria also emphasize the role of the clinician. 

“The biologically based diagnosis of Alzheimer’s disease is meant to assist, rather than supplant, the clinical evaluation of individuals with cognitive impairment,” the work group wrote in a related commentary published online in Nature Medicine

Recent diagnostics and therapeutic developments “herald a virtuous cycle in which improvements in diagnostic methods enable more sophisticated treatment approaches, which in turn steer advances in diagnostic methods,” they continued. “An unchanging principle, however, is that effective treatment will always rely on the ability to diagnose and stage the biology driving the disease process.”

Funding for this research was provided by the National Institutes of Health, Alexander family professorship, GHR Foundation, Alzheimer’s Association, Veterans Administration, Life Molecular Imaging, Michael J. Fox Foundation for Parkinson’s Research, Avid Radiopharmaceuticals, Eli Lilly, Gates Foundation, Biogen, C2N Diagnostics, Eisai, Fujirebio, GE Healthcare, Roche, National Institute on Aging, Roche/Genentech, BrightFocus Foundation, Hoffmann-La Roche, Novo Nordisk, Toyama, National MS Society, Alzheimer Drug Discovery Foundation, and others. A complete list of donors and disclosures is included in the original article.

 A version of this article appeared on Medscape.com.

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A work group convened by the Alzheimer’s Association has released revised biology-based criteria for the diagnosis and staging of Alzheimer’s disease, including a new biomarker classification system that incorporates fluid and imaging biomarkers as well as an updated disease staging system. 

“Plasma markers are here now, and it’s very important to incorporate them into the criteria for diagnosis,” said senior author Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer and medical affairs lead. 

The revised criteria are the first updates since 2018.

“Defining diseases biologically, rather than based on syndromic presentation, has long been standard in many areas of medicine — including cancer, heart disease, and diabetes — and is becoming a unifying concept common to all neurodegenerative diseases,” lead author Clifford Jack Jr, MD, with Mayo Clinic, Rochester, Minnesota, said in a news release from the Alzheimer’s Association. 

“These updates to the diagnostic criteria are needed now because we know more about the underlying biology of Alzheimer’s and we are able to measure those changes,” Dr. Jack added. 

The 2024 revised criteria for diagnosis and staging of Alzheimer’s disease were published online in Alzheimer’s & Dementia
 

Core Biomarkers Defined

The revised criteria define Alzheimer’s disease as a biologic process that begins with the appearance of Alzheimer’s disease neuropathologic change (ADNPC) in the absence of symptoms. Progression of the neuropathologic burden leads to the later appearance and progression of clinical symptoms.

The work group organized Alzheimer’s disease biomarkers into three broad categories: (1) core biomarkers of ADNPC, (2) nonspecific biomarkers that are important in Alzheimer’s disease but are also involved in other brain diseases, and (3) biomarkers of diseases or conditions that commonly coexist with Alzheimer’s disease.

Core Alzheimer’s biomarkers are subdivided into Core 1 and Core 2. 

Core 1 biomarkers become abnormal early in the disease course and directly measure either amyloid plaques or phosphorylated tau (p-tau). They include amyloid PET; cerebrospinal fluid (CSF) amyloid beta 42/40 ratio, CSF p-tau181/amyloid beta 42 ratio, and CSF total (t)-tau/amyloid beta 42 ratio; and “accurate” plasma biomarkers, such as p-tau217. 

“An abnormal Core 1 biomarker result is sufficient to establish a diagnosis of Alzheimer’s disease and to inform clinical decision making [sic] throughout the disease continuum,” the work group wrote. 

Core 2 biomarkers become abnormal later in the disease process and are more closely linked with the onset of symptoms. Core 2 biomarkers include tau PET and certain soluble tau fragments associated with tau proteinopathy (eg, MTBR-tau243) but also pT205 and nonphosphorylated mid-region tau fragments. 

Core 2 biomarkers, when combined with Core 1, may be used to stage biologic disease severity; abnormal Core 2 biomarkers “increase confidence that Alzheimer’s disease is contributing to symptoms,” the work group noted. 

The revised criteria give clinicians “the flexibility to use plasma or PET scans or CSF,” Dr. Carrillo said. “They will have several tools that they can choose from and offer this variety of tools to their patients. We need different tools for different individuals. There will be differences in coverage and access to these diagnostics.” 

The revised criteria also include an integrated biologic and clinical staging scheme that acknowledges the fact that common co-pathologies, cognitive reserve, and resistance may modify relationships between clinical and biologic Alzheimer’s disease stages. 
 

 

 

Formal Guidelines to Come 

The work group noted that currently, the clinical use of Alzheimer’s disease biomarkers is intended for the evaluation of symptomatic patients, not cognitively unimpaired individuals.

Disease-targeted therapies have not yet been approved for cognitively unimpaired individuals. For this reason, the work group currently recommends against diagnostic testing in cognitively unimpaired individuals outside the context of observational or therapeutic research studies. 

This recommendation would change in the future if disease-targeted therapies that are currently being evaluated in trials demonstrate a benefit in preventing cognitive decline and are approved for use in preclinical Alzheimer’s disease, they wrote. 

They emphasize that the revised criteria are not intended to provide step-by-step clinical practice guidelines for clinicians. Rather, they provide general principles to inform diagnosis and staging of Alzheimer’s disease that reflect current science.

“This is just the beginning,” said Dr. Carrillo. “This is a gathering of the evidence to date and putting it in one place so we can have a consensus and actually a way to test it and make it better as we add new science.”

This also serves as a “springboard” for the Alzheimer’s Association to create formal clinical guidelines. “That will come, hopefully, over the next 12 months. We’ll be working on it, and we hope to have that in 2025,” Dr. Carrillo said. 

The revised criteria also emphasize the role of the clinician. 

“The biologically based diagnosis of Alzheimer’s disease is meant to assist, rather than supplant, the clinical evaluation of individuals with cognitive impairment,” the work group wrote in a related commentary published online in Nature Medicine

Recent diagnostics and therapeutic developments “herald a virtuous cycle in which improvements in diagnostic methods enable more sophisticated treatment approaches, which in turn steer advances in diagnostic methods,” they continued. “An unchanging principle, however, is that effective treatment will always rely on the ability to diagnose and stage the biology driving the disease process.”

Funding for this research was provided by the National Institutes of Health, Alexander family professorship, GHR Foundation, Alzheimer’s Association, Veterans Administration, Life Molecular Imaging, Michael J. Fox Foundation for Parkinson’s Research, Avid Radiopharmaceuticals, Eli Lilly, Gates Foundation, Biogen, C2N Diagnostics, Eisai, Fujirebio, GE Healthcare, Roche, National Institute on Aging, Roche/Genentech, BrightFocus Foundation, Hoffmann-La Roche, Novo Nordisk, Toyama, National MS Society, Alzheimer Drug Discovery Foundation, and others. A complete list of donors and disclosures is included in the original article.

 A version of this article appeared on Medscape.com.

A work group convened by the Alzheimer’s Association has released revised biology-based criteria for the diagnosis and staging of Alzheimer’s disease, including a new biomarker classification system that incorporates fluid and imaging biomarkers as well as an updated disease staging system. 

“Plasma markers are here now, and it’s very important to incorporate them into the criteria for diagnosis,” said senior author Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer and medical affairs lead. 

The revised criteria are the first updates since 2018.

“Defining diseases biologically, rather than based on syndromic presentation, has long been standard in many areas of medicine — including cancer, heart disease, and diabetes — and is becoming a unifying concept common to all neurodegenerative diseases,” lead author Clifford Jack Jr, MD, with Mayo Clinic, Rochester, Minnesota, said in a news release from the Alzheimer’s Association. 

“These updates to the diagnostic criteria are needed now because we know more about the underlying biology of Alzheimer’s and we are able to measure those changes,” Dr. Jack added. 

The 2024 revised criteria for diagnosis and staging of Alzheimer’s disease were published online in Alzheimer’s & Dementia
 

Core Biomarkers Defined

The revised criteria define Alzheimer’s disease as a biologic process that begins with the appearance of Alzheimer’s disease neuropathologic change (ADNPC) in the absence of symptoms. Progression of the neuropathologic burden leads to the later appearance and progression of clinical symptoms.

The work group organized Alzheimer’s disease biomarkers into three broad categories: (1) core biomarkers of ADNPC, (2) nonspecific biomarkers that are important in Alzheimer’s disease but are also involved in other brain diseases, and (3) biomarkers of diseases or conditions that commonly coexist with Alzheimer’s disease.

Core Alzheimer’s biomarkers are subdivided into Core 1 and Core 2. 

Core 1 biomarkers become abnormal early in the disease course and directly measure either amyloid plaques or phosphorylated tau (p-tau). They include amyloid PET; cerebrospinal fluid (CSF) amyloid beta 42/40 ratio, CSF p-tau181/amyloid beta 42 ratio, and CSF total (t)-tau/amyloid beta 42 ratio; and “accurate” plasma biomarkers, such as p-tau217. 

“An abnormal Core 1 biomarker result is sufficient to establish a diagnosis of Alzheimer’s disease and to inform clinical decision making [sic] throughout the disease continuum,” the work group wrote. 

Core 2 biomarkers become abnormal later in the disease process and are more closely linked with the onset of symptoms. Core 2 biomarkers include tau PET and certain soluble tau fragments associated with tau proteinopathy (eg, MTBR-tau243) but also pT205 and nonphosphorylated mid-region tau fragments. 

Core 2 biomarkers, when combined with Core 1, may be used to stage biologic disease severity; abnormal Core 2 biomarkers “increase confidence that Alzheimer’s disease is contributing to symptoms,” the work group noted. 

The revised criteria give clinicians “the flexibility to use plasma or PET scans or CSF,” Dr. Carrillo said. “They will have several tools that they can choose from and offer this variety of tools to their patients. We need different tools for different individuals. There will be differences in coverage and access to these diagnostics.” 

The revised criteria also include an integrated biologic and clinical staging scheme that acknowledges the fact that common co-pathologies, cognitive reserve, and resistance may modify relationships between clinical and biologic Alzheimer’s disease stages. 
 

 

 

Formal Guidelines to Come 

The work group noted that currently, the clinical use of Alzheimer’s disease biomarkers is intended for the evaluation of symptomatic patients, not cognitively unimpaired individuals.

Disease-targeted therapies have not yet been approved for cognitively unimpaired individuals. For this reason, the work group currently recommends against diagnostic testing in cognitively unimpaired individuals outside the context of observational or therapeutic research studies. 

This recommendation would change in the future if disease-targeted therapies that are currently being evaluated in trials demonstrate a benefit in preventing cognitive decline and are approved for use in preclinical Alzheimer’s disease, they wrote. 

They emphasize that the revised criteria are not intended to provide step-by-step clinical practice guidelines for clinicians. Rather, they provide general principles to inform diagnosis and staging of Alzheimer’s disease that reflect current science.

“This is just the beginning,” said Dr. Carrillo. “This is a gathering of the evidence to date and putting it in one place so we can have a consensus and actually a way to test it and make it better as we add new science.”

This also serves as a “springboard” for the Alzheimer’s Association to create formal clinical guidelines. “That will come, hopefully, over the next 12 months. We’ll be working on it, and we hope to have that in 2025,” Dr. Carrillo said. 

The revised criteria also emphasize the role of the clinician. 

“The biologically based diagnosis of Alzheimer’s disease is meant to assist, rather than supplant, the clinical evaluation of individuals with cognitive impairment,” the work group wrote in a related commentary published online in Nature Medicine

Recent diagnostics and therapeutic developments “herald a virtuous cycle in which improvements in diagnostic methods enable more sophisticated treatment approaches, which in turn steer advances in diagnostic methods,” they continued. “An unchanging principle, however, is that effective treatment will always rely on the ability to diagnose and stage the biology driving the disease process.”

Funding for this research was provided by the National Institutes of Health, Alexander family professorship, GHR Foundation, Alzheimer’s Association, Veterans Administration, Life Molecular Imaging, Michael J. Fox Foundation for Parkinson’s Research, Avid Radiopharmaceuticals, Eli Lilly, Gates Foundation, Biogen, C2N Diagnostics, Eisai, Fujirebio, GE Healthcare, Roche, National Institute on Aging, Roche/Genentech, BrightFocus Foundation, Hoffmann-La Roche, Novo Nordisk, Toyama, National MS Society, Alzheimer Drug Discovery Foundation, and others. A complete list of donors and disclosures is included in the original article.

 A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>A work group convened by the Alzheimer’s Association has released revised biology-based criteria for the diagnosis and staging of Alzheimer’s disease</metaDescription> <articlePDF/> <teaserImage/> <teaser>The new Alzheimer’s disease criteria feature a new biomarker classification system that incorporates fluid and imaging biomarkers as well as an updated disease staging system.</teaser> <title>Revised Criteria for Alzheimer’s Diagnosis, Staging Released</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>CPN</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> <publicationData> <publicationCode>FP</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement>Copyright 2017 Frontline Medical News</copyrightStatement> </publicationData> <publicationData> <publicationCode>IM</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> <publicationData> <publicationCode>nr</publicationCode> <pubIssueName>January 2021</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle>Neurology Reviews</journalTitle> <journalFullTitle>Neurology Reviews</journalFullTitle> <copyrightStatement>2018 Frontline Medical Communications Inc.,</copyrightStatement> </publicationData> </publications_g> <publications> <term>9</term> <term>15</term> <term>21</term> <term canonical="true">22</term> </publications> <sections> <term>39313</term> <term>86</term> <term canonical="true">27970</term> </sections> <topics> <term canonical="true">180</term> <term>258</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Revised Criteria for Alzheimer’s Diagnosis, Staging Released</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">A work group convened by the Alzheimer’s Association has released revised biology-based criteria for the diagnosis and staging of Alzheimer’s disease</span>, including a new biomarker classification system that incorporates fluid and imaging biomarkers as well as an updated disease staging system. </p> <p>“Plasma markers are here now, and it’s very important to incorporate them into the criteria for diagnosis,” said senior author Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer and medical affairs lead. <br/><br/>The revised criteria are the first updates <span class="Hyperlink">since 2018</span>.<br/><br/>“Defining diseases biologically, rather than based on syndromic presentation, has long been standard in many areas of medicine — including cancer, heart disease, and diabetes — and is becoming a unifying concept common to all neurodegenerative diseases,” lead author Clifford Jack Jr, MD, with Mayo Clinic, Rochester, Minnesota, said in a news release from the Alzheimer’s Association. <br/><br/>“These updates to the diagnostic criteria are needed now because we know more about the underlying biology of Alzheimer’s and we are able to measure those changes,” Dr. Jack added. <br/><br/>The 2024 revised criteria for diagnosis and staging of Alzheimer’s disease were <span class="Hyperlink"><a href="https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13859">published online</a></span> in <em>Alzheimer’s &amp; Dementia</em>. <br/><br/></p> <h2>Core Biomarkers Defined</h2> <p>The revised criteria define Alzheimer’s disease as a biologic process that begins with the appearance of Alzheimer’s disease neuropathologic change (ADNPC) in the absence of symptoms. Progression of the neuropathologic burden leads to the later appearance and progression of clinical symptoms.</p> <p>The work group organized Alzheimer’s disease biomarkers into three broad categories: (1) core biomarkers of ADNPC, (2) nonspecific biomarkers that are important in Alzheimer’s disease but are also involved in other brain diseases, and (3) biomarkers of diseases or conditions that commonly coexist with Alzheimer’s disease.<br/><br/>Core Alzheimer’s biomarkers are subdivided into Core 1 and Core 2. <br/><br/>Core 1 biomarkers become abnormal early in the disease course and directly measure either amyloid plaques or phosphorylated tau (p-tau). They include amyloid PET; cerebrospinal fluid (CSF) amyloid beta 42/40 ratio, CSF p-tau181/amyloid beta 42 ratio, and CSF total (t)-tau/amyloid beta 42 ratio; and “accurate” plasma biomarkers, such as p-tau217. <br/><br/>“An abnormal Core 1 biomarker result is sufficient to establish a diagnosis of Alzheimer’s disease and to inform clinical decision making [sic] throughout the disease continuum,” the work group wrote. <br/><br/>Core 2 biomarkers become abnormal later in the disease process and are more closely linked with the onset of symptoms. Core 2 biomarkers include tau PET and certain soluble tau fragments associated with tau proteinopathy (eg, MTBR-tau243) but also pT205 and nonphosphorylated mid-region tau fragments. <br/><br/>Core 2 biomarkers, when combined with Core 1, may be used to stage biologic disease severity; abnormal Core 2 biomarkers “increase confidence that Alzheimer’s disease is contributing to symptoms,” the work group noted. <br/><br/>The revised criteria give clinicians “the flexibility to use plasma or PET scans or CSF,” Dr. Carrillo said. “They will have several tools that they can choose from and offer this variety of tools to their patients. We need different tools for different individuals. There will be differences in coverage and access to these diagnostics.” <br/><br/>The revised criteria also include an integrated biologic and clinical staging scheme that acknowledges the fact that common co-pathologies, cognitive reserve, and resistance may modify relationships between clinical and biologic Alzheimer’s disease stages. <br/><br/></p> <h2>Formal Guidelines to Come </h2> <p>The work group noted that currently, the clinical use of Alzheimer’s disease biomarkers is intended for the evaluation of symptomatic patients, not cognitively unimpaired individuals.</p> <p>Disease-targeted therapies have not yet been approved for cognitively unimpaired individuals. For this reason, the work group currently recommends against diagnostic testing in cognitively unimpaired individuals outside the context of observational or therapeutic research studies. <br/><br/>This recommendation would change in the future if disease-targeted therapies that are currently being evaluated in trials demonstrate a benefit in preventing cognitive decline and are approved for use in preclinical Alzheimer’s disease, they wrote. <br/><br/>They emphasize that the revised criteria are not intended to provide step-by-step clinical practice guidelines for clinicians. Rather, they provide general principles to inform diagnosis and staging of Alzheimer’s disease that reflect current science.<br/><br/>“This is just the beginning,” said Dr. Carrillo. “This is a gathering of the evidence to date and putting it in one place so we can have a consensus and actually a way to test it and make it better as we add new science.”<br/><br/>This also serves as a “springboard” for the Alzheimer’s Association to create formal clinical guidelines. “That will come, hopefully, over the next 12 months. We’ll be working on it, and we hope to have that in 2025,” Dr. Carrillo said. <br/><br/>The revised criteria also emphasize the role of the clinician. <br/><br/>“The biologically based diagnosis of Alzheimer’s disease is meant to assist, rather than supplant, the clinical evaluation of individuals with cognitive impairment,” the work group wrote in a related commentary <span class="Hyperlink"><a href="https://www.nature.com/articles/s41591-024-02988-7">published online</a></span> in <em>Nature Medicine</em>. <br/><br/>Recent diagnostics and therapeutic developments “herald a virtuous cycle in which improvements in diagnostic methods enable more sophisticated treatment approaches, which in turn steer advances in diagnostic methods,” they continued. “An unchanging principle, however, is that effective treatment will always rely on the ability to diagnose and stage the biology driving the disease process.”<br/><br/>Funding for this research was provided by the National Institutes of Health, Alexander family professorship, GHR Foundation, Alzheimer’s Association, Veterans Administration, Life Molecular Imaging, Michael J. Fox Foundation for Parkinson’s Research, Avid Radiopharmaceuticals, Eli Lilly, Gates Foundation, Biogen, C2N Diagnostics, Eisai, Fujirebio, GE Healthcare, Roche, National Institute on Aging, Roche/Genentech, BrightFocus Foundation, Hoffmann-La Roche, Novo Nordisk, Toyama, National MS Society, Alzheimer Drug Discovery Foundation, and others. A complete list of donors and disclosures is included in the original article.<span class="end"/><br/><br/> <i>A version of this article appeared on </i><span class="Hyperlink"><i><a href="https://www.medscape.com/viewarticle/revised-criteria-alzheimers-diagnosis-staging-released-2024a1000c4g">Medscape.com</a></i></span><i>.</i></p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Dengue Surge in US Cases This Year

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Changed
Thu, 06/27/2024 - 16:13

Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.

The global incidence of dengue in 2024 is the highest on record, reported the agency.

In the Americas, more than 9.7 million cases of dengue have been reported in the first 6 months of 2024 — more than double the 4.6 million cases reported in all of 2023.

In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.

The CDC reports 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.

Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.

The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
 

Monitoring for Dengue

With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:

  • Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.
  • Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.
  • Ensure timely reporting of dengue cases to public health authorities.
  • Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.

Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.

Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.
 

Disease Progression

Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.

One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.

Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.

“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.

The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.

The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.

A version of this article first appeared on Medscape.com.

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Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.

The global incidence of dengue in 2024 is the highest on record, reported the agency.

In the Americas, more than 9.7 million cases of dengue have been reported in the first 6 months of 2024 — more than double the 4.6 million cases reported in all of 2023.

In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.

The CDC reports 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.

Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.

The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
 

Monitoring for Dengue

With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:

  • Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.
  • Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.
  • Ensure timely reporting of dengue cases to public health authorities.
  • Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.

Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.

Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.
 

Disease Progression

Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.

One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.

Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.

“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.

The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.

The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.

A version of this article first appeared on Medscape.com.

Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.

The global incidence of dengue in 2024 is the highest on record, reported the agency.

In the Americas, more than 9.7 million cases of dengue have been reported in the first 6 months of 2024 — more than double the 4.6 million cases reported in all of 2023.

In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.

The CDC reports 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.

Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.

The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
 

Monitoring for Dengue

With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:

  • Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.
  • Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.
  • Ensure timely reporting of dengue cases to public health authorities.
  • Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.

Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.

Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.
 

Disease Progression

Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.

One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.

Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.

“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.

The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.

The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.

A version of this article first appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>In the Americas, more than 9.7 million cases of dengue have been reported in the first 6 months of 2024 — more than double the 4.6 million cases reported in all</metaDescription> <articlePDF/> <teaserImage/> <teaser>Mosquito-borne dengue is on the rise in the Americas, prompting an alert from the CDC about risk to the US population.</teaser> <title>Dengue Surge in US Cases This Year</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">20</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term>316</term> <term canonical="true">317</term> <term>234</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Dengue Surge in US Cases This Year</title> <deck/> </itemMeta> <itemContent> <p>Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.</p> <p>The global incidence of dengue in 2024 is the <a href="https://emergency.cdc.gov/han/2024/han00511.asp">highest on record</a>, reported the agency.<br/><br/><span class="tag metaDescription">In the Americas, more than 9.7 million cases of dengue have been reported in the first 6 months of 2024 — more than double the 4.6 million cases reported in all of 2023.</span><br/><br/>In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.<br/><br/>The CDC <a href="https://www.cdc.gov/dengue/data-research/facts-stats/current-data.html">reports</a> 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.<br/><br/>Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.<br/><br/>The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.<br/><br/></p> <h2>Monitoring for Dengue</h2> <p>With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:</p> <ul class="body"> <li>Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.</li> <li>Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.</li> <li>Ensure timely reporting of dengue cases to public health authorities.</li> <li>Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.</li> </ul> <p>Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.<br/><br/>Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.<br/><br/></p> <h2>Disease Progression</h2> <p>Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.</p> <p>One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.<br/><br/>Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.<br/><br/>“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.<br/><br/>The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.<br/><br/>The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/dengue-surge-us-cases-this-year-2024a1000bzw">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Liver Resection Beats Out Alternatives in Early Multinodular HCC

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Tue, 06/25/2024 - 16:33

 

TOPLINE:

For patients with early multinodular hepatocellular carcinoma (HCC) who are ineligible for liver transplant, liver resection provides a survival advantage over percutaneous radiofrequency ablation and transarterial chemoembolization (TACE).

METHODOLOGY:

  • The presentation of HCC is often multinodular — meaning patients have two or three nodules measuring ≤ 3 cm each. Although liver resection is considered the gold standard curative treatment for early-stage disease, experts debate its efficacy in multinodular HCC, researchers explained.
  • Using two large Italian registries with data from multiple centers, researchers compared the efficacy of liver resection, percutaneous radiofrequency ablation, and TACE in 720 patients with early multinodular HCC. Overall, 296 patients underwent liver resection, 240 had percutaneous radiofrequency ablation, and 184 underwent TACE.
  • To avoid crossovers between groups, the researchers considered liver resection, percutaneous radiofrequency ablation, and TACE the main treatments in each population in a hierarchical order. That meant, in the liver resection group, researchers excluded patients undergoing a superior treatment during the follow-up, such as liver transplant. In the ablation group, patients undergoing surgery to treat HCC recurrences were excluded.
  • The primary outcome was overall survival at 1, 3, and 5 years. The researchers used a matching-adjusted indirect comparison (MAIC) to balance data and control for confounding factors between the three treatment groups.

TAKEAWAY:

  • After MAIC adjustment, the survival rate at 1 year was slightly lower in the liver resection group — 89% vs 94% in the ablation group and 91% in the TACE group. However, at 3 and 5 years, survival rates were better in the liver resection group — 71% at 3 years and 56% at 5 years vs 65% and 40%, respectively, in the ablation group and 49% and 29%, respectively, in the TACE group.
  • Median overall survival was 69 months with liver resection, 54 months with ablation, and 34 months with TACE. Multivariable Cox survival analysis confirmed a significantly higher mortality risk with ablation (hazard ratio [HR], 1.41; P = .01) and TACE (HR, 1.86; P = .001) than with liver resection.
  • In competing risk analyses, patients who underwent liver resection had a lower risk for HCC-related death than peers who had ablation (HR, 1.38; P = .07) or TACE (HR, 1.91; P = .006).
  • In a subgroup survival analysis of patients with Child-Pugh class B cirrhosis, liver resection provided significantly better overall survival than TACE (HR, 2.79; P = .001) and higher overall survival than ablation (HR, 1.44; P = .21), but these findings were not statistically significant.

IN PRACTICE:

“The main result of the current study is the indisputable superiority” of liver resection over percutaneous radiofrequency ablation and TACE in patients with multinodular HCC, the researchers concluded. “For patients with early multinodular HCC who are ineligible for transplant, LR [liver resection] should be prioritized as the primary therapeutic option,” followed by percutaneous radiofrequency ablation and TACE, when resection is not feasible.

The authors of an invited commentary said the analysis provides “convincing” data that liver resection leads to superior 3- and 5-year survival. “All of our local therapies are getting better. Making each available under different clinical circumstances and combining these when appropriate provides patients with the best chance at cure with the least invasiveness,” the editorialists added.
 

SOURCE:

The study, with first author Alessandro Vitale, MD, PhD, with the Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padua, Italy, and the accompanying commentary were published online last month in JAMA Surgery.

LIMITATIONS:

Selection bias cannot be ruled out due to potential hidden variables that were not collected in the centers’ databases. Not all patients included in the study were potentially treatable with all three proposed approaches. The study population was derived from Italian centers, which may have limited the generalizability of the results.

DISCLOSURES:

The study reported no specific funding. The authors reported various disclosures during the conduct of the study, including ties to AstraZeneca, AbbVie, Bayer, MSD, Roche, and Eisai. An editorialist reported ties to Medtronic, Theromics, Vergent Bioscience, Imugene, Sovato Health, XDemics, and Imugene.

A version of this article first appeared on Medscape.com.

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TOPLINE:

For patients with early multinodular hepatocellular carcinoma (HCC) who are ineligible for liver transplant, liver resection provides a survival advantage over percutaneous radiofrequency ablation and transarterial chemoembolization (TACE).

METHODOLOGY:

  • The presentation of HCC is often multinodular — meaning patients have two or three nodules measuring ≤ 3 cm each. Although liver resection is considered the gold standard curative treatment for early-stage disease, experts debate its efficacy in multinodular HCC, researchers explained.
  • Using two large Italian registries with data from multiple centers, researchers compared the efficacy of liver resection, percutaneous radiofrequency ablation, and TACE in 720 patients with early multinodular HCC. Overall, 296 patients underwent liver resection, 240 had percutaneous radiofrequency ablation, and 184 underwent TACE.
  • To avoid crossovers between groups, the researchers considered liver resection, percutaneous radiofrequency ablation, and TACE the main treatments in each population in a hierarchical order. That meant, in the liver resection group, researchers excluded patients undergoing a superior treatment during the follow-up, such as liver transplant. In the ablation group, patients undergoing surgery to treat HCC recurrences were excluded.
  • The primary outcome was overall survival at 1, 3, and 5 years. The researchers used a matching-adjusted indirect comparison (MAIC) to balance data and control for confounding factors between the three treatment groups.

TAKEAWAY:

  • After MAIC adjustment, the survival rate at 1 year was slightly lower in the liver resection group — 89% vs 94% in the ablation group and 91% in the TACE group. However, at 3 and 5 years, survival rates were better in the liver resection group — 71% at 3 years and 56% at 5 years vs 65% and 40%, respectively, in the ablation group and 49% and 29%, respectively, in the TACE group.
  • Median overall survival was 69 months with liver resection, 54 months with ablation, and 34 months with TACE. Multivariable Cox survival analysis confirmed a significantly higher mortality risk with ablation (hazard ratio [HR], 1.41; P = .01) and TACE (HR, 1.86; P = .001) than with liver resection.
  • In competing risk analyses, patients who underwent liver resection had a lower risk for HCC-related death than peers who had ablation (HR, 1.38; P = .07) or TACE (HR, 1.91; P = .006).
  • In a subgroup survival analysis of patients with Child-Pugh class B cirrhosis, liver resection provided significantly better overall survival than TACE (HR, 2.79; P = .001) and higher overall survival than ablation (HR, 1.44; P = .21), but these findings were not statistically significant.

IN PRACTICE:

“The main result of the current study is the indisputable superiority” of liver resection over percutaneous radiofrequency ablation and TACE in patients with multinodular HCC, the researchers concluded. “For patients with early multinodular HCC who are ineligible for transplant, LR [liver resection] should be prioritized as the primary therapeutic option,” followed by percutaneous radiofrequency ablation and TACE, when resection is not feasible.

The authors of an invited commentary said the analysis provides “convincing” data that liver resection leads to superior 3- and 5-year survival. “All of our local therapies are getting better. Making each available under different clinical circumstances and combining these when appropriate provides patients with the best chance at cure with the least invasiveness,” the editorialists added.
 

SOURCE:

The study, with first author Alessandro Vitale, MD, PhD, with the Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padua, Italy, and the accompanying commentary were published online last month in JAMA Surgery.

LIMITATIONS:

Selection bias cannot be ruled out due to potential hidden variables that were not collected in the centers’ databases. Not all patients included in the study were potentially treatable with all three proposed approaches. The study population was derived from Italian centers, which may have limited the generalizability of the results.

DISCLOSURES:

The study reported no specific funding. The authors reported various disclosures during the conduct of the study, including ties to AstraZeneca, AbbVie, Bayer, MSD, Roche, and Eisai. An editorialist reported ties to Medtronic, Theromics, Vergent Bioscience, Imugene, Sovato Health, XDemics, and Imugene.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

For patients with early multinodular hepatocellular carcinoma (HCC) who are ineligible for liver transplant, liver resection provides a survival advantage over percutaneous radiofrequency ablation and transarterial chemoembolization (TACE).

METHODOLOGY:

  • The presentation of HCC is often multinodular — meaning patients have two or three nodules measuring ≤ 3 cm each. Although liver resection is considered the gold standard curative treatment for early-stage disease, experts debate its efficacy in multinodular HCC, researchers explained.
  • Using two large Italian registries with data from multiple centers, researchers compared the efficacy of liver resection, percutaneous radiofrequency ablation, and TACE in 720 patients with early multinodular HCC. Overall, 296 patients underwent liver resection, 240 had percutaneous radiofrequency ablation, and 184 underwent TACE.
  • To avoid crossovers between groups, the researchers considered liver resection, percutaneous radiofrequency ablation, and TACE the main treatments in each population in a hierarchical order. That meant, in the liver resection group, researchers excluded patients undergoing a superior treatment during the follow-up, such as liver transplant. In the ablation group, patients undergoing surgery to treat HCC recurrences were excluded.
  • The primary outcome was overall survival at 1, 3, and 5 years. The researchers used a matching-adjusted indirect comparison (MAIC) to balance data and control for confounding factors between the three treatment groups.

TAKEAWAY:

  • After MAIC adjustment, the survival rate at 1 year was slightly lower in the liver resection group — 89% vs 94% in the ablation group and 91% in the TACE group. However, at 3 and 5 years, survival rates were better in the liver resection group — 71% at 3 years and 56% at 5 years vs 65% and 40%, respectively, in the ablation group and 49% and 29%, respectively, in the TACE group.
  • Median overall survival was 69 months with liver resection, 54 months with ablation, and 34 months with TACE. Multivariable Cox survival analysis confirmed a significantly higher mortality risk with ablation (hazard ratio [HR], 1.41; P = .01) and TACE (HR, 1.86; P = .001) than with liver resection.
  • In competing risk analyses, patients who underwent liver resection had a lower risk for HCC-related death than peers who had ablation (HR, 1.38; P = .07) or TACE (HR, 1.91; P = .006).
  • In a subgroup survival analysis of patients with Child-Pugh class B cirrhosis, liver resection provided significantly better overall survival than TACE (HR, 2.79; P = .001) and higher overall survival than ablation (HR, 1.44; P = .21), but these findings were not statistically significant.

IN PRACTICE:

“The main result of the current study is the indisputable superiority” of liver resection over percutaneous radiofrequency ablation and TACE in patients with multinodular HCC, the researchers concluded. “For patients with early multinodular HCC who are ineligible for transplant, LR [liver resection] should be prioritized as the primary therapeutic option,” followed by percutaneous radiofrequency ablation and TACE, when resection is not feasible.

The authors of an invited commentary said the analysis provides “convincing” data that liver resection leads to superior 3- and 5-year survival. “All of our local therapies are getting better. Making each available under different clinical circumstances and combining these when appropriate provides patients with the best chance at cure with the least invasiveness,” the editorialists added.
 

SOURCE:

The study, with first author Alessandro Vitale, MD, PhD, with the Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padua, Italy, and the accompanying commentary were published online last month in JAMA Surgery.

LIMITATIONS:

Selection bias cannot be ruled out due to potential hidden variables that were not collected in the centers’ databases. Not all patients included in the study were potentially treatable with all three proposed approaches. The study population was derived from Italian centers, which may have limited the generalizability of the results.

DISCLOSURES:

The study reported no specific funding. The authors reported various disclosures during the conduct of the study, including ties to AstraZeneca, AbbVie, Bayer, MSD, Roche, and Eisai. An editorialist reported ties to Medtronic, Theromics, Vergent Bioscience, Imugene, Sovato Health, XDemics, and Imugene.

A version of this article first appeared on Medscape.com.

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Although liver resection is considered the gold standard curative treatment for early-stage disease, experts debate its efficacy in multinodular HCC, researchers explained.</li> <li>Using two large Italian registries with data from multiple centers, researchers compared the efficacy of liver resection, percutaneous radiofrequency ablation, and TACE in 720 patients with early multinodular HCC. Overall, 296 patients underwent liver resection, 240 had percutaneous radiofrequency ablation, and 184 underwent TACE.</li> <li>To avoid crossovers between groups, the researchers considered liver resection, percutaneous radiofrequency ablation, and TACE the main treatments in each population in a hierarchical order. That meant, in the liver resection group, researchers excluded patients undergoing a superior treatment during the follow-up, such as liver transplant. In the ablation group, patients undergoing surgery to treat HCC recurrences were excluded.</li> <li>The primary outcome was overall survival at 1, 3, and 5 years. The researchers used a matching-adjusted indirect comparison (MAIC) to balance data and control for confounding factors between the three treatment groups.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>After MAIC adjustment, the survival rate at 1 year was slightly lower in the liver resection group — 89% vs 94% in the ablation group and 91% in the TACE group. However, at 3 and 5 years, survival rates were better in the liver resection group — 71% at 3 years and 56% at 5 years vs 65% and 40%, respectively, in the ablation group and 49% and 29%, respectively, in the TACE group.</li> <li>Median overall survival was 69 months with liver resection, 54 months with ablation, and 34 months with TACE. Multivariable Cox survival analysis confirmed a significantly higher mortality risk with ablation (hazard ratio [HR], 1.41; <em>P</em> = .01) and TACE (HR, 1.86; <em>P</em> = .001) than with liver resection.</li> <li>In competing risk analyses, patients who underwent liver resection had a lower risk for HCC-related death than peers who had ablation (HR, 1.38; <em>P</em> = .07) or TACE (HR, 1.91; <em>P</em> = .006).</li> <li>In a subgroup survival analysis of patients with Child-Pugh class B cirrhosis, liver resection provided significantly better overall survival than TACE (HR, 2.79; <em>P</em> = .001) and higher overall survival than ablation (HR, 1.44; <em>P</em> = .21), but these findings were not statistically significant.</li> </ul> <h2>IN PRACTICE:</h2> <p>“The main result of the current study is the indisputable superiority” of liver resection over percutaneous radiofrequency ablation and TACE in patients with multinodular HCC, the researchers concluded. “For patients with early multinodular HCC who are ineligible for transplant, LR [liver resection] should be prioritized as the primary therapeutic option,” followed by percutaneous radiofrequency ablation and TACE, when resection is not feasible.</p> <p>The authors of an invited commentary said the analysis provides “convincing” data that liver resection leads to superior 3- and 5-year survival. “All of our local therapies are getting better. Making each available under different clinical circumstances and combining these when appropriate provides patients with the best chance at cure with the least invasiveness,” the editorialists added.<br/><br/></p> <h2>SOURCE:</h2> <p>The <a href="https://jamanetwork.com/journals/jamasurgery/article-abstract/2818741">study</a>, with first author Alessandro Vitale, MD, PhD, with the Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padua, Italy, and the <a href="https://jamanetwork.com/journals/jamasurgery/article-abstract/2818744">accompanying commentary</a> were published online last month in <em>JAMA Surgery</em>.</p> <h2>LIMITATIONS:</h2> <p>Selection bias cannot be ruled out due to potential hidden variables that were not collected in the centers’ databases. Not all patients included in the study were potentially treatable with all three proposed approaches. The study population was derived from Italian centers, which may have limited the generalizability of the results.</p> <h2>DISCLOSURES:</h2> <p>The study reported no specific funding. The authors reported various disclosures during the conduct of the study, including ties to AstraZeneca, AbbVie, Bayer, MSD, Roche, and Eisai. An editorialist reported ties to Medtronic, Theromics, Vergent Bioscience, Imugene, Sovato Health, XDemics, and Imugene.</p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/liver-resection-beats-out-alternatives-early-multinodular-2024a1000bkf">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Six Distinct Subtypes of Depression, Anxiety Identified via Brain Imaging

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Mon, 06/24/2024 - 12:41

Brain imaging combined with artificial intelligence has identified six distinct “biotypes” of depression and anxiety that may lead to more personalized and effective treatment.

This research has “immediate clinical implications,” study investigator Leanne Williams, PhD, director of the Stanford Medicine Center for Precision Mental Health and Wellness, told this news organization.

“At Stanford, we have started translating the imaging technology into use in a new precision mental health clinic. The technology is being actively developed for wider use in clinical settings, and we hope to make it accessible to more clinicians and patients,” Dr. Williams said.

The study was published online in Nature Medicine.

 

No More Trial and Error?

Depression is a highly heterogeneous disease, with individual patients having different symptoms and treatment responses. About 30% of patients with major depression are resistant to treatment, and about half of patients with generalized anxiety disorder do not respond to first-line treatment.

“The dominant ‘one-size-fits-all’ diagnostic approach in psychiatry leads to cycling through treatment options by trial and error, which is lengthy, expensive, and frustrating, with 30%-40% of patients not achieving remission after trying one treatment,” the authors noted.

“The goal of our work is figuring out how we can get it right the first time,” Dr. Williams said in a news release, and that requires a better understanding of the neurobiology of depression.

To that end, 801 adults diagnosed with depression and anxiety underwent functional MRI to measure brain activity at rest and when engaged in tasks designed to test cognitive and emotional functioning.

Researchers probed six brain circuits previously associated with depression: the default mode circuit, salience circuit, attention circuit, negative affect circuit, positive affect circuit, and the cognitive control circuit.

Using a machine learning technique known as cluster analysis to group the patients’ brain images, they identified six clinically distinct biotypes of depression and anxiety defined by specific profiles of dysfunction within both task-free and task-evoked brain circuits.

“Importantly for clinical translation, these biotypes predict response to different pharmacological and behavioral interventions,” investigators wrote.

For example, patients with a biotype characterized by overactivity in cognitive regions of the brain experienced the best response to the antidepressant venlafaxine, compared with patients with other biotypes.

Patients with a different biotype, characterized by higher at-rest levels of activity in three regions associated with depression and problem-solving, responded better to behavioral therapy.

In addition, those with a third biotype, who had lower levels of activity at rest in the brain circuit that controls attention, were less apt to see improvement of their symptoms with behavioral therapy than those with other biotypes. The various biotypes also correlated with differences in symptoms and task performance.

For example, individuals with overactive cognitive regions of the brain had higher levels of anhedonia than those with other biotypes, and they also performed worse on tasks measuring executive function. Those with the biotype that responded best to behavioral therapy also made errors on executive function tasks but performed well on cognitive tasks.
 

A Work in Progress

The findings provide a deeper understanding of the neurobiological underpinnings of depression and anxiety and could lead to improved diagnostic accuracy and more tailored treatment approaches, the researchers noted.

Naming the biotypes is a work in progress, Dr. Williams said.

“We have thought a lot about the naming. In the Nature Medicine paper, we use a technical convention to name the biotypes based on which brain circuit problems define each of them,” she explained.

“For example, the first biotype is called DC+SC+AC+ because it is defined by connectivity increases [C+] on three resting circuits — default mode [D], salience [S], and frontoparietal attention [A]. We are working with collaborators to generate biotype names that could be convergent across findings and labs. In the near future, we anticipate generating more descriptive medical names that clinicians could refer to alongside the technical names,” Dr. Williams said.

Commenting on the research for this news organization, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Research and Treatment at the Icahn School of Medicine at Mount Sinai, New York, called it “super exciting.”

“The work from this research group is an excellent example of where precision psychiatry research is right now, particularly with regard to the use of brain imaging to personalize treatment, and this paper gives us a glimpse of where we could be in the not-too-distant future,” Dr. Murrough said.

However, he cautioned that at this point, “we’re far from realizing the dream of precision psychiatry. We just don’t have robust evidence that brain imaging markers can really guide clinical decision-making currently.”

Funding for the study was provided by the National Institutes of Health and by Brain Resource Ltd. Dr. Williams declared US patent applications numbered 10/034,645 and 15/820,338: “Systems and methods for detecting complex networks in MRI data.” Dr. Murrough had no relevant disclosures.

A version of this article appeared on Medscape.com.

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Brain imaging combined with artificial intelligence has identified six distinct “biotypes” of depression and anxiety that may lead to more personalized and effective treatment.

This research has “immediate clinical implications,” study investigator Leanne Williams, PhD, director of the Stanford Medicine Center for Precision Mental Health and Wellness, told this news organization.

“At Stanford, we have started translating the imaging technology into use in a new precision mental health clinic. The technology is being actively developed for wider use in clinical settings, and we hope to make it accessible to more clinicians and patients,” Dr. Williams said.

The study was published online in Nature Medicine.

 

No More Trial and Error?

Depression is a highly heterogeneous disease, with individual patients having different symptoms and treatment responses. About 30% of patients with major depression are resistant to treatment, and about half of patients with generalized anxiety disorder do not respond to first-line treatment.

“The dominant ‘one-size-fits-all’ diagnostic approach in psychiatry leads to cycling through treatment options by trial and error, which is lengthy, expensive, and frustrating, with 30%-40% of patients not achieving remission after trying one treatment,” the authors noted.

“The goal of our work is figuring out how we can get it right the first time,” Dr. Williams said in a news release, and that requires a better understanding of the neurobiology of depression.

To that end, 801 adults diagnosed with depression and anxiety underwent functional MRI to measure brain activity at rest and when engaged in tasks designed to test cognitive and emotional functioning.

Researchers probed six brain circuits previously associated with depression: the default mode circuit, salience circuit, attention circuit, negative affect circuit, positive affect circuit, and the cognitive control circuit.

Using a machine learning technique known as cluster analysis to group the patients’ brain images, they identified six clinically distinct biotypes of depression and anxiety defined by specific profiles of dysfunction within both task-free and task-evoked brain circuits.

“Importantly for clinical translation, these biotypes predict response to different pharmacological and behavioral interventions,” investigators wrote.

For example, patients with a biotype characterized by overactivity in cognitive regions of the brain experienced the best response to the antidepressant venlafaxine, compared with patients with other biotypes.

Patients with a different biotype, characterized by higher at-rest levels of activity in three regions associated with depression and problem-solving, responded better to behavioral therapy.

In addition, those with a third biotype, who had lower levels of activity at rest in the brain circuit that controls attention, were less apt to see improvement of their symptoms with behavioral therapy than those with other biotypes. The various biotypes also correlated with differences in symptoms and task performance.

For example, individuals with overactive cognitive regions of the brain had higher levels of anhedonia than those with other biotypes, and they also performed worse on tasks measuring executive function. Those with the biotype that responded best to behavioral therapy also made errors on executive function tasks but performed well on cognitive tasks.
 

A Work in Progress

The findings provide a deeper understanding of the neurobiological underpinnings of depression and anxiety and could lead to improved diagnostic accuracy and more tailored treatment approaches, the researchers noted.

Naming the biotypes is a work in progress, Dr. Williams said.

“We have thought a lot about the naming. In the Nature Medicine paper, we use a technical convention to name the biotypes based on which brain circuit problems define each of them,” she explained.

“For example, the first biotype is called DC+SC+AC+ because it is defined by connectivity increases [C+] on three resting circuits — default mode [D], salience [S], and frontoparietal attention [A]. We are working with collaborators to generate biotype names that could be convergent across findings and labs. In the near future, we anticipate generating more descriptive medical names that clinicians could refer to alongside the technical names,” Dr. Williams said.

Commenting on the research for this news organization, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Research and Treatment at the Icahn School of Medicine at Mount Sinai, New York, called it “super exciting.”

“The work from this research group is an excellent example of where precision psychiatry research is right now, particularly with regard to the use of brain imaging to personalize treatment, and this paper gives us a glimpse of where we could be in the not-too-distant future,” Dr. Murrough said.

However, he cautioned that at this point, “we’re far from realizing the dream of precision psychiatry. We just don’t have robust evidence that brain imaging markers can really guide clinical decision-making currently.”

Funding for the study was provided by the National Institutes of Health and by Brain Resource Ltd. Dr. Williams declared US patent applications numbered 10/034,645 and 15/820,338: “Systems and methods for detecting complex networks in MRI data.” Dr. Murrough had no relevant disclosures.

A version of this article appeared on Medscape.com.

Brain imaging combined with artificial intelligence has identified six distinct “biotypes” of depression and anxiety that may lead to more personalized and effective treatment.

This research has “immediate clinical implications,” study investigator Leanne Williams, PhD, director of the Stanford Medicine Center for Precision Mental Health and Wellness, told this news organization.

“At Stanford, we have started translating the imaging technology into use in a new precision mental health clinic. The technology is being actively developed for wider use in clinical settings, and we hope to make it accessible to more clinicians and patients,” Dr. Williams said.

The study was published online in Nature Medicine.

 

No More Trial and Error?

Depression is a highly heterogeneous disease, with individual patients having different symptoms and treatment responses. About 30% of patients with major depression are resistant to treatment, and about half of patients with generalized anxiety disorder do not respond to first-line treatment.

“The dominant ‘one-size-fits-all’ diagnostic approach in psychiatry leads to cycling through treatment options by trial and error, which is lengthy, expensive, and frustrating, with 30%-40% of patients not achieving remission after trying one treatment,” the authors noted.

“The goal of our work is figuring out how we can get it right the first time,” Dr. Williams said in a news release, and that requires a better understanding of the neurobiology of depression.

To that end, 801 adults diagnosed with depression and anxiety underwent functional MRI to measure brain activity at rest and when engaged in tasks designed to test cognitive and emotional functioning.

Researchers probed six brain circuits previously associated with depression: the default mode circuit, salience circuit, attention circuit, negative affect circuit, positive affect circuit, and the cognitive control circuit.

Using a machine learning technique known as cluster analysis to group the patients’ brain images, they identified six clinically distinct biotypes of depression and anxiety defined by specific profiles of dysfunction within both task-free and task-evoked brain circuits.

“Importantly for clinical translation, these biotypes predict response to different pharmacological and behavioral interventions,” investigators wrote.

For example, patients with a biotype characterized by overactivity in cognitive regions of the brain experienced the best response to the antidepressant venlafaxine, compared with patients with other biotypes.

Patients with a different biotype, characterized by higher at-rest levels of activity in three regions associated with depression and problem-solving, responded better to behavioral therapy.

In addition, those with a third biotype, who had lower levels of activity at rest in the brain circuit that controls attention, were less apt to see improvement of their symptoms with behavioral therapy than those with other biotypes. The various biotypes also correlated with differences in symptoms and task performance.

For example, individuals with overactive cognitive regions of the brain had higher levels of anhedonia than those with other biotypes, and they also performed worse on tasks measuring executive function. Those with the biotype that responded best to behavioral therapy also made errors on executive function tasks but performed well on cognitive tasks.
 

A Work in Progress

The findings provide a deeper understanding of the neurobiological underpinnings of depression and anxiety and could lead to improved diagnostic accuracy and more tailored treatment approaches, the researchers noted.

Naming the biotypes is a work in progress, Dr. Williams said.

“We have thought a lot about the naming. In the Nature Medicine paper, we use a technical convention to name the biotypes based on which brain circuit problems define each of them,” she explained.

“For example, the first biotype is called DC+SC+AC+ because it is defined by connectivity increases [C+] on three resting circuits — default mode [D], salience [S], and frontoparietal attention [A]. We are working with collaborators to generate biotype names that could be convergent across findings and labs. In the near future, we anticipate generating more descriptive medical names that clinicians could refer to alongside the technical names,” Dr. Williams said.

Commenting on the research for this news organization, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Research and Treatment at the Icahn School of Medicine at Mount Sinai, New York, called it “super exciting.”

“The work from this research group is an excellent example of where precision psychiatry research is right now, particularly with regard to the use of brain imaging to personalize treatment, and this paper gives us a glimpse of where we could be in the not-too-distant future,” Dr. Murrough said.

However, he cautioned that at this point, “we’re far from realizing the dream of precision psychiatry. We just don’t have robust evidence that brain imaging markers can really guide clinical decision-making currently.”

Funding for the study was provided by the National Institutes of Health and by Brain Resource Ltd. Dr. Williams declared US patent applications numbered 10/034,645 and 15/820,338: “Systems and methods for detecting complex networks in MRI data.” Dr. Murrough had no relevant disclosures.

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Brain imaging combined with artificial intelligence has identified six distinct “biotypes” of depression and anxiety that may lead to more personalized and effe</metaDescription> <articlePDF/> <teaserImage/> <teaser>“Importantly for clinical translation, these biotypes predict response to different pharmacological and behavioral interventions.”</teaser> <title>Six Distinct Subtypes of Depression, Anxiety Identified via Brain Imaging</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>cpn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">9</term> <term>15</term> <term>21</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term>184</term> <term canonical="true">61423</term> <term>248</term> <term>202</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Six Distinct Subtypes of Depression, Anxiety Identified via Brain Imaging</title> <deck/> </itemMeta> <itemContent> <p> <span class="tag metaDescription">Brain imaging combined with artificial intelligence has identified six distinct “biotypes” of depression and anxiety that may lead to more personalized and effective treatment.</span> </p> <p>This research has “immediate clinical implications,” study investigator Leanne Williams, PhD, director of the Stanford Medicine Center for Precision Mental Health and Wellness, told this news organization.<br/><br/>“At Stanford, we have started translating the imaging technology into use in a new precision mental health clinic. The technology is being actively developed for wider use in clinical settings, and we hope to make it accessible to more clinicians and patients,” Dr. Williams said.<br/><br/>The study was <span class="Hyperlink"><a href="https://www.nature.com/articles/s41591-024-03057-9">published online</a></span> in <em>Nature Medicine</em>.<br/><br/><br/><br/></p> <h2>No More Trial and Error?</h2> <p>Depression is a highly heterogeneous disease, with individual patients having different symptoms and treatment responses. About 30% of patients with major depression are resistant to treatment, and about half of patients with generalized anxiety disorder do not respond to first-line treatment.</p> <p>“The dominant ‘one-size-fits-all’ diagnostic approach in psychiatry leads to cycling through treatment options by trial and error, which is lengthy, expensive, and frustrating, with 30%-40% of patients not achieving remission after trying one treatment,” the authors noted.<br/><br/>“The goal of our work is figuring out how we can get it right the first time,” Dr. Williams said in a news release, and that requires a better understanding of the neurobiology of depression.<br/><br/>To that end, 801 adults diagnosed with depression and anxiety underwent functional MRI to measure brain activity at rest and when engaged in tasks designed to test cognitive and emotional functioning.<br/><br/>Researchers probed six brain circuits previously associated with depression: the default mode circuit, salience circuit, attention circuit, negative affect circuit, positive affect circuit, and the cognitive control circuit.<br/><br/>Using a machine learning technique known as cluster analysis to group the patients’ brain images, they identified six clinically distinct biotypes of depression and anxiety defined by specific profiles of dysfunction within both task-free and task-evoked brain circuits.<br/><br/>“Importantly for clinical translation, these biotypes predict response to different pharmacological and behavioral interventions,” investigators wrote.<br/><br/>For example, patients with a biotype characterized by overactivity in cognitive regions of the brain experienced the best response to the antidepressant venlafaxine, compared with patients with other biotypes.<br/><br/>Patients with a different biotype, characterized by higher at-rest levels of activity in three regions associated with depression and problem-solving, responded better to behavioral therapy.<br/><br/>In addition, those with a third biotype, who had lower levels of activity at rest in the brain circuit that controls attention, were less apt to see improvement of their symptoms with behavioral therapy than those with other biotypes. The various biotypes also correlated with differences in symptoms and task performance.<br/><br/>For example, individuals with overactive cognitive regions of the brain had higher levels of anhedonia than those with other biotypes, and they also performed worse on tasks measuring executive function. Those with the biotype that responded best to behavioral therapy also made errors on executive function tasks but performed well on cognitive tasks.<br/><br/></p> <h2>A Work in Progress</h2> <p>The findings provide a deeper understanding of the neurobiological underpinnings of depression and anxiety and could lead to improved diagnostic accuracy and more tailored treatment approaches, the researchers noted.</p> <p>Naming the biotypes is a work in progress, Dr. Williams said.<br/><br/>“We have thought a lot about the naming. In the <em>Nature Medicine</em> paper, we use a technical convention to name the biotypes based on which brain circuit problems define each of them,” she explained.<br/><br/>“For example, the first biotype is called DC+SC+AC+ because it is defined by connectivity increases [C+] on three resting circuits — default mode [D], salience [S], and frontoparietal attention [A]. We are working with collaborators to generate biotype names that could be convergent across findings and labs. In the near future, we anticipate generating more descriptive medical names that clinicians could refer to alongside the technical names,” Dr. Williams said.<br/><br/>Commenting on the research for this news organization, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Research and Treatment at the Icahn School of Medicine at Mount Sinai, New York, called it “super exciting.”<br/><br/>“The work from this research group is an excellent example of where precision psychiatry research is right now, particularly with regard to the use of brain imaging to personalize treatment, and this paper gives us a glimpse of where we could be in the not-too-distant future,” Dr. Murrough said.<br/><br/>However, he cautioned that at this point, “we’re far from realizing the dream of precision psychiatry. We just don’t have robust evidence that brain imaging markers can really guide clinical decision-making currently.”<br/><br/>Funding for the study was provided by the National Institutes of Health and by Brain Resource Ltd. Dr. Williams declared US patent applications numbered 10/034,645 and 15/820,338: “Systems and methods for detecting complex networks in MRI data.” Dr. Murrough had no relevant disclosures.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/six-distinct-subtypes-depression-anxiety-identified-brain-2024a1000bmi">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Bariatric Surgery Beats GLP-1 RAs in Reducing Mortality Risk

Article Type
Changed
Fri, 06/21/2024 - 11:05

 

TOPLINE:

Bariatric metabolic surgery (BMS) offers a survival advantage over glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in adults with obesity and diabetes for 10 years or less, which may be explained by greater weight loss with surgery, new research shows.

METHODOLOGY:

  • There is limited evidence regarding the relative effectiveness of BMS and GLP-1 RAs in reducing mortality and major adverse cardiovascular events (MACE).
  • This observational, retrospective cohort study analyzed the electronic medical records of Clalit Health Services, Israel’s largest healthcare organization.
  • Researchers included patients aged 24 years or older who had diabetes and obesity but no prior cardiovascular disease and who either underwent BMS or received a GLP-1 RA.
  • The primary outcome was all-cause mortality, assessed by multivariate Cox proportional hazards regression models. The secondary outcome was nonfatal MACE, assessed by multivariate competing risk models.

TAKEAWAY:

  • Researchers included 3035 matched pairs of patients (total, 6070; mean age, 51 years; 65% women), who were followed for a median of 6.8 years.
  • Among patients with diabetes for 10 years or less, those who underwent BMS had a 62% lower risk for mortality than those treated with a GLP-1 RA (hazard ratio [HR], 0.38).
  • The survival advantage associated with BMS vs GLP-1 RA may be explained by the greater relative decrease in body mass index in the surgery group (–31.4% vs –12.8%, respectively).
  • Among patients with diabetes for more than 10 years, no survival advantage was observed for BMS over GLP-1 RA (HR, 0.65), which may be explained by the adverse effects of prolonged diabetes duration masking the benefit associated with weight loss.
  • The risk for nonfatal MACE did not differ significantly between the treatment groups in both diabetes duration categories.

IN PRACTICE:

“This study suggests that BMS was associated with greater reduced mortality compared with GLP-1 RAs among individuals with a diabetes duration of 10 years or less, mediated via greater weight loss,” the authors wrote.

SOURCE:

The study, with first author Dror Dicker, MD, Hasharon Hospital, Rabin Medical Center, Petah Tikva, Israel, was published online in JAMA Network Open.

LIMITATIONS:

The observational design may have introduced residual confounding despite matching and multivariable adjustment. The analyses did not account for the types of BMS or GLP-1 RAs or the level of adherence to GLP-1 RA treatment. Information regarding cause of death was unavailable.

DISCLOSURES:

The study was funded by the Israel Science Foundation. Dicker reported financial relationships with Novo Nordisk, Eli Lilly, and Boehringer Ingelheim.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Bariatric metabolic surgery (BMS) offers a survival advantage over glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in adults with obesity and diabetes for 10 years or less, which may be explained by greater weight loss with surgery, new research shows.

METHODOLOGY:

  • There is limited evidence regarding the relative effectiveness of BMS and GLP-1 RAs in reducing mortality and major adverse cardiovascular events (MACE).
  • This observational, retrospective cohort study analyzed the electronic medical records of Clalit Health Services, Israel’s largest healthcare organization.
  • Researchers included patients aged 24 years or older who had diabetes and obesity but no prior cardiovascular disease and who either underwent BMS or received a GLP-1 RA.
  • The primary outcome was all-cause mortality, assessed by multivariate Cox proportional hazards regression models. The secondary outcome was nonfatal MACE, assessed by multivariate competing risk models.

TAKEAWAY:

  • Researchers included 3035 matched pairs of patients (total, 6070; mean age, 51 years; 65% women), who were followed for a median of 6.8 years.
  • Among patients with diabetes for 10 years or less, those who underwent BMS had a 62% lower risk for mortality than those treated with a GLP-1 RA (hazard ratio [HR], 0.38).
  • The survival advantage associated with BMS vs GLP-1 RA may be explained by the greater relative decrease in body mass index in the surgery group (–31.4% vs –12.8%, respectively).
  • Among patients with diabetes for more than 10 years, no survival advantage was observed for BMS over GLP-1 RA (HR, 0.65), which may be explained by the adverse effects of prolonged diabetes duration masking the benefit associated with weight loss.
  • The risk for nonfatal MACE did not differ significantly between the treatment groups in both diabetes duration categories.

IN PRACTICE:

“This study suggests that BMS was associated with greater reduced mortality compared with GLP-1 RAs among individuals with a diabetes duration of 10 years or less, mediated via greater weight loss,” the authors wrote.

SOURCE:

The study, with first author Dror Dicker, MD, Hasharon Hospital, Rabin Medical Center, Petah Tikva, Israel, was published online in JAMA Network Open.

LIMITATIONS:

The observational design may have introduced residual confounding despite matching and multivariable adjustment. The analyses did not account for the types of BMS or GLP-1 RAs or the level of adherence to GLP-1 RA treatment. Information regarding cause of death was unavailable.

DISCLOSURES:

The study was funded by the Israel Science Foundation. Dicker reported financial relationships with Novo Nordisk, Eli Lilly, and Boehringer Ingelheim.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Bariatric metabolic surgery (BMS) offers a survival advantage over glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in adults with obesity and diabetes for 10 years or less, which may be explained by greater weight loss with surgery, new research shows.

METHODOLOGY:

  • There is limited evidence regarding the relative effectiveness of BMS and GLP-1 RAs in reducing mortality and major adverse cardiovascular events (MACE).
  • This observational, retrospective cohort study analyzed the electronic medical records of Clalit Health Services, Israel’s largest healthcare organization.
  • Researchers included patients aged 24 years or older who had diabetes and obesity but no prior cardiovascular disease and who either underwent BMS or received a GLP-1 RA.
  • The primary outcome was all-cause mortality, assessed by multivariate Cox proportional hazards regression models. The secondary outcome was nonfatal MACE, assessed by multivariate competing risk models.

TAKEAWAY:

  • Researchers included 3035 matched pairs of patients (total, 6070; mean age, 51 years; 65% women), who were followed for a median of 6.8 years.
  • Among patients with diabetes for 10 years or less, those who underwent BMS had a 62% lower risk for mortality than those treated with a GLP-1 RA (hazard ratio [HR], 0.38).
  • The survival advantage associated with BMS vs GLP-1 RA may be explained by the greater relative decrease in body mass index in the surgery group (–31.4% vs –12.8%, respectively).
  • Among patients with diabetes for more than 10 years, no survival advantage was observed for BMS over GLP-1 RA (HR, 0.65), which may be explained by the adverse effects of prolonged diabetes duration masking the benefit associated with weight loss.
  • The risk for nonfatal MACE did not differ significantly between the treatment groups in both diabetes duration categories.

IN PRACTICE:

“This study suggests that BMS was associated with greater reduced mortality compared with GLP-1 RAs among individuals with a diabetes duration of 10 years or less, mediated via greater weight loss,” the authors wrote.

SOURCE:

The study, with first author Dror Dicker, MD, Hasharon Hospital, Rabin Medical Center, Petah Tikva, Israel, was published online in JAMA Network Open.

LIMITATIONS:

The observational design may have introduced residual confounding despite matching and multivariable adjustment. The analyses did not account for the types of BMS or GLP-1 RAs or the level of adherence to GLP-1 RA treatment. Information regarding cause of death was unavailable.

DISCLOSURES:

The study was funded by the Israel Science Foundation. Dicker reported financial relationships with Novo Nordisk, Eli Lilly, and Boehringer Ingelheim.

A version of this article first appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Bariatric metabolic surgery (BMS) offers a survival advantage over glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in adults with obesity and diabetes for</metaDescription> <articlePDF/> <teaserImage/> <teaser>The reason may be greater weight loss with surgery.</teaser> <title>Bariatric Surgery Beats GLP-1 RAs in Reducing Mortality Risk</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>card</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>endo</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term>5</term> <term canonical="true">34</term> <term>15</term> <term>21</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term>205</term> <term canonical="true">261</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Bariatric Surgery Beats GLP-1 RAs in Reducing Mortality Risk</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p>Bariatric metabolic surgery (BMS) offers a survival advantage over glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in adults with obesity and diabetes for 10 years or less, which may be explained by greater weight loss with surgery, new research shows.</p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>There is limited evidence regarding the relative effectiveness of BMS and GLP-1 RAs in reducing mortality and major adverse cardiovascular events (MACE).</li> <li>This observational, retrospective cohort study analyzed the electronic medical records of Clalit Health Services, Israel’s largest healthcare organization.</li> <li>Researchers included patients aged 24 years or older who had diabetes and obesity but no prior cardiovascular disease and who either underwent BMS or received a GLP-1 RA.</li> <li>The primary outcome was all-cause mortality, assessed by multivariate Cox proportional hazards regression models. The secondary outcome was nonfatal MACE, assessed by multivariate competing risk models.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>Researchers included 3035 matched pairs of patients (total, 6070; mean age, 51 years; 65% women), who were followed for a median of 6.8 years.</li> <li>Among patients with diabetes for 10 years or less, those who underwent BMS had a 62% lower risk for mortality than those treated with a GLP-1 RA (hazard ratio [HR], 0.38).</li> <li>The survival advantage associated with BMS vs GLP-1 RA may be explained by the greater relative decrease in body mass index in the surgery group (–31.4% vs –12.8%, respectively).</li> <li>Among patients with diabetes for more than 10 years, no survival advantage was observed for BMS over GLP-1 RA (HR, 0.65), which may be explained by the adverse effects of prolonged diabetes duration masking the benefit associated with weight loss.</li> <li>The risk for nonfatal MACE did not differ significantly between the treatment groups in both diabetes duration categories.</li> </ul> <h2>IN PRACTICE:</h2> <p>“This study suggests that BMS was associated with greater reduced mortality compared with GLP-1 RAs among individuals with a diabetes duration of 10 years or less, mediated via greater weight loss,” the authors wrote.</p> <h2>SOURCE:</h2> <p>The study, with first author Dror Dicker, MD, Hasharon Hospital, Rabin Medical Center, Petah Tikva, Israel, was <a href="https://doi.org/10.1001/jamanetworkopen.2024.15392">published online</a> in <em>JAMA Network Open</em>.</p> <h2>LIMITATIONS:</h2> <p>The observational design may have introduced residual confounding despite matching and multivariable adjustment. The analyses did not account for the types of BMS or GLP-1 RAs or the level of adherence to GLP-1 RA treatment. Information regarding cause of death was unavailable.</p> <h2>DISCLOSURES:</h2> <p>The study was funded by the Israel Science Foundation. Dicker reported financial relationships with Novo Nordisk, Eli Lilly, and Boehringer Ingelheim.<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/bariatric-surgery-beats-glp-1-ras-reducing-mortality-risk-2024a1000bdm">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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FDA Approves Skyrizi for Ulcerative Colitis

Article Type
Changed
Thu, 06/20/2024 - 16:47

The US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa; AbbVie) for the treatment of moderately to severely active ulcerative colitis in adults. This approval makes it the first specific anti-interleukin 23 monoclonal antibody indicated for both ulcerative colitis and moderate to severe Crohn’s disease. 

The drug is also approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

The safety and efficacy of Skyrizi for ulcerative colitis is supported by data from two phase 3 clinical trials: a 12-week induction study (INSPIRE) and a 52-week maintenance study (COMMAND). 

The data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, which was a key secondary endpoint.

“When treating patients with ulcerative colitis, it’s important to prioritize both early and sustained clinical remission as well as endoscopic improvement,” Edward V. Loftus Jr., MD, AGAF, gastroenterologist at Mayo Clinic in Rochester, Minnesota, said in a news release. “This approval for Skyrizi is an important step toward addressing these treatment goals.”

For the treatment of ulcerative colitis, dosing includes a 12-week induction period with three 1200-mg doses delivered every 4 weeks followed by maintenance therapy of either 180 mg or 360 mg delivered every 8 weeks.

After the induction period, Skyrizi treatment can be maintained at home using an on-body injector (OBI). “The OBI is a hands-free device designed with patients in mind that adheres to the body and takes about 5 minutes to deliver the medication following preparation steps,” according to the news release. 

Full prescribing information is available online

A version of this article appeared on Medscape.com.

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The US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa; AbbVie) for the treatment of moderately to severely active ulcerative colitis in adults. This approval makes it the first specific anti-interleukin 23 monoclonal antibody indicated for both ulcerative colitis and moderate to severe Crohn’s disease. 

The drug is also approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

The safety and efficacy of Skyrizi for ulcerative colitis is supported by data from two phase 3 clinical trials: a 12-week induction study (INSPIRE) and a 52-week maintenance study (COMMAND). 

The data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, which was a key secondary endpoint.

“When treating patients with ulcerative colitis, it’s important to prioritize both early and sustained clinical remission as well as endoscopic improvement,” Edward V. Loftus Jr., MD, AGAF, gastroenterologist at Mayo Clinic in Rochester, Minnesota, said in a news release. “This approval for Skyrizi is an important step toward addressing these treatment goals.”

For the treatment of ulcerative colitis, dosing includes a 12-week induction period with three 1200-mg doses delivered every 4 weeks followed by maintenance therapy of either 180 mg or 360 mg delivered every 8 weeks.

After the induction period, Skyrizi treatment can be maintained at home using an on-body injector (OBI). “The OBI is a hands-free device designed with patients in mind that adheres to the body and takes about 5 minutes to deliver the medication following preparation steps,” according to the news release. 

Full prescribing information is available online

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa; AbbVie) for the treatment of moderately to severely active ulcerative colitis in adults. This approval makes it the first specific anti-interleukin 23 monoclonal antibody indicated for both ulcerative colitis and moderate to severe Crohn’s disease. 

The drug is also approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

The safety and efficacy of Skyrizi for ulcerative colitis is supported by data from two phase 3 clinical trials: a 12-week induction study (INSPIRE) and a 52-week maintenance study (COMMAND). 

The data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, which was a key secondary endpoint.

“When treating patients with ulcerative colitis, it’s important to prioritize both early and sustained clinical remission as well as endoscopic improvement,” Edward V. Loftus Jr., MD, AGAF, gastroenterologist at Mayo Clinic in Rochester, Minnesota, said in a news release. “This approval for Skyrizi is an important step toward addressing these treatment goals.”

For the treatment of ulcerative colitis, dosing includes a 12-week induction period with three 1200-mg doses delivered every 4 weeks followed by maintenance therapy of either 180 mg or 360 mg delivered every 8 weeks.

After the induction period, Skyrizi treatment can be maintained at home using an on-body injector (OBI). “The OBI is a hands-free device designed with patients in mind that adheres to the body and takes about 5 minutes to deliver the medication following preparation steps,” according to the news release. 

Full prescribing information is available online

A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168479</fileName> <TBEID>0C050A5A.SIG</TBEID> <TBUniqueIdentifier>MD_0C050A5A</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240620T152055</QCDate> <firstPublished>20240620T164328</firstPublished> <LastPublished>20240620T164328</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240620T164328</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Megan Brooks</byline> <bylineText>MEGAN BROOKS</bylineText> <bylineFull>MEGAN BROOKS</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa; AbbVie) for the treatment of moderately to severely active ulcerative colitis</metaDescription> <articlePDF/> <teaserImage/> <teaser>This approval makes risankizumab the first specific anti-interleukin 23 monoclonal antibody indicated for both ulcerative colitis and moderate to severe Crohn’s disease.</teaser> <title>FDA Approves Skyrizi for Ulcerative Colitis</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> <term>21</term> <term>15</term> </publications> <sections> <term canonical="true">27979</term> <term>39313</term> <term>37225</term> </sections> <topics> <term canonical="true">345</term> <term>213</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA Approves Skyrizi for Ulcerative Colitis</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">The US Food and Drug Administration (FDA) has approved Skyrizi (<span class="Hyperlink">risankizumab</span>-rzaa; AbbVie) for the treatment of moderately to severely active <span class="Hyperlink">ulcerative colitis</span> in adults.</span> This approval makes it the first specific anti-interleukin 23 monoclonal antibody indicated for both ulcerative colitis and moderate to severe Crohn’s disease. </p> <p>The drug is also approved in the United States for the treatment of adults with active <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/967072">psoriatic arthritis</a></span> and moderate to severe <span class="Hyperlink">plaque psoriasis</span>.<br/><br/>The safety and efficacy of Skyrizi for ulcerative colitis is supported by data from two phase 3 clinical trials: a 12-week induction study (INSPIRE) and a 52-week maintenance study (COMMAND). <br/><br/>The data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, which was a key secondary endpoint.<br/><br/>“When treating patients with ulcerative colitis, it’s important to prioritize both early and sustained clinical remission as well as endoscopic improvement,” Edward V. Loftus Jr., MD, AGAF, gastroenterologist at Mayo Clinic in Rochester, Minnesota, said in a <span class="Hyperlink"><a href="https://news.abbvie.com/2024-06-18-U-S-FDA-Approves-SKYRIZI-R-risankizumab-rzaa-for-Ulcerative-Colitis,-Expanding-AbbVies-Portfolio-Across-Inflammatory-Bowel-Disease">news release</a></span>. “This approval for Skyrizi is an important step toward addressing these treatment goals.”<br/><br/>For the treatment of ulcerative colitis, dosing includes a 12-week induction period with three 1200-mg doses delivered every 4 weeks followed by maintenance therapy of either 180 mg or 360 mg delivered every 8 weeks.<br/><br/>After the induction period, Skyrizi treatment can be maintained at home using an on-body injector (OBI). “The OBI is a hands-free device designed with patients in mind that adheres to the body and takes about 5 minutes to deliver the medication following preparation steps,” according to the news release. <br/><br/>Full prescribing information is <span class="Hyperlink"><a href="https://www.skyrizi.com/">available online</a></span>.<span class="end"/> </p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-risankizumab-ulcerative-colitis-2024a1000bf7?ecd=a2a">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Urgent Need for Better Care, New Policies to Lower Insomnia Burden

Article Type
Changed
Wed, 06/19/2024 - 13:45

HOUSTON — A new analysis highlights the high burden of insomnia across the Americas, with about 17% of adults suffering from this chronic sleep disorder.

“Our findings underscore the urgent need for enhanced clinical care pathways and policy interventions to effectively diagnose and treat insomnia. It is crucial to foster greater awareness of the critical role that sleep plays in overall health,” lead investigator Adam Benjafield, PhD, vice president for medical affairs at ResMed, Sydney, Australia, said in an interview.

“Insomnia not only affects individuals’ health and quality of life but also has broader implications for public health systems. Developing comprehensive care strategies and promoting education about sleep health could significantly improve outcomes for individuals suffering from insomnia disorder,” Dr. Benjafield said.

The findings were presented at SLEEP 2024: 38th Annual Meeting of the Associated Professional Sleep Societies.
 

Underdiagnosed, Undertreated

Sleep disruptions contribute to various medical problems, including cognitive impairment, reduced immune function, metabolic imbalance, and exacerbation of psychiatric conditions. While the prevalence of insomnia in developed countries like the United States and Canada is known, there is limited epidemiologic evidence, and no reliable estimate for the disorder across the Americas — especially in low- and middle-income countries.

The researchers used published nation-specific data to estimate the prevalence of adult insomnia disorder across the 55 countries defined by the United Nations as comprising the Americas.

Based on the available data, the researchers estimated that about 123 million adults across the Americas have insomnia disorder (16.8%) — with greater prevalence in women (73 million, 19.5%) than in men (50 million, 14%).

The nations with the greatest burden of insomnia disorder are the United States (37 million), Brazil (29 million), and Mexico (16 million).

“While our study did not specifically investigate trends over time due to its scope, evidence from other research suggests that insomnia is becoming more prevalent over the long term. This growing trend highlights the increasing need for awareness and intervention in managing sleep health,” Dr. Benjafield said.

Insomnia is underdiagnosed and undertreated partly because of general lack of awareness about the importance of addressing sleep disorders and the fact that cognitive-behavioral therapy for insomnia (CBT-I), which is recommended as first-line treatment, is not widely accessible because of a shortage of trained CBT-I practitioners.

“Many individuals with insomnia struggle to find and receive this effective nonpharmacological treatment. Consequently, there is an overreliance on pharmaceutical solutions, which are ideally used for short-term management but are often extended due to the lack of alternatives. These medications can lead to dependency and other side effects,” Dr. Benjafield said.
 

Ask About Sleep

Insomnia symptoms are a “common presenting complaint in doctors’ offices in the United States. The percentages in this poster show that insomnia disorder has a similar, high percent prevalence across countries in the Americas,” Boris Gilyadov, MD, assistant professor of pulmonary, critical care, and sleep medicine at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview.

“During preventive care visits and general physical exams, patients should be asked about the quality of their sleep. Patients may benefit from a referral to the sleep medicine clinic when appropriate,” said Dr. Gilyadov, who wasn’t involved in the study.

“CBT-I is the first-line treatment for chronic insomnia disorder and can be an effective treatment for most patients. An alternative to CBT-I, when it is not available, is digital CBT-I,” Dr. Gilyadov said.

“There are also behavioral therapies called BBT-I [brief behavioral treatment for insomnia] and ACT [acceptance and commitment therapy]. These are therapies that may be offered by psychologists who specialize in the treatment of chronic insomnia disorder,” Dr. Gilyadov noted.

The study was conducted in collaboration with medXcloud and funded by ResMed. Dr. Benjafield is an employee of ResMed. Dr. Gilyadov had no relevant disclosures.

A version of this article first appeared on Medscape.com.

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HOUSTON — A new analysis highlights the high burden of insomnia across the Americas, with about 17% of adults suffering from this chronic sleep disorder.

“Our findings underscore the urgent need for enhanced clinical care pathways and policy interventions to effectively diagnose and treat insomnia. It is crucial to foster greater awareness of the critical role that sleep plays in overall health,” lead investigator Adam Benjafield, PhD, vice president for medical affairs at ResMed, Sydney, Australia, said in an interview.

“Insomnia not only affects individuals’ health and quality of life but also has broader implications for public health systems. Developing comprehensive care strategies and promoting education about sleep health could significantly improve outcomes for individuals suffering from insomnia disorder,” Dr. Benjafield said.

The findings were presented at SLEEP 2024: 38th Annual Meeting of the Associated Professional Sleep Societies.
 

Underdiagnosed, Undertreated

Sleep disruptions contribute to various medical problems, including cognitive impairment, reduced immune function, metabolic imbalance, and exacerbation of psychiatric conditions. While the prevalence of insomnia in developed countries like the United States and Canada is known, there is limited epidemiologic evidence, and no reliable estimate for the disorder across the Americas — especially in low- and middle-income countries.

The researchers used published nation-specific data to estimate the prevalence of adult insomnia disorder across the 55 countries defined by the United Nations as comprising the Americas.

Based on the available data, the researchers estimated that about 123 million adults across the Americas have insomnia disorder (16.8%) — with greater prevalence in women (73 million, 19.5%) than in men (50 million, 14%).

The nations with the greatest burden of insomnia disorder are the United States (37 million), Brazil (29 million), and Mexico (16 million).

“While our study did not specifically investigate trends over time due to its scope, evidence from other research suggests that insomnia is becoming more prevalent over the long term. This growing trend highlights the increasing need for awareness and intervention in managing sleep health,” Dr. Benjafield said.

Insomnia is underdiagnosed and undertreated partly because of general lack of awareness about the importance of addressing sleep disorders and the fact that cognitive-behavioral therapy for insomnia (CBT-I), which is recommended as first-line treatment, is not widely accessible because of a shortage of trained CBT-I practitioners.

“Many individuals with insomnia struggle to find and receive this effective nonpharmacological treatment. Consequently, there is an overreliance on pharmaceutical solutions, which are ideally used for short-term management but are often extended due to the lack of alternatives. These medications can lead to dependency and other side effects,” Dr. Benjafield said.
 

Ask About Sleep

Insomnia symptoms are a “common presenting complaint in doctors’ offices in the United States. The percentages in this poster show that insomnia disorder has a similar, high percent prevalence across countries in the Americas,” Boris Gilyadov, MD, assistant professor of pulmonary, critical care, and sleep medicine at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview.

“During preventive care visits and general physical exams, patients should be asked about the quality of their sleep. Patients may benefit from a referral to the sleep medicine clinic when appropriate,” said Dr. Gilyadov, who wasn’t involved in the study.

“CBT-I is the first-line treatment for chronic insomnia disorder and can be an effective treatment for most patients. An alternative to CBT-I, when it is not available, is digital CBT-I,” Dr. Gilyadov said.

“There are also behavioral therapies called BBT-I [brief behavioral treatment for insomnia] and ACT [acceptance and commitment therapy]. These are therapies that may be offered by psychologists who specialize in the treatment of chronic insomnia disorder,” Dr. Gilyadov noted.

The study was conducted in collaboration with medXcloud and funded by ResMed. Dr. Benjafield is an employee of ResMed. Dr. Gilyadov had no relevant disclosures.

A version of this article first appeared on Medscape.com.

HOUSTON — A new analysis highlights the high burden of insomnia across the Americas, with about 17% of adults suffering from this chronic sleep disorder.

“Our findings underscore the urgent need for enhanced clinical care pathways and policy interventions to effectively diagnose and treat insomnia. It is crucial to foster greater awareness of the critical role that sleep plays in overall health,” lead investigator Adam Benjafield, PhD, vice president for medical affairs at ResMed, Sydney, Australia, said in an interview.

“Insomnia not only affects individuals’ health and quality of life but also has broader implications for public health systems. Developing comprehensive care strategies and promoting education about sleep health could significantly improve outcomes for individuals suffering from insomnia disorder,” Dr. Benjafield said.

The findings were presented at SLEEP 2024: 38th Annual Meeting of the Associated Professional Sleep Societies.
 

Underdiagnosed, Undertreated

Sleep disruptions contribute to various medical problems, including cognitive impairment, reduced immune function, metabolic imbalance, and exacerbation of psychiatric conditions. While the prevalence of insomnia in developed countries like the United States and Canada is known, there is limited epidemiologic evidence, and no reliable estimate for the disorder across the Americas — especially in low- and middle-income countries.

The researchers used published nation-specific data to estimate the prevalence of adult insomnia disorder across the 55 countries defined by the United Nations as comprising the Americas.

Based on the available data, the researchers estimated that about 123 million adults across the Americas have insomnia disorder (16.8%) — with greater prevalence in women (73 million, 19.5%) than in men (50 million, 14%).

The nations with the greatest burden of insomnia disorder are the United States (37 million), Brazil (29 million), and Mexico (16 million).

“While our study did not specifically investigate trends over time due to its scope, evidence from other research suggests that insomnia is becoming more prevalent over the long term. This growing trend highlights the increasing need for awareness and intervention in managing sleep health,” Dr. Benjafield said.

Insomnia is underdiagnosed and undertreated partly because of general lack of awareness about the importance of addressing sleep disorders and the fact that cognitive-behavioral therapy for insomnia (CBT-I), which is recommended as first-line treatment, is not widely accessible because of a shortage of trained CBT-I practitioners.

“Many individuals with insomnia struggle to find and receive this effective nonpharmacological treatment. Consequently, there is an overreliance on pharmaceutical solutions, which are ideally used for short-term management but are often extended due to the lack of alternatives. These medications can lead to dependency and other side effects,” Dr. Benjafield said.
 

Ask About Sleep

Insomnia symptoms are a “common presenting complaint in doctors’ offices in the United States. The percentages in this poster show that insomnia disorder has a similar, high percent prevalence across countries in the Americas,” Boris Gilyadov, MD, assistant professor of pulmonary, critical care, and sleep medicine at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview.

“During preventive care visits and general physical exams, patients should be asked about the quality of their sleep. Patients may benefit from a referral to the sleep medicine clinic when appropriate,” said Dr. Gilyadov, who wasn’t involved in the study.

“CBT-I is the first-line treatment for chronic insomnia disorder and can be an effective treatment for most patients. An alternative to CBT-I, when it is not available, is digital CBT-I,” Dr. Gilyadov said.

“There are also behavioral therapies called BBT-I [brief behavioral treatment for insomnia] and ACT [acceptance and commitment therapy]. These are therapies that may be offered by psychologists who specialize in the treatment of chronic insomnia disorder,” Dr. Gilyadov noted.

The study was conducted in collaboration with medXcloud and funded by ResMed. Dr. Benjafield is an employee of ResMed. Dr. Gilyadov had no relevant disclosures.

A version of this article first appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168463</fileName> <TBEID>0C050A13.SIG</TBEID> <TBUniqueIdentifier>MD_0C050A13</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240619T115558</QCDate> <firstPublished>20240619T134240</firstPublished> <LastPublished>20240619T134240</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240619T134240</CMSDate> <articleSource>FROM SLEEP 2024</articleSource> <facebookInfo/> <meetingNumber/> <byline>Megan Brooks</byline> <bylineText>MEGAN BROOKS</bylineText> <bylineFull>MEGAN BROOKS</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>HOUSTON — A new analysis highlights the high burden of insomnia across the Americas, with about 17% of adults suffering from this chronic sleep disorder.</metaDescription> <articlePDF/> <teaserImage/> <teaser>Sleep disruptions contribute to various medical problems, including cognitive impairment, reduced immune function, metabolic imbalance, and exacerbation of psychiatric conditions.</teaser> <title>Urgent Need for Better Care, New Policies to Lower Insomnia Burden</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">6</term> <term>15</term> <term>21</term> </publications> <sections> <term>53</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">296</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Urgent Need for Better Care, New Policies to Lower Insomnia Burden</title> <deck/> </itemMeta> <itemContent> <p>HOUSTON — A new analysis highlights the high burden of insomnia across the Americas, with about 17% of adults suffering from this chronic sleep disorder.</p> <p>“Our findings underscore the urgent need for enhanced clinical care pathways and policy interventions to effectively diagnose and treat insomnia. It is crucial to foster greater awareness of the critical role that sleep plays in overall health,” lead investigator Adam Benjafield, PhD, vice president for medical affairs at ResMed, Sydney, Australia, said in an interview.<br/><br/>“Insomnia not only affects individuals’ health and quality of life but also has broader implications for public health systems. Developing comprehensive care strategies and promoting education about sleep health could significantly improve outcomes for individuals suffering from insomnia disorder,” Dr. Benjafield said.<br/><br/>The findings were presented at <a href="https://www.medscape.com/viewcollection/37551">SLEEP 2024: 38th Annual Meeting of the Associated Professional Sleep Societies</a>.<br/><br/></p> <h2>Underdiagnosed, Undertreated</h2> <p>Sleep disruptions contribute to various medical problems, including cognitive impairment, reduced immune function, metabolic imbalance, and exacerbation of psychiatric conditions. While the prevalence of insomnia in developed countries like the United States and Canada is known, there is limited epidemiologic evidence, and no reliable estimate for the disorder across the Americas — especially in low- and middle-income countries.</p> <p>The researchers used published nation-specific data to estimate the prevalence of adult insomnia disorder across the 55 countries defined by the United Nations as comprising the Americas.<br/><br/>Based on the available data, the researchers estimated that about 123 million adults across the Americas have insomnia disorder (16.8%) — with greater prevalence in women (73 million, 19.5%) than in men (50 million, 14%).<br/><br/>The nations with the greatest burden of insomnia disorder are the United States (37 million), Brazil (29 million), and Mexico (16 million).<br/><br/>“While our study did not specifically investigate trends over time due to its scope, evidence from other research suggests that insomnia is becoming more prevalent over the long term. This growing trend highlights the increasing need for awareness and intervention in managing sleep health,” Dr. Benjafield said.<br/><br/>Insomnia is underdiagnosed and undertreated partly because of general lack of awareness about the importance of addressing sleep disorders and the fact that cognitive-behavioral therapy for insomnia (CBT-I), which is recommended as first-line treatment, is not widely accessible because of a shortage of trained CBT-I practitioners.<br/><br/>“Many individuals with insomnia struggle to find and receive this effective nonpharmacological treatment. Consequently, there is an overreliance on pharmaceutical solutions, which are ideally used for short-term management but are often extended due to the lack of alternatives. These medications can lead to dependency and other side effects,” Dr. Benjafield said.<br/><br/></p> <h2>Ask About Sleep</h2> <p>Insomnia symptoms are a “common presenting complaint in doctors’ offices in the United States. The percentages in this poster show that insomnia disorder has a similar, high percent prevalence across countries in the Americas,” Boris Gilyadov, MD, assistant professor of pulmonary, critical care, and sleep medicine at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview.</p> <p>“During preventive care visits and general physical exams, patients should be asked about the quality of their sleep. Patients may benefit from a referral to the sleep medicine clinic when appropriate,” said Dr. Gilyadov, who wasn’t involved in the study.<br/><br/>“CBT-I is the first-line treatment for chronic insomnia disorder and can be an effective treatment for most patients. An alternative to CBT-I, when it is not available, is digital CBT-I,” Dr. Gilyadov said.<br/><br/>“There are also behavioral therapies called BBT-I [brief behavioral treatment for insomnia] and ACT [acceptance and commitment therapy]. These are therapies that may be offered by psychologists who specialize in the treatment of chronic insomnia disorder,” Dr. Gilyadov noted.<br/><br/>The study was conducted in collaboration with medXcloud and funded by ResMed. Dr. Benjafield is an employee of ResMed. Dr. Gilyadov had no relevant disclosures.<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/urgent-need-better-care-new-policies-lower-insomnia-burden-2024a1000bbm">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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ChatGPT Enhances Readability of Cancer Information for Patients

Article Type
Changed
Tue, 06/18/2024 - 16:22

 

TOPLINE:

The artificial intelligence (AI) chatbot ChatGPT can significantly improve the readability of online cancer-related patient information while maintaining the content’s quality, a recent study found.

METHODOLOGY:

  • Patients with cancer often search for cancer information online after their diagnosis, with most seeking information from their oncologists’ websites. However, the online materials often exceed the average reading level of the US population, limiting accessibility and comprehension.
  • Researchers asked ChatGPT 4.0 to rewrite content about breast, colon, lung, prostate, and pancreas cancer, aiming for a sixth-grade readability level. The content came from a random sample of documents from 34 patient-facing websites associated with National Comprehensive Cancer Network (NCCN) member institutions.
  • Readability, accuracy, similarity, and quality of the rewritten content were assessed using several established metrics and tools, including an F1 score, which assesses the precision and recall of a machine-learning model; a cosine similarity score, which measures similarities and is often used to detect plagiarism; and the DISCERN instrument, which helps assess the quality of the AI-rewritten information.
  • The primary outcome was the mean readability score for the original and AI-generated content.

TAKEAWAY:

  • The original content had an average readability level equivalent to a university freshman (grade 13). Following the AI revision, the readability level improved to a high school freshman level (grade 9).
  • The rewritten content had high accuracy, with an overall F1 score of 0.87 (a good score is 0.8-0.9).
  • The rewritten content had a high cosine similarity score of 0.915 (scores range from 0 to 1, with 0 indicating no similarity and 1 indicating complete similarity). Researchers attributed the improved readability to the use of simpler words and shorter sentences.
  • Quality assessment using the DISCERN instrument showed that the AI-rewritten content maintained a “good” quality rating, similar to that of the original content.

IN PRACTICE:

Society has become increasingly dependent on online educational materials, and considering that more than half of Americans may not be literate beyond an eighth-grade level, our AI intervention offers a potential low-cost solution to narrow the gap between patient health literacy and content received from the nation’s leading cancer centers, the authors wrote.

SOURCE:

The study, with first author Andres A. Abreu, MD, with UT Southwestern Medical Center, Dallas, Texas, was published online in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The study was limited to English-language content from NCCN member websites, so the findings may not be generalizable to other sources or languages. Readability alone cannot guarantee comprehension. Factors such as material design and audiovisual aids were not evaluated.

DISCLOSURES:

The study did not report a funding source. The authors reported several disclosures but none related to the study. Herbert J. Zeh disclosed serving as a scientific advisor for Surgical Safety Technologies; Dr. Polanco disclosed serving as a consultant for Iota Biosciences and Palisade Bio and as a proctor for Intuitive Surgical.

A version of this article first appeared on Medscape.com.

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TOPLINE:

The artificial intelligence (AI) chatbot ChatGPT can significantly improve the readability of online cancer-related patient information while maintaining the content’s quality, a recent study found.

METHODOLOGY:

  • Patients with cancer often search for cancer information online after their diagnosis, with most seeking information from their oncologists’ websites. However, the online materials often exceed the average reading level of the US population, limiting accessibility and comprehension.
  • Researchers asked ChatGPT 4.0 to rewrite content about breast, colon, lung, prostate, and pancreas cancer, aiming for a sixth-grade readability level. The content came from a random sample of documents from 34 patient-facing websites associated with National Comprehensive Cancer Network (NCCN) member institutions.
  • Readability, accuracy, similarity, and quality of the rewritten content were assessed using several established metrics and tools, including an F1 score, which assesses the precision and recall of a machine-learning model; a cosine similarity score, which measures similarities and is often used to detect plagiarism; and the DISCERN instrument, which helps assess the quality of the AI-rewritten information.
  • The primary outcome was the mean readability score for the original and AI-generated content.

TAKEAWAY:

  • The original content had an average readability level equivalent to a university freshman (grade 13). Following the AI revision, the readability level improved to a high school freshman level (grade 9).
  • The rewritten content had high accuracy, with an overall F1 score of 0.87 (a good score is 0.8-0.9).
  • The rewritten content had a high cosine similarity score of 0.915 (scores range from 0 to 1, with 0 indicating no similarity and 1 indicating complete similarity). Researchers attributed the improved readability to the use of simpler words and shorter sentences.
  • Quality assessment using the DISCERN instrument showed that the AI-rewritten content maintained a “good” quality rating, similar to that of the original content.

IN PRACTICE:

Society has become increasingly dependent on online educational materials, and considering that more than half of Americans may not be literate beyond an eighth-grade level, our AI intervention offers a potential low-cost solution to narrow the gap between patient health literacy and content received from the nation’s leading cancer centers, the authors wrote.

SOURCE:

The study, with first author Andres A. Abreu, MD, with UT Southwestern Medical Center, Dallas, Texas, was published online in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The study was limited to English-language content from NCCN member websites, so the findings may not be generalizable to other sources or languages. Readability alone cannot guarantee comprehension. Factors such as material design and audiovisual aids were not evaluated.

DISCLOSURES:

The study did not report a funding source. The authors reported several disclosures but none related to the study. Herbert J. Zeh disclosed serving as a scientific advisor for Surgical Safety Technologies; Dr. Polanco disclosed serving as a consultant for Iota Biosciences and Palisade Bio and as a proctor for Intuitive Surgical.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

The artificial intelligence (AI) chatbot ChatGPT can significantly improve the readability of online cancer-related patient information while maintaining the content’s quality, a recent study found.

METHODOLOGY:

  • Patients with cancer often search for cancer information online after their diagnosis, with most seeking information from their oncologists’ websites. However, the online materials often exceed the average reading level of the US population, limiting accessibility and comprehension.
  • Researchers asked ChatGPT 4.0 to rewrite content about breast, colon, lung, prostate, and pancreas cancer, aiming for a sixth-grade readability level. The content came from a random sample of documents from 34 patient-facing websites associated with National Comprehensive Cancer Network (NCCN) member institutions.
  • Readability, accuracy, similarity, and quality of the rewritten content were assessed using several established metrics and tools, including an F1 score, which assesses the precision and recall of a machine-learning model; a cosine similarity score, which measures similarities and is often used to detect plagiarism; and the DISCERN instrument, which helps assess the quality of the AI-rewritten information.
  • The primary outcome was the mean readability score for the original and AI-generated content.

TAKEAWAY:

  • The original content had an average readability level equivalent to a university freshman (grade 13). Following the AI revision, the readability level improved to a high school freshman level (grade 9).
  • The rewritten content had high accuracy, with an overall F1 score of 0.87 (a good score is 0.8-0.9).
  • The rewritten content had a high cosine similarity score of 0.915 (scores range from 0 to 1, with 0 indicating no similarity and 1 indicating complete similarity). Researchers attributed the improved readability to the use of simpler words and shorter sentences.
  • Quality assessment using the DISCERN instrument showed that the AI-rewritten content maintained a “good” quality rating, similar to that of the original content.

IN PRACTICE:

Society has become increasingly dependent on online educational materials, and considering that more than half of Americans may not be literate beyond an eighth-grade level, our AI intervention offers a potential low-cost solution to narrow the gap between patient health literacy and content received from the nation’s leading cancer centers, the authors wrote.

SOURCE:

The study, with first author Andres A. Abreu, MD, with UT Southwestern Medical Center, Dallas, Texas, was published online in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The study was limited to English-language content from NCCN member websites, so the findings may not be generalizable to other sources or languages. Readability alone cannot guarantee comprehension. Factors such as material design and audiovisual aids were not evaluated.

DISCLOSURES:

The study did not report a funding source. The authors reported several disclosures but none related to the study. Herbert J. Zeh disclosed serving as a scientific advisor for Surgical Safety Technologies; Dr. Polanco disclosed serving as a consultant for Iota Biosciences and Palisade Bio and as a proctor for Intuitive Surgical.

A version of this article first appeared on Medscape.com.

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However, the online materials often exceed the average reading level of the US population, limiting accessibility and comprehension.</li> <li>Researchers asked ChatGPT 4.0 to rewrite content about breast, colon, lung, prostate, and pancreas cancer, aiming for a sixth-grade readability level. The content came from a random sample of documents from 34 patient-facing websites associated with National Comprehensive Cancer Network (NCCN) member institutions.</li> <li>Readability, accuracy, similarity, and quality of the rewritten content were assessed using several established metrics and tools, including an F1 score, which assesses the precision and recall of a machine-learning model; a cosine similarity score, which measures similarities and is often used to detect plagiarism; and the DISCERN instrument, which helps assess the quality of the AI-rewritten information.</li> <li>The primary outcome was the mean readability score for the original and AI-generated content.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>The original content had an average readability level equivalent to a university freshman (grade 13). Following the AI revision, the readability level improved to a high school freshman level (grade 9).</li> <li>The rewritten content had high accuracy, with an overall F1 score of 0.87 (a good score is 0.8-0.9).</li> <li>The rewritten content had a high cosine similarity score of 0.915 (scores range from 0 to 1, with 0 indicating no similarity and 1 indicating complete similarity). Researchers attributed the improved readability to the use of simpler words and shorter sentences.</li> <li>Quality assessment using the DISCERN instrument showed that the AI-rewritten content maintained a “good” quality rating, similar to that of the original content.</li> </ul> <h2>IN PRACTICE:</h2> <p>Society has become increasingly dependent on online educational materials, and considering that more than half of Americans may not be literate beyond an eighth-grade level, our AI intervention offers a potential low-cost solution to narrow the gap between patient health literacy and content received from the nation’s leading cancer centers, the authors wrote.</p> <h2>SOURCE:</h2> <p>The study, with first author Andres A. Abreu, MD, with UT Southwestern Medical Center, Dallas, Texas, was <a href="https://jnccn.org/configurable/content/journals$002fjnccn$002faop$002farticle-10.6004-jnccn.2023.7334$002farticle-10.6004-jnccn.2023.7334.xml?t:ac=journals$002fjnccn$002faop$002farticle-10.6004-jnccn.2023.7334$002farticle-10.6004-jnccn.2023.7334.xml">published online</a> in the <em>Journal of the National Comprehensive Cancer Network</em>.</p> <h2>LIMITATIONS:</h2> <p>The study was limited to English-language content from NCCN member websites, so the findings may not be generalizable to other sources or languages. Readability alone cannot guarantee comprehension. Factors such as material design and audiovisual aids were not evaluated.</p> <h2>DISCLOSURES:</h2> <p>The study did not report a funding source. The authors reported several disclosures but none related to the study. Herbert J. 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