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FDA clears endoscopic devices for sleeve gastroplasty, bariatric revision
The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.
The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.
“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.
The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.
The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.
Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.
TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.
The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.
“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.
The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.
The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.
Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.
TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.
The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.
“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.
The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.
The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.
Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.
TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.
A version of this article first appeared on Medscape.com.
Safest, most effective medications for spine-related pain in older adults?
, a new comprehensive literature review suggests.
Investigators assessed the evidence for medications used for this indication in older adults by reviewing 138 double-blind, placebo-controlled trials.
Among their key findings and recommendations: Acetaminophen has a favorable safety profile for spine-related pain but nonsteroidal anti-inflammatory drugs (NSAIDs) have greater efficacy.
However, NSAIDs should be used in lower doses in the short term, with gastrointestinal precaution, the researchers note.
Corticosteroids have the least evidence for treating nonspecific back pain, they add.
“Most older people experience neck or low back pain at some point, bothersome enough to see their doctor,” coinvestigator Michael Perloff, MD, PhD, department of neurology, Boston University, said in a news release.
“Our findings provide a helpful medication guide for physicians to use for spine pain in an older population that can have a complex medical history,” Dr. Perloff added.
The results were published online in Drugs and Aging.
Recommendations, warnings
With the graying of the U.S. population, spine-related pain is increasingly common, the investigators note.
Medications play an important role in pain management, but their use has limitations in the elderly, owing to reduced liver and renal function, comorbid medical problems, and polypharmacy.
Other key findings from the literature review include that, although the nerve pain medications gabapentin and pregabalin may cause dizziness or difficulty walking, they also have some demonstrated benefit for neck and back nerve pain, such as sciatica, in older adults.
These agents should be used in lower doses with smaller dose adjustments, the researchers note.
They caution that the muscle relaxants carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone, methocarbamol, and orphenadrine should be avoided in older adults because of their association with risk for sedation and falls.
‘Rational therapeutic choices’
Three other muscle relaxants – tizanidine, baclofen, and dantrolene – may be helpful for neck and back pain. The most evidence favors tizanidine and baclofen. These should be used in reduced doses. Tizanidine should be avoided in patients with liver disease, and for patients with kidney disease, the dosing of baclofen should be reduced, the investigators write.
Other findings include the following:
- Older tricyclic antidepressants should typically be avoided in this population because of their side effects, but nortriptyline and desipramine may be better tolerated for neck and back nerve pain at lower doses.
- Newer antidepressants, particularly the selective serotonin-norepinephrine reuptake inhibitor duloxetine, have a better safety profile and good efficacy for spine-related nerve pain.
- Traditional opioids are typically avoided in the treatment of spine-related pain in older adults, owing to their associated risks.
However, low-dose opioid therapy may be helpful for severe refractory pain, with close monitoring of patients, the researchers note.
Weaker opioids, such as tramadol, may be better tolerated by older patients. They work well when combined with acetaminophen, but they carry the risk for sedation, upset stomach, and constipation.
“Medications used at the correct dose, for the correct diagnosis, adjusting for preexisting medical problems can result in better use of treatments for spine pain,” coinvestigator Jonathan Fu, MD, also with the department of neurology, Boston University, said in the release.
“Rational therapeutic choices should be targeted to spine pain diagnosis, such as NSAIDs and acetaminophen for arthritic and myofascial-based complaints, gabapentinoids or duloxetine for neuropathic and radicular symptoms, antispastic agents for myofascial-based pain, and combination therapy for mixed etiologies,” the investigators write.
They also emphasize that medications should be coupled with physical therapy and exercise programs, as well as treatment of the underlying degenerative disease process and medical illness, while keeping in mind the need for possible interventions and/or corrective surgery.
The research had no specific funding. The investigators have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new comprehensive literature review suggests.
Investigators assessed the evidence for medications used for this indication in older adults by reviewing 138 double-blind, placebo-controlled trials.
Among their key findings and recommendations: Acetaminophen has a favorable safety profile for spine-related pain but nonsteroidal anti-inflammatory drugs (NSAIDs) have greater efficacy.
However, NSAIDs should be used in lower doses in the short term, with gastrointestinal precaution, the researchers note.
Corticosteroids have the least evidence for treating nonspecific back pain, they add.
“Most older people experience neck or low back pain at some point, bothersome enough to see their doctor,” coinvestigator Michael Perloff, MD, PhD, department of neurology, Boston University, said in a news release.
“Our findings provide a helpful medication guide for physicians to use for spine pain in an older population that can have a complex medical history,” Dr. Perloff added.
The results were published online in Drugs and Aging.
Recommendations, warnings
With the graying of the U.S. population, spine-related pain is increasingly common, the investigators note.
Medications play an important role in pain management, but their use has limitations in the elderly, owing to reduced liver and renal function, comorbid medical problems, and polypharmacy.
Other key findings from the literature review include that, although the nerve pain medications gabapentin and pregabalin may cause dizziness or difficulty walking, they also have some demonstrated benefit for neck and back nerve pain, such as sciatica, in older adults.
These agents should be used in lower doses with smaller dose adjustments, the researchers note.
They caution that the muscle relaxants carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone, methocarbamol, and orphenadrine should be avoided in older adults because of their association with risk for sedation and falls.
‘Rational therapeutic choices’
Three other muscle relaxants – tizanidine, baclofen, and dantrolene – may be helpful for neck and back pain. The most evidence favors tizanidine and baclofen. These should be used in reduced doses. Tizanidine should be avoided in patients with liver disease, and for patients with kidney disease, the dosing of baclofen should be reduced, the investigators write.
Other findings include the following:
- Older tricyclic antidepressants should typically be avoided in this population because of their side effects, but nortriptyline and desipramine may be better tolerated for neck and back nerve pain at lower doses.
- Newer antidepressants, particularly the selective serotonin-norepinephrine reuptake inhibitor duloxetine, have a better safety profile and good efficacy for spine-related nerve pain.
- Traditional opioids are typically avoided in the treatment of spine-related pain in older adults, owing to their associated risks.
However, low-dose opioid therapy may be helpful for severe refractory pain, with close monitoring of patients, the researchers note.
Weaker opioids, such as tramadol, may be better tolerated by older patients. They work well when combined with acetaminophen, but they carry the risk for sedation, upset stomach, and constipation.
“Medications used at the correct dose, for the correct diagnosis, adjusting for preexisting medical problems can result in better use of treatments for spine pain,” coinvestigator Jonathan Fu, MD, also with the department of neurology, Boston University, said in the release.
“Rational therapeutic choices should be targeted to spine pain diagnosis, such as NSAIDs and acetaminophen for arthritic and myofascial-based complaints, gabapentinoids or duloxetine for neuropathic and radicular symptoms, antispastic agents for myofascial-based pain, and combination therapy for mixed etiologies,” the investigators write.
They also emphasize that medications should be coupled with physical therapy and exercise programs, as well as treatment of the underlying degenerative disease process and medical illness, while keeping in mind the need for possible interventions and/or corrective surgery.
The research had no specific funding. The investigators have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new comprehensive literature review suggests.
Investigators assessed the evidence for medications used for this indication in older adults by reviewing 138 double-blind, placebo-controlled trials.
Among their key findings and recommendations: Acetaminophen has a favorable safety profile for spine-related pain but nonsteroidal anti-inflammatory drugs (NSAIDs) have greater efficacy.
However, NSAIDs should be used in lower doses in the short term, with gastrointestinal precaution, the researchers note.
Corticosteroids have the least evidence for treating nonspecific back pain, they add.
“Most older people experience neck or low back pain at some point, bothersome enough to see their doctor,” coinvestigator Michael Perloff, MD, PhD, department of neurology, Boston University, said in a news release.
“Our findings provide a helpful medication guide for physicians to use for spine pain in an older population that can have a complex medical history,” Dr. Perloff added.
The results were published online in Drugs and Aging.
Recommendations, warnings
With the graying of the U.S. population, spine-related pain is increasingly common, the investigators note.
Medications play an important role in pain management, but their use has limitations in the elderly, owing to reduced liver and renal function, comorbid medical problems, and polypharmacy.
Other key findings from the literature review include that, although the nerve pain medications gabapentin and pregabalin may cause dizziness or difficulty walking, they also have some demonstrated benefit for neck and back nerve pain, such as sciatica, in older adults.
These agents should be used in lower doses with smaller dose adjustments, the researchers note.
They caution that the muscle relaxants carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone, methocarbamol, and orphenadrine should be avoided in older adults because of their association with risk for sedation and falls.
‘Rational therapeutic choices’
Three other muscle relaxants – tizanidine, baclofen, and dantrolene – may be helpful for neck and back pain. The most evidence favors tizanidine and baclofen. These should be used in reduced doses. Tizanidine should be avoided in patients with liver disease, and for patients with kidney disease, the dosing of baclofen should be reduced, the investigators write.
Other findings include the following:
- Older tricyclic antidepressants should typically be avoided in this population because of their side effects, but nortriptyline and desipramine may be better tolerated for neck and back nerve pain at lower doses.
- Newer antidepressants, particularly the selective serotonin-norepinephrine reuptake inhibitor duloxetine, have a better safety profile and good efficacy for spine-related nerve pain.
- Traditional opioids are typically avoided in the treatment of spine-related pain in older adults, owing to their associated risks.
However, low-dose opioid therapy may be helpful for severe refractory pain, with close monitoring of patients, the researchers note.
Weaker opioids, such as tramadol, may be better tolerated by older patients. They work well when combined with acetaminophen, but they carry the risk for sedation, upset stomach, and constipation.
“Medications used at the correct dose, for the correct diagnosis, adjusting for preexisting medical problems can result in better use of treatments for spine pain,” coinvestigator Jonathan Fu, MD, also with the department of neurology, Boston University, said in the release.
“Rational therapeutic choices should be targeted to spine pain diagnosis, such as NSAIDs and acetaminophen for arthritic and myofascial-based complaints, gabapentinoids or duloxetine for neuropathic and radicular symptoms, antispastic agents for myofascial-based pain, and combination therapy for mixed etiologies,” the investigators write.
They also emphasize that medications should be coupled with physical therapy and exercise programs, as well as treatment of the underlying degenerative disease process and medical illness, while keeping in mind the need for possible interventions and/or corrective surgery.
The research had no specific funding. The investigators have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM DRUGS AND AGING
Anxiety spreads from mother to daughter, father to son
The new findings suggest that children learn anxious behavior from their parents, study investigator Barbara Pavlova, PhD, clinical psychologist with Nova Scotia Health Authority, told this news organization.
“This means that transmission of anxiety from parents to children may be preventable,” said Dr. Pavlova, assistant professor, department of psychiatry, Dalhousie University, Halifax, Canada.
“Treating parents’ anxiety is not just important for their own health but also for the health of their children. This may be especially true if the child and the parent are the same sex,” Dr. Pavlova added.
The study was published online in JAMA Network Open.
Parental anxiety a disruptor
Anxiety disorders run in families. Both genes and environment are thought to be at play, but there are few data on sex-specific transmission from parent to child.
To investigate, the researchers conducted a cross-sectional study of 203 girls and 195 boys and their parents. The average age of the children was 11 years, and they had a familial risk for mood disorders.
Anxiety disorder in a same-sex parent was significantly associated with anxiety disorder in offspring (odds ratio, 2.85; 95% confidence interval, 1.52-5.34; P = .001) but not in an opposite-sex parent (OR, 1.51; 95% CI, 0.81-2.81; P = .20).
Living with a same-sex parent without anxiety was associated with lower rates of offspring anxiety (OR, 0.38; 95% CI, 0.22-0.67; P = .001).
Among all 398 children, 108 (27%) had been diagnosed with one or more anxiety disorders, including generalized anxiety disorder (7.8%), social anxiety disorder (6.3%), separation anxiety disorder (8.6%), specific phobia (8%), and anxiety disorder not otherwise specified (5%).
Rates of anxiety disorders in children increased with age, from 14% in those younger than 9 years to 52% in those older than 15 years. Anxiety disorders were similarly common among boys (24%) and girls (30%).
Rates of anxiety disorders were lowest (24%) in children of two parents without anxiety disorders and highest (41%) in cases in which both parents had anxiety disorders.
The findings point to the possible role of environmental factors, “such as modeling and vicarious learning,” in the transmission of anxiety from parents to their children, the researchers note.
“A child receives [a] similar amount of genetic information from each biological parent. A strong same-sex parent effect suggests children learn resilience by modeling the behavior of their same-sex parent. A parent’s anxiety disorder may disrupt this protective learning,” said Dr. Pavlova.
Early diagnosis, treatment essential
Reached for comment, Jill Emanuele, PhD, vice president of clinical training for the Child MIND Institute, New York, said that when it comes to anxiety, it’s important to assess and treat both the parent and the child.
“We know that both environment and genetics play a role in anxiety disorders. From a clinical perspective, if we see a parent with an anxiety disorder, we know that there is a chance that that is also going to affect the child – whether or not the child has an anxiety disorder,” Dr. Emanuele said in an interview.
“Anxiety disorders are the most common psychiatric disorders diagnosed. We also know that anxiety disorders emerge earlier than mood disorders and certainly can emerge in childhood. It’s important to address anxiety early because those same problems can continue into adulthood if left untreated,” Dr. Emanuele added.
The study was supported by the Canada Research Chairs Program, the Canadian Institutes of Health Research, the Brain & Behavior Research Foundation, the Nova Scotia Health Research Foundation, and the Dalhousie Medical Research Foundation. The authors have disclosed no relevant financial relationships. Dr. Emanuele is a board member with the Anxiety and Depression Association of America.
A version of this article first appeared on Medscape.com.
The new findings suggest that children learn anxious behavior from their parents, study investigator Barbara Pavlova, PhD, clinical psychologist with Nova Scotia Health Authority, told this news organization.
“This means that transmission of anxiety from parents to children may be preventable,” said Dr. Pavlova, assistant professor, department of psychiatry, Dalhousie University, Halifax, Canada.
“Treating parents’ anxiety is not just important for their own health but also for the health of their children. This may be especially true if the child and the parent are the same sex,” Dr. Pavlova added.
The study was published online in JAMA Network Open.
Parental anxiety a disruptor
Anxiety disorders run in families. Both genes and environment are thought to be at play, but there are few data on sex-specific transmission from parent to child.
To investigate, the researchers conducted a cross-sectional study of 203 girls and 195 boys and their parents. The average age of the children was 11 years, and they had a familial risk for mood disorders.
Anxiety disorder in a same-sex parent was significantly associated with anxiety disorder in offspring (odds ratio, 2.85; 95% confidence interval, 1.52-5.34; P = .001) but not in an opposite-sex parent (OR, 1.51; 95% CI, 0.81-2.81; P = .20).
Living with a same-sex parent without anxiety was associated with lower rates of offspring anxiety (OR, 0.38; 95% CI, 0.22-0.67; P = .001).
Among all 398 children, 108 (27%) had been diagnosed with one or more anxiety disorders, including generalized anxiety disorder (7.8%), social anxiety disorder (6.3%), separation anxiety disorder (8.6%), specific phobia (8%), and anxiety disorder not otherwise specified (5%).
Rates of anxiety disorders in children increased with age, from 14% in those younger than 9 years to 52% in those older than 15 years. Anxiety disorders were similarly common among boys (24%) and girls (30%).
Rates of anxiety disorders were lowest (24%) in children of two parents without anxiety disorders and highest (41%) in cases in which both parents had anxiety disorders.
The findings point to the possible role of environmental factors, “such as modeling and vicarious learning,” in the transmission of anxiety from parents to their children, the researchers note.
“A child receives [a] similar amount of genetic information from each biological parent. A strong same-sex parent effect suggests children learn resilience by modeling the behavior of their same-sex parent. A parent’s anxiety disorder may disrupt this protective learning,” said Dr. Pavlova.
Early diagnosis, treatment essential
Reached for comment, Jill Emanuele, PhD, vice president of clinical training for the Child MIND Institute, New York, said that when it comes to anxiety, it’s important to assess and treat both the parent and the child.
“We know that both environment and genetics play a role in anxiety disorders. From a clinical perspective, if we see a parent with an anxiety disorder, we know that there is a chance that that is also going to affect the child – whether or not the child has an anxiety disorder,” Dr. Emanuele said in an interview.
“Anxiety disorders are the most common psychiatric disorders diagnosed. We also know that anxiety disorders emerge earlier than mood disorders and certainly can emerge in childhood. It’s important to address anxiety early because those same problems can continue into adulthood if left untreated,” Dr. Emanuele added.
The study was supported by the Canada Research Chairs Program, the Canadian Institutes of Health Research, the Brain & Behavior Research Foundation, the Nova Scotia Health Research Foundation, and the Dalhousie Medical Research Foundation. The authors have disclosed no relevant financial relationships. Dr. Emanuele is a board member with the Anxiety and Depression Association of America.
A version of this article first appeared on Medscape.com.
The new findings suggest that children learn anxious behavior from their parents, study investigator Barbara Pavlova, PhD, clinical psychologist with Nova Scotia Health Authority, told this news organization.
“This means that transmission of anxiety from parents to children may be preventable,” said Dr. Pavlova, assistant professor, department of psychiatry, Dalhousie University, Halifax, Canada.
“Treating parents’ anxiety is not just important for their own health but also for the health of their children. This may be especially true if the child and the parent are the same sex,” Dr. Pavlova added.
The study was published online in JAMA Network Open.
Parental anxiety a disruptor
Anxiety disorders run in families. Both genes and environment are thought to be at play, but there are few data on sex-specific transmission from parent to child.
To investigate, the researchers conducted a cross-sectional study of 203 girls and 195 boys and their parents. The average age of the children was 11 years, and they had a familial risk for mood disorders.
Anxiety disorder in a same-sex parent was significantly associated with anxiety disorder in offspring (odds ratio, 2.85; 95% confidence interval, 1.52-5.34; P = .001) but not in an opposite-sex parent (OR, 1.51; 95% CI, 0.81-2.81; P = .20).
Living with a same-sex parent without anxiety was associated with lower rates of offspring anxiety (OR, 0.38; 95% CI, 0.22-0.67; P = .001).
Among all 398 children, 108 (27%) had been diagnosed with one or more anxiety disorders, including generalized anxiety disorder (7.8%), social anxiety disorder (6.3%), separation anxiety disorder (8.6%), specific phobia (8%), and anxiety disorder not otherwise specified (5%).
Rates of anxiety disorders in children increased with age, from 14% in those younger than 9 years to 52% in those older than 15 years. Anxiety disorders were similarly common among boys (24%) and girls (30%).
Rates of anxiety disorders were lowest (24%) in children of two parents without anxiety disorders and highest (41%) in cases in which both parents had anxiety disorders.
The findings point to the possible role of environmental factors, “such as modeling and vicarious learning,” in the transmission of anxiety from parents to their children, the researchers note.
“A child receives [a] similar amount of genetic information from each biological parent. A strong same-sex parent effect suggests children learn resilience by modeling the behavior of their same-sex parent. A parent’s anxiety disorder may disrupt this protective learning,” said Dr. Pavlova.
Early diagnosis, treatment essential
Reached for comment, Jill Emanuele, PhD, vice president of clinical training for the Child MIND Institute, New York, said that when it comes to anxiety, it’s important to assess and treat both the parent and the child.
“We know that both environment and genetics play a role in anxiety disorders. From a clinical perspective, if we see a parent with an anxiety disorder, we know that there is a chance that that is also going to affect the child – whether or not the child has an anxiety disorder,” Dr. Emanuele said in an interview.
“Anxiety disorders are the most common psychiatric disorders diagnosed. We also know that anxiety disorders emerge earlier than mood disorders and certainly can emerge in childhood. It’s important to address anxiety early because those same problems can continue into adulthood if left untreated,” Dr. Emanuele added.
The study was supported by the Canada Research Chairs Program, the Canadian Institutes of Health Research, the Brain & Behavior Research Foundation, the Nova Scotia Health Research Foundation, and the Dalhousie Medical Research Foundation. The authors have disclosed no relevant financial relationships. Dr. Emanuele is a board member with the Anxiety and Depression Association of America.
A version of this article first appeared on Medscape.com.
Americans’ biggest source of anxiety? Hint: It’s not COVID-19
, results from a new national report from the American Psychiatric Association show.
“The economy seems to have supplanted COVID as a major factor in Americans’ day-to-day anxiety,” APA President Rebecca W. Brendel, MD, JD, said in a news release.
“Knowing that so many Americans are concerned about finances is important because it can prepare clinicians to be ready to approach the subject, which is one that people are often reluctant or ashamed to raise on their own,” Dr. Brendel told this news organization.
What’s the best way to bring up the sensitive topic of money?
“In general, it’s best to start with open-ended questions to allow individuals in therapy to share what is on their minds, explore their concerns, and develop strategies to address these issues. Once a patient raises a concern, that is a good time to ask more about the issues they’ve raised and to explore other potential sources of anxiety or stress,” said Dr. Brendel.
The latest APA poll was conducted by Morning Consult, June 18-20, 2022, among a nationally representative sample of 2,210 adults.
In addition to an uptick in worry about inflation, the poll shows that more than half (51%) of adults are worried about a potential loss of income.
Hispanic adults (66%), mothers (65%), millennials (63%), and genZers (62%) are among the groups most likely to be concerned about income loss.
“Stress is not good for health, mental or physical. So, while it’s a reality that Americans are faced with finding ways of making ends meet, it’s more important than ever to make sure that we are all accessing the care that we need,” said Dr. Brendel.
“People should be aware that there may be low- or no-cost options such as community mental health centers or employer-sponsored resources to address mental health concerns,” she added.
Coping with traumatic events
The latest poll also shows that about one-third of adults are worried about gun violence (35% overall, 47% among genZers) or a natural disaster (29%) personally affecting them.
Climate change anxiety is also up slightly in June, compared with May (+4%).
The same goes for mid-term election-related anxiety (+3%) – particularly among Democrats (54% vs. 59%) compared with Republicans (48% vs. 48%).
The latest poll provides insight how Americans would cope after a traumatic event. More adults report they will turn to family and friends for support (60%) than practice self-care (42%), speak openly about their feelings (37%), or seek help from a professional (31%). Nearly one-third (30%) say they will move on from it and not dwell on their feelings.
GenZers are the least likely to say they will speak openly about their feelings (29%) and are less likely than millennials to say they would speak to a health professional (28% vs. 38%).
“While many people show resilience, it’s troubling that most Americans wouldn’t speak openly about their feelings after a traumatic event,” APA CEO and Medical Director Saul Levin, MD, said in the news release.
“In many ways, naming feelings is the most important step toward healing, and this reluctance to air our thoughts may indicate that mental health stigma is still a powerful force in our society,” Dr. Levin said.
After a traumatic current event, 41% of Americans say they consume more news and 30% say they take in more social media, but the majority say this does not impact their mental health, the poll shows.
Two in five adults (43%) say the news of a traumatic event makes them feel more informed, 32% say it makes them feel more anxious, and about one-quarter say it makes them feel overwhelmed (27%) or discouraged (24%).
Dr. Brendel noted that, after a traumatic event, “it’s expected that people may experience anxiety or other symptoms for brief periods of time. However, no two people experience things the same way. If symptoms don’t go away, are overwhelming, or get worse over time, for example, it’s critical to seek help right away.”
The June poll shows that 50% of Americans are anxious about the future of reproductive rights but the poll was conducted before the Dobbs ruling.
Anxiety around COVID-19 continues to ease, with about 47% of Americans saying they are concerned about the pandemic, down 2% among all Americans and 16% among Black Americans since May.
The APA’s Healthy Minds Monthly tracks timely mental health issues throughout the year. The APA also releases its annual Healthy Minds Poll each May in conjunction with Mental Health Awareness Month.
A version of this article first appeared on Medscape.com.
, results from a new national report from the American Psychiatric Association show.
“The economy seems to have supplanted COVID as a major factor in Americans’ day-to-day anxiety,” APA President Rebecca W. Brendel, MD, JD, said in a news release.
“Knowing that so many Americans are concerned about finances is important because it can prepare clinicians to be ready to approach the subject, which is one that people are often reluctant or ashamed to raise on their own,” Dr. Brendel told this news organization.
What’s the best way to bring up the sensitive topic of money?
“In general, it’s best to start with open-ended questions to allow individuals in therapy to share what is on their minds, explore their concerns, and develop strategies to address these issues. Once a patient raises a concern, that is a good time to ask more about the issues they’ve raised and to explore other potential sources of anxiety or stress,” said Dr. Brendel.
The latest APA poll was conducted by Morning Consult, June 18-20, 2022, among a nationally representative sample of 2,210 adults.
In addition to an uptick in worry about inflation, the poll shows that more than half (51%) of adults are worried about a potential loss of income.
Hispanic adults (66%), mothers (65%), millennials (63%), and genZers (62%) are among the groups most likely to be concerned about income loss.
“Stress is not good for health, mental or physical. So, while it’s a reality that Americans are faced with finding ways of making ends meet, it’s more important than ever to make sure that we are all accessing the care that we need,” said Dr. Brendel.
“People should be aware that there may be low- or no-cost options such as community mental health centers or employer-sponsored resources to address mental health concerns,” she added.
Coping with traumatic events
The latest poll also shows that about one-third of adults are worried about gun violence (35% overall, 47% among genZers) or a natural disaster (29%) personally affecting them.
Climate change anxiety is also up slightly in June, compared with May (+4%).
The same goes for mid-term election-related anxiety (+3%) – particularly among Democrats (54% vs. 59%) compared with Republicans (48% vs. 48%).
The latest poll provides insight how Americans would cope after a traumatic event. More adults report they will turn to family and friends for support (60%) than practice self-care (42%), speak openly about their feelings (37%), or seek help from a professional (31%). Nearly one-third (30%) say they will move on from it and not dwell on their feelings.
GenZers are the least likely to say they will speak openly about their feelings (29%) and are less likely than millennials to say they would speak to a health professional (28% vs. 38%).
“While many people show resilience, it’s troubling that most Americans wouldn’t speak openly about their feelings after a traumatic event,” APA CEO and Medical Director Saul Levin, MD, said in the news release.
“In many ways, naming feelings is the most important step toward healing, and this reluctance to air our thoughts may indicate that mental health stigma is still a powerful force in our society,” Dr. Levin said.
After a traumatic current event, 41% of Americans say they consume more news and 30% say they take in more social media, but the majority say this does not impact their mental health, the poll shows.
Two in five adults (43%) say the news of a traumatic event makes them feel more informed, 32% say it makes them feel more anxious, and about one-quarter say it makes them feel overwhelmed (27%) or discouraged (24%).
Dr. Brendel noted that, after a traumatic event, “it’s expected that people may experience anxiety or other symptoms for brief periods of time. However, no two people experience things the same way. If symptoms don’t go away, are overwhelming, or get worse over time, for example, it’s critical to seek help right away.”
The June poll shows that 50% of Americans are anxious about the future of reproductive rights but the poll was conducted before the Dobbs ruling.
Anxiety around COVID-19 continues to ease, with about 47% of Americans saying they are concerned about the pandemic, down 2% among all Americans and 16% among Black Americans since May.
The APA’s Healthy Minds Monthly tracks timely mental health issues throughout the year. The APA also releases its annual Healthy Minds Poll each May in conjunction with Mental Health Awareness Month.
A version of this article first appeared on Medscape.com.
, results from a new national report from the American Psychiatric Association show.
“The economy seems to have supplanted COVID as a major factor in Americans’ day-to-day anxiety,” APA President Rebecca W. Brendel, MD, JD, said in a news release.
“Knowing that so many Americans are concerned about finances is important because it can prepare clinicians to be ready to approach the subject, which is one that people are often reluctant or ashamed to raise on their own,” Dr. Brendel told this news organization.
What’s the best way to bring up the sensitive topic of money?
“In general, it’s best to start with open-ended questions to allow individuals in therapy to share what is on their minds, explore their concerns, and develop strategies to address these issues. Once a patient raises a concern, that is a good time to ask more about the issues they’ve raised and to explore other potential sources of anxiety or stress,” said Dr. Brendel.
The latest APA poll was conducted by Morning Consult, June 18-20, 2022, among a nationally representative sample of 2,210 adults.
In addition to an uptick in worry about inflation, the poll shows that more than half (51%) of adults are worried about a potential loss of income.
Hispanic adults (66%), mothers (65%), millennials (63%), and genZers (62%) are among the groups most likely to be concerned about income loss.
“Stress is not good for health, mental or physical. So, while it’s a reality that Americans are faced with finding ways of making ends meet, it’s more important than ever to make sure that we are all accessing the care that we need,” said Dr. Brendel.
“People should be aware that there may be low- or no-cost options such as community mental health centers or employer-sponsored resources to address mental health concerns,” she added.
Coping with traumatic events
The latest poll also shows that about one-third of adults are worried about gun violence (35% overall, 47% among genZers) or a natural disaster (29%) personally affecting them.
Climate change anxiety is also up slightly in June, compared with May (+4%).
The same goes for mid-term election-related anxiety (+3%) – particularly among Democrats (54% vs. 59%) compared with Republicans (48% vs. 48%).
The latest poll provides insight how Americans would cope after a traumatic event. More adults report they will turn to family and friends for support (60%) than practice self-care (42%), speak openly about their feelings (37%), or seek help from a professional (31%). Nearly one-third (30%) say they will move on from it and not dwell on their feelings.
GenZers are the least likely to say they will speak openly about their feelings (29%) and are less likely than millennials to say they would speak to a health professional (28% vs. 38%).
“While many people show resilience, it’s troubling that most Americans wouldn’t speak openly about their feelings after a traumatic event,” APA CEO and Medical Director Saul Levin, MD, said in the news release.
“In many ways, naming feelings is the most important step toward healing, and this reluctance to air our thoughts may indicate that mental health stigma is still a powerful force in our society,” Dr. Levin said.
After a traumatic current event, 41% of Americans say they consume more news and 30% say they take in more social media, but the majority say this does not impact their mental health, the poll shows.
Two in five adults (43%) say the news of a traumatic event makes them feel more informed, 32% say it makes them feel more anxious, and about one-quarter say it makes them feel overwhelmed (27%) or discouraged (24%).
Dr. Brendel noted that, after a traumatic event, “it’s expected that people may experience anxiety or other symptoms for brief periods of time. However, no two people experience things the same way. If symptoms don’t go away, are overwhelming, or get worse over time, for example, it’s critical to seek help right away.”
The June poll shows that 50% of Americans are anxious about the future of reproductive rights but the poll was conducted before the Dobbs ruling.
Anxiety around COVID-19 continues to ease, with about 47% of Americans saying they are concerned about the pandemic, down 2% among all Americans and 16% among Black Americans since May.
The APA’s Healthy Minds Monthly tracks timely mental health issues throughout the year. The APA also releases its annual Healthy Minds Poll each May in conjunction with Mental Health Awareness Month.
A version of this article first appeared on Medscape.com.
Best meds for insomnia identified?
In a comprehensive comparative-effectiveness analysis, lemborexant and eszopiclone showed the best efficacy, acceptability, and tolerability for acute and long-term insomnia treatment.
However, eszopiclone may cause substantial side effects – and safety data on lemborexant were inconclusive, the researchers note.
Not surprisingly, short-acting, intermediate-acting, and long-acting benzodiazepines were effective in the acute treatment of insomnia, but they have unfavorable tolerability and safety profiles, and there are no long-term data on these issues.
For many insomnia medications, there is a “striking” and “appalling” lack of long-term data, study investigator Andrea Cipriani, MD, PhD, professor of psychiatry, University of Oxford, United Kingdom, noted during a press briefing.
“This is a call for regulators to raise the bar and ask for long-term data when companies submit an application for licensing insomnia drugs,” Dr. Cipriani said.
The findings were published online in The Lancet.
Prevalent, debilitating
Insomnia is highly prevalent, affecting up to 1 in 5 adults, and can have a profound impact on health, well-being, and productivity.
Sleep hygiene and cognitive-behavioral therapy for insomnia (CBT-I) are recommended first-line treatments, but they are often unavailable, which often leads patients and clinicians to turn to medications.
However, “insomnia drugs are not all created equal. Even within the same drug class there are differences,” Dr. Cipriani said.
In a large-scale systematic review and network meta-analysis, the researchers analyzed data from 154 double-blind, randomized controlled trials of medications (licensed or not) used for acute and long-term treatment of insomnia in 44,089 adults (mean age, 51.7 years; 63% women).
Results showed, for the acute treatment of insomnia, benzodiazepines, doxylamine, eszopiclone, lemborexant, seltorexant, zolpidem, and zopiclone were more effective than placebo (standardized mean difference range, 0.36-0.83; high-to-moderate certainty of evidence).
In addition, benzodiazepines, eszopiclone, zolpidem, and zopiclone were more effective than melatonin, ramelteon, and zaleplon (SMD, 0.27-0.71; moderate-to-very low certainty of evidence).
“Our results show that the melatonergic drugs melatonin and ramelteon are not really effective. The data do not support the regular use of these drugs,” co-investigator Phil Cowen, PhD, professor of psychopharmacology, University of Oxford, said at the briefing.
Best available evidence
What little long-term data is available suggest eszopiclone and lemborexant are more effective than placebo. Plus, eszopiclone is more effective than ramelteon and zolpidem but with “very low” certainty of evidence, the researchers report.
“There was insufficient evidence to support the prescription of benzodiazepines and zolpidem in long-term treatment,” they write.
Another problem was lack of data on other important outcomes, they add.
“We wanted to look at hangover effects, daytime sleepiness, [and] rebound effect, but often there was no data reported in trials. We need to collect data about these outcomes because they matter to clinicians and patients,” Dr. Cipriani said.
Summing up, the researchers note the current findings represent the “best available evidence base to guide the choice about pharmacological treatment for insomnia disorder in adults and will assist in shared decisionmaking between patients, carers, and their clinicians, as well as policy makers.”
They caution, however, that all statements comparing the merits of one drug with another “should be tempered by the potential limitations of the current analysis, the quality of the available evidence, the characteristics of the patient populations, and the uncertainties that might result from choice of dose or treatment setting.”
In addition, it is important to also consider nonpharmacologic treatments for insomnia disorder, as they are supported by “high-quality evidence and recommended as first-line treatment by guidelines,” the investigator write.
Shared decisionmaking
In an accompanying editorial, Myrto Samara, MD, University of Thessaly, Larissa, Greece, agrees with the researchers that discussion with patients is key.
“For insomnia treatment, patient-physician shared decisionmaking is crucial to decide when a pharmacological intervention is deemed necessary and which drug [is] to be given by considering the trade-offs for efficacy and side effects,” Dr. Samara writes.
The study was funded by the UK National Institute for Health Research (NIHR) Oxford Health Biomedical Research Center. Dr. Cipriani has received research and consultancy fees from the Italian Network for Pediatric Trials, CARIPLO Foundation, and Angelini Pharma, and is the chief and principal investigator of two trials of seltorexant in depression that are sponsored by Janssen. Dr. Samara has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a comprehensive comparative-effectiveness analysis, lemborexant and eszopiclone showed the best efficacy, acceptability, and tolerability for acute and long-term insomnia treatment.
However, eszopiclone may cause substantial side effects – and safety data on lemborexant were inconclusive, the researchers note.
Not surprisingly, short-acting, intermediate-acting, and long-acting benzodiazepines were effective in the acute treatment of insomnia, but they have unfavorable tolerability and safety profiles, and there are no long-term data on these issues.
For many insomnia medications, there is a “striking” and “appalling” lack of long-term data, study investigator Andrea Cipriani, MD, PhD, professor of psychiatry, University of Oxford, United Kingdom, noted during a press briefing.
“This is a call for regulators to raise the bar and ask for long-term data when companies submit an application for licensing insomnia drugs,” Dr. Cipriani said.
The findings were published online in The Lancet.
Prevalent, debilitating
Insomnia is highly prevalent, affecting up to 1 in 5 adults, and can have a profound impact on health, well-being, and productivity.
Sleep hygiene and cognitive-behavioral therapy for insomnia (CBT-I) are recommended first-line treatments, but they are often unavailable, which often leads patients and clinicians to turn to medications.
However, “insomnia drugs are not all created equal. Even within the same drug class there are differences,” Dr. Cipriani said.
In a large-scale systematic review and network meta-analysis, the researchers analyzed data from 154 double-blind, randomized controlled trials of medications (licensed or not) used for acute and long-term treatment of insomnia in 44,089 adults (mean age, 51.7 years; 63% women).
Results showed, for the acute treatment of insomnia, benzodiazepines, doxylamine, eszopiclone, lemborexant, seltorexant, zolpidem, and zopiclone were more effective than placebo (standardized mean difference range, 0.36-0.83; high-to-moderate certainty of evidence).
In addition, benzodiazepines, eszopiclone, zolpidem, and zopiclone were more effective than melatonin, ramelteon, and zaleplon (SMD, 0.27-0.71; moderate-to-very low certainty of evidence).
“Our results show that the melatonergic drugs melatonin and ramelteon are not really effective. The data do not support the regular use of these drugs,” co-investigator Phil Cowen, PhD, professor of psychopharmacology, University of Oxford, said at the briefing.
Best available evidence
What little long-term data is available suggest eszopiclone and lemborexant are more effective than placebo. Plus, eszopiclone is more effective than ramelteon and zolpidem but with “very low” certainty of evidence, the researchers report.
“There was insufficient evidence to support the prescription of benzodiazepines and zolpidem in long-term treatment,” they write.
Another problem was lack of data on other important outcomes, they add.
“We wanted to look at hangover effects, daytime sleepiness, [and] rebound effect, but often there was no data reported in trials. We need to collect data about these outcomes because they matter to clinicians and patients,” Dr. Cipriani said.
Summing up, the researchers note the current findings represent the “best available evidence base to guide the choice about pharmacological treatment for insomnia disorder in adults and will assist in shared decisionmaking between patients, carers, and their clinicians, as well as policy makers.”
They caution, however, that all statements comparing the merits of one drug with another “should be tempered by the potential limitations of the current analysis, the quality of the available evidence, the characteristics of the patient populations, and the uncertainties that might result from choice of dose or treatment setting.”
In addition, it is important to also consider nonpharmacologic treatments for insomnia disorder, as they are supported by “high-quality evidence and recommended as first-line treatment by guidelines,” the investigator write.
Shared decisionmaking
In an accompanying editorial, Myrto Samara, MD, University of Thessaly, Larissa, Greece, agrees with the researchers that discussion with patients is key.
“For insomnia treatment, patient-physician shared decisionmaking is crucial to decide when a pharmacological intervention is deemed necessary and which drug [is] to be given by considering the trade-offs for efficacy and side effects,” Dr. Samara writes.
The study was funded by the UK National Institute for Health Research (NIHR) Oxford Health Biomedical Research Center. Dr. Cipriani has received research and consultancy fees from the Italian Network for Pediatric Trials, CARIPLO Foundation, and Angelini Pharma, and is the chief and principal investigator of two trials of seltorexant in depression that are sponsored by Janssen. Dr. Samara has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a comprehensive comparative-effectiveness analysis, lemborexant and eszopiclone showed the best efficacy, acceptability, and tolerability for acute and long-term insomnia treatment.
However, eszopiclone may cause substantial side effects – and safety data on lemborexant were inconclusive, the researchers note.
Not surprisingly, short-acting, intermediate-acting, and long-acting benzodiazepines were effective in the acute treatment of insomnia, but they have unfavorable tolerability and safety profiles, and there are no long-term data on these issues.
For many insomnia medications, there is a “striking” and “appalling” lack of long-term data, study investigator Andrea Cipriani, MD, PhD, professor of psychiatry, University of Oxford, United Kingdom, noted during a press briefing.
“This is a call for regulators to raise the bar and ask for long-term data when companies submit an application for licensing insomnia drugs,” Dr. Cipriani said.
The findings were published online in The Lancet.
Prevalent, debilitating
Insomnia is highly prevalent, affecting up to 1 in 5 adults, and can have a profound impact on health, well-being, and productivity.
Sleep hygiene and cognitive-behavioral therapy for insomnia (CBT-I) are recommended first-line treatments, but they are often unavailable, which often leads patients and clinicians to turn to medications.
However, “insomnia drugs are not all created equal. Even within the same drug class there are differences,” Dr. Cipriani said.
In a large-scale systematic review and network meta-analysis, the researchers analyzed data from 154 double-blind, randomized controlled trials of medications (licensed or not) used for acute and long-term treatment of insomnia in 44,089 adults (mean age, 51.7 years; 63% women).
Results showed, for the acute treatment of insomnia, benzodiazepines, doxylamine, eszopiclone, lemborexant, seltorexant, zolpidem, and zopiclone were more effective than placebo (standardized mean difference range, 0.36-0.83; high-to-moderate certainty of evidence).
In addition, benzodiazepines, eszopiclone, zolpidem, and zopiclone were more effective than melatonin, ramelteon, and zaleplon (SMD, 0.27-0.71; moderate-to-very low certainty of evidence).
“Our results show that the melatonergic drugs melatonin and ramelteon are not really effective. The data do not support the regular use of these drugs,” co-investigator Phil Cowen, PhD, professor of psychopharmacology, University of Oxford, said at the briefing.
Best available evidence
What little long-term data is available suggest eszopiclone and lemborexant are more effective than placebo. Plus, eszopiclone is more effective than ramelteon and zolpidem but with “very low” certainty of evidence, the researchers report.
“There was insufficient evidence to support the prescription of benzodiazepines and zolpidem in long-term treatment,” they write.
Another problem was lack of data on other important outcomes, they add.
“We wanted to look at hangover effects, daytime sleepiness, [and] rebound effect, but often there was no data reported in trials. We need to collect data about these outcomes because they matter to clinicians and patients,” Dr. Cipriani said.
Summing up, the researchers note the current findings represent the “best available evidence base to guide the choice about pharmacological treatment for insomnia disorder in adults and will assist in shared decisionmaking between patients, carers, and their clinicians, as well as policy makers.”
They caution, however, that all statements comparing the merits of one drug with another “should be tempered by the potential limitations of the current analysis, the quality of the available evidence, the characteristics of the patient populations, and the uncertainties that might result from choice of dose or treatment setting.”
In addition, it is important to also consider nonpharmacologic treatments for insomnia disorder, as they are supported by “high-quality evidence and recommended as first-line treatment by guidelines,” the investigator write.
Shared decisionmaking
In an accompanying editorial, Myrto Samara, MD, University of Thessaly, Larissa, Greece, agrees with the researchers that discussion with patients is key.
“For insomnia treatment, patient-physician shared decisionmaking is crucial to decide when a pharmacological intervention is deemed necessary and which drug [is] to be given by considering the trade-offs for efficacy and side effects,” Dr. Samara writes.
The study was funded by the UK National Institute for Health Research (NIHR) Oxford Health Biomedical Research Center. Dr. Cipriani has received research and consultancy fees from the Italian Network for Pediatric Trials, CARIPLO Foundation, and Angelini Pharma, and is the chief and principal investigator of two trials of seltorexant in depression that are sponsored by Janssen. Dr. Samara has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET
Risky business: Most cancer drugs don’t reach the market
, a new analysis suggests.
The researchers also found that about 8% of approved agents were subsequently taken off the market.
“The 6% is not a big surprise to us, since a few other studies using different methodologies and foci have estimated similar percentages,” Alyson Haslam, PhD, University of California, San Francisco, told this news organization. “When you look at drug development, it makes sense that you have to test a lot of drugs to get one that works, but sometimes it is nice to quantify the actual percentage in order to fully appreciate the process.”
The fact that 8% were withdrawn, however, “elicits the question of how the approval process can be improved to avoid ineffective or harmful drugs from coming onto the market,” Dr. Haslam added.
The study was published online in the International Journal of Cancer.
More desirable features?
Monitoring trends over time helps oncologists assess whether more drugs are making it to market and if certain factors make some drugs more likely to get approved.
Prior published estimates put the likelihood of approval between 6.7% and 13.4%, but these estimates were for drugs tested more than a decade ago.
To provide updated estimates, the researchers searched the literature for all oncology drugs tested in phase 1 studies during 2015 and evaluated their fate in subsequent phase 2/3 studies through FDA clearance.
Overall, the team found 803 phase 1 studies that met initial inclusion criteria; 48 trials that included only Japanese participants were excluded because these studies often evaluated drugs already approved in the United States, leaving 755 studies for the analysis.
The most common tumor types were solid/multiple tumors (24.2%), leukemias (12.8%), and lung cancer (8.5%). Just under half (47%) of the trials tested a drug as monotherapy; 43% were combination trials with one dose-escalated drug; and about 10% were combination trials with both drugs dose-escalated.
The FDA approved 51 drugs during the study period. Four (7.8%) were subsequently withdrawn: nivolumab (Opdivo) and pembrolizumab (Keytruda) for small cell lung cancer, olaratumab (Lartruvo) for soft tissue sarcoma, and melflufen (Pepaxto) for multiple myeloma. These four were not counted in the overall number of approvals.
“We really wanted to look at the end fate of drugs (within a reasonable time frame), which is why we did not include the four drugs that were initially approved but later withdrawn, although this had little impact on the main finding,” Dr. Haslam explained.
The estimated probability of any drug or drug combination tested in a phase 1 trial published in 2015 and approved that year was 1.7% and reached 6.2% by the end of 2021, the researchers found.
Monoclonal antibodies had a higher probability of being approved (15.3%), compared with inhibitors (5.1%) and chemotherapy drugs (4.2%).
The FDA was also more apt to green-light drugs tested as monotherapy, compared with drug combinations (odds ratio, 0.22). Drugs tested in monotherapy had a 9.4% probability of approval versus those tested in combination, which had a 5.6% probability of being approved when pairing a novel drug with one or more established agents, as well as when combining two novel drugs. The probability of approval was less than 1% for trials testing two established drug combinations.
Other factors that boosted the odds of FDA approval include having a response rate over 40% in phase 1 testing, demonstrating an overall survival benefit in phase 3 testing, and having the trial sponsored by a top-20 drug company, compared with a non–top-20 drug company.
Dr. Haslam found the last finding rather surprising, given the recent trend for bigger companies to invest in smaller companies who are developing promising drugs, rather than doing all of the development themselves. “In fact, a recent analysis found that only 25% of new drugs are sponsored by larger companies,” she noted.
Reached for comment, Jeff Allen, PhD, who wasn’t involved in the study, noted that “these types of landscape analyses are quite helpful in understanding the current state of oncology science and drug development.”
When looking at a 6.2% success rate for phase 1–tested oncology drugs, “it can be difficult holistically to determine all factors for which development didn’t continue,” said Dr. Allen, president and CEO of the nonprofit Friends of Cancer Research.
For instance, lack of approval may not signal the drug was a failure “but rather an artifact of circumstances such as resource limitations or reprioritization,” Dr. Allen said.
Plus, he commented, “I don’t think that we should expect all these early studies to lead to eventual approvals, but it’s clear from the authors’ findings that continued efforts to improve the overall success rate in developing new cancer medicines are greatly needed.”
The study was funded by Arnold Ventures. Dr. Haslam and Dr. Allen have no relevant disclosures. Study author Vinay Prasad, MD, MPH, receives royalties from Arnold Ventures.
A version of this article first appeared on Medscape.com.
, a new analysis suggests.
The researchers also found that about 8% of approved agents were subsequently taken off the market.
“The 6% is not a big surprise to us, since a few other studies using different methodologies and foci have estimated similar percentages,” Alyson Haslam, PhD, University of California, San Francisco, told this news organization. “When you look at drug development, it makes sense that you have to test a lot of drugs to get one that works, but sometimes it is nice to quantify the actual percentage in order to fully appreciate the process.”
The fact that 8% were withdrawn, however, “elicits the question of how the approval process can be improved to avoid ineffective or harmful drugs from coming onto the market,” Dr. Haslam added.
The study was published online in the International Journal of Cancer.
More desirable features?
Monitoring trends over time helps oncologists assess whether more drugs are making it to market and if certain factors make some drugs more likely to get approved.
Prior published estimates put the likelihood of approval between 6.7% and 13.4%, but these estimates were for drugs tested more than a decade ago.
To provide updated estimates, the researchers searched the literature for all oncology drugs tested in phase 1 studies during 2015 and evaluated their fate in subsequent phase 2/3 studies through FDA clearance.
Overall, the team found 803 phase 1 studies that met initial inclusion criteria; 48 trials that included only Japanese participants were excluded because these studies often evaluated drugs already approved in the United States, leaving 755 studies for the analysis.
The most common tumor types were solid/multiple tumors (24.2%), leukemias (12.8%), and lung cancer (8.5%). Just under half (47%) of the trials tested a drug as monotherapy; 43% were combination trials with one dose-escalated drug; and about 10% were combination trials with both drugs dose-escalated.
The FDA approved 51 drugs during the study period. Four (7.8%) were subsequently withdrawn: nivolumab (Opdivo) and pembrolizumab (Keytruda) for small cell lung cancer, olaratumab (Lartruvo) for soft tissue sarcoma, and melflufen (Pepaxto) for multiple myeloma. These four were not counted in the overall number of approvals.
“We really wanted to look at the end fate of drugs (within a reasonable time frame), which is why we did not include the four drugs that were initially approved but later withdrawn, although this had little impact on the main finding,” Dr. Haslam explained.
The estimated probability of any drug or drug combination tested in a phase 1 trial published in 2015 and approved that year was 1.7% and reached 6.2% by the end of 2021, the researchers found.
Monoclonal antibodies had a higher probability of being approved (15.3%), compared with inhibitors (5.1%) and chemotherapy drugs (4.2%).
The FDA was also more apt to green-light drugs tested as monotherapy, compared with drug combinations (odds ratio, 0.22). Drugs tested in monotherapy had a 9.4% probability of approval versus those tested in combination, which had a 5.6% probability of being approved when pairing a novel drug with one or more established agents, as well as when combining two novel drugs. The probability of approval was less than 1% for trials testing two established drug combinations.
Other factors that boosted the odds of FDA approval include having a response rate over 40% in phase 1 testing, demonstrating an overall survival benefit in phase 3 testing, and having the trial sponsored by a top-20 drug company, compared with a non–top-20 drug company.
Dr. Haslam found the last finding rather surprising, given the recent trend for bigger companies to invest in smaller companies who are developing promising drugs, rather than doing all of the development themselves. “In fact, a recent analysis found that only 25% of new drugs are sponsored by larger companies,” she noted.
Reached for comment, Jeff Allen, PhD, who wasn’t involved in the study, noted that “these types of landscape analyses are quite helpful in understanding the current state of oncology science and drug development.”
When looking at a 6.2% success rate for phase 1–tested oncology drugs, “it can be difficult holistically to determine all factors for which development didn’t continue,” said Dr. Allen, president and CEO of the nonprofit Friends of Cancer Research.
For instance, lack of approval may not signal the drug was a failure “but rather an artifact of circumstances such as resource limitations or reprioritization,” Dr. Allen said.
Plus, he commented, “I don’t think that we should expect all these early studies to lead to eventual approvals, but it’s clear from the authors’ findings that continued efforts to improve the overall success rate in developing new cancer medicines are greatly needed.”
The study was funded by Arnold Ventures. Dr. Haslam and Dr. Allen have no relevant disclosures. Study author Vinay Prasad, MD, MPH, receives royalties from Arnold Ventures.
A version of this article first appeared on Medscape.com.
, a new analysis suggests.
The researchers also found that about 8% of approved agents were subsequently taken off the market.
“The 6% is not a big surprise to us, since a few other studies using different methodologies and foci have estimated similar percentages,” Alyson Haslam, PhD, University of California, San Francisco, told this news organization. “When you look at drug development, it makes sense that you have to test a lot of drugs to get one that works, but sometimes it is nice to quantify the actual percentage in order to fully appreciate the process.”
The fact that 8% were withdrawn, however, “elicits the question of how the approval process can be improved to avoid ineffective or harmful drugs from coming onto the market,” Dr. Haslam added.
The study was published online in the International Journal of Cancer.
More desirable features?
Monitoring trends over time helps oncologists assess whether more drugs are making it to market and if certain factors make some drugs more likely to get approved.
Prior published estimates put the likelihood of approval between 6.7% and 13.4%, but these estimates were for drugs tested more than a decade ago.
To provide updated estimates, the researchers searched the literature for all oncology drugs tested in phase 1 studies during 2015 and evaluated their fate in subsequent phase 2/3 studies through FDA clearance.
Overall, the team found 803 phase 1 studies that met initial inclusion criteria; 48 trials that included only Japanese participants were excluded because these studies often evaluated drugs already approved in the United States, leaving 755 studies for the analysis.
The most common tumor types were solid/multiple tumors (24.2%), leukemias (12.8%), and lung cancer (8.5%). Just under half (47%) of the trials tested a drug as monotherapy; 43% were combination trials with one dose-escalated drug; and about 10% were combination trials with both drugs dose-escalated.
The FDA approved 51 drugs during the study period. Four (7.8%) were subsequently withdrawn: nivolumab (Opdivo) and pembrolizumab (Keytruda) for small cell lung cancer, olaratumab (Lartruvo) for soft tissue sarcoma, and melflufen (Pepaxto) for multiple myeloma. These four were not counted in the overall number of approvals.
“We really wanted to look at the end fate of drugs (within a reasonable time frame), which is why we did not include the four drugs that were initially approved but later withdrawn, although this had little impact on the main finding,” Dr. Haslam explained.
The estimated probability of any drug or drug combination tested in a phase 1 trial published in 2015 and approved that year was 1.7% and reached 6.2% by the end of 2021, the researchers found.
Monoclonal antibodies had a higher probability of being approved (15.3%), compared with inhibitors (5.1%) and chemotherapy drugs (4.2%).
The FDA was also more apt to green-light drugs tested as monotherapy, compared with drug combinations (odds ratio, 0.22). Drugs tested in monotherapy had a 9.4% probability of approval versus those tested in combination, which had a 5.6% probability of being approved when pairing a novel drug with one or more established agents, as well as when combining two novel drugs. The probability of approval was less than 1% for trials testing two established drug combinations.
Other factors that boosted the odds of FDA approval include having a response rate over 40% in phase 1 testing, demonstrating an overall survival benefit in phase 3 testing, and having the trial sponsored by a top-20 drug company, compared with a non–top-20 drug company.
Dr. Haslam found the last finding rather surprising, given the recent trend for bigger companies to invest in smaller companies who are developing promising drugs, rather than doing all of the development themselves. “In fact, a recent analysis found that only 25% of new drugs are sponsored by larger companies,” she noted.
Reached for comment, Jeff Allen, PhD, who wasn’t involved in the study, noted that “these types of landscape analyses are quite helpful in understanding the current state of oncology science and drug development.”
When looking at a 6.2% success rate for phase 1–tested oncology drugs, “it can be difficult holistically to determine all factors for which development didn’t continue,” said Dr. Allen, president and CEO of the nonprofit Friends of Cancer Research.
For instance, lack of approval may not signal the drug was a failure “but rather an artifact of circumstances such as resource limitations or reprioritization,” Dr. Allen said.
Plus, he commented, “I don’t think that we should expect all these early studies to lead to eventual approvals, but it’s clear from the authors’ findings that continued efforts to improve the overall success rate in developing new cancer medicines are greatly needed.”
The study was funded by Arnold Ventures. Dr. Haslam and Dr. Allen have no relevant disclosures. Study author Vinay Prasad, MD, MPH, receives royalties from Arnold Ventures.
A version of this article first appeared on Medscape.com.
FROM INTERNATIONAL JOURNAL OF CANCER
Cancer drug significantly cuts risk for COVID-19 death
, an interim analysis of a phase 3 placebo-controlled trial found.
Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline World Health Organization scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.
The company has submitted an emergency use authorization request to the U.S. Food and Drug Administration to use sabizabulin to treat COVID-19.
The analysis was published online in NEJM Evidence.
Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.
Findings of the interim analysis are based on 150 adults hospitalized with moderate to severe COVID-19 at high risk for acute respiratory distress syndrome and death. The patients were randomly allocated to receive 9 mg oral sabizabulin (n = 98) or placebo (n = 52) once daily for up to 21 days.
Overall, the mortality rate was 20.2% in the sabizabulin group vs. 45.1% in the placebo group. Compared with placebo, treatment with sabizabulin led to a 24.9–percentage point absolute reduction and a 55.2% relative reduction in death (odds ratio, 3.23; P = .0042).
The key secondary endpoint of mortality through day 29 also favored sabizabulin over placebo, with a mortality rate of 17% vs. 35.3%. In this scenario, treatment with sabizabulin resulted in an absolute reduction in deaths of 18.3 percentage points and a relative reduction of 51.8%.
Sabizabulin led to a significant 43% relative reduction in ICU days, a 49% relative reduction in days on mechanical ventilation, and a 26% relative reduction in days in the hospital, compared with placebo.
Adverse and serious adverse events were also lower in the sabizabulin group (61.5%) than the placebo group (78.3%).
The data are “pretty impressive and in a group of patients that we really have limited things to offer,” Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y., said in an interview. “This is an interim analysis and obviously we’d like to see more data, but it certainly is something that is novel and quite interesting.”
David Boulware, MD, MPH, an infectious disease expert at the University of Minnesota, Minneapolis, told the New York Times that the large number of deaths in the placebo group seemed “rather high” and that the final analysis might reveal a more modest benefit for sabizabulin.
“I would be skeptical” that the reduced risk for death remains 55%, he noted.
The study was funded by Veru Pharmaceuticals. Several authors are employed by the company or have financial relationships with the company.
A version of this article first appeared on Medscape.com.
, an interim analysis of a phase 3 placebo-controlled trial found.
Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline World Health Organization scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.
The company has submitted an emergency use authorization request to the U.S. Food and Drug Administration to use sabizabulin to treat COVID-19.
The analysis was published online in NEJM Evidence.
Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.
Findings of the interim analysis are based on 150 adults hospitalized with moderate to severe COVID-19 at high risk for acute respiratory distress syndrome and death. The patients were randomly allocated to receive 9 mg oral sabizabulin (n = 98) or placebo (n = 52) once daily for up to 21 days.
Overall, the mortality rate was 20.2% in the sabizabulin group vs. 45.1% in the placebo group. Compared with placebo, treatment with sabizabulin led to a 24.9–percentage point absolute reduction and a 55.2% relative reduction in death (odds ratio, 3.23; P = .0042).
The key secondary endpoint of mortality through day 29 also favored sabizabulin over placebo, with a mortality rate of 17% vs. 35.3%. In this scenario, treatment with sabizabulin resulted in an absolute reduction in deaths of 18.3 percentage points and a relative reduction of 51.8%.
Sabizabulin led to a significant 43% relative reduction in ICU days, a 49% relative reduction in days on mechanical ventilation, and a 26% relative reduction in days in the hospital, compared with placebo.
Adverse and serious adverse events were also lower in the sabizabulin group (61.5%) than the placebo group (78.3%).
The data are “pretty impressive and in a group of patients that we really have limited things to offer,” Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y., said in an interview. “This is an interim analysis and obviously we’d like to see more data, but it certainly is something that is novel and quite interesting.”
David Boulware, MD, MPH, an infectious disease expert at the University of Minnesota, Minneapolis, told the New York Times that the large number of deaths in the placebo group seemed “rather high” and that the final analysis might reveal a more modest benefit for sabizabulin.
“I would be skeptical” that the reduced risk for death remains 55%, he noted.
The study was funded by Veru Pharmaceuticals. Several authors are employed by the company or have financial relationships with the company.
A version of this article first appeared on Medscape.com.
, an interim analysis of a phase 3 placebo-controlled trial found.
Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline World Health Organization scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.
The company has submitted an emergency use authorization request to the U.S. Food and Drug Administration to use sabizabulin to treat COVID-19.
The analysis was published online in NEJM Evidence.
Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.
Findings of the interim analysis are based on 150 adults hospitalized with moderate to severe COVID-19 at high risk for acute respiratory distress syndrome and death. The patients were randomly allocated to receive 9 mg oral sabizabulin (n = 98) or placebo (n = 52) once daily for up to 21 days.
Overall, the mortality rate was 20.2% in the sabizabulin group vs. 45.1% in the placebo group. Compared with placebo, treatment with sabizabulin led to a 24.9–percentage point absolute reduction and a 55.2% relative reduction in death (odds ratio, 3.23; P = .0042).
The key secondary endpoint of mortality through day 29 also favored sabizabulin over placebo, with a mortality rate of 17% vs. 35.3%. In this scenario, treatment with sabizabulin resulted in an absolute reduction in deaths of 18.3 percentage points and a relative reduction of 51.8%.
Sabizabulin led to a significant 43% relative reduction in ICU days, a 49% relative reduction in days on mechanical ventilation, and a 26% relative reduction in days in the hospital, compared with placebo.
Adverse and serious adverse events were also lower in the sabizabulin group (61.5%) than the placebo group (78.3%).
The data are “pretty impressive and in a group of patients that we really have limited things to offer,” Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y., said in an interview. “This is an interim analysis and obviously we’d like to see more data, but it certainly is something that is novel and quite interesting.”
David Boulware, MD, MPH, an infectious disease expert at the University of Minnesota, Minneapolis, told the New York Times that the large number of deaths in the placebo group seemed “rather high” and that the final analysis might reveal a more modest benefit for sabizabulin.
“I would be skeptical” that the reduced risk for death remains 55%, he noted.
The study was funded by Veru Pharmaceuticals. Several authors are employed by the company or have financial relationships with the company.
A version of this article first appeared on Medscape.com.
FROM NEJM EVIDENCE
Benzbromarone tops febuxostat for gout?
Benzbromarone is not approved in the United States because of concerns of acute liver injury but is approved in several other countries, including China, Brazil, and New Zealand.
“The results suggest that low dosing of benzbromarone may warrant stronger consideration as a safe and effective therapy to achieve serum urate target in gout without moderate chronic kidney disease,” the study team writes.
“Benzbromarone is severely hepatotoxic in some individuals and unlikely to ever gain approval in the United States,” one of the study’s investigators, Robert Terkeltaub, MD, professor of medicine, University of California, San Diego, told this news organization.
However, this study “illustrates the value and impact of uricosuric therapy in general in gout, including potentially as an initial urate-lowering monotherapy strategy, and the sheer number of subjects reaching urate target with low-dose uricosuric monotherapy was impressive,” Dr. Terkeltaub said.
The study was published online in Arthritis & Rheumatology.
“Renal uric acid underexcretion is the chief mechanism driving hyperuricemia in gout, yet the standard urate-lowering therapy recommendation is first-line xanthine oxidase inhibition irrespective of the cause of hyperuricemia,” the study team explains in their article.
Their prospective, randomized, single-center, open-labeled trial was conducted at the Gout Clinic of the Affiliated Hospital of Qingdao University, China.
A total of 196 relatively young healthy men with gout and uric acid underexcretion were randomly assigned to receive low-dose benzbromarone (25 mg/d) or low-dose febuxostat (20 mg/d) for 12 weeks.
Renal uric acid underexcretion was defined as fractional excretion of urate less than 5.5% and uric acid excretion less than or equal to 600 mg/d/1.73 m2.
A “major aspect” of this comparative effectiveness trial was its specific focus on gout-associated renal uric acid underexcretion, where the uricosuric targeted the dominant abnormality promoting the hyperuricemia, Dr. Terkeltaub told this news organization.
In addition, all participants received daily urine alkalinization with oral sodium bicarbonate. “This is not always done in clinical practice, nor in clinical trials of uricosuric agents,” Dr. Terkeltaub said.
The results showed that more participants in the benzbromarone group achieved the serum urate target of less than 6 mg/dL, compared with those in the febuxostat group (primary endpoint, 61% vs. 32%, P < .001).
Adverse events, including gout flares and urolithiasis, did not differ significantly between the two groups, with the exception of more transaminase elevation in the febuxostat group (15% vs. 4%; P = .008).
“We did not find severe hepatotoxicity with low-dose benzbromarone, but ethnic background may affect drug responses, and severe hepatotoxicity of benzbromarone has rarely been reported in Asia,” the authors write.
The incidence of urolithiasis was numerically, but not significantly, higher in the benzbromarone group (5% vs. 2%).
This study found no significant changes in participants’ triglyceride levels, though a previous study suggested febuxostat could increase serum triglycerides.
The investigators caution that the study only included patients who had baseline serum urate levels ranging from 8.0 to 10 mg/dL, who were relatively young and with few comorbidities.
The authors further noted that the “... results may not be generalizable to patients with higher serum urate levels or impaired kidney function, as well [as] patients from other geographical regions, age, and ethnicity groups. The study only included men, and the findings may not be generalizable to women with gout.”
‘Very useful’ in select cases
Weighing in on the results, Valderilio Feijó Azevedo, MD, PhD, adjunct professor of rheumatology, Federal University of Paraná, Brazil, noted that in some specific clinical circumstances, benzbromarone has been “a very useful medication, alone or combined, to treat gout patients.”
“We have great experience with the drug in Brazil. However, it is not used to treat all patients. Patients must be very well-selected in our clinical practice,” Dr. Azevedo said in an interview.
“For most patients, benzbromarone is effective for those who have failed to achieve serum uric acid goals with allopurinol treatment. We do not use it to treat patients with asymptomatic hyperuricemia. In general, we avoid patients with hepatic dysfunction due to previous hepatotoxicity reports. In every patient, we do active monitoring of enzymes,” Dr. Azevedo explained.
“We also avoid using it in patients with severe kidney disease. However, we have used it in some patients with estimated glomerular filtration rate less than 30. We also avoid dosage over 200 mg per day. On average, we use 100 mg per day combined with allopurinol or alone,” said Dr. Azevedo, who was not involved with the study.
Also weighing in, Michael Pillinger, MD, rheumatologist at NYU Langone Health, noted that while benzbromarone is not used in the United States, “in many parts of the world, it is used and is felt to be effective.” Dr. Pillinger was not associated with this current research.
This study, Dr. Pillinger said, “does underline the fact that an alternative drug that lowers urate by promoting urate excretion, if it could gain [U.S. Food and Drug Association] approval and if it were safe, could present a viable new option for therapy.”
He added, “If one conclusion to the study is that determining the basis of hyperuricemia is helpful in guiding benzbromarone use, that implies an additional layer of effort for physicians and patients in a disease that is already notoriously known for patient noncompliance – and in a case where febuxostat and allopurinol will work for both overproducers and underexcreters and would not need this additional assessment.”
The study was sponsored by Shandong Provincial Key Research and Development Plan, the National Natural Science Foundation of China, and Shandong Provincial Science Foundation for Outstanding Youth Scholarship. Dr. Terkeltaub was supported by the National Institutes of Health and the VA Research Service. Dr. Terkeltaub has received research funding from AstraZeneca, and has consulted with Horizon, Selecta, SOBI, Dyve BioSciences, Fortress, AstraZeneca, Allena, Fortress Biotech, and LG Life Sciences. Dr. Azevedo and Dr. Pillinger have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Benzbromarone is not approved in the United States because of concerns of acute liver injury but is approved in several other countries, including China, Brazil, and New Zealand.
“The results suggest that low dosing of benzbromarone may warrant stronger consideration as a safe and effective therapy to achieve serum urate target in gout without moderate chronic kidney disease,” the study team writes.
“Benzbromarone is severely hepatotoxic in some individuals and unlikely to ever gain approval in the United States,” one of the study’s investigators, Robert Terkeltaub, MD, professor of medicine, University of California, San Diego, told this news organization.
However, this study “illustrates the value and impact of uricosuric therapy in general in gout, including potentially as an initial urate-lowering monotherapy strategy, and the sheer number of subjects reaching urate target with low-dose uricosuric monotherapy was impressive,” Dr. Terkeltaub said.
The study was published online in Arthritis & Rheumatology.
“Renal uric acid underexcretion is the chief mechanism driving hyperuricemia in gout, yet the standard urate-lowering therapy recommendation is first-line xanthine oxidase inhibition irrespective of the cause of hyperuricemia,” the study team explains in their article.
Their prospective, randomized, single-center, open-labeled trial was conducted at the Gout Clinic of the Affiliated Hospital of Qingdao University, China.
A total of 196 relatively young healthy men with gout and uric acid underexcretion were randomly assigned to receive low-dose benzbromarone (25 mg/d) or low-dose febuxostat (20 mg/d) for 12 weeks.
Renal uric acid underexcretion was defined as fractional excretion of urate less than 5.5% and uric acid excretion less than or equal to 600 mg/d/1.73 m2.
A “major aspect” of this comparative effectiveness trial was its specific focus on gout-associated renal uric acid underexcretion, where the uricosuric targeted the dominant abnormality promoting the hyperuricemia, Dr. Terkeltaub told this news organization.
In addition, all participants received daily urine alkalinization with oral sodium bicarbonate. “This is not always done in clinical practice, nor in clinical trials of uricosuric agents,” Dr. Terkeltaub said.
The results showed that more participants in the benzbromarone group achieved the serum urate target of less than 6 mg/dL, compared with those in the febuxostat group (primary endpoint, 61% vs. 32%, P < .001).
Adverse events, including gout flares and urolithiasis, did not differ significantly between the two groups, with the exception of more transaminase elevation in the febuxostat group (15% vs. 4%; P = .008).
“We did not find severe hepatotoxicity with low-dose benzbromarone, but ethnic background may affect drug responses, and severe hepatotoxicity of benzbromarone has rarely been reported in Asia,” the authors write.
The incidence of urolithiasis was numerically, but not significantly, higher in the benzbromarone group (5% vs. 2%).
This study found no significant changes in participants’ triglyceride levels, though a previous study suggested febuxostat could increase serum triglycerides.
The investigators caution that the study only included patients who had baseline serum urate levels ranging from 8.0 to 10 mg/dL, who were relatively young and with few comorbidities.
The authors further noted that the “... results may not be generalizable to patients with higher serum urate levels or impaired kidney function, as well [as] patients from other geographical regions, age, and ethnicity groups. The study only included men, and the findings may not be generalizable to women with gout.”
‘Very useful’ in select cases
Weighing in on the results, Valderilio Feijó Azevedo, MD, PhD, adjunct professor of rheumatology, Federal University of Paraná, Brazil, noted that in some specific clinical circumstances, benzbromarone has been “a very useful medication, alone or combined, to treat gout patients.”
“We have great experience with the drug in Brazil. However, it is not used to treat all patients. Patients must be very well-selected in our clinical practice,” Dr. Azevedo said in an interview.
“For most patients, benzbromarone is effective for those who have failed to achieve serum uric acid goals with allopurinol treatment. We do not use it to treat patients with asymptomatic hyperuricemia. In general, we avoid patients with hepatic dysfunction due to previous hepatotoxicity reports. In every patient, we do active monitoring of enzymes,” Dr. Azevedo explained.
“We also avoid using it in patients with severe kidney disease. However, we have used it in some patients with estimated glomerular filtration rate less than 30. We also avoid dosage over 200 mg per day. On average, we use 100 mg per day combined with allopurinol or alone,” said Dr. Azevedo, who was not involved with the study.
Also weighing in, Michael Pillinger, MD, rheumatologist at NYU Langone Health, noted that while benzbromarone is not used in the United States, “in many parts of the world, it is used and is felt to be effective.” Dr. Pillinger was not associated with this current research.
This study, Dr. Pillinger said, “does underline the fact that an alternative drug that lowers urate by promoting urate excretion, if it could gain [U.S. Food and Drug Association] approval and if it were safe, could present a viable new option for therapy.”
He added, “If one conclusion to the study is that determining the basis of hyperuricemia is helpful in guiding benzbromarone use, that implies an additional layer of effort for physicians and patients in a disease that is already notoriously known for patient noncompliance – and in a case where febuxostat and allopurinol will work for both overproducers and underexcreters and would not need this additional assessment.”
The study was sponsored by Shandong Provincial Key Research and Development Plan, the National Natural Science Foundation of China, and Shandong Provincial Science Foundation for Outstanding Youth Scholarship. Dr. Terkeltaub was supported by the National Institutes of Health and the VA Research Service. Dr. Terkeltaub has received research funding from AstraZeneca, and has consulted with Horizon, Selecta, SOBI, Dyve BioSciences, Fortress, AstraZeneca, Allena, Fortress Biotech, and LG Life Sciences. Dr. Azevedo and Dr. Pillinger have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Benzbromarone is not approved in the United States because of concerns of acute liver injury but is approved in several other countries, including China, Brazil, and New Zealand.
“The results suggest that low dosing of benzbromarone may warrant stronger consideration as a safe and effective therapy to achieve serum urate target in gout without moderate chronic kidney disease,” the study team writes.
“Benzbromarone is severely hepatotoxic in some individuals and unlikely to ever gain approval in the United States,” one of the study’s investigators, Robert Terkeltaub, MD, professor of medicine, University of California, San Diego, told this news organization.
However, this study “illustrates the value and impact of uricosuric therapy in general in gout, including potentially as an initial urate-lowering monotherapy strategy, and the sheer number of subjects reaching urate target with low-dose uricosuric monotherapy was impressive,” Dr. Terkeltaub said.
The study was published online in Arthritis & Rheumatology.
“Renal uric acid underexcretion is the chief mechanism driving hyperuricemia in gout, yet the standard urate-lowering therapy recommendation is first-line xanthine oxidase inhibition irrespective of the cause of hyperuricemia,” the study team explains in their article.
Their prospective, randomized, single-center, open-labeled trial was conducted at the Gout Clinic of the Affiliated Hospital of Qingdao University, China.
A total of 196 relatively young healthy men with gout and uric acid underexcretion were randomly assigned to receive low-dose benzbromarone (25 mg/d) or low-dose febuxostat (20 mg/d) for 12 weeks.
Renal uric acid underexcretion was defined as fractional excretion of urate less than 5.5% and uric acid excretion less than or equal to 600 mg/d/1.73 m2.
A “major aspect” of this comparative effectiveness trial was its specific focus on gout-associated renal uric acid underexcretion, where the uricosuric targeted the dominant abnormality promoting the hyperuricemia, Dr. Terkeltaub told this news organization.
In addition, all participants received daily urine alkalinization with oral sodium bicarbonate. “This is not always done in clinical practice, nor in clinical trials of uricosuric agents,” Dr. Terkeltaub said.
The results showed that more participants in the benzbromarone group achieved the serum urate target of less than 6 mg/dL, compared with those in the febuxostat group (primary endpoint, 61% vs. 32%, P < .001).
Adverse events, including gout flares and urolithiasis, did not differ significantly between the two groups, with the exception of more transaminase elevation in the febuxostat group (15% vs. 4%; P = .008).
“We did not find severe hepatotoxicity with low-dose benzbromarone, but ethnic background may affect drug responses, and severe hepatotoxicity of benzbromarone has rarely been reported in Asia,” the authors write.
The incidence of urolithiasis was numerically, but not significantly, higher in the benzbromarone group (5% vs. 2%).
This study found no significant changes in participants’ triglyceride levels, though a previous study suggested febuxostat could increase serum triglycerides.
The investigators caution that the study only included patients who had baseline serum urate levels ranging from 8.0 to 10 mg/dL, who were relatively young and with few comorbidities.
The authors further noted that the “... results may not be generalizable to patients with higher serum urate levels or impaired kidney function, as well [as] patients from other geographical regions, age, and ethnicity groups. The study only included men, and the findings may not be generalizable to women with gout.”
‘Very useful’ in select cases
Weighing in on the results, Valderilio Feijó Azevedo, MD, PhD, adjunct professor of rheumatology, Federal University of Paraná, Brazil, noted that in some specific clinical circumstances, benzbromarone has been “a very useful medication, alone or combined, to treat gout patients.”
“We have great experience with the drug in Brazil. However, it is not used to treat all patients. Patients must be very well-selected in our clinical practice,” Dr. Azevedo said in an interview.
“For most patients, benzbromarone is effective for those who have failed to achieve serum uric acid goals with allopurinol treatment. We do not use it to treat patients with asymptomatic hyperuricemia. In general, we avoid patients with hepatic dysfunction due to previous hepatotoxicity reports. In every patient, we do active monitoring of enzymes,” Dr. Azevedo explained.
“We also avoid using it in patients with severe kidney disease. However, we have used it in some patients with estimated glomerular filtration rate less than 30. We also avoid dosage over 200 mg per day. On average, we use 100 mg per day combined with allopurinol or alone,” said Dr. Azevedo, who was not involved with the study.
Also weighing in, Michael Pillinger, MD, rheumatologist at NYU Langone Health, noted that while benzbromarone is not used in the United States, “in many parts of the world, it is used and is felt to be effective.” Dr. Pillinger was not associated with this current research.
This study, Dr. Pillinger said, “does underline the fact that an alternative drug that lowers urate by promoting urate excretion, if it could gain [U.S. Food and Drug Association] approval and if it were safe, could present a viable new option for therapy.”
He added, “If one conclusion to the study is that determining the basis of hyperuricemia is helpful in guiding benzbromarone use, that implies an additional layer of effort for physicians and patients in a disease that is already notoriously known for patient noncompliance – and in a case where febuxostat and allopurinol will work for both overproducers and underexcreters and would not need this additional assessment.”
The study was sponsored by Shandong Provincial Key Research and Development Plan, the National Natural Science Foundation of China, and Shandong Provincial Science Foundation for Outstanding Youth Scholarship. Dr. Terkeltaub was supported by the National Institutes of Health and the VA Research Service. Dr. Terkeltaub has received research funding from AstraZeneca, and has consulted with Horizon, Selecta, SOBI, Dyve BioSciences, Fortress, AstraZeneca, Allena, Fortress Biotech, and LG Life Sciences. Dr. Azevedo and Dr. Pillinger have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
High residual liver cancer risk in HCV-cured cirrhosis
A new study confirms the very high risk of hepatocellular carcinoma faced by patients with cirrhosis who have been cured of hepatitis C, a finding the researchers hope will encourage clinicians to communicate risk information to patients and encourage regular HCC screening.
On average, the predicted probability of HCC in cirrhosis patients was 410 times greater than the equivalent probability in the general population, the study team found.
Hamish Innes, PhD, with Public Health Scotland, Glasgow, and colleagues wrote.
“Central to this is ensuring that cured cirrhosis patients understand the risk of HCC and are provided with appropriate surveillance,” they added.
“Most patients with cirrhosis do not adhere to HCC screening guidelines,” Nina Beri, MD, medical oncologist with New York University Perlmutter Cancer Center, who wasn’t involved in the study, said in an interview.
The “important” finding in this study “should be conveyed to patients, as this may help improve screening adherence rates,” Dr. Beri said.
The study was published online in the American Journal of Gastroenterology.
Findings may help promote screening uptake
Dr. Innes and colleagues compared the predicted probability of HCC in 1,803 Scottish adults (mean age, 50 years; 74% male) with cirrhosis and cured hepatitis C to the background risk in the general population of Scotland.
The mean predicted 3-year probability of HCC at the time of sustained viral response (SVR), determined using the aMAP prognostic model, was 3.64% (range, 0.012%-36.12%).
This contrasts with a 3-year HCC probability in the general population ranging from less than 0.0001% to 0.25% depending on demographics.
All patients with cirrhosis – even those at lowest risk – had a higher probability of HCC than the general population, but there was considerable heterogeneity from one patient to the next.
For example, the mean 3-year predicted probability was 18 times higher in the top quintile (9.8%) versus the lowest quintile (0.5%) of risk, the researchers found.
They could not identify a patient subgroup who exhibited a similar HCC risk profile to the general population, as was their hope going into the study.
Dr. Innes and colleagues have developed an online tool that allows clinicians to frame a patient›s 3-year HCC probability against the equivalent probability in the general population.
In the future, they said the scope of the tool could be extended by incorporating general population data from countries beyond Scotland.
“Our hope is that this tool will springboard patient-clinician discussions about HCC risk, and could mitigate low screening uptake,” Dr. Innes and colleagues wrote.
Curing HCV doesn’t eliminate risk
Commenting on the study, Nancy Reau, MD, section chief of hepatology at Rush University Medical Center, Chicago, said curing HCV is “very important and significantly reduces risk for complications, but it doesn’t return you to the normal population.”
Dr. Reau’s advice to cirrhosis patients: “Get screened twice a year.”
Dr. Beri said, in addition to conveying this risk to patients, “it is also important to disseminate this information to the community and to primary care practices, particularly as some patients may not currently follow in a specialized liver disease clinic.”
Also weighing in, Amit Singal, MD, chief of hepatology at the University of Texas Southwestern Medical Center, Dallas, said this study highlights that underlying cirrhosis is “the strongest risk factor for the development of HCC.”
In contrast to other cancers, such as breast and colorectal cancer, in which high risk populations can be identified by readily available information such as age and sex, implementation of HCC screening programs requires identification of patients with cirrhosis, Dr. Singal noted.
“Underuse of HCC screening in clinical practice is often related to providers having difficulty at this step in the process and contributes to the high proportion of HCC detected at late stages,” he told this news organization.
“Availability of accurate noninvasive markers of fibrosis will hopefully help with better identification of patients with cirrhosis moving forward,” Dr. Singal said, “although we as hepatologists need to work closely with our primary care colleagues to ensure these tools are used routinely in at-risk patients, such as those with nonalcoholic fatty liver disease, alcohol-associated liver disease, or history of cured (post-SVR) hepatitis C infection.”
The study was supported by the Medical Research Foundation and Public Health Scotland. Dr. Innes, Dr. Beri, Dr. Reau, and Dr. Singal reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study confirms the very high risk of hepatocellular carcinoma faced by patients with cirrhosis who have been cured of hepatitis C, a finding the researchers hope will encourage clinicians to communicate risk information to patients and encourage regular HCC screening.
On average, the predicted probability of HCC in cirrhosis patients was 410 times greater than the equivalent probability in the general population, the study team found.
Hamish Innes, PhD, with Public Health Scotland, Glasgow, and colleagues wrote.
“Central to this is ensuring that cured cirrhosis patients understand the risk of HCC and are provided with appropriate surveillance,” they added.
“Most patients with cirrhosis do not adhere to HCC screening guidelines,” Nina Beri, MD, medical oncologist with New York University Perlmutter Cancer Center, who wasn’t involved in the study, said in an interview.
The “important” finding in this study “should be conveyed to patients, as this may help improve screening adherence rates,” Dr. Beri said.
The study was published online in the American Journal of Gastroenterology.
Findings may help promote screening uptake
Dr. Innes and colleagues compared the predicted probability of HCC in 1,803 Scottish adults (mean age, 50 years; 74% male) with cirrhosis and cured hepatitis C to the background risk in the general population of Scotland.
The mean predicted 3-year probability of HCC at the time of sustained viral response (SVR), determined using the aMAP prognostic model, was 3.64% (range, 0.012%-36.12%).
This contrasts with a 3-year HCC probability in the general population ranging from less than 0.0001% to 0.25% depending on demographics.
All patients with cirrhosis – even those at lowest risk – had a higher probability of HCC than the general population, but there was considerable heterogeneity from one patient to the next.
For example, the mean 3-year predicted probability was 18 times higher in the top quintile (9.8%) versus the lowest quintile (0.5%) of risk, the researchers found.
They could not identify a patient subgroup who exhibited a similar HCC risk profile to the general population, as was their hope going into the study.
Dr. Innes and colleagues have developed an online tool that allows clinicians to frame a patient›s 3-year HCC probability against the equivalent probability in the general population.
In the future, they said the scope of the tool could be extended by incorporating general population data from countries beyond Scotland.
“Our hope is that this tool will springboard patient-clinician discussions about HCC risk, and could mitigate low screening uptake,” Dr. Innes and colleagues wrote.
Curing HCV doesn’t eliminate risk
Commenting on the study, Nancy Reau, MD, section chief of hepatology at Rush University Medical Center, Chicago, said curing HCV is “very important and significantly reduces risk for complications, but it doesn’t return you to the normal population.”
Dr. Reau’s advice to cirrhosis patients: “Get screened twice a year.”
Dr. Beri said, in addition to conveying this risk to patients, “it is also important to disseminate this information to the community and to primary care practices, particularly as some patients may not currently follow in a specialized liver disease clinic.”
Also weighing in, Amit Singal, MD, chief of hepatology at the University of Texas Southwestern Medical Center, Dallas, said this study highlights that underlying cirrhosis is “the strongest risk factor for the development of HCC.”
In contrast to other cancers, such as breast and colorectal cancer, in which high risk populations can be identified by readily available information such as age and sex, implementation of HCC screening programs requires identification of patients with cirrhosis, Dr. Singal noted.
“Underuse of HCC screening in clinical practice is often related to providers having difficulty at this step in the process and contributes to the high proportion of HCC detected at late stages,” he told this news organization.
“Availability of accurate noninvasive markers of fibrosis will hopefully help with better identification of patients with cirrhosis moving forward,” Dr. Singal said, “although we as hepatologists need to work closely with our primary care colleagues to ensure these tools are used routinely in at-risk patients, such as those with nonalcoholic fatty liver disease, alcohol-associated liver disease, or history of cured (post-SVR) hepatitis C infection.”
The study was supported by the Medical Research Foundation and Public Health Scotland. Dr. Innes, Dr. Beri, Dr. Reau, and Dr. Singal reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study confirms the very high risk of hepatocellular carcinoma faced by patients with cirrhosis who have been cured of hepatitis C, a finding the researchers hope will encourage clinicians to communicate risk information to patients and encourage regular HCC screening.
On average, the predicted probability of HCC in cirrhosis patients was 410 times greater than the equivalent probability in the general population, the study team found.
Hamish Innes, PhD, with Public Health Scotland, Glasgow, and colleagues wrote.
“Central to this is ensuring that cured cirrhosis patients understand the risk of HCC and are provided with appropriate surveillance,” they added.
“Most patients with cirrhosis do not adhere to HCC screening guidelines,” Nina Beri, MD, medical oncologist with New York University Perlmutter Cancer Center, who wasn’t involved in the study, said in an interview.
The “important” finding in this study “should be conveyed to patients, as this may help improve screening adherence rates,” Dr. Beri said.
The study was published online in the American Journal of Gastroenterology.
Findings may help promote screening uptake
Dr. Innes and colleagues compared the predicted probability of HCC in 1,803 Scottish adults (mean age, 50 years; 74% male) with cirrhosis and cured hepatitis C to the background risk in the general population of Scotland.
The mean predicted 3-year probability of HCC at the time of sustained viral response (SVR), determined using the aMAP prognostic model, was 3.64% (range, 0.012%-36.12%).
This contrasts with a 3-year HCC probability in the general population ranging from less than 0.0001% to 0.25% depending on demographics.
All patients with cirrhosis – even those at lowest risk – had a higher probability of HCC than the general population, but there was considerable heterogeneity from one patient to the next.
For example, the mean 3-year predicted probability was 18 times higher in the top quintile (9.8%) versus the lowest quintile (0.5%) of risk, the researchers found.
They could not identify a patient subgroup who exhibited a similar HCC risk profile to the general population, as was their hope going into the study.
Dr. Innes and colleagues have developed an online tool that allows clinicians to frame a patient›s 3-year HCC probability against the equivalent probability in the general population.
In the future, they said the scope of the tool could be extended by incorporating general population data from countries beyond Scotland.
“Our hope is that this tool will springboard patient-clinician discussions about HCC risk, and could mitigate low screening uptake,” Dr. Innes and colleagues wrote.
Curing HCV doesn’t eliminate risk
Commenting on the study, Nancy Reau, MD, section chief of hepatology at Rush University Medical Center, Chicago, said curing HCV is “very important and significantly reduces risk for complications, but it doesn’t return you to the normal population.”
Dr. Reau’s advice to cirrhosis patients: “Get screened twice a year.”
Dr. Beri said, in addition to conveying this risk to patients, “it is also important to disseminate this information to the community and to primary care practices, particularly as some patients may not currently follow in a specialized liver disease clinic.”
Also weighing in, Amit Singal, MD, chief of hepatology at the University of Texas Southwestern Medical Center, Dallas, said this study highlights that underlying cirrhosis is “the strongest risk factor for the development of HCC.”
In contrast to other cancers, such as breast and colorectal cancer, in which high risk populations can be identified by readily available information such as age and sex, implementation of HCC screening programs requires identification of patients with cirrhosis, Dr. Singal noted.
“Underuse of HCC screening in clinical practice is often related to providers having difficulty at this step in the process and contributes to the high proportion of HCC detected at late stages,” he told this news organization.
“Availability of accurate noninvasive markers of fibrosis will hopefully help with better identification of patients with cirrhosis moving forward,” Dr. Singal said, “although we as hepatologists need to work closely with our primary care colleagues to ensure these tools are used routinely in at-risk patients, such as those with nonalcoholic fatty liver disease, alcohol-associated liver disease, or history of cured (post-SVR) hepatitis C infection.”
The study was supported by the Medical Research Foundation and Public Health Scotland. Dr. Innes, Dr. Beri, Dr. Reau, and Dr. Singal reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
‘Striking’ jump in cost of brand-name epilepsy meds
, a new analysis shows.
After adjustment for inflation, the cost of a 1-year supply of brand-name ASMs grew 277%, while generics became 42% less expensive.
“Our study makes transparent striking trends in brand name prescribing patterns,” the study team wrote.
Since 2010, the costs for brand-name ASMs have “consistently” increased. Costs were particularly boosted by increases in prescriptions for lacosamide (Vimpat), in addition to a “steep increase in the cost per pill, with brand-name drugs costing 10 times more than their generic counterparts,” first author Samuel Waller Terman, MD, of the University of Michigan, Ann Arbor, added in a news release.
The study was published online in Neurology.
Is a 10-fold increase in cost worth it?
To evaluate trends in ASM prescriptions and costs, the researchers used a random sample of 20% of Medicare beneficiaries with coverage from 2008 to 2018. There were 77,000 to 133,000 patients with epilepsy each year.
Over time, likely because of increasing availability of generics, brand-name ASMs made up a smaller proportion of pills prescribed, from 56% in 2008 to 14% in 2018, but still made up 79% of prescription drug costs in 2018.
The annual cost of brand-name ASMs rose from $2,800 in 2008 to $10,700 in 2018, while the cost of generic drugs decreased from $800 to $460 during that time.
An increased number of prescriptions for lacosamide was responsible for 45% of the total increase in brand-name costs.
As of 2018, lacosamide comprised 30% of all brand-name pill supply (followed by pregabalin, at 15%) and 30% of all brand-name costs (followed by clobazam and pregabalin, both at 9%), the investigators reported.
Brand-name antiepileptic drug costs decreased from 2008 to 2010, but after the introduction of lacosamide, total brand-name costs steadily rose from $72 million in 2010 (in 2018 dollars) to $256 million in 2018, they noted.
Because the dataset consists of a 20% random Medicare sample, total Medicare costs for brand-name ASMs for beneficiaries with epilepsy alone likely rose from roughly $360 million in 2010 to $1.3 billion in 2018, they added.
“Clinicians must remain cognizant of this societal cost magnitude when judging whether the 10-fold increased expense per pill for brand name medications is worth the possible benefits,” they wrote.
“While newer-generation drugs have potential advantages such as limited drug interactions and different side effect profiles, there have been conflicting studies on whether they are cost effective,” Dr. Terman noted in a news release.
A barrier to treatment
The authors of an accompanying editorial propose that the problem of prescription drug costs could be solved through a combination of competition and government regulation of prices. Patients and physicians are the most important stakeholders in this issue.
“When something represents 14% of the total use, but contributes 79% of the cost, it would be wise to consider alternatives, assuming that these alternatives are not of lower quality,” wrote Wyatt Bensken, with Case Western Reserve University, Cleveland, and Iván Sánchez Fernández, MD, with Boston Medical Center.
“When there are several ASMs with a similar mechanism of action, similar efficacy, similar safety and tolerability profile, and different costs, it would be unwise to choose the more expensive alternative just because it is newer,” they said.
This study, they added, provides data to “understand, and begin to act, on the challenging problem of the cost of prescription ASMs. After all, what is the point of having a large number of ASMs if their cost severely limits their use?”
A limitation of the study is that only Medicare prescription claims were included, so the results may not apply to younger patients with private insurance.
The study received no direct funding. The authors and editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new analysis shows.
After adjustment for inflation, the cost of a 1-year supply of brand-name ASMs grew 277%, while generics became 42% less expensive.
“Our study makes transparent striking trends in brand name prescribing patterns,” the study team wrote.
Since 2010, the costs for brand-name ASMs have “consistently” increased. Costs were particularly boosted by increases in prescriptions for lacosamide (Vimpat), in addition to a “steep increase in the cost per pill, with brand-name drugs costing 10 times more than their generic counterparts,” first author Samuel Waller Terman, MD, of the University of Michigan, Ann Arbor, added in a news release.
The study was published online in Neurology.
Is a 10-fold increase in cost worth it?
To evaluate trends in ASM prescriptions and costs, the researchers used a random sample of 20% of Medicare beneficiaries with coverage from 2008 to 2018. There were 77,000 to 133,000 patients with epilepsy each year.
Over time, likely because of increasing availability of generics, brand-name ASMs made up a smaller proportion of pills prescribed, from 56% in 2008 to 14% in 2018, but still made up 79% of prescription drug costs in 2018.
The annual cost of brand-name ASMs rose from $2,800 in 2008 to $10,700 in 2018, while the cost of generic drugs decreased from $800 to $460 during that time.
An increased number of prescriptions for lacosamide was responsible for 45% of the total increase in brand-name costs.
As of 2018, lacosamide comprised 30% of all brand-name pill supply (followed by pregabalin, at 15%) and 30% of all brand-name costs (followed by clobazam and pregabalin, both at 9%), the investigators reported.
Brand-name antiepileptic drug costs decreased from 2008 to 2010, but after the introduction of lacosamide, total brand-name costs steadily rose from $72 million in 2010 (in 2018 dollars) to $256 million in 2018, they noted.
Because the dataset consists of a 20% random Medicare sample, total Medicare costs for brand-name ASMs for beneficiaries with epilepsy alone likely rose from roughly $360 million in 2010 to $1.3 billion in 2018, they added.
“Clinicians must remain cognizant of this societal cost magnitude when judging whether the 10-fold increased expense per pill for brand name medications is worth the possible benefits,” they wrote.
“While newer-generation drugs have potential advantages such as limited drug interactions and different side effect profiles, there have been conflicting studies on whether they are cost effective,” Dr. Terman noted in a news release.
A barrier to treatment
The authors of an accompanying editorial propose that the problem of prescription drug costs could be solved through a combination of competition and government regulation of prices. Patients and physicians are the most important stakeholders in this issue.
“When something represents 14% of the total use, but contributes 79% of the cost, it would be wise to consider alternatives, assuming that these alternatives are not of lower quality,” wrote Wyatt Bensken, with Case Western Reserve University, Cleveland, and Iván Sánchez Fernández, MD, with Boston Medical Center.
“When there are several ASMs with a similar mechanism of action, similar efficacy, similar safety and tolerability profile, and different costs, it would be unwise to choose the more expensive alternative just because it is newer,” they said.
This study, they added, provides data to “understand, and begin to act, on the challenging problem of the cost of prescription ASMs. After all, what is the point of having a large number of ASMs if their cost severely limits their use?”
A limitation of the study is that only Medicare prescription claims were included, so the results may not apply to younger patients with private insurance.
The study received no direct funding. The authors and editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new analysis shows.
After adjustment for inflation, the cost of a 1-year supply of brand-name ASMs grew 277%, while generics became 42% less expensive.
“Our study makes transparent striking trends in brand name prescribing patterns,” the study team wrote.
Since 2010, the costs for brand-name ASMs have “consistently” increased. Costs were particularly boosted by increases in prescriptions for lacosamide (Vimpat), in addition to a “steep increase in the cost per pill, with brand-name drugs costing 10 times more than their generic counterparts,” first author Samuel Waller Terman, MD, of the University of Michigan, Ann Arbor, added in a news release.
The study was published online in Neurology.
Is a 10-fold increase in cost worth it?
To evaluate trends in ASM prescriptions and costs, the researchers used a random sample of 20% of Medicare beneficiaries with coverage from 2008 to 2018. There were 77,000 to 133,000 patients with epilepsy each year.
Over time, likely because of increasing availability of generics, brand-name ASMs made up a smaller proportion of pills prescribed, from 56% in 2008 to 14% in 2018, but still made up 79% of prescription drug costs in 2018.
The annual cost of brand-name ASMs rose from $2,800 in 2008 to $10,700 in 2018, while the cost of generic drugs decreased from $800 to $460 during that time.
An increased number of prescriptions for lacosamide was responsible for 45% of the total increase in brand-name costs.
As of 2018, lacosamide comprised 30% of all brand-name pill supply (followed by pregabalin, at 15%) and 30% of all brand-name costs (followed by clobazam and pregabalin, both at 9%), the investigators reported.
Brand-name antiepileptic drug costs decreased from 2008 to 2010, but after the introduction of lacosamide, total brand-name costs steadily rose from $72 million in 2010 (in 2018 dollars) to $256 million in 2018, they noted.
Because the dataset consists of a 20% random Medicare sample, total Medicare costs for brand-name ASMs for beneficiaries with epilepsy alone likely rose from roughly $360 million in 2010 to $1.3 billion in 2018, they added.
“Clinicians must remain cognizant of this societal cost magnitude when judging whether the 10-fold increased expense per pill for brand name medications is worth the possible benefits,” they wrote.
“While newer-generation drugs have potential advantages such as limited drug interactions and different side effect profiles, there have been conflicting studies on whether they are cost effective,” Dr. Terman noted in a news release.
A barrier to treatment
The authors of an accompanying editorial propose that the problem of prescription drug costs could be solved through a combination of competition and government regulation of prices. Patients and physicians are the most important stakeholders in this issue.
“When something represents 14% of the total use, but contributes 79% of the cost, it would be wise to consider alternatives, assuming that these alternatives are not of lower quality,” wrote Wyatt Bensken, with Case Western Reserve University, Cleveland, and Iván Sánchez Fernández, MD, with Boston Medical Center.
“When there are several ASMs with a similar mechanism of action, similar efficacy, similar safety and tolerability profile, and different costs, it would be unwise to choose the more expensive alternative just because it is newer,” they said.
This study, they added, provides data to “understand, and begin to act, on the challenging problem of the cost of prescription ASMs. After all, what is the point of having a large number of ASMs if their cost severely limits their use?”
A limitation of the study is that only Medicare prescription claims were included, so the results may not apply to younger patients with private insurance.
The study received no direct funding. The authors and editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.