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Cognitive decline risk in adult childhood cancer survivors
Among more than 2,300 adult survivors of childhood cancer and their siblings, who served as controls, new-onset memory impairment emerged more often in survivors decades later.
The increased risk was associated with the cancer treatment that was provided as well as modifiable health behaviors and chronic health conditions.
Even 35 years after being diagnosed, cancer survivors who never received chemotherapies or radiation therapies known to damage the brain reported far greater memory impairment than did their siblings, first author Nicholas Phillips, MD, told this news organization.
What the findings suggest is that “we need to educate oncologists and primary care providers on the risks our survivors face long after completion of therapy,” said Dr. Phillips, of the epidemiology and cancer control department at St. Jude Children’s Research Hospital, Memphis, Tenn.
The study was published online in JAMA Network Open.
Cancer survivors face an elevated risk for severe neurocognitive effects that can emerge 5-10 years following their diagnosis and treatment. However, it’s unclear whether new-onset neurocognitive problems can still develop a decade or more following diagnosis.
Over a long-term follow-up, Dr. Phillips and colleagues explored this question in 2,375 adult survivors of childhood cancer from the Childhood Cancer Survivor Study and 232 of their siblings.
Among the cancer cohort, 1,316 patients were survivors of acute lymphoblastic leukemia (ALL), 488 were survivors of central nervous system (CNS) tumors, and 571 had survived Hodgkin lymphoma.
The researchers determined the prevalence of new-onset neurocognitive impairment between baseline (23 years after diagnosis) and follow-up (35 years after diagnosis). New-onset neurocognitive impairment – present at follow-up but not at baseline – was defined as having a score in the worst 10% of the sibling cohort.
A higher proportion of survivors had new-onset memory impairment at follow-up compared with siblings. Specifically, about 8% of siblings had new-onset memory trouble, compared with 14% of ALL survivors treated with chemotherapy only, 26% of ALL survivors treated with cranial radiation, 35% of CNS tumor survivors, and 17% of Hodgkin lymphoma survivors.
New-onset memory impairment was associated with cranial radiation among CNS tumor survivors (relative risk [RR], 1.97) and alkylator chemotherapy at or above 8,000 mg/m2 among survivors of ALL who were treated without cranial radiation (RR, 2.80). The authors also found that smoking, low educational attainment, and low physical activity were associated with an elevated risk for new-onset memory impairment.
Dr. Phillips noted that current guidelines emphasize the importance of short-term monitoring of a survivor’s neurocognitive status on the basis of that person’s chemotherapy and radiation exposures.
However, “our study suggests that all survivors, regardless of their therapy, should be screened regularly for new-onset neurocognitive problems. And this screening should be done regularly for decades after diagnosis,” he said in an interview.
Dr. Phillips also noted the importance of communicating lifestyle modifications, such as not smoking and maintaining an active lifestyle.
“We need to start early and use the power of repetition when communicating with our survivors and their families,” Dr. Phillips said. “When our families and survivors hear the word ‘exercise,’ they think of gym memberships, lifting weights, and running on treadmills. But what we really want our survivors to do is stay active.”
What this means is engaging for about 2.5 hours a week in a range of activities, such as ballet, basketball, volleyball, bicycling, or swimming.
“And if our kids want to quit after 3 months, let them know that this is okay. They just need to replace that activity with another activity,” said Dr. Phillips. “We want them to find a fun hobby that they will enjoy that will keep them active.”
The study was supported by the National Cancer Institute. Dr. Phillips has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among more than 2,300 adult survivors of childhood cancer and their siblings, who served as controls, new-onset memory impairment emerged more often in survivors decades later.
The increased risk was associated with the cancer treatment that was provided as well as modifiable health behaviors and chronic health conditions.
Even 35 years after being diagnosed, cancer survivors who never received chemotherapies or radiation therapies known to damage the brain reported far greater memory impairment than did their siblings, first author Nicholas Phillips, MD, told this news organization.
What the findings suggest is that “we need to educate oncologists and primary care providers on the risks our survivors face long after completion of therapy,” said Dr. Phillips, of the epidemiology and cancer control department at St. Jude Children’s Research Hospital, Memphis, Tenn.
The study was published online in JAMA Network Open.
Cancer survivors face an elevated risk for severe neurocognitive effects that can emerge 5-10 years following their diagnosis and treatment. However, it’s unclear whether new-onset neurocognitive problems can still develop a decade or more following diagnosis.
Over a long-term follow-up, Dr. Phillips and colleagues explored this question in 2,375 adult survivors of childhood cancer from the Childhood Cancer Survivor Study and 232 of their siblings.
Among the cancer cohort, 1,316 patients were survivors of acute lymphoblastic leukemia (ALL), 488 were survivors of central nervous system (CNS) tumors, and 571 had survived Hodgkin lymphoma.
The researchers determined the prevalence of new-onset neurocognitive impairment between baseline (23 years after diagnosis) and follow-up (35 years after diagnosis). New-onset neurocognitive impairment – present at follow-up but not at baseline – was defined as having a score in the worst 10% of the sibling cohort.
A higher proportion of survivors had new-onset memory impairment at follow-up compared with siblings. Specifically, about 8% of siblings had new-onset memory trouble, compared with 14% of ALL survivors treated with chemotherapy only, 26% of ALL survivors treated with cranial radiation, 35% of CNS tumor survivors, and 17% of Hodgkin lymphoma survivors.
New-onset memory impairment was associated with cranial radiation among CNS tumor survivors (relative risk [RR], 1.97) and alkylator chemotherapy at or above 8,000 mg/m2 among survivors of ALL who were treated without cranial radiation (RR, 2.80). The authors also found that smoking, low educational attainment, and low physical activity were associated with an elevated risk for new-onset memory impairment.
Dr. Phillips noted that current guidelines emphasize the importance of short-term monitoring of a survivor’s neurocognitive status on the basis of that person’s chemotherapy and radiation exposures.
However, “our study suggests that all survivors, regardless of their therapy, should be screened regularly for new-onset neurocognitive problems. And this screening should be done regularly for decades after diagnosis,” he said in an interview.
Dr. Phillips also noted the importance of communicating lifestyle modifications, such as not smoking and maintaining an active lifestyle.
“We need to start early and use the power of repetition when communicating with our survivors and their families,” Dr. Phillips said. “When our families and survivors hear the word ‘exercise,’ they think of gym memberships, lifting weights, and running on treadmills. But what we really want our survivors to do is stay active.”
What this means is engaging for about 2.5 hours a week in a range of activities, such as ballet, basketball, volleyball, bicycling, or swimming.
“And if our kids want to quit after 3 months, let them know that this is okay. They just need to replace that activity with another activity,” said Dr. Phillips. “We want them to find a fun hobby that they will enjoy that will keep them active.”
The study was supported by the National Cancer Institute. Dr. Phillips has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among more than 2,300 adult survivors of childhood cancer and their siblings, who served as controls, new-onset memory impairment emerged more often in survivors decades later.
The increased risk was associated with the cancer treatment that was provided as well as modifiable health behaviors and chronic health conditions.
Even 35 years after being diagnosed, cancer survivors who never received chemotherapies or radiation therapies known to damage the brain reported far greater memory impairment than did their siblings, first author Nicholas Phillips, MD, told this news organization.
What the findings suggest is that “we need to educate oncologists and primary care providers on the risks our survivors face long after completion of therapy,” said Dr. Phillips, of the epidemiology and cancer control department at St. Jude Children’s Research Hospital, Memphis, Tenn.
The study was published online in JAMA Network Open.
Cancer survivors face an elevated risk for severe neurocognitive effects that can emerge 5-10 years following their diagnosis and treatment. However, it’s unclear whether new-onset neurocognitive problems can still develop a decade or more following diagnosis.
Over a long-term follow-up, Dr. Phillips and colleagues explored this question in 2,375 adult survivors of childhood cancer from the Childhood Cancer Survivor Study and 232 of their siblings.
Among the cancer cohort, 1,316 patients were survivors of acute lymphoblastic leukemia (ALL), 488 were survivors of central nervous system (CNS) tumors, and 571 had survived Hodgkin lymphoma.
The researchers determined the prevalence of new-onset neurocognitive impairment between baseline (23 years after diagnosis) and follow-up (35 years after diagnosis). New-onset neurocognitive impairment – present at follow-up but not at baseline – was defined as having a score in the worst 10% of the sibling cohort.
A higher proportion of survivors had new-onset memory impairment at follow-up compared with siblings. Specifically, about 8% of siblings had new-onset memory trouble, compared with 14% of ALL survivors treated with chemotherapy only, 26% of ALL survivors treated with cranial radiation, 35% of CNS tumor survivors, and 17% of Hodgkin lymphoma survivors.
New-onset memory impairment was associated with cranial radiation among CNS tumor survivors (relative risk [RR], 1.97) and alkylator chemotherapy at or above 8,000 mg/m2 among survivors of ALL who were treated without cranial radiation (RR, 2.80). The authors also found that smoking, low educational attainment, and low physical activity were associated with an elevated risk for new-onset memory impairment.
Dr. Phillips noted that current guidelines emphasize the importance of short-term monitoring of a survivor’s neurocognitive status on the basis of that person’s chemotherapy and radiation exposures.
However, “our study suggests that all survivors, regardless of their therapy, should be screened regularly for new-onset neurocognitive problems. And this screening should be done regularly for decades after diagnosis,” he said in an interview.
Dr. Phillips also noted the importance of communicating lifestyle modifications, such as not smoking and maintaining an active lifestyle.
“We need to start early and use the power of repetition when communicating with our survivors and their families,” Dr. Phillips said. “When our families and survivors hear the word ‘exercise,’ they think of gym memberships, lifting weights, and running on treadmills. But what we really want our survivors to do is stay active.”
What this means is engaging for about 2.5 hours a week in a range of activities, such as ballet, basketball, volleyball, bicycling, or swimming.
“And if our kids want to quit after 3 months, let them know that this is okay. They just need to replace that activity with another activity,” said Dr. Phillips. “We want them to find a fun hobby that they will enjoy that will keep them active.”
The study was supported by the National Cancer Institute. Dr. Phillips has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Regular, optimal sleep tied to lower mortality risk
INDIANAPOLIS –
In a diverse group of older adults, those with regular and optimal sleep had about a 40% lower risk of dying of any cause during follow-up compared with peers who had irregular and insufficient sleep.
“If sleep were an 8-hour pill, it would be beneficial to take the full dose at regular times consistently,” lead researcher Joon Chung, PhD, of Harvard Medical School and Brigham and Women’s Hospital, Boston, said in a news release.
The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
Broad adverse health effects
“Evidence is mounting that irregular sleep is associated with pretty broad adverse health outcomes, most prominently cardiometabolic disease, obesity, and cardiovascular disease,” Dr. Chungsaid in an interview.
In the current study, the researchers estimated the association of regular sleep of optimal sleep duration with all-cause mortality using data from 1,759 adults the Multi-Ethnic Study of Atherosclerosis Sleep Study.
Sleep regularity and duration were classified using 7 days of data gathered by wrist actigraphy. Adults were categorized as “regular-optimal” sleepers (n = 1,015) or “irregular-insufficient” sleepers (n = 744).
During 7 years of follow-up, 176 people died. In the fully adjusted model, the regular-optimal group had a 39% lower mortality risk compared with the irregular-insufficient sleep group (hazard ratio, 0.61;95% confidence interval [CI], 0.45-0.83). The findings were robust in sensitivity analyses.
The regular and optimal duration sleep pattern maps behaviorally to regular bed and wake times, suggesting potential health benefits of adherence to recommended sleep practices, the researchers noted.
“Results suggest benefits of expanding the public conversation on getting ‘a good night’s sleep’ and broadening this goal to getting many good nights of sleep, in a row, on weekdays and weekends,” Dr. Chung said in the release.
He further said that “getting adequate, regular sleep seems to be something that is good for all. I don’t know of anyone who wouldn’t benefit.”
Fariha Abassi-Feinberg, MD, spokesperson for the American Academy of Sleep Medicine and sleep specialist with the Millennium Physician Group, Fort Myers, Fla., agreed.
“We know our bodies have an internal clock, known as the circadian rhythm, which regulates various biological processes, including sleep-wake cycles. Sticking to a consistent sleep schedule allows your body to align its natural rhythm with the external day-night cycle. This synchronization promotes better sleep quality and therefore better health,” said Dr. Abassi-Feinberg, who wasn’t involved in the study.
“The AASM recommends adults try to aim for at least 7 hours of sleep and I often tell my patients that keeping a regular routine is best for your sleep and health,” she said in an interview.
Funding for the study was provided by the American Academy of Sleep Medicine Foundation and the National Institutes of Health. Dr. Chung and Dr. Abassi-Feinberg report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
INDIANAPOLIS –
In a diverse group of older adults, those with regular and optimal sleep had about a 40% lower risk of dying of any cause during follow-up compared with peers who had irregular and insufficient sleep.
“If sleep were an 8-hour pill, it would be beneficial to take the full dose at regular times consistently,” lead researcher Joon Chung, PhD, of Harvard Medical School and Brigham and Women’s Hospital, Boston, said in a news release.
The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
Broad adverse health effects
“Evidence is mounting that irregular sleep is associated with pretty broad adverse health outcomes, most prominently cardiometabolic disease, obesity, and cardiovascular disease,” Dr. Chungsaid in an interview.
In the current study, the researchers estimated the association of regular sleep of optimal sleep duration with all-cause mortality using data from 1,759 adults the Multi-Ethnic Study of Atherosclerosis Sleep Study.
Sleep regularity and duration were classified using 7 days of data gathered by wrist actigraphy. Adults were categorized as “regular-optimal” sleepers (n = 1,015) or “irregular-insufficient” sleepers (n = 744).
During 7 years of follow-up, 176 people died. In the fully adjusted model, the regular-optimal group had a 39% lower mortality risk compared with the irregular-insufficient sleep group (hazard ratio, 0.61;95% confidence interval [CI], 0.45-0.83). The findings were robust in sensitivity analyses.
The regular and optimal duration sleep pattern maps behaviorally to regular bed and wake times, suggesting potential health benefits of adherence to recommended sleep practices, the researchers noted.
“Results suggest benefits of expanding the public conversation on getting ‘a good night’s sleep’ and broadening this goal to getting many good nights of sleep, in a row, on weekdays and weekends,” Dr. Chung said in the release.
He further said that “getting adequate, regular sleep seems to be something that is good for all. I don’t know of anyone who wouldn’t benefit.”
Fariha Abassi-Feinberg, MD, spokesperson for the American Academy of Sleep Medicine and sleep specialist with the Millennium Physician Group, Fort Myers, Fla., agreed.
“We know our bodies have an internal clock, known as the circadian rhythm, which regulates various biological processes, including sleep-wake cycles. Sticking to a consistent sleep schedule allows your body to align its natural rhythm with the external day-night cycle. This synchronization promotes better sleep quality and therefore better health,” said Dr. Abassi-Feinberg, who wasn’t involved in the study.
“The AASM recommends adults try to aim for at least 7 hours of sleep and I often tell my patients that keeping a regular routine is best for your sleep and health,” she said in an interview.
Funding for the study was provided by the American Academy of Sleep Medicine Foundation and the National Institutes of Health. Dr. Chung and Dr. Abassi-Feinberg report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
INDIANAPOLIS –
In a diverse group of older adults, those with regular and optimal sleep had about a 40% lower risk of dying of any cause during follow-up compared with peers who had irregular and insufficient sleep.
“If sleep were an 8-hour pill, it would be beneficial to take the full dose at regular times consistently,” lead researcher Joon Chung, PhD, of Harvard Medical School and Brigham and Women’s Hospital, Boston, said in a news release.
The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
Broad adverse health effects
“Evidence is mounting that irregular sleep is associated with pretty broad adverse health outcomes, most prominently cardiometabolic disease, obesity, and cardiovascular disease,” Dr. Chungsaid in an interview.
In the current study, the researchers estimated the association of regular sleep of optimal sleep duration with all-cause mortality using data from 1,759 adults the Multi-Ethnic Study of Atherosclerosis Sleep Study.
Sleep regularity and duration were classified using 7 days of data gathered by wrist actigraphy. Adults were categorized as “regular-optimal” sleepers (n = 1,015) or “irregular-insufficient” sleepers (n = 744).
During 7 years of follow-up, 176 people died. In the fully adjusted model, the regular-optimal group had a 39% lower mortality risk compared with the irregular-insufficient sleep group (hazard ratio, 0.61;95% confidence interval [CI], 0.45-0.83). The findings were robust in sensitivity analyses.
The regular and optimal duration sleep pattern maps behaviorally to regular bed and wake times, suggesting potential health benefits of adherence to recommended sleep practices, the researchers noted.
“Results suggest benefits of expanding the public conversation on getting ‘a good night’s sleep’ and broadening this goal to getting many good nights of sleep, in a row, on weekdays and weekends,” Dr. Chung said in the release.
He further said that “getting adequate, regular sleep seems to be something that is good for all. I don’t know of anyone who wouldn’t benefit.”
Fariha Abassi-Feinberg, MD, spokesperson for the American Academy of Sleep Medicine and sleep specialist with the Millennium Physician Group, Fort Myers, Fla., agreed.
“We know our bodies have an internal clock, known as the circadian rhythm, which regulates various biological processes, including sleep-wake cycles. Sticking to a consistent sleep schedule allows your body to align its natural rhythm with the external day-night cycle. This synchronization promotes better sleep quality and therefore better health,” said Dr. Abassi-Feinberg, who wasn’t involved in the study.
“The AASM recommends adults try to aim for at least 7 hours of sleep and I often tell my patients that keeping a regular routine is best for your sleep and health,” she said in an interview.
Funding for the study was provided by the American Academy of Sleep Medicine Foundation and the National Institutes of Health. Dr. Chung and Dr. Abassi-Feinberg report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT SLEEP 2023
Suicidality risk in youth at highest at night
Investigators found that suicidal ideation and attempts were lowest in the mornings and highest in the evenings, particularly among youth with higher levels of self-critical rumination.
“These are preliminary findings, and there is a need for more data, but they signal potentially that there’s a need for support, particularly at nighttime, and that there might be a potential of targeting self-critical rumination in daily lives of youth,” said lead researcher Anastacia Kudinova, PhD, with the department of psychiatry and human behavior, Alpert Medical School of Brown University, Providence, R.I.
The findings were presented at the late-breaker session at the annual meeting of the Associated Professional Sleep Societies.
Urgent need
Suicidal ideation (SI) is a “robust” predictor of suicidal behavior and, “alarmingly,” both suicidal ideation and suicidal behavior have been increasing, Dr. Kudinova said.
“There is an urgent need to describe proximal time-period risk factors for suicide so that we can identify who is at a greater suicide risk on the time scale of weeks, days, or even hours,” she told attendees.
The researchers asked 165 psychiatrically hospitalized youth aged 11-18 (72% female) about the time of day of their most recent suicide attempt.
More than half (58%) said it occurred in the evenings and nights, followed by daytime (35%) and mornings (7%).
They also assessed the timing of suicidal ideation at home in 61 youth aged 12-15 (61% female) who were discharged after a partial hospitalization program.
They did this using ecological momentary assessments (EMAs) three times a day over 2 weeks. EMAs study people’s thoughts and behavior in their daily lives by repeatedly collecting data in an individual’s normal environment at or close to the time they carry out that behavior.
As in the other sample, youth in this sample also experienced significantly more frequent suicidal ideation later in the day (P < .01).
There was also a significant moderating effect of self-criticism (P < .01), such that more self-critical youth evidenced the highest levels of suicidal ideation later in the day.
True variation or mechanics?
Reached for comment, Paul Nestadt, MD, with Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that EMA is becoming “an interesting way to track high-resolution temporal variation in suicidal ideation and other psych symptoms.”
Dr. Nestadt, who was not involved in the study, said that “it’s not surprising” that the majority of youth attempted suicide in evenings and nights, “as adolescents are generally being supervised in a school setting during daytime hours. It may not be the fluctuation in suicidality that impacts attempt timing so much as the mechanics – it is very hard to attempt suicide in math class.”
The same may be true for the youth in the second sample who were in the partial hospital program. “During the day, they were in therapy groups where feelings of suicidal ideation would have been solicited and addressed in real time,” Dr. Nestadt noted.
“Again, suicidal ideation later in the day may be a practical effect of how they are occupied in the partial hospital program, as opposed to some inherent suicidal ideation increase linked to something endogenous, such as circadian rhythm or cortisol level rises. That said, we do often see more attempts in the evenings in adults as well,” he added.
A vulnerable time
Also weighing in, Casey O’Brien, PsyD, a psychologist in the department of psychiatry at Columbia University Irving Medical Center, New York, said the findings in this study “track” with what she sees in the clinic.
Teens often report in session that the “unstructured time of night – especially the time when they usually should be getting to bed but are kind of staying up – tends to be a very vulnerable time for them,” Dr. O’Brien said in an interview.
“It’s really nice to have research confirm a lot of what we see reported anecdotally from the teens we work with,” said Dr. O’Brien.
Dr. O’Brien heads the intensive adolescent dialectical behavior therapy (DBT) program at Columbia for young people struggling with mental health issues.
“Within the DBT framework, we try to really focus on accepting that this is a vulnerable time and then planning ahead for what the strategies are that they can use to help them transition to bed quickly and smoothly,” Dr. O’Brien said.
These strategies may include spending time with their parents before bed, reading, or building into their bedtime routines things that they find soothing and comforting, like taking a longer shower or having comfortable pajamas to change into, she explained.
“We also work a lot on sleep hygiene strategies to help develop a regular bedtime and have a consistent sleep-wake cycle. We also will plan ahead for using distress tolerance skills during times of emotional vulnerability,” Dr. O’Brien said.
The Columbia DBT program also offers phone coaching “so teens can reach out to a therapist for help using skills outside of a therapeutic hour, and we do find that we get more coaching calls closer to around bedtime,” Dr. O’Brien said.
Support for the study was provided by the National Institute of Mental Health and Bradley Hospital COBRE Center. Dr. Kudinova, Dr. Nestadt, and Dr. O’Brien have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators found that suicidal ideation and attempts were lowest in the mornings and highest in the evenings, particularly among youth with higher levels of self-critical rumination.
“These are preliminary findings, and there is a need for more data, but they signal potentially that there’s a need for support, particularly at nighttime, and that there might be a potential of targeting self-critical rumination in daily lives of youth,” said lead researcher Anastacia Kudinova, PhD, with the department of psychiatry and human behavior, Alpert Medical School of Brown University, Providence, R.I.
The findings were presented at the late-breaker session at the annual meeting of the Associated Professional Sleep Societies.
Urgent need
Suicidal ideation (SI) is a “robust” predictor of suicidal behavior and, “alarmingly,” both suicidal ideation and suicidal behavior have been increasing, Dr. Kudinova said.
“There is an urgent need to describe proximal time-period risk factors for suicide so that we can identify who is at a greater suicide risk on the time scale of weeks, days, or even hours,” she told attendees.
The researchers asked 165 psychiatrically hospitalized youth aged 11-18 (72% female) about the time of day of their most recent suicide attempt.
More than half (58%) said it occurred in the evenings and nights, followed by daytime (35%) and mornings (7%).
They also assessed the timing of suicidal ideation at home in 61 youth aged 12-15 (61% female) who were discharged after a partial hospitalization program.
They did this using ecological momentary assessments (EMAs) three times a day over 2 weeks. EMAs study people’s thoughts and behavior in their daily lives by repeatedly collecting data in an individual’s normal environment at or close to the time they carry out that behavior.
As in the other sample, youth in this sample also experienced significantly more frequent suicidal ideation later in the day (P < .01).
There was also a significant moderating effect of self-criticism (P < .01), such that more self-critical youth evidenced the highest levels of suicidal ideation later in the day.
True variation or mechanics?
Reached for comment, Paul Nestadt, MD, with Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that EMA is becoming “an interesting way to track high-resolution temporal variation in suicidal ideation and other psych symptoms.”
Dr. Nestadt, who was not involved in the study, said that “it’s not surprising” that the majority of youth attempted suicide in evenings and nights, “as adolescents are generally being supervised in a school setting during daytime hours. It may not be the fluctuation in suicidality that impacts attempt timing so much as the mechanics – it is very hard to attempt suicide in math class.”
The same may be true for the youth in the second sample who were in the partial hospital program. “During the day, they were in therapy groups where feelings of suicidal ideation would have been solicited and addressed in real time,” Dr. Nestadt noted.
“Again, suicidal ideation later in the day may be a practical effect of how they are occupied in the partial hospital program, as opposed to some inherent suicidal ideation increase linked to something endogenous, such as circadian rhythm or cortisol level rises. That said, we do often see more attempts in the evenings in adults as well,” he added.
A vulnerable time
Also weighing in, Casey O’Brien, PsyD, a psychologist in the department of psychiatry at Columbia University Irving Medical Center, New York, said the findings in this study “track” with what she sees in the clinic.
Teens often report in session that the “unstructured time of night – especially the time when they usually should be getting to bed but are kind of staying up – tends to be a very vulnerable time for them,” Dr. O’Brien said in an interview.
“It’s really nice to have research confirm a lot of what we see reported anecdotally from the teens we work with,” said Dr. O’Brien.
Dr. O’Brien heads the intensive adolescent dialectical behavior therapy (DBT) program at Columbia for young people struggling with mental health issues.
“Within the DBT framework, we try to really focus on accepting that this is a vulnerable time and then planning ahead for what the strategies are that they can use to help them transition to bed quickly and smoothly,” Dr. O’Brien said.
These strategies may include spending time with their parents before bed, reading, or building into their bedtime routines things that they find soothing and comforting, like taking a longer shower or having comfortable pajamas to change into, she explained.
“We also work a lot on sleep hygiene strategies to help develop a regular bedtime and have a consistent sleep-wake cycle. We also will plan ahead for using distress tolerance skills during times of emotional vulnerability,” Dr. O’Brien said.
The Columbia DBT program also offers phone coaching “so teens can reach out to a therapist for help using skills outside of a therapeutic hour, and we do find that we get more coaching calls closer to around bedtime,” Dr. O’Brien said.
Support for the study was provided by the National Institute of Mental Health and Bradley Hospital COBRE Center. Dr. Kudinova, Dr. Nestadt, and Dr. O’Brien have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators found that suicidal ideation and attempts were lowest in the mornings and highest in the evenings, particularly among youth with higher levels of self-critical rumination.
“These are preliminary findings, and there is a need for more data, but they signal potentially that there’s a need for support, particularly at nighttime, and that there might be a potential of targeting self-critical rumination in daily lives of youth,” said lead researcher Anastacia Kudinova, PhD, with the department of psychiatry and human behavior, Alpert Medical School of Brown University, Providence, R.I.
The findings were presented at the late-breaker session at the annual meeting of the Associated Professional Sleep Societies.
Urgent need
Suicidal ideation (SI) is a “robust” predictor of suicidal behavior and, “alarmingly,” both suicidal ideation and suicidal behavior have been increasing, Dr. Kudinova said.
“There is an urgent need to describe proximal time-period risk factors for suicide so that we can identify who is at a greater suicide risk on the time scale of weeks, days, or even hours,” she told attendees.
The researchers asked 165 psychiatrically hospitalized youth aged 11-18 (72% female) about the time of day of their most recent suicide attempt.
More than half (58%) said it occurred in the evenings and nights, followed by daytime (35%) and mornings (7%).
They also assessed the timing of suicidal ideation at home in 61 youth aged 12-15 (61% female) who were discharged after a partial hospitalization program.
They did this using ecological momentary assessments (EMAs) three times a day over 2 weeks. EMAs study people’s thoughts and behavior in their daily lives by repeatedly collecting data in an individual’s normal environment at or close to the time they carry out that behavior.
As in the other sample, youth in this sample also experienced significantly more frequent suicidal ideation later in the day (P < .01).
There was also a significant moderating effect of self-criticism (P < .01), such that more self-critical youth evidenced the highest levels of suicidal ideation later in the day.
True variation or mechanics?
Reached for comment, Paul Nestadt, MD, with Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that EMA is becoming “an interesting way to track high-resolution temporal variation in suicidal ideation and other psych symptoms.”
Dr. Nestadt, who was not involved in the study, said that “it’s not surprising” that the majority of youth attempted suicide in evenings and nights, “as adolescents are generally being supervised in a school setting during daytime hours. It may not be the fluctuation in suicidality that impacts attempt timing so much as the mechanics – it is very hard to attempt suicide in math class.”
The same may be true for the youth in the second sample who were in the partial hospital program. “During the day, they were in therapy groups where feelings of suicidal ideation would have been solicited and addressed in real time,” Dr. Nestadt noted.
“Again, suicidal ideation later in the day may be a practical effect of how they are occupied in the partial hospital program, as opposed to some inherent suicidal ideation increase linked to something endogenous, such as circadian rhythm or cortisol level rises. That said, we do often see more attempts in the evenings in adults as well,” he added.
A vulnerable time
Also weighing in, Casey O’Brien, PsyD, a psychologist in the department of psychiatry at Columbia University Irving Medical Center, New York, said the findings in this study “track” with what she sees in the clinic.
Teens often report in session that the “unstructured time of night – especially the time when they usually should be getting to bed but are kind of staying up – tends to be a very vulnerable time for them,” Dr. O’Brien said in an interview.
“It’s really nice to have research confirm a lot of what we see reported anecdotally from the teens we work with,” said Dr. O’Brien.
Dr. O’Brien heads the intensive adolescent dialectical behavior therapy (DBT) program at Columbia for young people struggling with mental health issues.
“Within the DBT framework, we try to really focus on accepting that this is a vulnerable time and then planning ahead for what the strategies are that they can use to help them transition to bed quickly and smoothly,” Dr. O’Brien said.
These strategies may include spending time with their parents before bed, reading, or building into their bedtime routines things that they find soothing and comforting, like taking a longer shower or having comfortable pajamas to change into, she explained.
“We also work a lot on sleep hygiene strategies to help develop a regular bedtime and have a consistent sleep-wake cycle. We also will plan ahead for using distress tolerance skills during times of emotional vulnerability,” Dr. O’Brien said.
The Columbia DBT program also offers phone coaching “so teens can reach out to a therapist for help using skills outside of a therapeutic hour, and we do find that we get more coaching calls closer to around bedtime,” Dr. O’Brien said.
Support for the study was provided by the National Institute of Mental Health and Bradley Hospital COBRE Center. Dr. Kudinova, Dr. Nestadt, and Dr. O’Brien have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM SLEEP 2023
FDA class 1 recall for some Abiomed Impella heart pumps
“If a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation,” the U.S. Food and Drug Administration says in an advisory posted on its website.
“If the leak issue is not resolved, persistent low purge pressure and purge flow may lead to pump stop and loss of therapy. In patients who are critical, failure of the pump’s support can lead to further deterioration and worsening of their already critical condition and may even lead to serious injury or death,” the FDA says.
The FDA has identified this as a class I recall, the most serious type, because of the potential for serious injury or death.
To date, Abiomed says it has received 179 complaints; there have been three injuries and no deaths related to this problem.
The Impella 5.5 with SmartAssist System is used for up to 14 days to support the ventricles in the setting of ongoing cardiogenic shock that occurs less than 48 hours after acute myocardial infarction, open-heart surgery, or when the heart is not functioning well owing to cardiomyopathy.
All the devices that are being recalled were distributed from September 2021 to March 2023. Detailed product information is available on the FDA website.
Abiomed has sent an urgent medical device recall letter to customers asking them to review their inventory to check for any recalled product and to contact Abiomed customer support to coordinate return of the product.
Customers are advised not to use affected products unless no other product is available. The letter includes “best practices” for situations in which no other option is available and the device must be used until a replacement is available.
Customers with questions about this recall should contact Abiomed’s clinical support center at 1-800-422-8666.
A version of this article was first published on Medscape.com.
“If a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation,” the U.S. Food and Drug Administration says in an advisory posted on its website.
“If the leak issue is not resolved, persistent low purge pressure and purge flow may lead to pump stop and loss of therapy. In patients who are critical, failure of the pump’s support can lead to further deterioration and worsening of their already critical condition and may even lead to serious injury or death,” the FDA says.
The FDA has identified this as a class I recall, the most serious type, because of the potential for serious injury or death.
To date, Abiomed says it has received 179 complaints; there have been three injuries and no deaths related to this problem.
The Impella 5.5 with SmartAssist System is used for up to 14 days to support the ventricles in the setting of ongoing cardiogenic shock that occurs less than 48 hours after acute myocardial infarction, open-heart surgery, or when the heart is not functioning well owing to cardiomyopathy.
All the devices that are being recalled were distributed from September 2021 to March 2023. Detailed product information is available on the FDA website.
Abiomed has sent an urgent medical device recall letter to customers asking them to review their inventory to check for any recalled product and to contact Abiomed customer support to coordinate return of the product.
Customers are advised not to use affected products unless no other product is available. The letter includes “best practices” for situations in which no other option is available and the device must be used until a replacement is available.
Customers with questions about this recall should contact Abiomed’s clinical support center at 1-800-422-8666.
A version of this article was first published on Medscape.com.
“If a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation,” the U.S. Food and Drug Administration says in an advisory posted on its website.
“If the leak issue is not resolved, persistent low purge pressure and purge flow may lead to pump stop and loss of therapy. In patients who are critical, failure of the pump’s support can lead to further deterioration and worsening of their already critical condition and may even lead to serious injury or death,” the FDA says.
The FDA has identified this as a class I recall, the most serious type, because of the potential for serious injury or death.
To date, Abiomed says it has received 179 complaints; there have been three injuries and no deaths related to this problem.
The Impella 5.5 with SmartAssist System is used for up to 14 days to support the ventricles in the setting of ongoing cardiogenic shock that occurs less than 48 hours after acute myocardial infarction, open-heart surgery, or when the heart is not functioning well owing to cardiomyopathy.
All the devices that are being recalled were distributed from September 2021 to March 2023. Detailed product information is available on the FDA website.
Abiomed has sent an urgent medical device recall letter to customers asking them to review their inventory to check for any recalled product and to contact Abiomed customer support to coordinate return of the product.
Customers are advised not to use affected products unless no other product is available. The letter includes “best practices” for situations in which no other option is available and the device must be used until a replacement is available.
Customers with questions about this recall should contact Abiomed’s clinical support center at 1-800-422-8666.
A version of this article was first published on Medscape.com.
FDA OKs Injectafer for iron deficiency anemia in heart failure
“This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure,” Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release.
Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease.
The new indication in HF was supported by data from the CONFIRM-HF randomized controlled trial that evaluated the efficacy and safety of ferric carboxymaltose injection in adults with chronic HF and iron deficiency.
In the study, results showed that treatment with ferric carboxymaltose injection significantly improved exercise capacity compared with placebo in iron-deficient patients with HF.
No new safety signals emerged. The most common treatment emergent adverse events were headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness.
According to the company, ferric carboxymaltose injection has been studied in more than 40 clinical trials that included over 8,800 patients worldwide and has been approved in 86 countries.
A version of this article first appeared on Medscape.com.
“This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure,” Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release.
Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease.
The new indication in HF was supported by data from the CONFIRM-HF randomized controlled trial that evaluated the efficacy and safety of ferric carboxymaltose injection in adults with chronic HF and iron deficiency.
In the study, results showed that treatment with ferric carboxymaltose injection significantly improved exercise capacity compared with placebo in iron-deficient patients with HF.
No new safety signals emerged. The most common treatment emergent adverse events were headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness.
According to the company, ferric carboxymaltose injection has been studied in more than 40 clinical trials that included over 8,800 patients worldwide and has been approved in 86 countries.
A version of this article first appeared on Medscape.com.
“This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure,” Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release.
Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease.
The new indication in HF was supported by data from the CONFIRM-HF randomized controlled trial that evaluated the efficacy and safety of ferric carboxymaltose injection in adults with chronic HF and iron deficiency.
In the study, results showed that treatment with ferric carboxymaltose injection significantly improved exercise capacity compared with placebo in iron-deficient patients with HF.
No new safety signals emerged. The most common treatment emergent adverse events were headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness.
According to the company, ferric carboxymaltose injection has been studied in more than 40 clinical trials that included over 8,800 patients worldwide and has been approved in 86 countries.
A version of this article first appeared on Medscape.com.
U.S. psychiatrist shortage causing months-long wait times
SAN FRANCISCO –
“Long wait times for mental health care were a huge problem even before the pandemic but especially during the pandemic,” study investigator Erin McDaid, BS, Virginia Tech Carilion School of Medicine, Roanoke, said in an interview.
“It’s not like you have a cold or a virus and maybe you wait a little bit and it goes away. Mental health problems can completely impact your life; you can’t do anything, you can’t go to work, you can’t build relationships, you can’t take care of your kids. It’s a really big issue,” Ms. McDaid said.
The study was presented at the annual meeting of the American Psychiatric Association.
Few psychiatrists taking new patients
To find out just how big an issue wait times are, the researchers examined general psychiatry outpatient availability during the COVID-19 pandemic in five states – New York, California, North Dakota, Virginia, and Wyoming.
Altogether, 948 psychiatrists were sampled. Simulated adult patients made 864 calls seeking an initial psychiatric evaluation for general mental health care. The calls were made late in the pandemic, between May and July 2022.
Only 18.5% of psychiatrists were available to see new patients. The median wait time was 67 days for in-person appointments and 43 days for telepsychiatry appointments (P < .001).
More than half of psychiatrists who were contacted said they were not taking new patients, which was the most common reason given for unavailability.
“This is happening at the worst time, when we are seeing mental health issues spike,” Ms. McDaid said.
Telepsychiatry helpful but no panacea
The fact that wait times were a bit shorter for telepsychiatry is encouraging, Ms. McDaid said.
Telepsychiatry is a potential solution to provider shortages and geographic barriers, but it does not resolve the concerning shortage of psychiatric outpatient care, she noted.
“Psychiatrists adapted very well to telepsychiatry during COVID,” Saul Levin, MD, MPA, chief executive officer and medical director of the APA, noted during a preconference briefing with reporters.
“Before COVID, we always thought that the psychiatrist had to be with the patient in the room,” said Dr. Levin. But now we see that either “sitting inside the room with your psychiatrist or mental health specialist or [being there virtually] has the same effect. The patient is concentrating and working out their problems with you. I think that’s one of the positives – if anything coming out of COVID is positive.”
In an interview, Robert Trestman, MD, chair of the APA Council on Healthcare Systems and Financing, said telepsychiatry “will help, but there is not one simple solution that will fix the problem” regarding access to mental health care.
One promising approach is the collaborative care model, which enlists primary care physicians to provide mental health care in consultation with psychiatry and case management, Dr. Trestman said.
“There’s no question that there aren’t enough providers. There aren’t enough primary care doctors, and there certainly aren’t enough psychiatrists,” Dr. Trestman noted.
Encouragingly, however, the past few years have seen a steady increase in medical students choosing psychiatry.
“Psychiatry is now being thought of as a branch of neuroscience. We are understanding so much more about the field and about the brain. So that’s intriguing and intellectually challenging to many,” Dr. Trestman said.
He also noted that the pandemic has helped to “break down stigma. More people acknowledge and talk about mental health, and when an area is destigmatized, it’s so much easier for people to consider.”
Jack Resneck, Jr., MD, president of the American Medical Association, acknowledged that there is a “severe workforce shortage in health care right now.”
“I’m a physician and the president of the AMA, and it took me way too long to be able to find a primary care physician for myself,” he said.
“I also am a physician who refers patients to rheumatology and endocrinology, psychiatry, and other areas of medicine, and it is, in many geographic areas both rural and urban, a huge struggle right now,” said Dr. Resneck.
The study had no specific funding. Ms. McDaid, Dr. Levin, and Dr. Trestman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO –
“Long wait times for mental health care were a huge problem even before the pandemic but especially during the pandemic,” study investigator Erin McDaid, BS, Virginia Tech Carilion School of Medicine, Roanoke, said in an interview.
“It’s not like you have a cold or a virus and maybe you wait a little bit and it goes away. Mental health problems can completely impact your life; you can’t do anything, you can’t go to work, you can’t build relationships, you can’t take care of your kids. It’s a really big issue,” Ms. McDaid said.
The study was presented at the annual meeting of the American Psychiatric Association.
Few psychiatrists taking new patients
To find out just how big an issue wait times are, the researchers examined general psychiatry outpatient availability during the COVID-19 pandemic in five states – New York, California, North Dakota, Virginia, and Wyoming.
Altogether, 948 psychiatrists were sampled. Simulated adult patients made 864 calls seeking an initial psychiatric evaluation for general mental health care. The calls were made late in the pandemic, between May and July 2022.
Only 18.5% of psychiatrists were available to see new patients. The median wait time was 67 days for in-person appointments and 43 days for telepsychiatry appointments (P < .001).
More than half of psychiatrists who were contacted said they were not taking new patients, which was the most common reason given for unavailability.
“This is happening at the worst time, when we are seeing mental health issues spike,” Ms. McDaid said.
Telepsychiatry helpful but no panacea
The fact that wait times were a bit shorter for telepsychiatry is encouraging, Ms. McDaid said.
Telepsychiatry is a potential solution to provider shortages and geographic barriers, but it does not resolve the concerning shortage of psychiatric outpatient care, she noted.
“Psychiatrists adapted very well to telepsychiatry during COVID,” Saul Levin, MD, MPA, chief executive officer and medical director of the APA, noted during a preconference briefing with reporters.
“Before COVID, we always thought that the psychiatrist had to be with the patient in the room,” said Dr. Levin. But now we see that either “sitting inside the room with your psychiatrist or mental health specialist or [being there virtually] has the same effect. The patient is concentrating and working out their problems with you. I think that’s one of the positives – if anything coming out of COVID is positive.”
In an interview, Robert Trestman, MD, chair of the APA Council on Healthcare Systems and Financing, said telepsychiatry “will help, but there is not one simple solution that will fix the problem” regarding access to mental health care.
One promising approach is the collaborative care model, which enlists primary care physicians to provide mental health care in consultation with psychiatry and case management, Dr. Trestman said.
“There’s no question that there aren’t enough providers. There aren’t enough primary care doctors, and there certainly aren’t enough psychiatrists,” Dr. Trestman noted.
Encouragingly, however, the past few years have seen a steady increase in medical students choosing psychiatry.
“Psychiatry is now being thought of as a branch of neuroscience. We are understanding so much more about the field and about the brain. So that’s intriguing and intellectually challenging to many,” Dr. Trestman said.
He also noted that the pandemic has helped to “break down stigma. More people acknowledge and talk about mental health, and when an area is destigmatized, it’s so much easier for people to consider.”
Jack Resneck, Jr., MD, president of the American Medical Association, acknowledged that there is a “severe workforce shortage in health care right now.”
“I’m a physician and the president of the AMA, and it took me way too long to be able to find a primary care physician for myself,” he said.
“I also am a physician who refers patients to rheumatology and endocrinology, psychiatry, and other areas of medicine, and it is, in many geographic areas both rural and urban, a huge struggle right now,” said Dr. Resneck.
The study had no specific funding. Ms. McDaid, Dr. Levin, and Dr. Trestman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO –
“Long wait times for mental health care were a huge problem even before the pandemic but especially during the pandemic,” study investigator Erin McDaid, BS, Virginia Tech Carilion School of Medicine, Roanoke, said in an interview.
“It’s not like you have a cold or a virus and maybe you wait a little bit and it goes away. Mental health problems can completely impact your life; you can’t do anything, you can’t go to work, you can’t build relationships, you can’t take care of your kids. It’s a really big issue,” Ms. McDaid said.
The study was presented at the annual meeting of the American Psychiatric Association.
Few psychiatrists taking new patients
To find out just how big an issue wait times are, the researchers examined general psychiatry outpatient availability during the COVID-19 pandemic in five states – New York, California, North Dakota, Virginia, and Wyoming.
Altogether, 948 psychiatrists were sampled. Simulated adult patients made 864 calls seeking an initial psychiatric evaluation for general mental health care. The calls were made late in the pandemic, between May and July 2022.
Only 18.5% of psychiatrists were available to see new patients. The median wait time was 67 days for in-person appointments and 43 days for telepsychiatry appointments (P < .001).
More than half of psychiatrists who were contacted said they were not taking new patients, which was the most common reason given for unavailability.
“This is happening at the worst time, when we are seeing mental health issues spike,” Ms. McDaid said.
Telepsychiatry helpful but no panacea
The fact that wait times were a bit shorter for telepsychiatry is encouraging, Ms. McDaid said.
Telepsychiatry is a potential solution to provider shortages and geographic barriers, but it does not resolve the concerning shortage of psychiatric outpatient care, she noted.
“Psychiatrists adapted very well to telepsychiatry during COVID,” Saul Levin, MD, MPA, chief executive officer and medical director of the APA, noted during a preconference briefing with reporters.
“Before COVID, we always thought that the psychiatrist had to be with the patient in the room,” said Dr. Levin. But now we see that either “sitting inside the room with your psychiatrist or mental health specialist or [being there virtually] has the same effect. The patient is concentrating and working out their problems with you. I think that’s one of the positives – if anything coming out of COVID is positive.”
In an interview, Robert Trestman, MD, chair of the APA Council on Healthcare Systems and Financing, said telepsychiatry “will help, but there is not one simple solution that will fix the problem” regarding access to mental health care.
One promising approach is the collaborative care model, which enlists primary care physicians to provide mental health care in consultation with psychiatry and case management, Dr. Trestman said.
“There’s no question that there aren’t enough providers. There aren’t enough primary care doctors, and there certainly aren’t enough psychiatrists,” Dr. Trestman noted.
Encouragingly, however, the past few years have seen a steady increase in medical students choosing psychiatry.
“Psychiatry is now being thought of as a branch of neuroscience. We are understanding so much more about the field and about the brain. So that’s intriguing and intellectually challenging to many,” Dr. Trestman said.
He also noted that the pandemic has helped to “break down stigma. More people acknowledge and talk about mental health, and when an area is destigmatized, it’s so much easier for people to consider.”
Jack Resneck, Jr., MD, president of the American Medical Association, acknowledged that there is a “severe workforce shortage in health care right now.”
“I’m a physician and the president of the AMA, and it took me way too long to be able to find a primary care physician for myself,” he said.
“I also am a physician who refers patients to rheumatology and endocrinology, psychiatry, and other areas of medicine, and it is, in many geographic areas both rural and urban, a huge struggle right now,” said Dr. Resneck.
The study had no specific funding. Ms. McDaid, Dr. Levin, and Dr. Trestman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT APA 2023
CMS to cover Alzheimer’s drugs after traditional FDA okay
The Centers for Medicare & Medicaid Services has announced that
The one caveat is that CMS will require physicians to participate in registries that collect evidence about how these drugs work in the real world.
Physicians will be able to submit this evidence through a nationwide, CMS-facilitated portal that will be available when any product gains traditional approval and will collect information via an easy-to-use format.
“If the FDA grants traditional approval, then Medicare will cover it in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare,” the CMS says in a news release.
“CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” added CMS Administrator Chiquita Brooks-LaSure.
“If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered,” Ms. Brooks-LaSure explained.
The CMS says broader Medicare coverage for an Alzheimer’s drug would begin on the same day the FDA grants traditional approval. Under CMS’ current coverage policy, if the FDA grants traditional approval to other drugs in this class, they would also be eligible for broader coverage.
Currently two drugs in this class – aducanumab (Aduhelm) and lecanemab (Leqembi) – have received accelerated approval from the FDA, but no product has received traditional approval.
Lecanemab might be the first to cross the line.
On June 9, the FDA Peripheral and Central Nervous System Drugs Advisory Committee will discuss results of a confirmatory trial of lecanemab, with a potential decision on traditional approval expected shortly thereafter.
A version of this article first appeared on Medscape.com.
The Centers for Medicare & Medicaid Services has announced that
The one caveat is that CMS will require physicians to participate in registries that collect evidence about how these drugs work in the real world.
Physicians will be able to submit this evidence through a nationwide, CMS-facilitated portal that will be available when any product gains traditional approval and will collect information via an easy-to-use format.
“If the FDA grants traditional approval, then Medicare will cover it in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare,” the CMS says in a news release.
“CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” added CMS Administrator Chiquita Brooks-LaSure.
“If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered,” Ms. Brooks-LaSure explained.
The CMS says broader Medicare coverage for an Alzheimer’s drug would begin on the same day the FDA grants traditional approval. Under CMS’ current coverage policy, if the FDA grants traditional approval to other drugs in this class, they would also be eligible for broader coverage.
Currently two drugs in this class – aducanumab (Aduhelm) and lecanemab (Leqembi) – have received accelerated approval from the FDA, but no product has received traditional approval.
Lecanemab might be the first to cross the line.
On June 9, the FDA Peripheral and Central Nervous System Drugs Advisory Committee will discuss results of a confirmatory trial of lecanemab, with a potential decision on traditional approval expected shortly thereafter.
A version of this article first appeared on Medscape.com.
The Centers for Medicare & Medicaid Services has announced that
The one caveat is that CMS will require physicians to participate in registries that collect evidence about how these drugs work in the real world.
Physicians will be able to submit this evidence through a nationwide, CMS-facilitated portal that will be available when any product gains traditional approval and will collect information via an easy-to-use format.
“If the FDA grants traditional approval, then Medicare will cover it in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare,” the CMS says in a news release.
“CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” added CMS Administrator Chiquita Brooks-LaSure.
“If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered,” Ms. Brooks-LaSure explained.
The CMS says broader Medicare coverage for an Alzheimer’s drug would begin on the same day the FDA grants traditional approval. Under CMS’ current coverage policy, if the FDA grants traditional approval to other drugs in this class, they would also be eligible for broader coverage.
Currently two drugs in this class – aducanumab (Aduhelm) and lecanemab (Leqembi) – have received accelerated approval from the FDA, but no product has received traditional approval.
Lecanemab might be the first to cross the line.
On June 9, the FDA Peripheral and Central Nervous System Drugs Advisory Committee will discuss results of a confirmatory trial of lecanemab, with a potential decision on traditional approval expected shortly thereafter.
A version of this article first appeared on Medscape.com.
APA launches online eating disorder assessment tool
The American Psychiatric Association has released an online screening and assessment tool for eating disorders.
“People with eating disorders have a high rate of mortality and [the disorder is] growing in prevalence among young adults and adolescents,” APA CEO and medical director Saul Levin, MD, MPA, said in a news release.
“It is vital that we equip our clinicians, especially primary care clinicians, with the latest evidence from the APA to empower their decision-making and improve care for their patients,” Dr. Levin added.
The clinical decision support tool was developed by the APA’s guideline writing group in collaboration with AvoMD, a software company that translates clinical evidence into the workflow.
The tool guides clinicians through the screening, assessing, diagnosing, and treatment planning of patients with anorexia nervosa, bulimia nervosa, binge-eating disorder, and other eating disorders.
It’s available free in the electronic health record, on the APA website, and on the AvoMD mobile app.
The tool is based on the APA’s updated practice guidelines for the management of eating disorders, which were released in March.
The tool incorporates guidance on screening tools, levels of care, nutrition, exercise, psychotherapy, and more. Additionally, the tool provides a summary of responses that can be leveraged for easy documentation.
It is intended for use by pediatricians, family physicians, and other primary care and mental health clinicians, including psychiatrists and therapists.
Data published earlier this year show that more than 1 in 5 children worldwide are at risk of developing an eating disorder. Girls are significantly more likely than boys to have disordered eating.
Early diagnosis and treatment are associated with a higher rate of recovery, and extended illness is associated with potentially devastating consequences, the APA notes.
“As an internal medicine physician myself, I see a wide variety of patients and clinical issues,” Joongheum Park, MD, head of product and engineering at AvoMD, said in the release.
“Easy access to the expertise in me and my peers’ workflow is essential to ensuring high-quality care, and partnering with the leading authority on eating disorders to provide this tool will improve clinician efficiency and most importantly, patient outcomes,” Dr. Park added.
A version of this article first appeared on Medscape.com.
The American Psychiatric Association has released an online screening and assessment tool for eating disorders.
“People with eating disorders have a high rate of mortality and [the disorder is] growing in prevalence among young adults and adolescents,” APA CEO and medical director Saul Levin, MD, MPA, said in a news release.
“It is vital that we equip our clinicians, especially primary care clinicians, with the latest evidence from the APA to empower their decision-making and improve care for their patients,” Dr. Levin added.
The clinical decision support tool was developed by the APA’s guideline writing group in collaboration with AvoMD, a software company that translates clinical evidence into the workflow.
The tool guides clinicians through the screening, assessing, diagnosing, and treatment planning of patients with anorexia nervosa, bulimia nervosa, binge-eating disorder, and other eating disorders.
It’s available free in the electronic health record, on the APA website, and on the AvoMD mobile app.
The tool is based on the APA’s updated practice guidelines for the management of eating disorders, which were released in March.
The tool incorporates guidance on screening tools, levels of care, nutrition, exercise, psychotherapy, and more. Additionally, the tool provides a summary of responses that can be leveraged for easy documentation.
It is intended for use by pediatricians, family physicians, and other primary care and mental health clinicians, including psychiatrists and therapists.
Data published earlier this year show that more than 1 in 5 children worldwide are at risk of developing an eating disorder. Girls are significantly more likely than boys to have disordered eating.
Early diagnosis and treatment are associated with a higher rate of recovery, and extended illness is associated with potentially devastating consequences, the APA notes.
“As an internal medicine physician myself, I see a wide variety of patients and clinical issues,” Joongheum Park, MD, head of product and engineering at AvoMD, said in the release.
“Easy access to the expertise in me and my peers’ workflow is essential to ensuring high-quality care, and partnering with the leading authority on eating disorders to provide this tool will improve clinician efficiency and most importantly, patient outcomes,” Dr. Park added.
A version of this article first appeared on Medscape.com.
The American Psychiatric Association has released an online screening and assessment tool for eating disorders.
“People with eating disorders have a high rate of mortality and [the disorder is] growing in prevalence among young adults and adolescents,” APA CEO and medical director Saul Levin, MD, MPA, said in a news release.
“It is vital that we equip our clinicians, especially primary care clinicians, with the latest evidence from the APA to empower their decision-making and improve care for their patients,” Dr. Levin added.
The clinical decision support tool was developed by the APA’s guideline writing group in collaboration with AvoMD, a software company that translates clinical evidence into the workflow.
The tool guides clinicians through the screening, assessing, diagnosing, and treatment planning of patients with anorexia nervosa, bulimia nervosa, binge-eating disorder, and other eating disorders.
It’s available free in the electronic health record, on the APA website, and on the AvoMD mobile app.
The tool is based on the APA’s updated practice guidelines for the management of eating disorders, which were released in March.
The tool incorporates guidance on screening tools, levels of care, nutrition, exercise, psychotherapy, and more. Additionally, the tool provides a summary of responses that can be leveraged for easy documentation.
It is intended for use by pediatricians, family physicians, and other primary care and mental health clinicians, including psychiatrists and therapists.
Data published earlier this year show that more than 1 in 5 children worldwide are at risk of developing an eating disorder. Girls are significantly more likely than boys to have disordered eating.
Early diagnosis and treatment are associated with a higher rate of recovery, and extended illness is associated with potentially devastating consequences, the APA notes.
“As an internal medicine physician myself, I see a wide variety of patients and clinical issues,” Joongheum Park, MD, head of product and engineering at AvoMD, said in the release.
“Easy access to the expertise in me and my peers’ workflow is essential to ensuring high-quality care, and partnering with the leading authority on eating disorders to provide this tool will improve clinician efficiency and most importantly, patient outcomes,” Dr. Park added.
A version of this article first appeared on Medscape.com.
United Healthcare ditches prior authorization in favor of new policy
Instead, the giant health insurer will adopt an “advance notification” program for nonscreening and nonemergent gastrointestinal procedures.
The company has not made any changes to their policy regarding screening colonoscopies for preventive care, and the advance notification policy does not impact screening colonoscopies.
UHC alerted physicians to changes to the program yesterday, including updated notices on UHCProvider.com with a new Frequently Asked Questions document.
The advance notification program “will not result in the denial of care for clinical reasons or for failure to notify and will help educate physicians who are not following clinical best practices. Provider groups who do not submit advance notification during this period will not be eligible for the United Healthcare Gold Card program,” a spokesperson for the company said.
The previously announced Gold Card program, which is scheduled to start in early 2024, would eliminate prior authorization requirements for providers that meet certain eligibility requirements.
The American Gastroenterological Association remains “extremely concerned” that UHC’s advance notification program is a “temporary patch” likely to have significant repercussions for patient access. The organization says the program only temporarily postpones prior authorization requirements set to impact the insurer’s 27.4 million commercial beneficiaries while increasing the administrative burden on clinicians.
The AGA called the program “nebulous” and “poorly defined.” It would ostensibly require physicians to input “copious” amounts of highly complex and granular patient data prior to performing colonoscopies and endoscopies, the AGA says.
AGA President Barbara H. Jung, MD, AGAF, said UHC’s “slap-dash approach to rolling out a policy that will ultimately control patient access to critical, often life-saving, medical procedures flies in the face of common sense and responsible medical practice.”
“It also indicates that UHC does not currently have data that show any significant overutilization of critical endoscopy and colonoscopy procedures that would ostensibly justify this program or prior authorization. UHC is not acting in good faith, and its actions will compromise patient access to potentially lifesaving procedures,” Dr. Jung added.
Recent data show 62% of high-risk patients in the United States who had polyps removed had evidence of delayed or no use of surveillance colonoscopies after 10 years.
“If other prior authorization requirements imposed on patients for specialty care are any indication, we expect to see negative patient outcomes with an enormous cost to patient well-being and physician resources,” AGA Vice President Lawrence Kim, MD, wrote in a news release.
“Given the high percentage of eventual approvals by insurers mandating prior authorization, we anticipate there will be little to no benefit from this prior authorization requirement. When utilized this way, it becomes a nonsensical and harmful policy,” Dr. Kim added.
AGA says it will continue to work closely with its members to assess the full impact of the new requirements and urges UHC to make endoscopy procedures more accessible to patients.
A recent American Medical Association survey on prior authorization found that one-third (33%) of doctors said the insurance barrier has led to a serious adverse event such as hospitalization, permanent disability, or death for a patient in their care. Nearly half (46%) of physicians reported that prior authorization has led to immediate care and/or emergency department visits.
In a 2023 survey of AGA membership, conducted before UHC announced its proposed prior authorization policy, 95% of respondents said prior authorization restrictions have impacted patient access to clinically appropriate treatments and patient clinical outcomes. And 84% said the burdens associated with prior authorization policies have increased “significantly” (60%) or “somewhat” (24%) over the last 5 years.
A version of this article first appeared on Medscape.com.
Instead, the giant health insurer will adopt an “advance notification” program for nonscreening and nonemergent gastrointestinal procedures.
The company has not made any changes to their policy regarding screening colonoscopies for preventive care, and the advance notification policy does not impact screening colonoscopies.
UHC alerted physicians to changes to the program yesterday, including updated notices on UHCProvider.com with a new Frequently Asked Questions document.
The advance notification program “will not result in the denial of care for clinical reasons or for failure to notify and will help educate physicians who are not following clinical best practices. Provider groups who do not submit advance notification during this period will not be eligible for the United Healthcare Gold Card program,” a spokesperson for the company said.
The previously announced Gold Card program, which is scheduled to start in early 2024, would eliminate prior authorization requirements for providers that meet certain eligibility requirements.
The American Gastroenterological Association remains “extremely concerned” that UHC’s advance notification program is a “temporary patch” likely to have significant repercussions for patient access. The organization says the program only temporarily postpones prior authorization requirements set to impact the insurer’s 27.4 million commercial beneficiaries while increasing the administrative burden on clinicians.
The AGA called the program “nebulous” and “poorly defined.” It would ostensibly require physicians to input “copious” amounts of highly complex and granular patient data prior to performing colonoscopies and endoscopies, the AGA says.
AGA President Barbara H. Jung, MD, AGAF, said UHC’s “slap-dash approach to rolling out a policy that will ultimately control patient access to critical, often life-saving, medical procedures flies in the face of common sense and responsible medical practice.”
“It also indicates that UHC does not currently have data that show any significant overutilization of critical endoscopy and colonoscopy procedures that would ostensibly justify this program or prior authorization. UHC is not acting in good faith, and its actions will compromise patient access to potentially lifesaving procedures,” Dr. Jung added.
Recent data show 62% of high-risk patients in the United States who had polyps removed had evidence of delayed or no use of surveillance colonoscopies after 10 years.
“If other prior authorization requirements imposed on patients for specialty care are any indication, we expect to see negative patient outcomes with an enormous cost to patient well-being and physician resources,” AGA Vice President Lawrence Kim, MD, wrote in a news release.
“Given the high percentage of eventual approvals by insurers mandating prior authorization, we anticipate there will be little to no benefit from this prior authorization requirement. When utilized this way, it becomes a nonsensical and harmful policy,” Dr. Kim added.
AGA says it will continue to work closely with its members to assess the full impact of the new requirements and urges UHC to make endoscopy procedures more accessible to patients.
A recent American Medical Association survey on prior authorization found that one-third (33%) of doctors said the insurance barrier has led to a serious adverse event such as hospitalization, permanent disability, or death for a patient in their care. Nearly half (46%) of physicians reported that prior authorization has led to immediate care and/or emergency department visits.
In a 2023 survey of AGA membership, conducted before UHC announced its proposed prior authorization policy, 95% of respondents said prior authorization restrictions have impacted patient access to clinically appropriate treatments and patient clinical outcomes. And 84% said the burdens associated with prior authorization policies have increased “significantly” (60%) or “somewhat” (24%) over the last 5 years.
A version of this article first appeared on Medscape.com.
Instead, the giant health insurer will adopt an “advance notification” program for nonscreening and nonemergent gastrointestinal procedures.
The company has not made any changes to their policy regarding screening colonoscopies for preventive care, and the advance notification policy does not impact screening colonoscopies.
UHC alerted physicians to changes to the program yesterday, including updated notices on UHCProvider.com with a new Frequently Asked Questions document.
The advance notification program “will not result in the denial of care for clinical reasons or for failure to notify and will help educate physicians who are not following clinical best practices. Provider groups who do not submit advance notification during this period will not be eligible for the United Healthcare Gold Card program,” a spokesperson for the company said.
The previously announced Gold Card program, which is scheduled to start in early 2024, would eliminate prior authorization requirements for providers that meet certain eligibility requirements.
The American Gastroenterological Association remains “extremely concerned” that UHC’s advance notification program is a “temporary patch” likely to have significant repercussions for patient access. The organization says the program only temporarily postpones prior authorization requirements set to impact the insurer’s 27.4 million commercial beneficiaries while increasing the administrative burden on clinicians.
The AGA called the program “nebulous” and “poorly defined.” It would ostensibly require physicians to input “copious” amounts of highly complex and granular patient data prior to performing colonoscopies and endoscopies, the AGA says.
AGA President Barbara H. Jung, MD, AGAF, said UHC’s “slap-dash approach to rolling out a policy that will ultimately control patient access to critical, often life-saving, medical procedures flies in the face of common sense and responsible medical practice.”
“It also indicates that UHC does not currently have data that show any significant overutilization of critical endoscopy and colonoscopy procedures that would ostensibly justify this program or prior authorization. UHC is not acting in good faith, and its actions will compromise patient access to potentially lifesaving procedures,” Dr. Jung added.
Recent data show 62% of high-risk patients in the United States who had polyps removed had evidence of delayed or no use of surveillance colonoscopies after 10 years.
“If other prior authorization requirements imposed on patients for specialty care are any indication, we expect to see negative patient outcomes with an enormous cost to patient well-being and physician resources,” AGA Vice President Lawrence Kim, MD, wrote in a news release.
“Given the high percentage of eventual approvals by insurers mandating prior authorization, we anticipate there will be little to no benefit from this prior authorization requirement. When utilized this way, it becomes a nonsensical and harmful policy,” Dr. Kim added.
AGA says it will continue to work closely with its members to assess the full impact of the new requirements and urges UHC to make endoscopy procedures more accessible to patients.
A recent American Medical Association survey on prior authorization found that one-third (33%) of doctors said the insurance barrier has led to a serious adverse event such as hospitalization, permanent disability, or death for a patient in their care. Nearly half (46%) of physicians reported that prior authorization has led to immediate care and/or emergency department visits.
In a 2023 survey of AGA membership, conducted before UHC announced its proposed prior authorization policy, 95% of respondents said prior authorization restrictions have impacted patient access to clinically appropriate treatments and patient clinical outcomes. And 84% said the burdens associated with prior authorization policies have increased “significantly” (60%) or “somewhat” (24%) over the last 5 years.
A version of this article first appeared on Medscape.com.
Positive top-line results for cannabinoid-based med for nerve pain
, new top-line results released by Zelira Therapeutics suggest.
“The implications of these results for patients are incredibly promising,” principal investigator Bryan Doner, DO, medical director of HealthyWays Integrated Wellness Solutions, Gibsonia, Pa., said in a news release.
“Through this rigorously designed study, we have demonstrated that ZLT-L-007 is a safe, effective, and well-tolerated alternative for patients who would typically seek a Lyrica-level of pain relief,” he added.
The observational, nonblinded trial tested the efficacy, safety, and tolerability of ZLT-L-007 against pregabalin in 60 adults with diabetic nerve pain.
The study had three groups with 20 patients each (pregabalin alone, pregabalin plus ZLT-L-007, and ZLT-L-007 alone).
Top-line results show the study met its primary endpoint for change in daily pain severity as measured by the percent change from baseline at 30, 60, and 90 days on the Numerical Rating Scale.
For the pregabalin-only group, there was a reduction in symptom severity at all follow-up points, ranging from 20% to 35% (median percent change from baseline), the company said.
For the ZLT-L-007 only group, there was about a 33% reduction in symptom severity at 30 days, and 71% and 78% reduction, respectively, at 60 and 90 days, suggesting a larger improvement in symptom severity than with pregabalin alone, the company said.
For the pregabalin plus ZLT-L-007 group, there was a moderate 20% reduction in symptom severity at 30 days, but a larger reduction at 60 and 90 days (50% and 72%, respectively), which indicates substantially greater improvement in symptom severity than with pregabalin alone, the company said.
The study also met secondary endpoints, including significant decreases in daily pain severity as measured by the Visual Analog Scale and measurable changes in the short-form McGill Pain Questionnaire and Neuropathic Pain Symptom Inventory.
Dr. Doner noted that the top-line data showed “no serious adverse events, and participants’ blood pressure and other safety vitals remained unaffected throughout. This confirms that ZLT-L-007 is a well-tolerated product that delivers statistically significant pain relief, surpassing the levels achieved by Lyrica.”
The company plans to report additional insights from the full study, as they become available, during fiscal year 2023-2024.
A version of this article first appeared on Medscape.com.
, new top-line results released by Zelira Therapeutics suggest.
“The implications of these results for patients are incredibly promising,” principal investigator Bryan Doner, DO, medical director of HealthyWays Integrated Wellness Solutions, Gibsonia, Pa., said in a news release.
“Through this rigorously designed study, we have demonstrated that ZLT-L-007 is a safe, effective, and well-tolerated alternative for patients who would typically seek a Lyrica-level of pain relief,” he added.
The observational, nonblinded trial tested the efficacy, safety, and tolerability of ZLT-L-007 against pregabalin in 60 adults with diabetic nerve pain.
The study had three groups with 20 patients each (pregabalin alone, pregabalin plus ZLT-L-007, and ZLT-L-007 alone).
Top-line results show the study met its primary endpoint for change in daily pain severity as measured by the percent change from baseline at 30, 60, and 90 days on the Numerical Rating Scale.
For the pregabalin-only group, there was a reduction in symptom severity at all follow-up points, ranging from 20% to 35% (median percent change from baseline), the company said.
For the ZLT-L-007 only group, there was about a 33% reduction in symptom severity at 30 days, and 71% and 78% reduction, respectively, at 60 and 90 days, suggesting a larger improvement in symptom severity than with pregabalin alone, the company said.
For the pregabalin plus ZLT-L-007 group, there was a moderate 20% reduction in symptom severity at 30 days, but a larger reduction at 60 and 90 days (50% and 72%, respectively), which indicates substantially greater improvement in symptom severity than with pregabalin alone, the company said.
The study also met secondary endpoints, including significant decreases in daily pain severity as measured by the Visual Analog Scale and measurable changes in the short-form McGill Pain Questionnaire and Neuropathic Pain Symptom Inventory.
Dr. Doner noted that the top-line data showed “no serious adverse events, and participants’ blood pressure and other safety vitals remained unaffected throughout. This confirms that ZLT-L-007 is a well-tolerated product that delivers statistically significant pain relief, surpassing the levels achieved by Lyrica.”
The company plans to report additional insights from the full study, as they become available, during fiscal year 2023-2024.
A version of this article first appeared on Medscape.com.
, new top-line results released by Zelira Therapeutics suggest.
“The implications of these results for patients are incredibly promising,” principal investigator Bryan Doner, DO, medical director of HealthyWays Integrated Wellness Solutions, Gibsonia, Pa., said in a news release.
“Through this rigorously designed study, we have demonstrated that ZLT-L-007 is a safe, effective, and well-tolerated alternative for patients who would typically seek a Lyrica-level of pain relief,” he added.
The observational, nonblinded trial tested the efficacy, safety, and tolerability of ZLT-L-007 against pregabalin in 60 adults with diabetic nerve pain.
The study had three groups with 20 patients each (pregabalin alone, pregabalin plus ZLT-L-007, and ZLT-L-007 alone).
Top-line results show the study met its primary endpoint for change in daily pain severity as measured by the percent change from baseline at 30, 60, and 90 days on the Numerical Rating Scale.
For the pregabalin-only group, there was a reduction in symptom severity at all follow-up points, ranging from 20% to 35% (median percent change from baseline), the company said.
For the ZLT-L-007 only group, there was about a 33% reduction in symptom severity at 30 days, and 71% and 78% reduction, respectively, at 60 and 90 days, suggesting a larger improvement in symptom severity than with pregabalin alone, the company said.
For the pregabalin plus ZLT-L-007 group, there was a moderate 20% reduction in symptom severity at 30 days, but a larger reduction at 60 and 90 days (50% and 72%, respectively), which indicates substantially greater improvement in symptom severity than with pregabalin alone, the company said.
The study also met secondary endpoints, including significant decreases in daily pain severity as measured by the Visual Analog Scale and measurable changes in the short-form McGill Pain Questionnaire and Neuropathic Pain Symptom Inventory.
Dr. Doner noted that the top-line data showed “no serious adverse events, and participants’ blood pressure and other safety vitals remained unaffected throughout. This confirms that ZLT-L-007 is a well-tolerated product that delivers statistically significant pain relief, surpassing the levels achieved by Lyrica.”
The company plans to report additional insights from the full study, as they become available, during fiscal year 2023-2024.
A version of this article first appeared on Medscape.com.