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FDA approves first over-the-counter birth control pill
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.
Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.
The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”
But doctors largely disagreed.
“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.
While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.
Pricing unknown
Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.
“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.
The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.
Caveats to consider
There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.
Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”
Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.
The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.
Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”
Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”
Just the beginning?
The American Medical Association hopes this approval signals more to come.
“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”
The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.
“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.
A version of this article first appeared on WebMD.com.
This article was updated 7/13/23.
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.
Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.
The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”
But doctors largely disagreed.
“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.
While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.
Pricing unknown
Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.
“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.
The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.
Caveats to consider
There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.
Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”
Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.
The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.
Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”
Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”
Just the beginning?
The American Medical Association hopes this approval signals more to come.
“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”
The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.
“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.
A version of this article first appeared on WebMD.com.
This article was updated 7/13/23.
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.
Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.
The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”
But doctors largely disagreed.
“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.
While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.
Pricing unknown
Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.
“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.
The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.
Caveats to consider
There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.
Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”
Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.
The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.
Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”
Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”
Just the beginning?
The American Medical Association hopes this approval signals more to come.
“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”
The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.
“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.
A version of this article first appeared on WebMD.com.
This article was updated 7/13/23.
How psychedelics can heal a broken mind
As children learn to walk and talk, their brains are remarkably open to new information. They gather knowledge from parents, their environment, and trial and error. Teenagers do too, as they adopt the emotional and intellectual skills needed to become adults.
In adulthood, however, our minds become relatively locked, closed to new information. This saves energy and lets us navigate the world more efficiently. But that also makes it harder to adapt, learn a new language or skill, or recover from psychological or physical trauma. For those who’ve dealt with abuse, abandonment, or physical violence, that lockdown can lead to a lifetime of suffering, substance abuse, and other maladaptive behaviors.
The study, published in Nature, reflects a renaissance of using and researching psychedelics to treat a range of mental health conditions.
Scientists at Johns Hopkins University in Baltimore were investigating the drugs’ effects on “critical periods” for social learning, times when the brain is more open to new information that diminish as we age. Success in mice suggests that psychedelics can start a fresh period of learning.
If the finding bears out in future studies, the therapeutic horizon for psychedelics could expand to other opportunities to retrain the brain, including recovery from a stroke, traumatic brain injury, and even hearing loss and paralysis.
The stakes are big, and the future is promising, said lead researcher Gul Dolen, MD, PhD, an associate professor of neuroscience at Johns Hopkins University. Psychedelics “could be the key that unlocks the brain and helps people after one dose, rather than subjecting them to a lifetime of drugs.”
The psychedelic advantage
Dr. Dolen, who launched her career in addiction studies, has long been fascinated by critical periods and their influence on adult behavior.
“There have been three Nobel Prizes awarded for work on critical periods,” she said. One study in mice, for instance, identified 15 periods of social learning that define their behaviors for a lifetime.
Prior research has found that MDMA (commonly known as ecstasy) can help soldiers reconsider traumatic events on the battlefield, learn from them, and move on. That phenomenon had all the earmarks of a critical period for social learning. Perhaps, Dr. Dolen said, psychedelics could open a critical period in a soldier’s life – or a drug-addicted person’s or rape survivor’s – and give them tools to process their trauma.
In the placebo-controlled experiment, she and her team gave mice psychedelic drugs and a behavioral test to gauge the rodents’ ability to learn from their environment.
“All of the psychedelics opened the critical period of social learning for varying lengths of time,” said Dr. Dolen.
Ketamine achieved that reopening for 2 days, while the other drugs – ibogaine, LSD, MDMA, and psilocybin – opened critical periods of between 2 and 4 weeks, long after the drugs’ acute effects had worn off.
In humans, Dr. Dolen stressed, opening a critical period would be a sensitive process.
“You wouldn’t achieve these results if you dropped ecstasy and attended a rave,” she said. “The key seems to be to establish an intention for the therapy: Discuss what you hope to get from the experience, be guided through it, and process it with the therapist after the fact.”
“You need to be careful with a patient once they’re off the psychedelic,” she said, “because they’re in a state of openness and vulnerability similar to a child.”
The push for psychedelic therapy
Another psychedelics researcher, Matthew Lowe, PhD, sees promise in the Johns Hopkins study. The drugs “place the brain in a more malleable and flexible state,” said Dr. Lowe, the executive director and chief science officer for Unlimited Sciences, a psychedelics research nonprofit.
He expects that psychedelics may help people break out of negative behavior patterns.
“These findings show significant promise for treating a wide range of neuropsychiatric diseases, including depression, PTSD, and addiction,” he said.
Dr. Dolen said using psychedelics in critical-period therapy “opens up all sorts of possibilities for the rest of the brain.” Future research may also lead to treatments for deafness, physical disabilities, and drug and alcohol addiction. She is currently raising funds for a clinical trial to see if psychedelics can improve motor impairment after a stroke.
“Growing legislative openness” to the use of psychedelics could open the door for millions to benefit from mental health treatment “through clinical trials and legal therapeutic pathways as they open up,” said Benjamin Lightburn, CEO and cofounder of Filament Health, a company based in British Columbia that provides naturally derived psilocybin for clinical trials.
Several states have made moves toward decriminalization or permitting the drugs’ use under medical supervision. In a scientific paper, Washington University researchers, using an analytic model based on marijuana legalization, projected that most states will legalize psychedelics in the next 10-15 years. And on July 1, Australia became the first country to allow psilocybin and MDMA to be prescribed by doctors to treat psychiatric conditions. The U.S. could potentially approve MDMA for therapy later in 2023.
A version of this article first appeared on WebMD.com.
As children learn to walk and talk, their brains are remarkably open to new information. They gather knowledge from parents, their environment, and trial and error. Teenagers do too, as they adopt the emotional and intellectual skills needed to become adults.
In adulthood, however, our minds become relatively locked, closed to new information. This saves energy and lets us navigate the world more efficiently. But that also makes it harder to adapt, learn a new language or skill, or recover from psychological or physical trauma. For those who’ve dealt with abuse, abandonment, or physical violence, that lockdown can lead to a lifetime of suffering, substance abuse, and other maladaptive behaviors.
The study, published in Nature, reflects a renaissance of using and researching psychedelics to treat a range of mental health conditions.
Scientists at Johns Hopkins University in Baltimore were investigating the drugs’ effects on “critical periods” for social learning, times when the brain is more open to new information that diminish as we age. Success in mice suggests that psychedelics can start a fresh period of learning.
If the finding bears out in future studies, the therapeutic horizon for psychedelics could expand to other opportunities to retrain the brain, including recovery from a stroke, traumatic brain injury, and even hearing loss and paralysis.
The stakes are big, and the future is promising, said lead researcher Gul Dolen, MD, PhD, an associate professor of neuroscience at Johns Hopkins University. Psychedelics “could be the key that unlocks the brain and helps people after one dose, rather than subjecting them to a lifetime of drugs.”
The psychedelic advantage
Dr. Dolen, who launched her career in addiction studies, has long been fascinated by critical periods and their influence on adult behavior.
“There have been three Nobel Prizes awarded for work on critical periods,” she said. One study in mice, for instance, identified 15 periods of social learning that define their behaviors for a lifetime.
Prior research has found that MDMA (commonly known as ecstasy) can help soldiers reconsider traumatic events on the battlefield, learn from them, and move on. That phenomenon had all the earmarks of a critical period for social learning. Perhaps, Dr. Dolen said, psychedelics could open a critical period in a soldier’s life – or a drug-addicted person’s or rape survivor’s – and give them tools to process their trauma.
In the placebo-controlled experiment, she and her team gave mice psychedelic drugs and a behavioral test to gauge the rodents’ ability to learn from their environment.
“All of the psychedelics opened the critical period of social learning for varying lengths of time,” said Dr. Dolen.
Ketamine achieved that reopening for 2 days, while the other drugs – ibogaine, LSD, MDMA, and psilocybin – opened critical periods of between 2 and 4 weeks, long after the drugs’ acute effects had worn off.
In humans, Dr. Dolen stressed, opening a critical period would be a sensitive process.
“You wouldn’t achieve these results if you dropped ecstasy and attended a rave,” she said. “The key seems to be to establish an intention for the therapy: Discuss what you hope to get from the experience, be guided through it, and process it with the therapist after the fact.”
“You need to be careful with a patient once they’re off the psychedelic,” she said, “because they’re in a state of openness and vulnerability similar to a child.”
The push for psychedelic therapy
Another psychedelics researcher, Matthew Lowe, PhD, sees promise in the Johns Hopkins study. The drugs “place the brain in a more malleable and flexible state,” said Dr. Lowe, the executive director and chief science officer for Unlimited Sciences, a psychedelics research nonprofit.
He expects that psychedelics may help people break out of negative behavior patterns.
“These findings show significant promise for treating a wide range of neuropsychiatric diseases, including depression, PTSD, and addiction,” he said.
Dr. Dolen said using psychedelics in critical-period therapy “opens up all sorts of possibilities for the rest of the brain.” Future research may also lead to treatments for deafness, physical disabilities, and drug and alcohol addiction. She is currently raising funds for a clinical trial to see if psychedelics can improve motor impairment after a stroke.
“Growing legislative openness” to the use of psychedelics could open the door for millions to benefit from mental health treatment “through clinical trials and legal therapeutic pathways as they open up,” said Benjamin Lightburn, CEO and cofounder of Filament Health, a company based in British Columbia that provides naturally derived psilocybin for clinical trials.
Several states have made moves toward decriminalization or permitting the drugs’ use under medical supervision. In a scientific paper, Washington University researchers, using an analytic model based on marijuana legalization, projected that most states will legalize psychedelics in the next 10-15 years. And on July 1, Australia became the first country to allow psilocybin and MDMA to be prescribed by doctors to treat psychiatric conditions. The U.S. could potentially approve MDMA for therapy later in 2023.
A version of this article first appeared on WebMD.com.
As children learn to walk and talk, their brains are remarkably open to new information. They gather knowledge from parents, their environment, and trial and error. Teenagers do too, as they adopt the emotional and intellectual skills needed to become adults.
In adulthood, however, our minds become relatively locked, closed to new information. This saves energy and lets us navigate the world more efficiently. But that also makes it harder to adapt, learn a new language or skill, or recover from psychological or physical trauma. For those who’ve dealt with abuse, abandonment, or physical violence, that lockdown can lead to a lifetime of suffering, substance abuse, and other maladaptive behaviors.
The study, published in Nature, reflects a renaissance of using and researching psychedelics to treat a range of mental health conditions.
Scientists at Johns Hopkins University in Baltimore were investigating the drugs’ effects on “critical periods” for social learning, times when the brain is more open to new information that diminish as we age. Success in mice suggests that psychedelics can start a fresh period of learning.
If the finding bears out in future studies, the therapeutic horizon for psychedelics could expand to other opportunities to retrain the brain, including recovery from a stroke, traumatic brain injury, and even hearing loss and paralysis.
The stakes are big, and the future is promising, said lead researcher Gul Dolen, MD, PhD, an associate professor of neuroscience at Johns Hopkins University. Psychedelics “could be the key that unlocks the brain and helps people after one dose, rather than subjecting them to a lifetime of drugs.”
The psychedelic advantage
Dr. Dolen, who launched her career in addiction studies, has long been fascinated by critical periods and their influence on adult behavior.
“There have been three Nobel Prizes awarded for work on critical periods,” she said. One study in mice, for instance, identified 15 periods of social learning that define their behaviors for a lifetime.
Prior research has found that MDMA (commonly known as ecstasy) can help soldiers reconsider traumatic events on the battlefield, learn from them, and move on. That phenomenon had all the earmarks of a critical period for social learning. Perhaps, Dr. Dolen said, psychedelics could open a critical period in a soldier’s life – or a drug-addicted person’s or rape survivor’s – and give them tools to process their trauma.
In the placebo-controlled experiment, she and her team gave mice psychedelic drugs and a behavioral test to gauge the rodents’ ability to learn from their environment.
“All of the psychedelics opened the critical period of social learning for varying lengths of time,” said Dr. Dolen.
Ketamine achieved that reopening for 2 days, while the other drugs – ibogaine, LSD, MDMA, and psilocybin – opened critical periods of between 2 and 4 weeks, long after the drugs’ acute effects had worn off.
In humans, Dr. Dolen stressed, opening a critical period would be a sensitive process.
“You wouldn’t achieve these results if you dropped ecstasy and attended a rave,” she said. “The key seems to be to establish an intention for the therapy: Discuss what you hope to get from the experience, be guided through it, and process it with the therapist after the fact.”
“You need to be careful with a patient once they’re off the psychedelic,” she said, “because they’re in a state of openness and vulnerability similar to a child.”
The push for psychedelic therapy
Another psychedelics researcher, Matthew Lowe, PhD, sees promise in the Johns Hopkins study. The drugs “place the brain in a more malleable and flexible state,” said Dr. Lowe, the executive director and chief science officer for Unlimited Sciences, a psychedelics research nonprofit.
He expects that psychedelics may help people break out of negative behavior patterns.
“These findings show significant promise for treating a wide range of neuropsychiatric diseases, including depression, PTSD, and addiction,” he said.
Dr. Dolen said using psychedelics in critical-period therapy “opens up all sorts of possibilities for the rest of the brain.” Future research may also lead to treatments for deafness, physical disabilities, and drug and alcohol addiction. She is currently raising funds for a clinical trial to see if psychedelics can improve motor impairment after a stroke.
“Growing legislative openness” to the use of psychedelics could open the door for millions to benefit from mental health treatment “through clinical trials and legal therapeutic pathways as they open up,” said Benjamin Lightburn, CEO and cofounder of Filament Health, a company based in British Columbia that provides naturally derived psilocybin for clinical trials.
Several states have made moves toward decriminalization or permitting the drugs’ use under medical supervision. In a scientific paper, Washington University researchers, using an analytic model based on marijuana legalization, projected that most states will legalize psychedelics in the next 10-15 years. And on July 1, Australia became the first country to allow psilocybin and MDMA to be prescribed by doctors to treat psychiatric conditions. The U.S. could potentially approve MDMA for therapy later in 2023.
A version of this article first appeared on WebMD.com.
FROM NATURE
Eosinophilic esophagitis: A year in review
At the AGA postgraduate course in May, we highlighted recent noteworthy randomized controlled trials (RCT) using eosinophil-targeting biologic therapy, esophageal-optimized corticosteroid preparations, and dietary elimination in EoE.
Dupilumab, a monoclonal antibody that blocks interleukin-4 and IL-13 signaling, was tested in a phase 3 trial for adults and adolescents with EoE.1 In this double-blind, randomized, placebo-controlled trial, the efficacy of subcutaneous dupilumab 300 mg weekly or every other week was compared against placebo. Stringent histologic remission (≤ 6 eosinophils/high power field) occurred in approximately 60% who received dupilumab (either dose) versus 5% in placebo. However, significant symptom improvement was seen only with 300 g weekly dupilumab.
On the topical corticosteroid front, the results of two RCTs using fluticasone orally disintegrating tablet (APT-1011) and budesonide oral suspension (BOS) were published. In the APT-1011 phase 2b trial, patients were randomized to receive 1.5 mg or 3 mg daily or b.i.d. versus placebo for 12 weeks.2 High histologic response rates and improvement in dysphagia frequency were seen with all ≥ 3-mg daily-dose APT-1011, compared with placebo. However, adverse events (that is, candidiasis) were highest among those on 3 mg b.i.d. Thus, 3 mg daily APT-1011 was thought to offer the most favorable risk-benefit profile. In the BOS phase 3 trial, patients were randomized 2:1 to received BOS 2 mg b.i.d. or placebo for 12 weeks.3 BOS was superior to placebo in histologic, symptomatic, and endoscopic outcomes.
Diet remains the only therapy targeting the cause of EoE and offers a potential drug-free remission. In the randomized, open label trial of 1- versus 6-food elimination diet, adult patients were allocated 1:1 to 1FED (animal milk) or 6FED (animal milk, wheat, egg, soy, fish/shellfish, and peanuts/tree nuts) for 6 weeks.4 No significant difference in partial or stringent remission was found between the two groups. Step-up therapy resulted in an additional 43% histologic response in those who underwent 6FED after failing 1FED and 82% histologic response in those who received swallowed fluticasone 880 mcg b.i.d after failing 6FED. Hence, eliminating animal milk alone in a step-up treatment approach is reasonable.
We have witnessed major progress to expand EoE treatment options in the last year. Long-term efficacy and side-effect data, as well as studies comparing between therapies are needed to improve shared decision-making and strategies to implement tailored care in EoE.
Dr. Chen is with the division of gastroenterology and hepatology, department of internal medicine at the University of Michigan, Ann Arbor. She disclosed consultancy work with Phathom Pharmaceuticals.
References
1. Dellon ES et al. N Engl J Med. 2022;387(25):2317-30.
2. Dellon ES et al. Clin Gastroenterol Hepatol. 2022;20(11):2485-94e15.
3. Hirano I et al. Budesonide. Clin Gastroenterol Hepatol. 2022;20(3):525-34e10.
4. Kliewer KL et al. Lancet Gastroenterol Hepatol. 2023;8(5):408-21.
At the AGA postgraduate course in May, we highlighted recent noteworthy randomized controlled trials (RCT) using eosinophil-targeting biologic therapy, esophageal-optimized corticosteroid preparations, and dietary elimination in EoE.
Dupilumab, a monoclonal antibody that blocks interleukin-4 and IL-13 signaling, was tested in a phase 3 trial for adults and adolescents with EoE.1 In this double-blind, randomized, placebo-controlled trial, the efficacy of subcutaneous dupilumab 300 mg weekly or every other week was compared against placebo. Stringent histologic remission (≤ 6 eosinophils/high power field) occurred in approximately 60% who received dupilumab (either dose) versus 5% in placebo. However, significant symptom improvement was seen only with 300 g weekly dupilumab.
On the topical corticosteroid front, the results of two RCTs using fluticasone orally disintegrating tablet (APT-1011) and budesonide oral suspension (BOS) were published. In the APT-1011 phase 2b trial, patients were randomized to receive 1.5 mg or 3 mg daily or b.i.d. versus placebo for 12 weeks.2 High histologic response rates and improvement in dysphagia frequency were seen with all ≥ 3-mg daily-dose APT-1011, compared with placebo. However, adverse events (that is, candidiasis) were highest among those on 3 mg b.i.d. Thus, 3 mg daily APT-1011 was thought to offer the most favorable risk-benefit profile. In the BOS phase 3 trial, patients were randomized 2:1 to received BOS 2 mg b.i.d. or placebo for 12 weeks.3 BOS was superior to placebo in histologic, symptomatic, and endoscopic outcomes.
Diet remains the only therapy targeting the cause of EoE and offers a potential drug-free remission. In the randomized, open label trial of 1- versus 6-food elimination diet, adult patients were allocated 1:1 to 1FED (animal milk) or 6FED (animal milk, wheat, egg, soy, fish/shellfish, and peanuts/tree nuts) for 6 weeks.4 No significant difference in partial or stringent remission was found between the two groups. Step-up therapy resulted in an additional 43% histologic response in those who underwent 6FED after failing 1FED and 82% histologic response in those who received swallowed fluticasone 880 mcg b.i.d after failing 6FED. Hence, eliminating animal milk alone in a step-up treatment approach is reasonable.
We have witnessed major progress to expand EoE treatment options in the last year. Long-term efficacy and side-effect data, as well as studies comparing between therapies are needed to improve shared decision-making and strategies to implement tailored care in EoE.
Dr. Chen is with the division of gastroenterology and hepatology, department of internal medicine at the University of Michigan, Ann Arbor. She disclosed consultancy work with Phathom Pharmaceuticals.
References
1. Dellon ES et al. N Engl J Med. 2022;387(25):2317-30.
2. Dellon ES et al. Clin Gastroenterol Hepatol. 2022;20(11):2485-94e15.
3. Hirano I et al. Budesonide. Clin Gastroenterol Hepatol. 2022;20(3):525-34e10.
4. Kliewer KL et al. Lancet Gastroenterol Hepatol. 2023;8(5):408-21.
At the AGA postgraduate course in May, we highlighted recent noteworthy randomized controlled trials (RCT) using eosinophil-targeting biologic therapy, esophageal-optimized corticosteroid preparations, and dietary elimination in EoE.
Dupilumab, a monoclonal antibody that blocks interleukin-4 and IL-13 signaling, was tested in a phase 3 trial for adults and adolescents with EoE.1 In this double-blind, randomized, placebo-controlled trial, the efficacy of subcutaneous dupilumab 300 mg weekly or every other week was compared against placebo. Stringent histologic remission (≤ 6 eosinophils/high power field) occurred in approximately 60% who received dupilumab (either dose) versus 5% in placebo. However, significant symptom improvement was seen only with 300 g weekly dupilumab.
On the topical corticosteroid front, the results of two RCTs using fluticasone orally disintegrating tablet (APT-1011) and budesonide oral suspension (BOS) were published. In the APT-1011 phase 2b trial, patients were randomized to receive 1.5 mg or 3 mg daily or b.i.d. versus placebo for 12 weeks.2 High histologic response rates and improvement in dysphagia frequency were seen with all ≥ 3-mg daily-dose APT-1011, compared with placebo. However, adverse events (that is, candidiasis) were highest among those on 3 mg b.i.d. Thus, 3 mg daily APT-1011 was thought to offer the most favorable risk-benefit profile. In the BOS phase 3 trial, patients were randomized 2:1 to received BOS 2 mg b.i.d. or placebo for 12 weeks.3 BOS was superior to placebo in histologic, symptomatic, and endoscopic outcomes.
Diet remains the only therapy targeting the cause of EoE and offers a potential drug-free remission. In the randomized, open label trial of 1- versus 6-food elimination diet, adult patients were allocated 1:1 to 1FED (animal milk) or 6FED (animal milk, wheat, egg, soy, fish/shellfish, and peanuts/tree nuts) for 6 weeks.4 No significant difference in partial or stringent remission was found between the two groups. Step-up therapy resulted in an additional 43% histologic response in those who underwent 6FED after failing 1FED and 82% histologic response in those who received swallowed fluticasone 880 mcg b.i.d after failing 6FED. Hence, eliminating animal milk alone in a step-up treatment approach is reasonable.
We have witnessed major progress to expand EoE treatment options in the last year. Long-term efficacy and side-effect data, as well as studies comparing between therapies are needed to improve shared decision-making and strategies to implement tailored care in EoE.
Dr. Chen is with the division of gastroenterology and hepatology, department of internal medicine at the University of Michigan, Ann Arbor. She disclosed consultancy work with Phathom Pharmaceuticals.
References
1. Dellon ES et al. N Engl J Med. 2022;387(25):2317-30.
2. Dellon ES et al. Clin Gastroenterol Hepatol. 2022;20(11):2485-94e15.
3. Hirano I et al. Budesonide. Clin Gastroenterol Hepatol. 2022;20(3):525-34e10.
4. Kliewer KL et al. Lancet Gastroenterol Hepatol. 2023;8(5):408-21.
Deer populations pose COVID risk to humans: Study
According to the U.S. Department of Agriculture, which led the research project, humans transmitted the virus to deer at least 100 times. The virus then spread widely among free-ranging deer populations, and there were three possible cases of the deer transmitting the virus to humans.
The data comes from tests done between November 2021 and April 2022 on more than 12,000 deer found across half of the United States. Sequencing of the virus found in the deer showed that deer had been exposed to all of the prominent variants, including Alpha, Gamma, Delta, and Omicron.
Some of the findings about transmission were published in the journal Nature Communications, in which researchers noted that in addition to being identified in deer, the virus has been found in wild and domestic animals, including mink, rats, otters, ferrets, hamsters, gorillas, cats, dogs, lions, and tigers. Animal-to-human transmission has been documented or suspected in mink and domestic cats, in addition to white-tailed deer.
The findings are important because the animal populations can become “reservoirs ... in which the virus circulates covertly, persisting in the population and can be transmitted to other animals or humans potentially causing disease outbreaks,” according to the paper, which was a collaboration among scientists from the U.S. Department of Agriculture, CDC, and the University of Missouri–Columbia.
In the three cases of possible deer-to-human transmission, researchers said that mutated versions of the virus previously found only in deer had been found in COVID test samples taken from one person in North Carolina and two people in Massachusetts. Those deer-specific mutated versions of the virus have not been found in any other human samples, lending evidence that the mutations occurred within deer.
“Deer regularly interact with humans and are commonly found in human environments – near our homes, pets, wastewater, and trash,” researcher and University of Missouri–Columbia professor Xiu-Feng “Henry” Wan, PhD, said in a statement. “The potential for SARS-CoV-2, or any zoonotic disease, to persist and evolve in wildlife populations can pose unique public health risks.”
In the Nature Communications paper, the researchers suggested that deer may be exposed to the virus from human food waste, masks, or other waste products. The authors concluded that further study is needed to determine how virus transmission occurs between deer and humans.
A version of this article first appeared on WebMD.com.
According to the U.S. Department of Agriculture, which led the research project, humans transmitted the virus to deer at least 100 times. The virus then spread widely among free-ranging deer populations, and there were three possible cases of the deer transmitting the virus to humans.
The data comes from tests done between November 2021 and April 2022 on more than 12,000 deer found across half of the United States. Sequencing of the virus found in the deer showed that deer had been exposed to all of the prominent variants, including Alpha, Gamma, Delta, and Omicron.
Some of the findings about transmission were published in the journal Nature Communications, in which researchers noted that in addition to being identified in deer, the virus has been found in wild and domestic animals, including mink, rats, otters, ferrets, hamsters, gorillas, cats, dogs, lions, and tigers. Animal-to-human transmission has been documented or suspected in mink and domestic cats, in addition to white-tailed deer.
The findings are important because the animal populations can become “reservoirs ... in which the virus circulates covertly, persisting in the population and can be transmitted to other animals or humans potentially causing disease outbreaks,” according to the paper, which was a collaboration among scientists from the U.S. Department of Agriculture, CDC, and the University of Missouri–Columbia.
In the three cases of possible deer-to-human transmission, researchers said that mutated versions of the virus previously found only in deer had been found in COVID test samples taken from one person in North Carolina and two people in Massachusetts. Those deer-specific mutated versions of the virus have not been found in any other human samples, lending evidence that the mutations occurred within deer.
“Deer regularly interact with humans and are commonly found in human environments – near our homes, pets, wastewater, and trash,” researcher and University of Missouri–Columbia professor Xiu-Feng “Henry” Wan, PhD, said in a statement. “The potential for SARS-CoV-2, or any zoonotic disease, to persist and evolve in wildlife populations can pose unique public health risks.”
In the Nature Communications paper, the researchers suggested that deer may be exposed to the virus from human food waste, masks, or other waste products. The authors concluded that further study is needed to determine how virus transmission occurs between deer and humans.
A version of this article first appeared on WebMD.com.
According to the U.S. Department of Agriculture, which led the research project, humans transmitted the virus to deer at least 100 times. The virus then spread widely among free-ranging deer populations, and there were three possible cases of the deer transmitting the virus to humans.
The data comes from tests done between November 2021 and April 2022 on more than 12,000 deer found across half of the United States. Sequencing of the virus found in the deer showed that deer had been exposed to all of the prominent variants, including Alpha, Gamma, Delta, and Omicron.
Some of the findings about transmission were published in the journal Nature Communications, in which researchers noted that in addition to being identified in deer, the virus has been found in wild and domestic animals, including mink, rats, otters, ferrets, hamsters, gorillas, cats, dogs, lions, and tigers. Animal-to-human transmission has been documented or suspected in mink and domestic cats, in addition to white-tailed deer.
The findings are important because the animal populations can become “reservoirs ... in which the virus circulates covertly, persisting in the population and can be transmitted to other animals or humans potentially causing disease outbreaks,” according to the paper, which was a collaboration among scientists from the U.S. Department of Agriculture, CDC, and the University of Missouri–Columbia.
In the three cases of possible deer-to-human transmission, researchers said that mutated versions of the virus previously found only in deer had been found in COVID test samples taken from one person in North Carolina and two people in Massachusetts. Those deer-specific mutated versions of the virus have not been found in any other human samples, lending evidence that the mutations occurred within deer.
“Deer regularly interact with humans and are commonly found in human environments – near our homes, pets, wastewater, and trash,” researcher and University of Missouri–Columbia professor Xiu-Feng “Henry” Wan, PhD, said in a statement. “The potential for SARS-CoV-2, or any zoonotic disease, to persist and evolve in wildlife populations can pose unique public health risks.”
In the Nature Communications paper, the researchers suggested that deer may be exposed to the virus from human food waste, masks, or other waste products. The authors concluded that further study is needed to determine how virus transmission occurs between deer and humans.
A version of this article first appeared on WebMD.com.
FROM NATURE COMMUNICATIONS
FDA approves new device for enlarged prostate treatment
Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.
“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.
Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.
“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.
More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.
A version of this article first appeared on Medscape.com.
Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.
“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.
Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.
“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.
More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.
A version of this article first appeared on Medscape.com.
Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.
“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.
Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.
“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.
More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.
A version of this article first appeared on Medscape.com.
Incidental hepatic steatosis
It is important to identify patients at risk of progressive fibrosis.
Calculation of the fibrosis-4 (FIB-4) score (based on age, alanine and aspartate aminotransferase [ALT and AST] levels, and platelet count by the primary care provider, using either an online calculator or the dot phrase “.fib4” in Epic) is a useful first step. If the value is low (with a high negative predictive value for advanced fibrosis), the patient does not need to be referred but can be managed for risk factors for nonalcoholic fatty liver disease. If the value is high, suggesting advanced fibrosis, the patient requires further evaluation. If the value is indeterminate, options for assessing liver stiffness include vibration-controlled transient elastography (with a controlled attenuation parameter to assess the degree of steatosis) and ultrasound elastography. A low liver stiffness score argues against the need for subspecialty management. An indeterminate score may be followed by magnetic resonance elastography, if available. An alternative to elastography is the enhanced liver fibrosis (ELF) blood test, based on serum levels of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid.
Dr. Friedman is the Anton R. Fried, MD, chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., and assistant chief of medicine at Massachusetts General Hospital, and a professor of medicine at Harvard Medical School and Tufts University, Boston. Dr. Martin is chief of the division of digestive health and liver diseases at the University of Miami, where he is the Mandel Chair of Gastroenterology. The authors disclose no conflicts.
Published previously in Gastro Hep Advances (doi: 10.1016/j.gastha.2023.03.008).
It is important to identify patients at risk of progressive fibrosis.
Calculation of the fibrosis-4 (FIB-4) score (based on age, alanine and aspartate aminotransferase [ALT and AST] levels, and platelet count by the primary care provider, using either an online calculator or the dot phrase “.fib4” in Epic) is a useful first step. If the value is low (with a high negative predictive value for advanced fibrosis), the patient does not need to be referred but can be managed for risk factors for nonalcoholic fatty liver disease. If the value is high, suggesting advanced fibrosis, the patient requires further evaluation. If the value is indeterminate, options for assessing liver stiffness include vibration-controlled transient elastography (with a controlled attenuation parameter to assess the degree of steatosis) and ultrasound elastography. A low liver stiffness score argues against the need for subspecialty management. An indeterminate score may be followed by magnetic resonance elastography, if available. An alternative to elastography is the enhanced liver fibrosis (ELF) blood test, based on serum levels of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid.
Dr. Friedman is the Anton R. Fried, MD, chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., and assistant chief of medicine at Massachusetts General Hospital, and a professor of medicine at Harvard Medical School and Tufts University, Boston. Dr. Martin is chief of the division of digestive health and liver diseases at the University of Miami, where he is the Mandel Chair of Gastroenterology. The authors disclose no conflicts.
Published previously in Gastro Hep Advances (doi: 10.1016/j.gastha.2023.03.008).
It is important to identify patients at risk of progressive fibrosis.
Calculation of the fibrosis-4 (FIB-4) score (based on age, alanine and aspartate aminotransferase [ALT and AST] levels, and platelet count by the primary care provider, using either an online calculator or the dot phrase “.fib4” in Epic) is a useful first step. If the value is low (with a high negative predictive value for advanced fibrosis), the patient does not need to be referred but can be managed for risk factors for nonalcoholic fatty liver disease. If the value is high, suggesting advanced fibrosis, the patient requires further evaluation. If the value is indeterminate, options for assessing liver stiffness include vibration-controlled transient elastography (with a controlled attenuation parameter to assess the degree of steatosis) and ultrasound elastography. A low liver stiffness score argues against the need for subspecialty management. An indeterminate score may be followed by magnetic resonance elastography, if available. An alternative to elastography is the enhanced liver fibrosis (ELF) blood test, based on serum levels of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid.
Dr. Friedman is the Anton R. Fried, MD, chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., and assistant chief of medicine at Massachusetts General Hospital, and a professor of medicine at Harvard Medical School and Tufts University, Boston. Dr. Martin is chief of the division of digestive health and liver diseases at the University of Miami, where he is the Mandel Chair of Gastroenterology. The authors disclose no conflicts.
Published previously in Gastro Hep Advances (doi: 10.1016/j.gastha.2023.03.008).
FROM GASTRO HEP ADVANCES
Spirometry predicts mortality in type 2 diabetes
Among adults with type 2 diabetes, the presence of preserved ratio impaired spirometry (PRISm) was significantly associated with increased risk of mortality and both macro- and microvascular complications, as well as increased mortality, based on data from more than 20,000 individuals.
Guochen Li, MD, of the Medical College of Soochow University, Suzhou, China, and colleagues wrote.
“A growing number of studies have demonstrated that impaired lung function and type 2 diabetes could trigger shared pathophysiological injuries, such as microangiopathy and chronic inflammation,” they said, but the potential role of PRISm as an early predictor of adverse outcomes in patients with type 2 diabetes has not been fully examined.
In a study published in the journal Chest, the researchers reviewed data from 20,047 individuals with type 2 diabetes in the UK Biobank, a population-based cohort of adults aged 37-73 years recruited between 2006 and 2010.
The main exposure was lung function based on spirometry. PRISm was defined as predicted forced expiratory volume per second (FEV1) less than 80%, with an FEV1/ forced vital capacity (FVC) ratio of at least 0.70. Individuals with normal spirometry (defined as predicted FEV1 ≥ 80% with an FEV1/FVC ratio ≥ 0.70) served as controls.
The primary outcomes were major complications of type 2 diabetes including macrovascular events (myocardial infarction, unstable angina, coronary heart disease [CHD], ischemic stroke, and any type of stroke), microvascular events (diabetic retinopathy and diabetic kidney disease) and mortality (all-cause, cardiovascular, and respiratory).
Overall, 16.9% of study participants (3385 patients) had obstructive spirometry and 22.6% (4521 patients) had PRISm. Compared with individuals with normal spirometry, those with PRISm were more likely to be current smokers, obese, and living in economically disadvantaged areas. Individuals with PRISm also were significantly more likely to be long-term patients with diabetes who were taking glucose-lowering or lipid-lowering drugs (P < .001 for all).
The median follow-up for each of the type 2 diabetes complications and mortality was approximately 12 years. Over this time, 5.0% of patients developed incident MI, 1.3% developed unstable angina, 15.6% had CHD, 3.5% had an ischemic stroke, and 4.7% had any type of stroke. As for microvascular events, 7.8% developed diabetic retinopathy and 6.7% developed diabetic kidney disease. A total of 2588 patients died during the study period (15.1%), including 544 from cardiovascular disease and 319 from respiratory disease.
PRISm was significantly associated with increased risk of each of the complications and mortality types. These associations persisted after adjusting for lifestyle and other factors. The fully adjusted hazard ratios for PRISm versus normal spirometry were 1.23 for MI, 1.23 for unstable angina, 1.21 for CHD, 1.38 for ischemic stroke, 1.41 for any type of stroke, 1.31 for diabetic retinopathy, and 1.38 for diabetic kidney disease. Adjusted HRs for mortality were 1.34, 1.60, and 1.56 for all-cause, cardiovascular, and respiratory mortality, respectively.
The researchers also found that adding PRISm to an office-based risk score significantly improved the risk classification and predictive power for type 2 diabetes complications with the exception of unstable angina and mortality. They found little evidence for an association with sex, smoking, or PRISm duration and any mortality types. However, in subgroup analyses by age, sex, and duration of diabetes, PRISm remained associated with increased risk of macrovascular and microvascular complications, as well as mortality.
Potential mechanisms for the association between PRISm and diabetes complications include the role of insulin resistance in the exacerbation of lung damage in patients with type 2 diabetes, the increased rate of supplemental oxygen use among individuals with PRISm, and the increased prevalence of pulmonary artery enlargement in the PRISm subjects, the researchers wrote.
The findings were limited by several factors including the prospective design, the homogeneous population of individuals primarily of British or Irish ancestry, and the exclusion of diabetic neuropathy from the analysis, the researchers noted.
However, the results were strengthened by the large cohort, use of professional spirometry, and relatively long follow-up. “The findings underscore the relevance of PRISm for prognostic classification in type 2 diabetes and its potential for optimizing prevention strategies in this condition,” they concluded.
The study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangsu Province, and the Priority Academic Program Development of Jiangsu Higher Education Institutions. The researchers reported no relevant financial relationships.
A version of this article first appeared on Medscape.com
Among adults with type 2 diabetes, the presence of preserved ratio impaired spirometry (PRISm) was significantly associated with increased risk of mortality and both macro- and microvascular complications, as well as increased mortality, based on data from more than 20,000 individuals.
Guochen Li, MD, of the Medical College of Soochow University, Suzhou, China, and colleagues wrote.
“A growing number of studies have demonstrated that impaired lung function and type 2 diabetes could trigger shared pathophysiological injuries, such as microangiopathy and chronic inflammation,” they said, but the potential role of PRISm as an early predictor of adverse outcomes in patients with type 2 diabetes has not been fully examined.
In a study published in the journal Chest, the researchers reviewed data from 20,047 individuals with type 2 diabetes in the UK Biobank, a population-based cohort of adults aged 37-73 years recruited between 2006 and 2010.
The main exposure was lung function based on spirometry. PRISm was defined as predicted forced expiratory volume per second (FEV1) less than 80%, with an FEV1/ forced vital capacity (FVC) ratio of at least 0.70. Individuals with normal spirometry (defined as predicted FEV1 ≥ 80% with an FEV1/FVC ratio ≥ 0.70) served as controls.
The primary outcomes were major complications of type 2 diabetes including macrovascular events (myocardial infarction, unstable angina, coronary heart disease [CHD], ischemic stroke, and any type of stroke), microvascular events (diabetic retinopathy and diabetic kidney disease) and mortality (all-cause, cardiovascular, and respiratory).
Overall, 16.9% of study participants (3385 patients) had obstructive spirometry and 22.6% (4521 patients) had PRISm. Compared with individuals with normal spirometry, those with PRISm were more likely to be current smokers, obese, and living in economically disadvantaged areas. Individuals with PRISm also were significantly more likely to be long-term patients with diabetes who were taking glucose-lowering or lipid-lowering drugs (P < .001 for all).
The median follow-up for each of the type 2 diabetes complications and mortality was approximately 12 years. Over this time, 5.0% of patients developed incident MI, 1.3% developed unstable angina, 15.6% had CHD, 3.5% had an ischemic stroke, and 4.7% had any type of stroke. As for microvascular events, 7.8% developed diabetic retinopathy and 6.7% developed diabetic kidney disease. A total of 2588 patients died during the study period (15.1%), including 544 from cardiovascular disease and 319 from respiratory disease.
PRISm was significantly associated with increased risk of each of the complications and mortality types. These associations persisted after adjusting for lifestyle and other factors. The fully adjusted hazard ratios for PRISm versus normal spirometry were 1.23 for MI, 1.23 for unstable angina, 1.21 for CHD, 1.38 for ischemic stroke, 1.41 for any type of stroke, 1.31 for diabetic retinopathy, and 1.38 for diabetic kidney disease. Adjusted HRs for mortality were 1.34, 1.60, and 1.56 for all-cause, cardiovascular, and respiratory mortality, respectively.
The researchers also found that adding PRISm to an office-based risk score significantly improved the risk classification and predictive power for type 2 diabetes complications with the exception of unstable angina and mortality. They found little evidence for an association with sex, smoking, or PRISm duration and any mortality types. However, in subgroup analyses by age, sex, and duration of diabetes, PRISm remained associated with increased risk of macrovascular and microvascular complications, as well as mortality.
Potential mechanisms for the association between PRISm and diabetes complications include the role of insulin resistance in the exacerbation of lung damage in patients with type 2 diabetes, the increased rate of supplemental oxygen use among individuals with PRISm, and the increased prevalence of pulmonary artery enlargement in the PRISm subjects, the researchers wrote.
The findings were limited by several factors including the prospective design, the homogeneous population of individuals primarily of British or Irish ancestry, and the exclusion of diabetic neuropathy from the analysis, the researchers noted.
However, the results were strengthened by the large cohort, use of professional spirometry, and relatively long follow-up. “The findings underscore the relevance of PRISm for prognostic classification in type 2 diabetes and its potential for optimizing prevention strategies in this condition,” they concluded.
The study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangsu Province, and the Priority Academic Program Development of Jiangsu Higher Education Institutions. The researchers reported no relevant financial relationships.
A version of this article first appeared on Medscape.com
Among adults with type 2 diabetes, the presence of preserved ratio impaired spirometry (PRISm) was significantly associated with increased risk of mortality and both macro- and microvascular complications, as well as increased mortality, based on data from more than 20,000 individuals.
Guochen Li, MD, of the Medical College of Soochow University, Suzhou, China, and colleagues wrote.
“A growing number of studies have demonstrated that impaired lung function and type 2 diabetes could trigger shared pathophysiological injuries, such as microangiopathy and chronic inflammation,” they said, but the potential role of PRISm as an early predictor of adverse outcomes in patients with type 2 diabetes has not been fully examined.
In a study published in the journal Chest, the researchers reviewed data from 20,047 individuals with type 2 diabetes in the UK Biobank, a population-based cohort of adults aged 37-73 years recruited between 2006 and 2010.
The main exposure was lung function based on spirometry. PRISm was defined as predicted forced expiratory volume per second (FEV1) less than 80%, with an FEV1/ forced vital capacity (FVC) ratio of at least 0.70. Individuals with normal spirometry (defined as predicted FEV1 ≥ 80% with an FEV1/FVC ratio ≥ 0.70) served as controls.
The primary outcomes were major complications of type 2 diabetes including macrovascular events (myocardial infarction, unstable angina, coronary heart disease [CHD], ischemic stroke, and any type of stroke), microvascular events (diabetic retinopathy and diabetic kidney disease) and mortality (all-cause, cardiovascular, and respiratory).
Overall, 16.9% of study participants (3385 patients) had obstructive spirometry and 22.6% (4521 patients) had PRISm. Compared with individuals with normal spirometry, those with PRISm were more likely to be current smokers, obese, and living in economically disadvantaged areas. Individuals with PRISm also were significantly more likely to be long-term patients with diabetes who were taking glucose-lowering or lipid-lowering drugs (P < .001 for all).
The median follow-up for each of the type 2 diabetes complications and mortality was approximately 12 years. Over this time, 5.0% of patients developed incident MI, 1.3% developed unstable angina, 15.6% had CHD, 3.5% had an ischemic stroke, and 4.7% had any type of stroke. As for microvascular events, 7.8% developed diabetic retinopathy and 6.7% developed diabetic kidney disease. A total of 2588 patients died during the study period (15.1%), including 544 from cardiovascular disease and 319 from respiratory disease.
PRISm was significantly associated with increased risk of each of the complications and mortality types. These associations persisted after adjusting for lifestyle and other factors. The fully adjusted hazard ratios for PRISm versus normal spirometry were 1.23 for MI, 1.23 for unstable angina, 1.21 for CHD, 1.38 for ischemic stroke, 1.41 for any type of stroke, 1.31 for diabetic retinopathy, and 1.38 for diabetic kidney disease. Adjusted HRs for mortality were 1.34, 1.60, and 1.56 for all-cause, cardiovascular, and respiratory mortality, respectively.
The researchers also found that adding PRISm to an office-based risk score significantly improved the risk classification and predictive power for type 2 diabetes complications with the exception of unstable angina and mortality. They found little evidence for an association with sex, smoking, or PRISm duration and any mortality types. However, in subgroup analyses by age, sex, and duration of diabetes, PRISm remained associated with increased risk of macrovascular and microvascular complications, as well as mortality.
Potential mechanisms for the association between PRISm and diabetes complications include the role of insulin resistance in the exacerbation of lung damage in patients with type 2 diabetes, the increased rate of supplemental oxygen use among individuals with PRISm, and the increased prevalence of pulmonary artery enlargement in the PRISm subjects, the researchers wrote.
The findings were limited by several factors including the prospective design, the homogeneous population of individuals primarily of British or Irish ancestry, and the exclusion of diabetic neuropathy from the analysis, the researchers noted.
However, the results were strengthened by the large cohort, use of professional spirometry, and relatively long follow-up. “The findings underscore the relevance of PRISm for prognostic classification in type 2 diabetes and its potential for optimizing prevention strategies in this condition,” they concluded.
The study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangsu Province, and the Priority Academic Program Development of Jiangsu Higher Education Institutions. The researchers reported no relevant financial relationships.
A version of this article first appeared on Medscape.com
FROM THE JOURNAL CHEST
Biologics, thiopurines, or methotrexate doesn’t affect fertility or birth outcomes in men with IBD
published in Clinical Gastroenterology and Hepatology.
The effort is the first meta-analysis to assess semen parameters and the risk of adverse outcomes in pregnancy for male patients with IBD who have taken biologics, thiopurines or methotrexate for the condition, the researchers said.
“We provide encouraging evidence that biologic, thiopurine, and methotrexate therapy among male patients with IBD are not associated with impairments in male fertility or with increased risk of adverse pregnancy outcomes,” said the researchers, led in part by John Gubatan, MD, instructor in medicine at Stanford (Calif.) University, who worked with investigators in Copenhagen and Toronto. “Taken together, our data support the safety of continuing biologics, thiopurines, or methotrexate across the reproductive spectrum.”
Questions of fertility and pregnancy outcomes are of particular importance in IBD, since patients are often diagnosed around the time of their reproductive years – about 30 years old for Crohn’s disease and 35 years old for ulcerative colitis. There has been far more research attention paid to female than male reproductive considerations, mainly the health of the fetus when the mother takes biologic therapy for IBD during pregnancy, which has generally found to be safe.
Their search found 13 studies with male IBD patients exposed to biologics, 10 exposed to thiopurines and 6 to methotrexate. Researchers extracted data on sperm count, sperm motility, and abnormal sperm morphology – three metrics considered a proxy for male fertility – as well as early pregnancy loss, preterm birth and congenital malformations.
Researchers found no differences between sperm count, motility or morphology between those exposed and not exposed to biologics, thiopurines and methotrexate, with a couple of exceptions. They actually found that sperm count was higher for thiopurine users, compared with nonusers, and there was only one study on methotrexate and abnormal sperm morphology, so there was no data to pool together for that comparison.
In a subgroup analysis, there was a trend toward higher sperm count in thiopurine users, compared with biologic or methotrexate users, but no differences were seen in the other parameters.
Similarly, there were no significant differences for users and nonusers of these medications for early pregnancy loss, preterm births or congenital malformations, the researchers found.
A prior systematic review suggested that azathioprine might be associated with low sperm count, but this new analysis calls that into question.
“Our results, which demonstrated that thiopurine use among male patients with IBD is associated with increased sperm count, refute this prior finding,” the researchers said. The previous finding, they noted, was only qualitative because the authors didn’t do an analysis to calculate effect size or determine statistical significance.
“Furthermore,” the researchers said, “our study included more updated studies and a greater number of patients.”
The authors disclosed no conflicts of interest.
Understanding the impact of inflammatory bowel disease therapies on fertility and pregnancy outcomes is key toward managing patients with IBD. While there is substantial research on the implications of maternal exposure to IBD medications with reassuring safety data, research in the context of paternal exposure to IBD medications is limited.
This study represents the largest report summarizing data across diverse populations on the topic with reassuring results. It carries important implications in clinical practice and provides further evidence in support of continuing IBD therapy among male patients through pregnancy planning. Certainly, active IBD in male patients is associated with adverse effects on sperm quality and conception likelihood, and it is important to achieve remission prior to pregnancy planning.
Further research on the impact of paternal exposure to newer biologics, including small molecule drugs, and additional analyses after adjusting for potential confounders will advance the field and provide further guidance in clinical practice.
Manasi Agrawal, MD, MS, is an assistant professor of medicine in the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. She is a research associate with the Center for Molecular Prediction of Inflammatory Bowel Disease. Aalborg University, Copenhagen. She reports no conflicts.
Understanding the impact of inflammatory bowel disease therapies on fertility and pregnancy outcomes is key toward managing patients with IBD. While there is substantial research on the implications of maternal exposure to IBD medications with reassuring safety data, research in the context of paternal exposure to IBD medications is limited.
This study represents the largest report summarizing data across diverse populations on the topic with reassuring results. It carries important implications in clinical practice and provides further evidence in support of continuing IBD therapy among male patients through pregnancy planning. Certainly, active IBD in male patients is associated with adverse effects on sperm quality and conception likelihood, and it is important to achieve remission prior to pregnancy planning.
Further research on the impact of paternal exposure to newer biologics, including small molecule drugs, and additional analyses after adjusting for potential confounders will advance the field and provide further guidance in clinical practice.
Manasi Agrawal, MD, MS, is an assistant professor of medicine in the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. She is a research associate with the Center for Molecular Prediction of Inflammatory Bowel Disease. Aalborg University, Copenhagen. She reports no conflicts.
Understanding the impact of inflammatory bowel disease therapies on fertility and pregnancy outcomes is key toward managing patients with IBD. While there is substantial research on the implications of maternal exposure to IBD medications with reassuring safety data, research in the context of paternal exposure to IBD medications is limited.
This study represents the largest report summarizing data across diverse populations on the topic with reassuring results. It carries important implications in clinical practice and provides further evidence in support of continuing IBD therapy among male patients through pregnancy planning. Certainly, active IBD in male patients is associated with adverse effects on sperm quality and conception likelihood, and it is important to achieve remission prior to pregnancy planning.
Further research on the impact of paternal exposure to newer biologics, including small molecule drugs, and additional analyses after adjusting for potential confounders will advance the field and provide further guidance in clinical practice.
Manasi Agrawal, MD, MS, is an assistant professor of medicine in the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. She is a research associate with the Center for Molecular Prediction of Inflammatory Bowel Disease. Aalborg University, Copenhagen. She reports no conflicts.
published in Clinical Gastroenterology and Hepatology.
The effort is the first meta-analysis to assess semen parameters and the risk of adverse outcomes in pregnancy for male patients with IBD who have taken biologics, thiopurines or methotrexate for the condition, the researchers said.
“We provide encouraging evidence that biologic, thiopurine, and methotrexate therapy among male patients with IBD are not associated with impairments in male fertility or with increased risk of adverse pregnancy outcomes,” said the researchers, led in part by John Gubatan, MD, instructor in medicine at Stanford (Calif.) University, who worked with investigators in Copenhagen and Toronto. “Taken together, our data support the safety of continuing biologics, thiopurines, or methotrexate across the reproductive spectrum.”
Questions of fertility and pregnancy outcomes are of particular importance in IBD, since patients are often diagnosed around the time of their reproductive years – about 30 years old for Crohn’s disease and 35 years old for ulcerative colitis. There has been far more research attention paid to female than male reproductive considerations, mainly the health of the fetus when the mother takes biologic therapy for IBD during pregnancy, which has generally found to be safe.
Their search found 13 studies with male IBD patients exposed to biologics, 10 exposed to thiopurines and 6 to methotrexate. Researchers extracted data on sperm count, sperm motility, and abnormal sperm morphology – three metrics considered a proxy for male fertility – as well as early pregnancy loss, preterm birth and congenital malformations.
Researchers found no differences between sperm count, motility or morphology between those exposed and not exposed to biologics, thiopurines and methotrexate, with a couple of exceptions. They actually found that sperm count was higher for thiopurine users, compared with nonusers, and there was only one study on methotrexate and abnormal sperm morphology, so there was no data to pool together for that comparison.
In a subgroup analysis, there was a trend toward higher sperm count in thiopurine users, compared with biologic or methotrexate users, but no differences were seen in the other parameters.
Similarly, there were no significant differences for users and nonusers of these medications for early pregnancy loss, preterm births or congenital malformations, the researchers found.
A prior systematic review suggested that azathioprine might be associated with low sperm count, but this new analysis calls that into question.
“Our results, which demonstrated that thiopurine use among male patients with IBD is associated with increased sperm count, refute this prior finding,” the researchers said. The previous finding, they noted, was only qualitative because the authors didn’t do an analysis to calculate effect size or determine statistical significance.
“Furthermore,” the researchers said, “our study included more updated studies and a greater number of patients.”
The authors disclosed no conflicts of interest.
published in Clinical Gastroenterology and Hepatology.
The effort is the first meta-analysis to assess semen parameters and the risk of adverse outcomes in pregnancy for male patients with IBD who have taken biologics, thiopurines or methotrexate for the condition, the researchers said.
“We provide encouraging evidence that biologic, thiopurine, and methotrexate therapy among male patients with IBD are not associated with impairments in male fertility or with increased risk of adverse pregnancy outcomes,” said the researchers, led in part by John Gubatan, MD, instructor in medicine at Stanford (Calif.) University, who worked with investigators in Copenhagen and Toronto. “Taken together, our data support the safety of continuing biologics, thiopurines, or methotrexate across the reproductive spectrum.”
Questions of fertility and pregnancy outcomes are of particular importance in IBD, since patients are often diagnosed around the time of their reproductive years – about 30 years old for Crohn’s disease and 35 years old for ulcerative colitis. There has been far more research attention paid to female than male reproductive considerations, mainly the health of the fetus when the mother takes biologic therapy for IBD during pregnancy, which has generally found to be safe.
Their search found 13 studies with male IBD patients exposed to biologics, 10 exposed to thiopurines and 6 to methotrexate. Researchers extracted data on sperm count, sperm motility, and abnormal sperm morphology – three metrics considered a proxy for male fertility – as well as early pregnancy loss, preterm birth and congenital malformations.
Researchers found no differences between sperm count, motility or morphology between those exposed and not exposed to biologics, thiopurines and methotrexate, with a couple of exceptions. They actually found that sperm count was higher for thiopurine users, compared with nonusers, and there was only one study on methotrexate and abnormal sperm morphology, so there was no data to pool together for that comparison.
In a subgroup analysis, there was a trend toward higher sperm count in thiopurine users, compared with biologic or methotrexate users, but no differences were seen in the other parameters.
Similarly, there were no significant differences for users and nonusers of these medications for early pregnancy loss, preterm births or congenital malformations, the researchers found.
A prior systematic review suggested that azathioprine might be associated with low sperm count, but this new analysis calls that into question.
“Our results, which demonstrated that thiopurine use among male patients with IBD is associated with increased sperm count, refute this prior finding,” the researchers said. The previous finding, they noted, was only qualitative because the authors didn’t do an analysis to calculate effect size or determine statistical significance.
“Furthermore,” the researchers said, “our study included more updated studies and a greater number of patients.”
The authors disclosed no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Higher risk of death with endocrine therapy nonadherence
TOPLINE:
a new systematic review found.
METHODOLOGY:
- The investigators conducted a systematic literature search of five databases, looking for studies involving patients with nonmetastatic hormone receptor–positive breast cancer that were published between 2010 and 2020.
- Adequate adherence was defined as a medical possession ratio – the percentage of days the prescribed treatment dose of adjuvant endocrine therapy was available to the patient – of at least 80%.
- Medication nonpersistence was defined as a period in which no new adjuvant endocrine therapy prescriptions were filled before the scheduled end of treatment of 90-180 days, depending on the study.
- The impact of both parameters on event-free survival, which included breast cancer recurrence, disease-free survival, breast cancer–specific survival, and overall survival cancer was calculated.
- Of 2,026 articles retrieved, 14 studies, with sample sizes ranging from 857 to 30,573 patients, met the eligibility and quality criteria; 11 examined patient adherence, and 6 examined patient persistence.
TAKEAWAY:
- Of 10 studies that assessed event-free survival, 7 showed significantly worse survival for nonadherent or nonpersistent patients, at hazard ratios of 1.39-2.44.
- Of nine studies that examined overall survival, seven demonstrated a significantly higher risk for mortality in the groups with nonadherence and nonpersistence, at HRs of 1.26-2.18.
- The largest study, which included data on more than 30,000 patients in Taiwan, found that nonadherence and nonpersistence were associated with a significantly increased risk for mortality, at HRs of 1.98 and 2.18, respectively.
IN PRACTICE:
“The available data highlight the dangers of nonadherence and nonpersistence, showing an up to twofold higher risk of relapse or death for patients who do not use endocrine treatment as prescribed,” the researchers said. “Importantly, improving adherence and persistence represents a low-hanging fruit for increasing survival in luminal breast cancer.”
SOURCE:
The study, led by Finn Magnus Eliassen, MD, department of surgery, Stavanger (Norway) University Hospital, was published online on July 4 in BMC Cancer.
LIMITATIONS:
- The review is limited by the relatively small number of studies that met the eligibility criteria and by their heterogeneity, which ruled out a meta-analysis.
- There are no gold-standard definitions of adherence and persistence.
DISCLOSURES:
- No funding was declared. No relevant financial relationships were declared.
- A version of this article first appeared on Medscape.com.
TOPLINE:
a new systematic review found.
METHODOLOGY:
- The investigators conducted a systematic literature search of five databases, looking for studies involving patients with nonmetastatic hormone receptor–positive breast cancer that were published between 2010 and 2020.
- Adequate adherence was defined as a medical possession ratio – the percentage of days the prescribed treatment dose of adjuvant endocrine therapy was available to the patient – of at least 80%.
- Medication nonpersistence was defined as a period in which no new adjuvant endocrine therapy prescriptions were filled before the scheduled end of treatment of 90-180 days, depending on the study.
- The impact of both parameters on event-free survival, which included breast cancer recurrence, disease-free survival, breast cancer–specific survival, and overall survival cancer was calculated.
- Of 2,026 articles retrieved, 14 studies, with sample sizes ranging from 857 to 30,573 patients, met the eligibility and quality criteria; 11 examined patient adherence, and 6 examined patient persistence.
TAKEAWAY:
- Of 10 studies that assessed event-free survival, 7 showed significantly worse survival for nonadherent or nonpersistent patients, at hazard ratios of 1.39-2.44.
- Of nine studies that examined overall survival, seven demonstrated a significantly higher risk for mortality in the groups with nonadherence and nonpersistence, at HRs of 1.26-2.18.
- The largest study, which included data on more than 30,000 patients in Taiwan, found that nonadherence and nonpersistence were associated with a significantly increased risk for mortality, at HRs of 1.98 and 2.18, respectively.
IN PRACTICE:
“The available data highlight the dangers of nonadherence and nonpersistence, showing an up to twofold higher risk of relapse or death for patients who do not use endocrine treatment as prescribed,” the researchers said. “Importantly, improving adherence and persistence represents a low-hanging fruit for increasing survival in luminal breast cancer.”
SOURCE:
The study, led by Finn Magnus Eliassen, MD, department of surgery, Stavanger (Norway) University Hospital, was published online on July 4 in BMC Cancer.
LIMITATIONS:
- The review is limited by the relatively small number of studies that met the eligibility criteria and by their heterogeneity, which ruled out a meta-analysis.
- There are no gold-standard definitions of adherence and persistence.
DISCLOSURES:
- No funding was declared. No relevant financial relationships were declared.
- A version of this article first appeared on Medscape.com.
TOPLINE:
a new systematic review found.
METHODOLOGY:
- The investigators conducted a systematic literature search of five databases, looking for studies involving patients with nonmetastatic hormone receptor–positive breast cancer that were published between 2010 and 2020.
- Adequate adherence was defined as a medical possession ratio – the percentage of days the prescribed treatment dose of adjuvant endocrine therapy was available to the patient – of at least 80%.
- Medication nonpersistence was defined as a period in which no new adjuvant endocrine therapy prescriptions were filled before the scheduled end of treatment of 90-180 days, depending on the study.
- The impact of both parameters on event-free survival, which included breast cancer recurrence, disease-free survival, breast cancer–specific survival, and overall survival cancer was calculated.
- Of 2,026 articles retrieved, 14 studies, with sample sizes ranging from 857 to 30,573 patients, met the eligibility and quality criteria; 11 examined patient adherence, and 6 examined patient persistence.
TAKEAWAY:
- Of 10 studies that assessed event-free survival, 7 showed significantly worse survival for nonadherent or nonpersistent patients, at hazard ratios of 1.39-2.44.
- Of nine studies that examined overall survival, seven demonstrated a significantly higher risk for mortality in the groups with nonadherence and nonpersistence, at HRs of 1.26-2.18.
- The largest study, which included data on more than 30,000 patients in Taiwan, found that nonadherence and nonpersistence were associated with a significantly increased risk for mortality, at HRs of 1.98 and 2.18, respectively.
IN PRACTICE:
“The available data highlight the dangers of nonadherence and nonpersistence, showing an up to twofold higher risk of relapse or death for patients who do not use endocrine treatment as prescribed,” the researchers said. “Importantly, improving adherence and persistence represents a low-hanging fruit for increasing survival in luminal breast cancer.”
SOURCE:
The study, led by Finn Magnus Eliassen, MD, department of surgery, Stavanger (Norway) University Hospital, was published online on July 4 in BMC Cancer.
LIMITATIONS:
- The review is limited by the relatively small number of studies that met the eligibility criteria and by their heterogeneity, which ruled out a meta-analysis.
- There are no gold-standard definitions of adherence and persistence.
DISCLOSURES:
- No funding was declared. No relevant financial relationships were declared.
- A version of this article first appeared on Medscape.com.