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Parkinson’s in Marines linked to toxic drinking water at Camp Lejeune
in Jacksonville, N.C.
In one of the best-documented, large-scale contaminations in U.S. history, the drinking water at the Marine Corps base was contaminated with TCE and other volatile organic compounds from about 1953 to 1987.
The new study of more than 340,000 service members found the risk of PD was 70% higher in Marines stationed at Camp Lejeune in North Carolina during the years 1975-1985, compared with Marines stationed at Camp Pendleton in Oceanside, Calif.
“This is by far the largest study to look at the association of TCE and PD and the evidence is pretty strong,” lead investigator Samuel M. Goldman, MD, MPH, with University of California, San Francisco, said in an interview.
The link is supported by animal models that show that TCE can induce a neurodegenerative syndrome that is “very similar pathologically to what we see in PD,” Dr. Goldman said.
The study was published online in JAMA Neurology.
‘Hundreds of thousands’ at risk
At Camp Lejeune during the years 1975-1985, the period of maximal contamination, the estimated monthly median TCE level was more than 70-fold the Environmental Protection Agency maximum contaminant level. Maximum contaminant levels were also exceeded for perchloroethylene (PCE) and vinyl chloride.
Dr. Goldman and colleagues had health data on 158,122 veterans – 84,824 from Camp Lejeune and 73,298 from Camp Pendleton – who served for at least 3 months between 1975 and 1985, with follow up from Jan. 1, 1997, to Feb. 17, 2021.
Demographic characteristics were similar between the two groups; most were White men with an average age of 59 years.
A total of 430 veterans had PD: 279 from Camp Lejeune (prevalence, 0.33%) and 151 from Camp Pendleton (prevalence, 0.21%).
In multivariable models, Camp Lejeune veterans had a 70% higher risk for PD (odds ratio, 1.70; 95% confidence interval, 1.39-2.07; P < .001).
“Remarkably,” the researchers noted, among veterans without PD, residence at Camp Lejeune was also associated with a significantly higher risk of having several well-established prodromal features of PD, including tremor, suggesting they may be in a prediagnostic phase of evolving PD pathology.
Importantly, they added, in addition to the exposed service members, “hundreds of thousands of family members and civilian workers exposed to contaminated water at Camp Lejeune may also be at increased risk of PD, cancers, and other health consequences. Continued prospective follow-up of this population is essential.”
‘An unreasonable risk’
The new study supports a prior, and much smaller, study by Dr. Goldman and colleagues showing TCE exposure was associated with a sixfold increased risk for PD.
TCE is a ubiquitous environmental contaminant. The EPA Toxics Release Inventory estimates 2.05 million pounds of TCE was released into the environment from industrial sites in 2017.
In an accompanying editorial, E. Ray Dorsey, MD, with the University of Rochester (N.Y.) and coauthors noted the work of Dr. Goldman and colleagues “increases the certainty” that environmental exposure to TCE and the similar compound PCE “contribute importantly to the cause of the world’s fastest-growing brain disease.”
In December, the EPA found that PCE posed “an unreasonable risk” to human health, and 1 month later, it reached the same conclusion for TCE.
“These actions could lay the foundation for increased regulation and possibly a ban of these two chemicals that have contributed to immeasurable death and disability for generations,” Dr. Dorsey and colleagues noted.
“A U.S. ban would be a step forward but would not address the tens of thousands of TCE/PCE-contaminated sites in the U.S. and around the world or the rising global use of the toxic solvents,” they added.
This research was supported by Department of Veterans Affairs. Dr. Goldman reported no relevant financial relationships. Dr. Dorsey has received personal fees from organizations including the American Neurological Association, Elsevier, International Parkinson and Movement Disorder Society, Massachusetts Medical Society, Michael J. Fox Foundation, National Institutes of Health, and WebMD, as well as numerous pharmaceutical companies.
A version of this article originally appeared on Medscape.com.
in Jacksonville, N.C.
In one of the best-documented, large-scale contaminations in U.S. history, the drinking water at the Marine Corps base was contaminated with TCE and other volatile organic compounds from about 1953 to 1987.
The new study of more than 340,000 service members found the risk of PD was 70% higher in Marines stationed at Camp Lejeune in North Carolina during the years 1975-1985, compared with Marines stationed at Camp Pendleton in Oceanside, Calif.
“This is by far the largest study to look at the association of TCE and PD and the evidence is pretty strong,” lead investigator Samuel M. Goldman, MD, MPH, with University of California, San Francisco, said in an interview.
The link is supported by animal models that show that TCE can induce a neurodegenerative syndrome that is “very similar pathologically to what we see in PD,” Dr. Goldman said.
The study was published online in JAMA Neurology.
‘Hundreds of thousands’ at risk
At Camp Lejeune during the years 1975-1985, the period of maximal contamination, the estimated monthly median TCE level was more than 70-fold the Environmental Protection Agency maximum contaminant level. Maximum contaminant levels were also exceeded for perchloroethylene (PCE) and vinyl chloride.
Dr. Goldman and colleagues had health data on 158,122 veterans – 84,824 from Camp Lejeune and 73,298 from Camp Pendleton – who served for at least 3 months between 1975 and 1985, with follow up from Jan. 1, 1997, to Feb. 17, 2021.
Demographic characteristics were similar between the two groups; most were White men with an average age of 59 years.
A total of 430 veterans had PD: 279 from Camp Lejeune (prevalence, 0.33%) and 151 from Camp Pendleton (prevalence, 0.21%).
In multivariable models, Camp Lejeune veterans had a 70% higher risk for PD (odds ratio, 1.70; 95% confidence interval, 1.39-2.07; P < .001).
“Remarkably,” the researchers noted, among veterans without PD, residence at Camp Lejeune was also associated with a significantly higher risk of having several well-established prodromal features of PD, including tremor, suggesting they may be in a prediagnostic phase of evolving PD pathology.
Importantly, they added, in addition to the exposed service members, “hundreds of thousands of family members and civilian workers exposed to contaminated water at Camp Lejeune may also be at increased risk of PD, cancers, and other health consequences. Continued prospective follow-up of this population is essential.”
‘An unreasonable risk’
The new study supports a prior, and much smaller, study by Dr. Goldman and colleagues showing TCE exposure was associated with a sixfold increased risk for PD.
TCE is a ubiquitous environmental contaminant. The EPA Toxics Release Inventory estimates 2.05 million pounds of TCE was released into the environment from industrial sites in 2017.
In an accompanying editorial, E. Ray Dorsey, MD, with the University of Rochester (N.Y.) and coauthors noted the work of Dr. Goldman and colleagues “increases the certainty” that environmental exposure to TCE and the similar compound PCE “contribute importantly to the cause of the world’s fastest-growing brain disease.”
In December, the EPA found that PCE posed “an unreasonable risk” to human health, and 1 month later, it reached the same conclusion for TCE.
“These actions could lay the foundation for increased regulation and possibly a ban of these two chemicals that have contributed to immeasurable death and disability for generations,” Dr. Dorsey and colleagues noted.
“A U.S. ban would be a step forward but would not address the tens of thousands of TCE/PCE-contaminated sites in the U.S. and around the world or the rising global use of the toxic solvents,” they added.
This research was supported by Department of Veterans Affairs. Dr. Goldman reported no relevant financial relationships. Dr. Dorsey has received personal fees from organizations including the American Neurological Association, Elsevier, International Parkinson and Movement Disorder Society, Massachusetts Medical Society, Michael J. Fox Foundation, National Institutes of Health, and WebMD, as well as numerous pharmaceutical companies.
A version of this article originally appeared on Medscape.com.
in Jacksonville, N.C.
In one of the best-documented, large-scale contaminations in U.S. history, the drinking water at the Marine Corps base was contaminated with TCE and other volatile organic compounds from about 1953 to 1987.
The new study of more than 340,000 service members found the risk of PD was 70% higher in Marines stationed at Camp Lejeune in North Carolina during the years 1975-1985, compared with Marines stationed at Camp Pendleton in Oceanside, Calif.
“This is by far the largest study to look at the association of TCE and PD and the evidence is pretty strong,” lead investigator Samuel M. Goldman, MD, MPH, with University of California, San Francisco, said in an interview.
The link is supported by animal models that show that TCE can induce a neurodegenerative syndrome that is “very similar pathologically to what we see in PD,” Dr. Goldman said.
The study was published online in JAMA Neurology.
‘Hundreds of thousands’ at risk
At Camp Lejeune during the years 1975-1985, the period of maximal contamination, the estimated monthly median TCE level was more than 70-fold the Environmental Protection Agency maximum contaminant level. Maximum contaminant levels were also exceeded for perchloroethylene (PCE) and vinyl chloride.
Dr. Goldman and colleagues had health data on 158,122 veterans – 84,824 from Camp Lejeune and 73,298 from Camp Pendleton – who served for at least 3 months between 1975 and 1985, with follow up from Jan. 1, 1997, to Feb. 17, 2021.
Demographic characteristics were similar between the two groups; most were White men with an average age of 59 years.
A total of 430 veterans had PD: 279 from Camp Lejeune (prevalence, 0.33%) and 151 from Camp Pendleton (prevalence, 0.21%).
In multivariable models, Camp Lejeune veterans had a 70% higher risk for PD (odds ratio, 1.70; 95% confidence interval, 1.39-2.07; P < .001).
“Remarkably,” the researchers noted, among veterans without PD, residence at Camp Lejeune was also associated with a significantly higher risk of having several well-established prodromal features of PD, including tremor, suggesting they may be in a prediagnostic phase of evolving PD pathology.
Importantly, they added, in addition to the exposed service members, “hundreds of thousands of family members and civilian workers exposed to contaminated water at Camp Lejeune may also be at increased risk of PD, cancers, and other health consequences. Continued prospective follow-up of this population is essential.”
‘An unreasonable risk’
The new study supports a prior, and much smaller, study by Dr. Goldman and colleagues showing TCE exposure was associated with a sixfold increased risk for PD.
TCE is a ubiquitous environmental contaminant. The EPA Toxics Release Inventory estimates 2.05 million pounds of TCE was released into the environment from industrial sites in 2017.
In an accompanying editorial, E. Ray Dorsey, MD, with the University of Rochester (N.Y.) and coauthors noted the work of Dr. Goldman and colleagues “increases the certainty” that environmental exposure to TCE and the similar compound PCE “contribute importantly to the cause of the world’s fastest-growing brain disease.”
In December, the EPA found that PCE posed “an unreasonable risk” to human health, and 1 month later, it reached the same conclusion for TCE.
“These actions could lay the foundation for increased regulation and possibly a ban of these two chemicals that have contributed to immeasurable death and disability for generations,” Dr. Dorsey and colleagues noted.
“A U.S. ban would be a step forward but would not address the tens of thousands of TCE/PCE-contaminated sites in the U.S. and around the world or the rising global use of the toxic solvents,” they added.
This research was supported by Department of Veterans Affairs. Dr. Goldman reported no relevant financial relationships. Dr. Dorsey has received personal fees from organizations including the American Neurological Association, Elsevier, International Parkinson and Movement Disorder Society, Massachusetts Medical Society, Michael J. Fox Foundation, National Institutes of Health, and WebMD, as well as numerous pharmaceutical companies.
A version of this article originally appeared on Medscape.com.
FROM JAMA NEUROLOGY
Common gut bacteria linked to Parkinson’s disease
, a small study suggests.
Environmental factors as well as genetics are also suspected to play a role in PD etiology, although the exact cause remains unknown.
“Our findings indicate that specific strains of Desulfovibrio bacteria are likely to cause Parkinson’s disease,” study investigator Per Erik Saris, PhD, from the University of Helsinki, Finland, says in a news release.
The study was published online in Frontiers in Cellular and Infection Microbiology.
Screen and treat?
It builds on earlier work by the researchers that showed that Desulfovibrio bacteria were more prevalent and more abundant in quantity in patients with PD, especially patients with more severe disease, than in healthy individuals.
Desulfovibrio is a genus of gram-negative bacteria commonly found in aquatic environments in which levels of organic material are elevated, as well as in waterlogged soils.
In their latest study, Dr. Saris and colleagues looked for Desulfovibrio species in fecal samples from 10 patients with PD and their healthy spouses. Isolated Desulfovibrio strains were fed to a strain of Caenorhabditis elegans roundworms that expressed human alpha-syn fused with yellow fluorescent protein.
They found that worms fed Desulfovibrio bacteria from patients with PD harbored significantly more (P < .001) and larger alpha-syn aggregates (P < .001) than worms fed Desulfovibrio bacteria from healthy individuals or worms fed Escherichia coli strains.
In addition, worms fed Desulfovibrio strains from patients with PD died in significantly higher quantities than worms fed E. coli bacteria (P < .01).
Desulfovibrio strains isolated from patients with PD and strains isolated from healthy individuals appear to have different traits. Comparative genomics studies are needed to identify genetic differences and pathogenic genes from Desulfovibrio strains from patients with PD, the researchers note.
“Taking into account that aggregation of alpha-syn is a hallmark of PD, the ability of Desulfovibrio bacteria to induce alpha-syn aggregation in large numbers and sizes, as demonstrated in the present study, provides further evidence for the pathogenic role of Desulfovibrio bacteria in PD, as previously suggested,” they add.
The findings highlight the potential for screening and targeted removal of harmful Desulfovibrio bacteria, Dr. Saris suggests in the news release.
No clinical implications
In a comment, James Beck, PhD, chief scientific officer at the Parkinson’s Foundation, cautioned that “this research is in a very early stage, uses a nonvertebrate animal model, and the number of participants is small.
“Understanding the role of the gut microbiome in influencing PD is in its infancy. These are important steps to determining what – if any – link may be between gut bacteria and PD,” Dr. Beck said.
“Right now, there are no implications for the screening/treatment of carriers,” Dr. Beck said.
“It seems that a lot of people, whether with PD or not, harbor Desulfovibrio bacteria in their gut. More research is needed to understand what is different between the Desulfovibrio bacteria of people with PD vs. those who do not have PD,” Dr. Beck added.
The study was supported by the Magnus Ehrnrooth Foundation and the Jane and Aatos Erkko Foundation. Dr. Saris and Dr. Beck have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a small study suggests.
Environmental factors as well as genetics are also suspected to play a role in PD etiology, although the exact cause remains unknown.
“Our findings indicate that specific strains of Desulfovibrio bacteria are likely to cause Parkinson’s disease,” study investigator Per Erik Saris, PhD, from the University of Helsinki, Finland, says in a news release.
The study was published online in Frontiers in Cellular and Infection Microbiology.
Screen and treat?
It builds on earlier work by the researchers that showed that Desulfovibrio bacteria were more prevalent and more abundant in quantity in patients with PD, especially patients with more severe disease, than in healthy individuals.
Desulfovibrio is a genus of gram-negative bacteria commonly found in aquatic environments in which levels of organic material are elevated, as well as in waterlogged soils.
In their latest study, Dr. Saris and colleagues looked for Desulfovibrio species in fecal samples from 10 patients with PD and their healthy spouses. Isolated Desulfovibrio strains were fed to a strain of Caenorhabditis elegans roundworms that expressed human alpha-syn fused with yellow fluorescent protein.
They found that worms fed Desulfovibrio bacteria from patients with PD harbored significantly more (P < .001) and larger alpha-syn aggregates (P < .001) than worms fed Desulfovibrio bacteria from healthy individuals or worms fed Escherichia coli strains.
In addition, worms fed Desulfovibrio strains from patients with PD died in significantly higher quantities than worms fed E. coli bacteria (P < .01).
Desulfovibrio strains isolated from patients with PD and strains isolated from healthy individuals appear to have different traits. Comparative genomics studies are needed to identify genetic differences and pathogenic genes from Desulfovibrio strains from patients with PD, the researchers note.
“Taking into account that aggregation of alpha-syn is a hallmark of PD, the ability of Desulfovibrio bacteria to induce alpha-syn aggregation in large numbers and sizes, as demonstrated in the present study, provides further evidence for the pathogenic role of Desulfovibrio bacteria in PD, as previously suggested,” they add.
The findings highlight the potential for screening and targeted removal of harmful Desulfovibrio bacteria, Dr. Saris suggests in the news release.
No clinical implications
In a comment, James Beck, PhD, chief scientific officer at the Parkinson’s Foundation, cautioned that “this research is in a very early stage, uses a nonvertebrate animal model, and the number of participants is small.
“Understanding the role of the gut microbiome in influencing PD is in its infancy. These are important steps to determining what – if any – link may be between gut bacteria and PD,” Dr. Beck said.
“Right now, there are no implications for the screening/treatment of carriers,” Dr. Beck said.
“It seems that a lot of people, whether with PD or not, harbor Desulfovibrio bacteria in their gut. More research is needed to understand what is different between the Desulfovibrio bacteria of people with PD vs. those who do not have PD,” Dr. Beck added.
The study was supported by the Magnus Ehrnrooth Foundation and the Jane and Aatos Erkko Foundation. Dr. Saris and Dr. Beck have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a small study suggests.
Environmental factors as well as genetics are also suspected to play a role in PD etiology, although the exact cause remains unknown.
“Our findings indicate that specific strains of Desulfovibrio bacteria are likely to cause Parkinson’s disease,” study investigator Per Erik Saris, PhD, from the University of Helsinki, Finland, says in a news release.
The study was published online in Frontiers in Cellular and Infection Microbiology.
Screen and treat?
It builds on earlier work by the researchers that showed that Desulfovibrio bacteria were more prevalent and more abundant in quantity in patients with PD, especially patients with more severe disease, than in healthy individuals.
Desulfovibrio is a genus of gram-negative bacteria commonly found in aquatic environments in which levels of organic material are elevated, as well as in waterlogged soils.
In their latest study, Dr. Saris and colleagues looked for Desulfovibrio species in fecal samples from 10 patients with PD and their healthy spouses. Isolated Desulfovibrio strains were fed to a strain of Caenorhabditis elegans roundworms that expressed human alpha-syn fused with yellow fluorescent protein.
They found that worms fed Desulfovibrio bacteria from patients with PD harbored significantly more (P < .001) and larger alpha-syn aggregates (P < .001) than worms fed Desulfovibrio bacteria from healthy individuals or worms fed Escherichia coli strains.
In addition, worms fed Desulfovibrio strains from patients with PD died in significantly higher quantities than worms fed E. coli bacteria (P < .01).
Desulfovibrio strains isolated from patients with PD and strains isolated from healthy individuals appear to have different traits. Comparative genomics studies are needed to identify genetic differences and pathogenic genes from Desulfovibrio strains from patients with PD, the researchers note.
“Taking into account that aggregation of alpha-syn is a hallmark of PD, the ability of Desulfovibrio bacteria to induce alpha-syn aggregation in large numbers and sizes, as demonstrated in the present study, provides further evidence for the pathogenic role of Desulfovibrio bacteria in PD, as previously suggested,” they add.
The findings highlight the potential for screening and targeted removal of harmful Desulfovibrio bacteria, Dr. Saris suggests in the news release.
No clinical implications
In a comment, James Beck, PhD, chief scientific officer at the Parkinson’s Foundation, cautioned that “this research is in a very early stage, uses a nonvertebrate animal model, and the number of participants is small.
“Understanding the role of the gut microbiome in influencing PD is in its infancy. These are important steps to determining what – if any – link may be between gut bacteria and PD,” Dr. Beck said.
“Right now, there are no implications for the screening/treatment of carriers,” Dr. Beck said.
“It seems that a lot of people, whether with PD or not, harbor Desulfovibrio bacteria in their gut. More research is needed to understand what is different between the Desulfovibrio bacteria of people with PD vs. those who do not have PD,” Dr. Beck added.
The study was supported by the Magnus Ehrnrooth Foundation and the Jane and Aatos Erkko Foundation. Dr. Saris and Dr. Beck have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM FRONTIERS IN CELLULAR AND INFECTION MICROBIOLOGY
FDA moves to curb misuse of ADHD meds
“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.
Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.
The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.
Patient medication guides will be updated to educate patients and caregivers about these risks.
The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
Friends and family
A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.
Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.
Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).
The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.
Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
A version of this article first appeared on Medscape.com.
“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.
Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.
The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.
Patient medication guides will be updated to educate patients and caregivers about these risks.
The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
Friends and family
A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.
Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.
Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).
The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.
Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
A version of this article first appeared on Medscape.com.
“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.
Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.
The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.
Patient medication guides will be updated to educate patients and caregivers about these risks.
The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
Friends and family
A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.
Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.
Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).
The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.
Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
A version of this article first appeared on Medscape.com.
Statins appear to guard against liver disease progression
The Swedish population-based study found that adults with noncirrhotic CLD who were on statin therapy had a statistically significant 40% lower risk of developing severe liver disease, compared with matched patients who were not on statin therapy.
The statin users were also less apt to progress to cirrhosis or hepatocellular carcinoma (HCC) and to die of liver disease, Rajani Sharma, MD, MSc, division of digestive and liver diseases, Columbia University Irving Medical Center, New York, and colleagues reported.
Their study was published online in Clinical Gastroenterology and Hepatology.
More than just cholesterol lowering
The study “continues the theme that cholesterol-lowering statins are good for a lot more things than just lowering cholesterol,” William Carey, MD, who wasn’t involved with the study, said in an interview.
The results are “very consistent with other trials that show that people with liver disease on statins do better in many respects than those who are not on statins,” said Dr. Carey, acting head of the hepatology section, department of gastroenterology, hepatology, and nutrition, Cleveland Clinic.
“The effects are not trivial,” Dr. Carey added. “It’s a very significant advantage in terms of fibrosis progression and survival.”
Statins have been shown to inhibit inflammatory pathways, promote endothelial cell function, and reduce hepatic stellate cell activity, suggesting that statins could lessen the progression of liver fibrosis, Dr. Sharma and coauthors wrote.
A few prior studies have looked at the effects of statins in noncirrhotic CLD specifically, but most only included patients with viral hepatitis, and the identification of precirrhotic liver disease was largely based on fibrosis scores or ICD coding, leading to a risk for misclassification and heterogeneity in results, they wrote.
Using histopathology data in a nationwide Swedish cohort, Dr. Sharma and colleagues identified 3862 adults with noncirrhotic CLD who were statin users and a like number of propensity score–matched nonstatin users with noncirrhotic CLD. The adults with CLD included in the study were required to have a liver biopsy showing fibrosis or inflammation between the years 1969 and 2017 and at least one ICD code for CLD.
In both groups, 45% of patients had nonalcoholic fatty liver disease (NAFLD), 22% had alcohol-related liver disease (ALD), 18% had viral hepatitis, and 15% had autoimmune hepatitis (AIH).
The analysis found 234 (6.1%) statin users developed severe liver disease versus 276 (7.1%) nonusers, with incidence rates of 10.5 versus 18.1 per 1,000 person-years, respectively.
Statin use was associated with a statistically significant 40% lower rate of severe liver disease (hazard ratio, 0.60; 95% confidence interval, 0.48-0.74).
This was the case in ALD (HR, 0.30; 95% CI, 0.19-0.49) and NAFLD (HR, 0.68; 95% CI 0.45-1.00), but the results were not statistically significant for individuals with viral hepatitis (HR, 0.76; 95% CI, 0.51-1.14) or AIH (HR, 0.88; 0.48-1.58).
Statin use had a protective association in both prefibrosis and fibrosis stages at diagnosis, the researchers reported.
Statin use was also associated with lower rates of progression to cirrhosis (HR, 0.62; 95% CI, 0.49-0.78), HCC (HR, 0.44; 95% CI, 0.27-0.71) and liver-related death or liver transplant (HR, 0.55; 95% CI, 0.36-0.82).
The authors noted that their “study provides the most robust estimates available thus far.” However, they cautioned that “prospective randomized controlled trials are necessary in order to recommend statin use in clinical practice.”
‘Reassuring and pleasantly surprising’
The study is “very interesting, reassuring, and pleasantly surprising,” Scott L. Friedman, MD, chief of the division of liver diseases and dean for therapeutic discovery at the Icahn School of Medicine at Mount Sinai. New York, said in an interview.
“Statins have been around for a long time, and in earlier days, there was fear of using them because they might induce liver injury. But ample and consistent data exclude the possibility that they are more toxic in patients with liver disease,” said Dr. Friedman, who was not associated with this research.
“What’s interesting and new about this paper is that those studies that have looked at the effects of statins on liver disease have primarily focused on patients who have cirrhosis because there’s some scientific evidence [that] statins can lead to vasodilation and reduce the elevated liver blood flow that occurs in cirrhosis,” he explained.
“Instead, this study, which is quite sizable, includes patients who do not have evidence of cirrhosis based on biopsies. The results suggest that statins have a significant protective effect in these patients,” Dr. Friedman said.
The study was supported by the Karolinska Institute in Stockholm, the Columbia University Irving Medical Center, the Swedish Research Council, the Swedish Cancer Society, and the U.S. National Institutes of Health. Dr. Sharma is a consultant for Takeda and Volv. Other coauthors reported current or past relationships with Bristol-Myers Squibb, Gilead, Salix, and GlaxoSmithKline. Dr. Carey and Dr. Friedman reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The Swedish population-based study found that adults with noncirrhotic CLD who were on statin therapy had a statistically significant 40% lower risk of developing severe liver disease, compared with matched patients who were not on statin therapy.
The statin users were also less apt to progress to cirrhosis or hepatocellular carcinoma (HCC) and to die of liver disease, Rajani Sharma, MD, MSc, division of digestive and liver diseases, Columbia University Irving Medical Center, New York, and colleagues reported.
Their study was published online in Clinical Gastroenterology and Hepatology.
More than just cholesterol lowering
The study “continues the theme that cholesterol-lowering statins are good for a lot more things than just lowering cholesterol,” William Carey, MD, who wasn’t involved with the study, said in an interview.
The results are “very consistent with other trials that show that people with liver disease on statins do better in many respects than those who are not on statins,” said Dr. Carey, acting head of the hepatology section, department of gastroenterology, hepatology, and nutrition, Cleveland Clinic.
“The effects are not trivial,” Dr. Carey added. “It’s a very significant advantage in terms of fibrosis progression and survival.”
Statins have been shown to inhibit inflammatory pathways, promote endothelial cell function, and reduce hepatic stellate cell activity, suggesting that statins could lessen the progression of liver fibrosis, Dr. Sharma and coauthors wrote.
A few prior studies have looked at the effects of statins in noncirrhotic CLD specifically, but most only included patients with viral hepatitis, and the identification of precirrhotic liver disease was largely based on fibrosis scores or ICD coding, leading to a risk for misclassification and heterogeneity in results, they wrote.
Using histopathology data in a nationwide Swedish cohort, Dr. Sharma and colleagues identified 3862 adults with noncirrhotic CLD who were statin users and a like number of propensity score–matched nonstatin users with noncirrhotic CLD. The adults with CLD included in the study were required to have a liver biopsy showing fibrosis or inflammation between the years 1969 and 2017 and at least one ICD code for CLD.
In both groups, 45% of patients had nonalcoholic fatty liver disease (NAFLD), 22% had alcohol-related liver disease (ALD), 18% had viral hepatitis, and 15% had autoimmune hepatitis (AIH).
The analysis found 234 (6.1%) statin users developed severe liver disease versus 276 (7.1%) nonusers, with incidence rates of 10.5 versus 18.1 per 1,000 person-years, respectively.
Statin use was associated with a statistically significant 40% lower rate of severe liver disease (hazard ratio, 0.60; 95% confidence interval, 0.48-0.74).
This was the case in ALD (HR, 0.30; 95% CI, 0.19-0.49) and NAFLD (HR, 0.68; 95% CI 0.45-1.00), but the results were not statistically significant for individuals with viral hepatitis (HR, 0.76; 95% CI, 0.51-1.14) or AIH (HR, 0.88; 0.48-1.58).
Statin use had a protective association in both prefibrosis and fibrosis stages at diagnosis, the researchers reported.
Statin use was also associated with lower rates of progression to cirrhosis (HR, 0.62; 95% CI, 0.49-0.78), HCC (HR, 0.44; 95% CI, 0.27-0.71) and liver-related death or liver transplant (HR, 0.55; 95% CI, 0.36-0.82).
The authors noted that their “study provides the most robust estimates available thus far.” However, they cautioned that “prospective randomized controlled trials are necessary in order to recommend statin use in clinical practice.”
‘Reassuring and pleasantly surprising’
The study is “very interesting, reassuring, and pleasantly surprising,” Scott L. Friedman, MD, chief of the division of liver diseases and dean for therapeutic discovery at the Icahn School of Medicine at Mount Sinai. New York, said in an interview.
“Statins have been around for a long time, and in earlier days, there was fear of using them because they might induce liver injury. But ample and consistent data exclude the possibility that they are more toxic in patients with liver disease,” said Dr. Friedman, who was not associated with this research.
“What’s interesting and new about this paper is that those studies that have looked at the effects of statins on liver disease have primarily focused on patients who have cirrhosis because there’s some scientific evidence [that] statins can lead to vasodilation and reduce the elevated liver blood flow that occurs in cirrhosis,” he explained.
“Instead, this study, which is quite sizable, includes patients who do not have evidence of cirrhosis based on biopsies. The results suggest that statins have a significant protective effect in these patients,” Dr. Friedman said.
The study was supported by the Karolinska Institute in Stockholm, the Columbia University Irving Medical Center, the Swedish Research Council, the Swedish Cancer Society, and the U.S. National Institutes of Health. Dr. Sharma is a consultant for Takeda and Volv. Other coauthors reported current or past relationships with Bristol-Myers Squibb, Gilead, Salix, and GlaxoSmithKline. Dr. Carey and Dr. Friedman reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The Swedish population-based study found that adults with noncirrhotic CLD who were on statin therapy had a statistically significant 40% lower risk of developing severe liver disease, compared with matched patients who were not on statin therapy.
The statin users were also less apt to progress to cirrhosis or hepatocellular carcinoma (HCC) and to die of liver disease, Rajani Sharma, MD, MSc, division of digestive and liver diseases, Columbia University Irving Medical Center, New York, and colleagues reported.
Their study was published online in Clinical Gastroenterology and Hepatology.
More than just cholesterol lowering
The study “continues the theme that cholesterol-lowering statins are good for a lot more things than just lowering cholesterol,” William Carey, MD, who wasn’t involved with the study, said in an interview.
The results are “very consistent with other trials that show that people with liver disease on statins do better in many respects than those who are not on statins,” said Dr. Carey, acting head of the hepatology section, department of gastroenterology, hepatology, and nutrition, Cleveland Clinic.
“The effects are not trivial,” Dr. Carey added. “It’s a very significant advantage in terms of fibrosis progression and survival.”
Statins have been shown to inhibit inflammatory pathways, promote endothelial cell function, and reduce hepatic stellate cell activity, suggesting that statins could lessen the progression of liver fibrosis, Dr. Sharma and coauthors wrote.
A few prior studies have looked at the effects of statins in noncirrhotic CLD specifically, but most only included patients with viral hepatitis, and the identification of precirrhotic liver disease was largely based on fibrosis scores or ICD coding, leading to a risk for misclassification and heterogeneity in results, they wrote.
Using histopathology data in a nationwide Swedish cohort, Dr. Sharma and colleagues identified 3862 adults with noncirrhotic CLD who were statin users and a like number of propensity score–matched nonstatin users with noncirrhotic CLD. The adults with CLD included in the study were required to have a liver biopsy showing fibrosis or inflammation between the years 1969 and 2017 and at least one ICD code for CLD.
In both groups, 45% of patients had nonalcoholic fatty liver disease (NAFLD), 22% had alcohol-related liver disease (ALD), 18% had viral hepatitis, and 15% had autoimmune hepatitis (AIH).
The analysis found 234 (6.1%) statin users developed severe liver disease versus 276 (7.1%) nonusers, with incidence rates of 10.5 versus 18.1 per 1,000 person-years, respectively.
Statin use was associated with a statistically significant 40% lower rate of severe liver disease (hazard ratio, 0.60; 95% confidence interval, 0.48-0.74).
This was the case in ALD (HR, 0.30; 95% CI, 0.19-0.49) and NAFLD (HR, 0.68; 95% CI 0.45-1.00), but the results were not statistically significant for individuals with viral hepatitis (HR, 0.76; 95% CI, 0.51-1.14) or AIH (HR, 0.88; 0.48-1.58).
Statin use had a protective association in both prefibrosis and fibrosis stages at diagnosis, the researchers reported.
Statin use was also associated with lower rates of progression to cirrhosis (HR, 0.62; 95% CI, 0.49-0.78), HCC (HR, 0.44; 95% CI, 0.27-0.71) and liver-related death or liver transplant (HR, 0.55; 95% CI, 0.36-0.82).
The authors noted that their “study provides the most robust estimates available thus far.” However, they cautioned that “prospective randomized controlled trials are necessary in order to recommend statin use in clinical practice.”
‘Reassuring and pleasantly surprising’
The study is “very interesting, reassuring, and pleasantly surprising,” Scott L. Friedman, MD, chief of the division of liver diseases and dean for therapeutic discovery at the Icahn School of Medicine at Mount Sinai. New York, said in an interview.
“Statins have been around for a long time, and in earlier days, there was fear of using them because they might induce liver injury. But ample and consistent data exclude the possibility that they are more toxic in patients with liver disease,” said Dr. Friedman, who was not associated with this research.
“What’s interesting and new about this paper is that those studies that have looked at the effects of statins on liver disease have primarily focused on patients who have cirrhosis because there’s some scientific evidence [that] statins can lead to vasodilation and reduce the elevated liver blood flow that occurs in cirrhosis,” he explained.
“Instead, this study, which is quite sizable, includes patients who do not have evidence of cirrhosis based on biopsies. The results suggest that statins have a significant protective effect in these patients,” Dr. Friedman said.
The study was supported by the Karolinska Institute in Stockholm, the Columbia University Irving Medical Center, the Swedish Research Council, the Swedish Cancer Society, and the U.S. National Institutes of Health. Dr. Sharma is a consultant for Takeda and Volv. Other coauthors reported current or past relationships with Bristol-Myers Squibb, Gilead, Salix, and GlaxoSmithKline. Dr. Carey and Dr. Friedman reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key red flags for early-onset colorectal cancer
As the number of cases of early-onset colorectal cancer (CRC) diagnosed before age 50 continues to rise, early detection has become increasingly important.
The signs and symptoms are abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia.
Two symptoms in particular – rectal bleeding and iron-deficiency anemia – point to the need for timely endoscopy and follow-up, the researchers say.
“Colorectal cancer is not simply a disease affecting older people; we want younger adults to be aware of and act on these potentially very telling signs and symptoms – particularly because people under 50 are considered to be at low risk, and they don’t receive routine colorectal cancer screening,” senior investigator Yin Cao, ScD, with Washington University School of Medicine, St. Louis, said in a news release.
“It’s also crucial to spread awareness among primary care doctors, gastroenterologists, and emergency medicine doctors,” Dr. Cao added. “To date, many early-onset colorectal cancers are detected in emergency rooms, and there often are significant diagnostic delays with this cancer.”
The study was published online in the Journal of the National Cancer Institute.
Although previous research has identified rectal bleeding, iron-deficiency anemia, and rectal/abdominal pain as symptoms of early-onset CRC, most studies “have aggregated symptoms till the time of diagnosis,” which limits their use for early detection, the authors explain.
In the current study, the researchers analyzed data from more than 5,000 cases of early-onset CRC and from more than 22,000 control patients using the IBM MarketScan commercial database.
Dr. Cao and colleagues found that between 3 months and 2 years before diagnosis, abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia each indicated an increased risk for early-onset CRC.
Among patients with early-onset CRC, 19.3% presented with one or more of the four red flags between 3 months and 2 years prior to the index date; 15.6% had one symptom, and 3.7% had two or more.
After multivariable adjustment, having one symptom almost doubled the risk for early-onset CRC (odds ratio, 1.94); having two symptoms increased risk by more than threefold (OR, 3.59); and having three or more boosted the risk by more than 6.5-fold (OR, 6.52).
Abdominal pain was associated with a 34% higher risk of early-onset CRC (11.6% among case patients vs. 7.7% among controls; OR, 1.34).
Although not as common, rectal bleeding was associated with the highest odds for early-onset CRC (7.2% case patients vs. 1.3% controls; OR, 5.13).
The other predictive signs and symptoms included diarrhea (2.8% case patients vs. 1.4% controls; OR, 1.43) and iron-deficiency anemia (2.3% case patients vs. 0.9% controls; OR, 2.07).
No differences were observed by gender for each sign or symptom.
Among patients with a red-flag symptom who presented between 3 months and 2 years before diagnosis, for those with early-onset CRC, the median diagnostic interval was 8.7 months.
The researchers suggest that clinicians prioritize prompt diagnostic workups for patients younger than 50 who present with rectal bleeding and/or iron-deficiency anemia and that they also keep abdominal pain and diarrhea in mind as early symptoms.
Dr. Cao noted that since most early-onset CRC cases “have been and will continue to be diagnosed after symptom presentation, it is crucial to recognize these red-flag signs and symptoms promptly and conduct a diagnostic workup as soon as possible.
“By doing so, we can diagnose the disease earlier, which in turn can reduce the need for more aggressive treatment and improve patients’ quality of life and survival rates,” said Dr. Cao.
The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article originally appeared on Medscape.com.
As the number of cases of early-onset colorectal cancer (CRC) diagnosed before age 50 continues to rise, early detection has become increasingly important.
The signs and symptoms are abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia.
Two symptoms in particular – rectal bleeding and iron-deficiency anemia – point to the need for timely endoscopy and follow-up, the researchers say.
“Colorectal cancer is not simply a disease affecting older people; we want younger adults to be aware of and act on these potentially very telling signs and symptoms – particularly because people under 50 are considered to be at low risk, and they don’t receive routine colorectal cancer screening,” senior investigator Yin Cao, ScD, with Washington University School of Medicine, St. Louis, said in a news release.
“It’s also crucial to spread awareness among primary care doctors, gastroenterologists, and emergency medicine doctors,” Dr. Cao added. “To date, many early-onset colorectal cancers are detected in emergency rooms, and there often are significant diagnostic delays with this cancer.”
The study was published online in the Journal of the National Cancer Institute.
Although previous research has identified rectal bleeding, iron-deficiency anemia, and rectal/abdominal pain as symptoms of early-onset CRC, most studies “have aggregated symptoms till the time of diagnosis,” which limits their use for early detection, the authors explain.
In the current study, the researchers analyzed data from more than 5,000 cases of early-onset CRC and from more than 22,000 control patients using the IBM MarketScan commercial database.
Dr. Cao and colleagues found that between 3 months and 2 years before diagnosis, abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia each indicated an increased risk for early-onset CRC.
Among patients with early-onset CRC, 19.3% presented with one or more of the four red flags between 3 months and 2 years prior to the index date; 15.6% had one symptom, and 3.7% had two or more.
After multivariable adjustment, having one symptom almost doubled the risk for early-onset CRC (odds ratio, 1.94); having two symptoms increased risk by more than threefold (OR, 3.59); and having three or more boosted the risk by more than 6.5-fold (OR, 6.52).
Abdominal pain was associated with a 34% higher risk of early-onset CRC (11.6% among case patients vs. 7.7% among controls; OR, 1.34).
Although not as common, rectal bleeding was associated with the highest odds for early-onset CRC (7.2% case patients vs. 1.3% controls; OR, 5.13).
The other predictive signs and symptoms included diarrhea (2.8% case patients vs. 1.4% controls; OR, 1.43) and iron-deficiency anemia (2.3% case patients vs. 0.9% controls; OR, 2.07).
No differences were observed by gender for each sign or symptom.
Among patients with a red-flag symptom who presented between 3 months and 2 years before diagnosis, for those with early-onset CRC, the median diagnostic interval was 8.7 months.
The researchers suggest that clinicians prioritize prompt diagnostic workups for patients younger than 50 who present with rectal bleeding and/or iron-deficiency anemia and that they also keep abdominal pain and diarrhea in mind as early symptoms.
Dr. Cao noted that since most early-onset CRC cases “have been and will continue to be diagnosed after symptom presentation, it is crucial to recognize these red-flag signs and symptoms promptly and conduct a diagnostic workup as soon as possible.
“By doing so, we can diagnose the disease earlier, which in turn can reduce the need for more aggressive treatment and improve patients’ quality of life and survival rates,” said Dr. Cao.
The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article originally appeared on Medscape.com.
As the number of cases of early-onset colorectal cancer (CRC) diagnosed before age 50 continues to rise, early detection has become increasingly important.
The signs and symptoms are abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia.
Two symptoms in particular – rectal bleeding and iron-deficiency anemia – point to the need for timely endoscopy and follow-up, the researchers say.
“Colorectal cancer is not simply a disease affecting older people; we want younger adults to be aware of and act on these potentially very telling signs and symptoms – particularly because people under 50 are considered to be at low risk, and they don’t receive routine colorectal cancer screening,” senior investigator Yin Cao, ScD, with Washington University School of Medicine, St. Louis, said in a news release.
“It’s also crucial to spread awareness among primary care doctors, gastroenterologists, and emergency medicine doctors,” Dr. Cao added. “To date, many early-onset colorectal cancers are detected in emergency rooms, and there often are significant diagnostic delays with this cancer.”
The study was published online in the Journal of the National Cancer Institute.
Although previous research has identified rectal bleeding, iron-deficiency anemia, and rectal/abdominal pain as symptoms of early-onset CRC, most studies “have aggregated symptoms till the time of diagnosis,” which limits their use for early detection, the authors explain.
In the current study, the researchers analyzed data from more than 5,000 cases of early-onset CRC and from more than 22,000 control patients using the IBM MarketScan commercial database.
Dr. Cao and colleagues found that between 3 months and 2 years before diagnosis, abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia each indicated an increased risk for early-onset CRC.
Among patients with early-onset CRC, 19.3% presented with one or more of the four red flags between 3 months and 2 years prior to the index date; 15.6% had one symptom, and 3.7% had two or more.
After multivariable adjustment, having one symptom almost doubled the risk for early-onset CRC (odds ratio, 1.94); having two symptoms increased risk by more than threefold (OR, 3.59); and having three or more boosted the risk by more than 6.5-fold (OR, 6.52).
Abdominal pain was associated with a 34% higher risk of early-onset CRC (11.6% among case patients vs. 7.7% among controls; OR, 1.34).
Although not as common, rectal bleeding was associated with the highest odds for early-onset CRC (7.2% case patients vs. 1.3% controls; OR, 5.13).
The other predictive signs and symptoms included diarrhea (2.8% case patients vs. 1.4% controls; OR, 1.43) and iron-deficiency anemia (2.3% case patients vs. 0.9% controls; OR, 2.07).
No differences were observed by gender for each sign or symptom.
Among patients with a red-flag symptom who presented between 3 months and 2 years before diagnosis, for those with early-onset CRC, the median diagnostic interval was 8.7 months.
The researchers suggest that clinicians prioritize prompt diagnostic workups for patients younger than 50 who present with rectal bleeding and/or iron-deficiency anemia and that they also keep abdominal pain and diarrhea in mind as early symptoms.
Dr. Cao noted that since most early-onset CRC cases “have been and will continue to be diagnosed after symptom presentation, it is crucial to recognize these red-flag signs and symptoms promptly and conduct a diagnostic workup as soon as possible.
“By doing so, we can diagnose the disease earlier, which in turn can reduce the need for more aggressive treatment and improve patients’ quality of life and survival rates,” said Dr. Cao.
The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article originally appeared on Medscape.com.
FROM JOURNAL OF THE NATIONAL CANCER INSTITUTE
ChatGPT delivers credible answers to colonoscopy queries
, new research suggests.
“This study shows that a conversational AI program can generate credible medical information in response to common patient questions,” say the investigators, led by Tsung-Chun Lee, MD, division of gastroenterology and hepatology, Taipei Medical University Shuang Ho Hospital, New Taipei City, Taiwan.
“With dedicated domain training, there is meaningful potential to optimize clinical communication to patients undergoing colonoscopy,” they add.
The study was published online in Gastroenterology.
ChatGPT, developed by OpenAI, is a natural language processing tool that allows users to have personalized conversations with an artificial intelligence (AI) bot capable of providing a detailed response to any question posed.
For their first-of-its-kind study, Dr. Lee and colleagues assessed the quality of ChatGPT-generated answers to eight common patient questions about colonoscopy, including what a colonoscopy entails, why it’s performed, how to prepare for it, potential complications, what to expect after the procedure, and what happens with a positive/negative result.
They retrieved the questions from the websites of three randomly selected top hospitals for gastroenterology and gastrointestinal surgery and had ChatGPT (Jan. 30, 2023, version) answer the questions twice.
Using plagiarism detection software, they found that text similarity was extremely low between ChatGPT answers and those on hospital websites (0%-16%). Text similarity ranged from 28% to 77% between the two ChatGPT answers for the same question, except on the question of what to do after a positive colonoscopy result, which had 0% text similarity.
To objectively gauge the quality of the ChatGPT answers, four gastroenterologists (two senior gastroenterologists and two fellows) rated 36 pairs of common questions and answers on a seven-point Likert scale according to ease of understanding, scientific adequacy, and satisfaction with the answer.
The gastroenterologists rated the ChatGPT answers highly and similarly to non-AI answers for all three quality indicators, with some AI scores even higher than non-AI scores.
Interestingly, they could correctly identify AI-generated answers only 48% of the time. Three raters had an accuracy of less than 50%, whereas one (a fellow) was 81% accurate.
The researchers note that publications about ChatGPT in PubMed grew 10-fold from Feb. 3 to April 14, 2023, with topics such as board examinations authorship, editorial policies, medical education, and clinical decision support.
Although in their early days, ChatGPT and other AI bots may represent a “transformative innovation” in how medical information is created by physicians and consumed by patients, they say.
It could also be a time-saver for health care professionals.
“AI-generated medical information, with appropriate provider oversight, accreditation, and periodic surveillance, could improve efficiency of care and free providers for more cognitively intensive patient communications,” they add.
However, several challenges remain, such as the lack of clinical evidence in constructing AI-generated answers.
In addition, AI-generated answers were written at significantly higher reading levels than were answers on hospital websites, which could be a barrier for some patients.
The study received no specific funding. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
, new research suggests.
“This study shows that a conversational AI program can generate credible medical information in response to common patient questions,” say the investigators, led by Tsung-Chun Lee, MD, division of gastroenterology and hepatology, Taipei Medical University Shuang Ho Hospital, New Taipei City, Taiwan.
“With dedicated domain training, there is meaningful potential to optimize clinical communication to patients undergoing colonoscopy,” they add.
The study was published online in Gastroenterology.
ChatGPT, developed by OpenAI, is a natural language processing tool that allows users to have personalized conversations with an artificial intelligence (AI) bot capable of providing a detailed response to any question posed.
For their first-of-its-kind study, Dr. Lee and colleagues assessed the quality of ChatGPT-generated answers to eight common patient questions about colonoscopy, including what a colonoscopy entails, why it’s performed, how to prepare for it, potential complications, what to expect after the procedure, and what happens with a positive/negative result.
They retrieved the questions from the websites of three randomly selected top hospitals for gastroenterology and gastrointestinal surgery and had ChatGPT (Jan. 30, 2023, version) answer the questions twice.
Using plagiarism detection software, they found that text similarity was extremely low between ChatGPT answers and those on hospital websites (0%-16%). Text similarity ranged from 28% to 77% between the two ChatGPT answers for the same question, except on the question of what to do after a positive colonoscopy result, which had 0% text similarity.
To objectively gauge the quality of the ChatGPT answers, four gastroenterologists (two senior gastroenterologists and two fellows) rated 36 pairs of common questions and answers on a seven-point Likert scale according to ease of understanding, scientific adequacy, and satisfaction with the answer.
The gastroenterologists rated the ChatGPT answers highly and similarly to non-AI answers for all three quality indicators, with some AI scores even higher than non-AI scores.
Interestingly, they could correctly identify AI-generated answers only 48% of the time. Three raters had an accuracy of less than 50%, whereas one (a fellow) was 81% accurate.
The researchers note that publications about ChatGPT in PubMed grew 10-fold from Feb. 3 to April 14, 2023, with topics such as board examinations authorship, editorial policies, medical education, and clinical decision support.
Although in their early days, ChatGPT and other AI bots may represent a “transformative innovation” in how medical information is created by physicians and consumed by patients, they say.
It could also be a time-saver for health care professionals.
“AI-generated medical information, with appropriate provider oversight, accreditation, and periodic surveillance, could improve efficiency of care and free providers for more cognitively intensive patient communications,” they add.
However, several challenges remain, such as the lack of clinical evidence in constructing AI-generated answers.
In addition, AI-generated answers were written at significantly higher reading levels than were answers on hospital websites, which could be a barrier for some patients.
The study received no specific funding. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
, new research suggests.
“This study shows that a conversational AI program can generate credible medical information in response to common patient questions,” say the investigators, led by Tsung-Chun Lee, MD, division of gastroenterology and hepatology, Taipei Medical University Shuang Ho Hospital, New Taipei City, Taiwan.
“With dedicated domain training, there is meaningful potential to optimize clinical communication to patients undergoing colonoscopy,” they add.
The study was published online in Gastroenterology.
ChatGPT, developed by OpenAI, is a natural language processing tool that allows users to have personalized conversations with an artificial intelligence (AI) bot capable of providing a detailed response to any question posed.
For their first-of-its-kind study, Dr. Lee and colleagues assessed the quality of ChatGPT-generated answers to eight common patient questions about colonoscopy, including what a colonoscopy entails, why it’s performed, how to prepare for it, potential complications, what to expect after the procedure, and what happens with a positive/negative result.
They retrieved the questions from the websites of three randomly selected top hospitals for gastroenterology and gastrointestinal surgery and had ChatGPT (Jan. 30, 2023, version) answer the questions twice.
Using plagiarism detection software, they found that text similarity was extremely low between ChatGPT answers and those on hospital websites (0%-16%). Text similarity ranged from 28% to 77% between the two ChatGPT answers for the same question, except on the question of what to do after a positive colonoscopy result, which had 0% text similarity.
To objectively gauge the quality of the ChatGPT answers, four gastroenterologists (two senior gastroenterologists and two fellows) rated 36 pairs of common questions and answers on a seven-point Likert scale according to ease of understanding, scientific adequacy, and satisfaction with the answer.
The gastroenterologists rated the ChatGPT answers highly and similarly to non-AI answers for all three quality indicators, with some AI scores even higher than non-AI scores.
Interestingly, they could correctly identify AI-generated answers only 48% of the time. Three raters had an accuracy of less than 50%, whereas one (a fellow) was 81% accurate.
The researchers note that publications about ChatGPT in PubMed grew 10-fold from Feb. 3 to April 14, 2023, with topics such as board examinations authorship, editorial policies, medical education, and clinical decision support.
Although in their early days, ChatGPT and other AI bots may represent a “transformative innovation” in how medical information is created by physicians and consumed by patients, they say.
It could also be a time-saver for health care professionals.
“AI-generated medical information, with appropriate provider oversight, accreditation, and periodic surveillance, could improve efficiency of care and free providers for more cognitively intensive patient communications,” they add.
However, several challenges remain, such as the lack of clinical evidence in constructing AI-generated answers.
In addition, AI-generated answers were written at significantly higher reading levels than were answers on hospital websites, which could be a barrier for some patients.
The study received no specific funding. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM GASTROENTEROLOGY
Anxiety high among Americans, national poll shows
results of a national mental health poll conducted by the American Psychiatric Association (APA) show.
“There is a lot of worry in the world right now about economic uncertainty, about violence, about how we’re going to come out of this period of time,” APA President Rebecca W. Brendel, MD, JD, said during an APA press briefing announcing the latest poll results.
Brendel said the results are an important reminder and opportunity for psychiatrists to put their finger on the pulse of Americans’ mental health.
“If 70% of people are feeling unsafe, we need to come up with individual and also society-based solutions to help people move forward so that we can see a brighter future and not experience so much anxiety,” she added.
The poll was conducted between April 20 and 22, 2023, among a nationally representative sample of 2,201 adults. The analysis also tracks data from a poll conducted between April 23 and 24, 2022, among a sample of 2,210 adults.
Overall, nearly two in five adults (37%) reported feeling more anxious than they were at this time last year, which is higher than in 2022 (32%) but lower than in 2021 (41%) and 2020 (62%).
About one-third (30%) of adults said they have consulted a mental health care professional, a slight uptick from 2022.
Other issues keeping Americans up at night include keeping their identity safe (68%), their health (66%), paying bills or expenses (65%), climate change (59%), the opioid epidemic (50%) and the impact of emerging technology on day-to-day life (45%).
Half of respondents reported they would be likely to consider a mental health treatment involving cannabis or marijuana, while most said they would be unlikely to consider a treatment involving psychedelics (59%) or ketamine (56%).
Two-thirds (68%) of American adults reported that their children and teenagers have more mental health problems than they did a decade ago.
More than 50% of parents are concerned about their children’s technology use (59%) and mental state (55%), and 31% have encountered difficulty scheduling appointments with mental health professionals for their children.
More than three-quarters (78%) of U.S. adults believe mental health affects physical health and that untreated mental illness has a significant negative effect on families (78%). About two-thirds (64%) believe untreated mental illness harms the economy.
One in three adults (34%) would not vote for a candidate for elected office who has a mental illness – up 7% from 2022.
“The majority of the public understands something we’ve been saying for a long time: Your mental health is about your health,” Saul Levin, MD, MPA, chief executive officer and medical director at the American Psychiatric Association, said in the release.
“It’s contingent upon us as a field to continue to spread that message, and that those who are experiencing mental health concerns aren’t alone and that there are ways to receive help,” Dr. Levin added.
A version of this article originally appeared on Medscape.com.
results of a national mental health poll conducted by the American Psychiatric Association (APA) show.
“There is a lot of worry in the world right now about economic uncertainty, about violence, about how we’re going to come out of this period of time,” APA President Rebecca W. Brendel, MD, JD, said during an APA press briefing announcing the latest poll results.
Brendel said the results are an important reminder and opportunity for psychiatrists to put their finger on the pulse of Americans’ mental health.
“If 70% of people are feeling unsafe, we need to come up with individual and also society-based solutions to help people move forward so that we can see a brighter future and not experience so much anxiety,” she added.
The poll was conducted between April 20 and 22, 2023, among a nationally representative sample of 2,201 adults. The analysis also tracks data from a poll conducted between April 23 and 24, 2022, among a sample of 2,210 adults.
Overall, nearly two in five adults (37%) reported feeling more anxious than they were at this time last year, which is higher than in 2022 (32%) but lower than in 2021 (41%) and 2020 (62%).
About one-third (30%) of adults said they have consulted a mental health care professional, a slight uptick from 2022.
Other issues keeping Americans up at night include keeping their identity safe (68%), their health (66%), paying bills or expenses (65%), climate change (59%), the opioid epidemic (50%) and the impact of emerging technology on day-to-day life (45%).
Half of respondents reported they would be likely to consider a mental health treatment involving cannabis or marijuana, while most said they would be unlikely to consider a treatment involving psychedelics (59%) or ketamine (56%).
Two-thirds (68%) of American adults reported that their children and teenagers have more mental health problems than they did a decade ago.
More than 50% of parents are concerned about their children’s technology use (59%) and mental state (55%), and 31% have encountered difficulty scheduling appointments with mental health professionals for their children.
More than three-quarters (78%) of U.S. adults believe mental health affects physical health and that untreated mental illness has a significant negative effect on families (78%). About two-thirds (64%) believe untreated mental illness harms the economy.
One in three adults (34%) would not vote for a candidate for elected office who has a mental illness – up 7% from 2022.
“The majority of the public understands something we’ve been saying for a long time: Your mental health is about your health,” Saul Levin, MD, MPA, chief executive officer and medical director at the American Psychiatric Association, said in the release.
“It’s contingent upon us as a field to continue to spread that message, and that those who are experiencing mental health concerns aren’t alone and that there are ways to receive help,” Dr. Levin added.
A version of this article originally appeared on Medscape.com.
results of a national mental health poll conducted by the American Psychiatric Association (APA) show.
“There is a lot of worry in the world right now about economic uncertainty, about violence, about how we’re going to come out of this period of time,” APA President Rebecca W. Brendel, MD, JD, said during an APA press briefing announcing the latest poll results.
Brendel said the results are an important reminder and opportunity for psychiatrists to put their finger on the pulse of Americans’ mental health.
“If 70% of people are feeling unsafe, we need to come up with individual and also society-based solutions to help people move forward so that we can see a brighter future and not experience so much anxiety,” she added.
The poll was conducted between April 20 and 22, 2023, among a nationally representative sample of 2,201 adults. The analysis also tracks data from a poll conducted between April 23 and 24, 2022, among a sample of 2,210 adults.
Overall, nearly two in five adults (37%) reported feeling more anxious than they were at this time last year, which is higher than in 2022 (32%) but lower than in 2021 (41%) and 2020 (62%).
About one-third (30%) of adults said they have consulted a mental health care professional, a slight uptick from 2022.
Other issues keeping Americans up at night include keeping their identity safe (68%), their health (66%), paying bills or expenses (65%), climate change (59%), the opioid epidemic (50%) and the impact of emerging technology on day-to-day life (45%).
Half of respondents reported they would be likely to consider a mental health treatment involving cannabis or marijuana, while most said they would be unlikely to consider a treatment involving psychedelics (59%) or ketamine (56%).
Two-thirds (68%) of American adults reported that their children and teenagers have more mental health problems than they did a decade ago.
More than 50% of parents are concerned about their children’s technology use (59%) and mental state (55%), and 31% have encountered difficulty scheduling appointments with mental health professionals for their children.
More than three-quarters (78%) of U.S. adults believe mental health affects physical health and that untreated mental illness has a significant negative effect on families (78%). About two-thirds (64%) believe untreated mental illness harms the economy.
One in three adults (34%) would not vote for a candidate for elected office who has a mental illness – up 7% from 2022.
“The majority of the public understands something we’ve been saying for a long time: Your mental health is about your health,” Saul Levin, MD, MPA, chief executive officer and medical director at the American Psychiatric Association, said in the release.
“It’s contingent upon us as a field to continue to spread that message, and that those who are experiencing mental health concerns aren’t alone and that there are ways to receive help,” Dr. Levin added.
A version of this article originally appeared on Medscape.com.
FDA OKs new drug for Fabry disease
Fabry disease is a rare inherited X-linked lysosomal disorder caused by a deficiency of the enzyme alpha-galactosidase A (GLA), which leads to the buildup of globotriaosylceramide (GL-3) in blood vessels, kidneys, the heart, nerves, and other organs, increasing the risk for kidney failure, myocardial infarction, stroke, and other problems.
Elfabrio delivers a functional version of GLA. It’s given by intravenous infusion every 2 weeks.
Evidence for safety, tolerability, and efficacy of Elfabrio stems from a comprehensive clinical program in more than 140 patients with up to 7.5 years of follow up treatment.
It has been studied in both ERT-naïve and ERT-experienced patients. In one head-to-head trial, Elfabrio was non-inferior in safety and efficacy to agalsidase beta (Fabrazyme, Sanofi Genzyme), the companies said in a press statement announcing approval.
“The totality of clinical data suggests that Elfabrio has the potential to be a long-lasting therapy,” Dror Bashan, president and CEO of Protalix, said in the statement.
Patients treated with Elfabrio have experienced hypersensitivity reactions, including anaphylaxis. In clinical trials, 20 (14%) patients treated with Elfabrio experienced hypersensitivity reactions; 4 patients (3%) experienced anaphylaxis reactions that occurred within 5-40 minutes of the start of the initial infusion.
Before administering Elfabrio, pretreatment with antihistamines, antipyretics, and/or corticosteroids should be considered, the label advises.
Patients and caregivers should be informed of the signs and symptoms of hypersensitivity reactions and infusion-associated reactions and instructed to seek medical care immediately if such symptoms occur.
A case of membranoproliferative glomerulonephritis with immune depositions in the kidney was reported during clinical trials. Monitoring serum creatinine and urinary protein-to-creatinine ratio is advised. If glomerulonephritis is suspected, treatment should be stopped until a diagnostic evaluation can be conducted.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
Fabry disease is a rare inherited X-linked lysosomal disorder caused by a deficiency of the enzyme alpha-galactosidase A (GLA), which leads to the buildup of globotriaosylceramide (GL-3) in blood vessels, kidneys, the heart, nerves, and other organs, increasing the risk for kidney failure, myocardial infarction, stroke, and other problems.
Elfabrio delivers a functional version of GLA. It’s given by intravenous infusion every 2 weeks.
Evidence for safety, tolerability, and efficacy of Elfabrio stems from a comprehensive clinical program in more than 140 patients with up to 7.5 years of follow up treatment.
It has been studied in both ERT-naïve and ERT-experienced patients. In one head-to-head trial, Elfabrio was non-inferior in safety and efficacy to agalsidase beta (Fabrazyme, Sanofi Genzyme), the companies said in a press statement announcing approval.
“The totality of clinical data suggests that Elfabrio has the potential to be a long-lasting therapy,” Dror Bashan, president and CEO of Protalix, said in the statement.
Patients treated with Elfabrio have experienced hypersensitivity reactions, including anaphylaxis. In clinical trials, 20 (14%) patients treated with Elfabrio experienced hypersensitivity reactions; 4 patients (3%) experienced anaphylaxis reactions that occurred within 5-40 minutes of the start of the initial infusion.
Before administering Elfabrio, pretreatment with antihistamines, antipyretics, and/or corticosteroids should be considered, the label advises.
Patients and caregivers should be informed of the signs and symptoms of hypersensitivity reactions and infusion-associated reactions and instructed to seek medical care immediately if such symptoms occur.
A case of membranoproliferative glomerulonephritis with immune depositions in the kidney was reported during clinical trials. Monitoring serum creatinine and urinary protein-to-creatinine ratio is advised. If glomerulonephritis is suspected, treatment should be stopped until a diagnostic evaluation can be conducted.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
Fabry disease is a rare inherited X-linked lysosomal disorder caused by a deficiency of the enzyme alpha-galactosidase A (GLA), which leads to the buildup of globotriaosylceramide (GL-3) in blood vessels, kidneys, the heart, nerves, and other organs, increasing the risk for kidney failure, myocardial infarction, stroke, and other problems.
Elfabrio delivers a functional version of GLA. It’s given by intravenous infusion every 2 weeks.
Evidence for safety, tolerability, and efficacy of Elfabrio stems from a comprehensive clinical program in more than 140 patients with up to 7.5 years of follow up treatment.
It has been studied in both ERT-naïve and ERT-experienced patients. In one head-to-head trial, Elfabrio was non-inferior in safety and efficacy to agalsidase beta (Fabrazyme, Sanofi Genzyme), the companies said in a press statement announcing approval.
“The totality of clinical data suggests that Elfabrio has the potential to be a long-lasting therapy,” Dror Bashan, president and CEO of Protalix, said in the statement.
Patients treated with Elfabrio have experienced hypersensitivity reactions, including anaphylaxis. In clinical trials, 20 (14%) patients treated with Elfabrio experienced hypersensitivity reactions; 4 patients (3%) experienced anaphylaxis reactions that occurred within 5-40 minutes of the start of the initial infusion.
Before administering Elfabrio, pretreatment with antihistamines, antipyretics, and/or corticosteroids should be considered, the label advises.
Patients and caregivers should be informed of the signs and symptoms of hypersensitivity reactions and infusion-associated reactions and instructed to seek medical care immediately if such symptoms occur.
A case of membranoproliferative glomerulonephritis with immune depositions in the kidney was reported during clinical trials. Monitoring serum creatinine and urinary protein-to-creatinine ratio is advised. If glomerulonephritis is suspected, treatment should be stopped until a diagnostic evaluation can be conducted.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
FDA approves first drug to treat Alzheimer’s agitation
(AD), making it the first FDA-approved drug for this indication.
“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a news release.
Agitation can include symptoms that range from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Dr. Farchione said.
Brexpiprazole was approved by the FDA in 2015 as an adjunctive therapy to antidepressants for adults with major depressive disorder and for adults with schizophrenia.
Approval of the supplemental application for brexpiprazole for agitation associated with AD dementia was based on results of two randomized, double-blind, placebo-controlled studies.
In both studies, patients who received 2 mg or 3 mg of brexpiprazole showed statistically significant and clinically meaningful improvements in agitation symptoms, as shown by total Cohen-Mansfield Agitation Inventory (CMAI) score, compared with patients who received placebo.
The recommended starting dosage for the treatment of agitation associated with AD dementia is 0.5 mg once daily on days 1-7; it was increased to 1 mg once daily on days 8-14 and then to the recommended target dose of 2 mg once daily.
The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, depending on clinical response and tolerability.
The most common side effects of brexpiprazole in patients with agitation associated with AD dementia include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances.
The drug includes a boxed warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The supplemental application for brexpiprazole for agitation had fast-track designation.
A version of this article first appeared on Medscape.com.
(AD), making it the first FDA-approved drug for this indication.
“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a news release.
Agitation can include symptoms that range from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Dr. Farchione said.
Brexpiprazole was approved by the FDA in 2015 as an adjunctive therapy to antidepressants for adults with major depressive disorder and for adults with schizophrenia.
Approval of the supplemental application for brexpiprazole for agitation associated with AD dementia was based on results of two randomized, double-blind, placebo-controlled studies.
In both studies, patients who received 2 mg or 3 mg of brexpiprazole showed statistically significant and clinically meaningful improvements in agitation symptoms, as shown by total Cohen-Mansfield Agitation Inventory (CMAI) score, compared with patients who received placebo.
The recommended starting dosage for the treatment of agitation associated with AD dementia is 0.5 mg once daily on days 1-7; it was increased to 1 mg once daily on days 8-14 and then to the recommended target dose of 2 mg once daily.
The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, depending on clinical response and tolerability.
The most common side effects of brexpiprazole in patients with agitation associated with AD dementia include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances.
The drug includes a boxed warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The supplemental application for brexpiprazole for agitation had fast-track designation.
A version of this article first appeared on Medscape.com.
(AD), making it the first FDA-approved drug for this indication.
“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a news release.
Agitation can include symptoms that range from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Dr. Farchione said.
Brexpiprazole was approved by the FDA in 2015 as an adjunctive therapy to antidepressants for adults with major depressive disorder and for adults with schizophrenia.
Approval of the supplemental application for brexpiprazole for agitation associated with AD dementia was based on results of two randomized, double-blind, placebo-controlled studies.
In both studies, patients who received 2 mg or 3 mg of brexpiprazole showed statistically significant and clinically meaningful improvements in agitation symptoms, as shown by total Cohen-Mansfield Agitation Inventory (CMAI) score, compared with patients who received placebo.
The recommended starting dosage for the treatment of agitation associated with AD dementia is 0.5 mg once daily on days 1-7; it was increased to 1 mg once daily on days 8-14 and then to the recommended target dose of 2 mg once daily.
The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, depending on clinical response and tolerability.
The most common side effects of brexpiprazole in patients with agitation associated with AD dementia include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances.
The drug includes a boxed warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The supplemental application for brexpiprazole for agitation had fast-track designation.
A version of this article first appeared on Medscape.com.
FDA expands use of dapagliflozin to broader range of HF
– including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).
The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).
The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.
In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.
In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.
The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.
The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.
A version of this article first appeared on Medscape.com.
– including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).
The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).
The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.
In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.
In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.
The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.
The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.
A version of this article first appeared on Medscape.com.
– including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).
The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).
The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.
In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.
In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.
The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.
The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.
A version of this article first appeared on Medscape.com.