Screening youth to identify those at risk for suicide is particularly important in medical settings, given the increasing rates of adolescent suicide, and screening can take as little as 20 seconds, according to Lisa Horowitz, PhD, MPH, a staff scientist and clinical psychologist at the National Institute of Mental Health, Bethesda, Md.

Steve Debenport/Getty Images

But clinicians need to use validated screening instruments that are both population specific and site specific, and they need practice guidelines to treat patients screening positive.

Currently, many practitioners use depression screens – such as question #9 on suicide ideation and self harm on the Patient Health Questionnaire for Adolescents (PHQ-A) – to identify suicide risk, but preliminary data suggest these screens often are inadequate, Dr. Horowitz said. Just one question, especially one without precise language, does not appear to identify as many at-risk youths as more direct questions about suicidal thoughts and behaviors.

A Pathways to Clinical Care suicide risk screening work group therefore designed a three-tiered clinical pathway for suicide risk screenings in emergency departments, inpatient care, and outpatient primary care. It begins with the Ask Suicide-Screening Questions (ASQ), which takes about 20 seconds and was specifically developed for pediatric patients in the emergency department and validated in both inpatient and outpatient settings.

Dr Horowitz, also the lead principal investigator for development of the ASQ, currently is leading six National Institute of Mental Health studies to validate and implement the screening tool in medical settings. She explained the three-tiered system during a session on youth suicide screening at the Pediatric Academic Societies annual meeting in Baltimore this year.

If a patient screens positive on the ASQ, a trained clinician should conduct a brief suicide safety assessment (BSSA), which takes approximately 10 minutes, Dr Horowitz said. Those who screen positive on the BSSA should receive the Patient Resource List and then be referred for a full mental health and safety evaluation, which takes about 30 minutes. Resources, such as nurse scripts and parent/guardian flyers, are available at the NIMH website, as well as translations of the ASQ in Arabic, Chinese, Dutch, French, Hebrew, Italian, Japanese, Korean, Portuguese, Russian, Somali, Spanish, and Vietnamese.

Acknowledging the importance of suicide screening

During the same session, John V. Campo, MD, an assistant dean for behavioral health and professor of behavioral medicine and psychiatry at West Virginia University in Morgantown, discussed why suicide risk screening is so crucial in general medical settings. As someone who trained as a pediatrician before crossing over to behavioral health, he acknowledged that primary care physicians already have many priorities to cover in short visits, and that the national answer to most public health problems is to deal with it in primary care.

“Anyone who has done primary care pediatrics understands the challenges involved with screening for anything – particularly when you identify someone who is extensively at risk,” he said.

But suicide has a disproportionately high impact on young populations, and “identifying youth at risk for suicide identifies a group of young people who are at risk for a variety of threats to their health and well-being,” he said.

For youth aged 10-19 years in 2016, suicide was the second leading cause of death behind accidents, according to the Centers for Disease Control and Prevention (Natl Vital Stat Rep. 2018 Jun;67[4]:1-16). In fact, accidents, suicide, and homicide account for three-quarters of deaths among youth aged 10-24 years (Natl Vital Stat Rep. 2019 Jun;68[6]:1-77), yet it’s typically the other 25% that most physicians trained for in residency.

“Suicide kills more kids than cancer, heart disease, infections – all kinds, sepsis, meningitis, pneumonia, influenza, HIV, respiratory conditions. Suicide kills more young people every year than all of that [combined],” Dr. Campo said. “And yet, when you walk through a modern emergency department, we see all these specialized programs for those who present with physical trauma or chest pain or all these other things, but zero specialized mental health services. There’s a disconnect.”

There is some good news in the data, he said. Observational data have shown that suicide rates negatively correlate with indicators of better access to health and medical health services, and researchers increasingly are identifying proven strategies that help prevent suicide in young people – once they have been identified.

But that’s the problem, “and we all know it,” Dr. Campo continued. “Most youth who are at risk for suicide aren’t recognized, and those who are recognized most often are untreated or inadequately treated,” he said. Further, “the best predictor of future behavior is past behavior,” but most adolescents die by suicide on their first attempt.

Again, however, Dr. Campo pivoted to the good news. Data also have shown that most youth who die by suicide had at least one health contact in the previous year, which means there are opportunities for screening and intervention.

The most common risk factor for suicide is having a mental health or substance use condition, present in about 90% of completed suicides and affecting approximately one in five youth. Prevalence is even higher in those with physical health conditions and among those with Medicaid or no insurance (J Child Psychol Psychiatry. 2006 Mar-Apr;47[3-4]372-94).

Yet, “the majority of them have not been treated at all for mental disorder, which seems to be the most important remediable risk factor for suicide, and even fewer are in current treatment at the time of the death,” Dr. Campo said. Suicide also is correlated with a number of other high-risk behaviors or circumstances, such as “vulnerabilities to substance abuse, riding in a car with someone who is intoxicated, carrying a weapon to school, fighting, and meeting criteria for depression” (Pediatrics. 2010 May;125[5]:945-52). Screening for suicide risk therefore allows physicians to identify youth vulnerable to a wide range of risks, conditions, or death.

Overcoming barriers to suicide screening in primary care

Given the high prevalence of suicide and its link to so many other risks for youth, screening in primary care can send the message that suicide screening “really is a part of health care,” Dr. Campo said. Incorporating screening into primary care also can help overcome distrust of behavioral health specialists in the general public and stigma associated with behavioral health disorders.

Primary care screening emphasizes the importance and credibility of mental health and challenges attitudinal barriers to care, he said.

At the same time, however, he acknowledged that providers themselves often are uneasy about addressing behavioral health. Therefore, “having the guideline and the expectation [of suicide risk screening] really drives home the point that this needs to be integrated into the rest of primary care,” he said. “It’s also consistent with the idea of the medical home.” With suicide the second leading cause of death among youth, “if there’s anything that we’re going to be thinking about screening for, one would think suicide would be high on the list.”

In fact, observational evidence has shown that educating and training primary care providers to recognize people with depression or a high risk for suicide can reduce suicide attempts and the suicide rate, Dr. Campo said (JAMA Psychiatry. 2017 Jun 1;74[6]:563-70). It also can help with the mismatch between where at-risk patients are and where behavioral health specialists are. About 90% of behavioral health specialists work only in specialty settings, and only 5% typically work in general medical settings, he said. Yet “most people who are in mental distress or in crisis don’t present in specialty behavioral health settings. They present in general medical settings.”

More data are needed to demonstrate more definitively whether and how much suicide risk screening changes outcomes, but we know a few things, Dr. Campo said, summing up his key points: “We know suicide’s a major source of mortality in youth that’s been relatively neglected in pediatric health care. Second, we know that suicide risk is associated with risk for other important causes of death, for mental disorders, and for alcohol and substance use.

“We know that most suicide decedents are unrecognized prior to the time of death, and those who are recognized often are not treated. We know that the majority of suicide deaths occur on the very first attempt. We also know that we increasingly have treatments, mental disorders that can be identified, and remediable risk factors, and [that at-risk youth] typically present at general medical settings. Beyond that, focusing on the general medical setting has both conceptual and practical advantages as a site for really helping us to detect patients at risk and then managing them.”

No funding was used for the presentations. Dr. Horowitz and Dr. Campo had no relevant financial disclosures.

Screening youth to identify those at risk for suicide is particularly important in medical settings, given the increasing rates of adolescent suicide, and screening can take as little as 20 seconds, according to Lisa Horowitz, PhD, MPH, a staff scientist and clinical psychologist at the National Institute of Mental Health, Bethesda, Md.

Steve Debenport/Getty Images

But clinicians need to use validated screening instruments that are both population specific and site specific, and they need practice guidelines to treat patients screening positive.

Currently, many practitioners use depression screens – such as question #9 on suicide ideation and self harm on the Patient Health Questionnaire for Adolescents (PHQ-A) – to identify suicide risk, but preliminary data suggest these screens often are inadequate, Dr. Horowitz said. Just one question, especially one without precise language, does not appear to identify as many at-risk youths as more direct questions about suicidal thoughts and behaviors.

A Pathways to Clinical Care suicide risk screening work group therefore designed a three-tiered clinical pathway for suicide risk screenings in emergency departments, inpatient care, and outpatient primary care. It begins with the Ask Suicide-Screening Questions (ASQ), which takes about 20 seconds and was specifically developed for pediatric patients in the emergency department and validated in both inpatient and outpatient settings.

Dr Horowitz, also the lead principal investigator for development of the ASQ, currently is leading six National Institute of Mental Health studies to validate and implement the screening tool in medical settings. She explained the three-tiered system during a session on youth suicide screening at the Pediatric Academic Societies annual meeting in Baltimore this year.

If a patient screens positive on the ASQ, a trained clinician should conduct a brief suicide safety assessment (BSSA), which takes approximately 10 minutes, Dr Horowitz said. Those who screen positive on the BSSA should receive the Patient Resource List and then be referred for a full mental health and safety evaluation, which takes about 30 minutes. Resources, such as nurse scripts and parent/guardian flyers, are available at the NIMH website, as well as translations of the ASQ in Arabic, Chinese, Dutch, French, Hebrew, Italian, Japanese, Korean, Portuguese, Russian, Somali, Spanish, and Vietnamese.

Acknowledging the importance of suicide screening

During the same session, John V. Campo, MD, an assistant dean for behavioral health and professor of behavioral medicine and psychiatry at West Virginia University in Morgantown, discussed why suicide risk screening is so crucial in general medical settings. As someone who trained as a pediatrician before crossing over to behavioral health, he acknowledged that primary care physicians already have many priorities to cover in short visits, and that the national answer to most public health problems is to deal with it in primary care.

“Anyone who has done primary care pediatrics understands the challenges involved with screening for anything – particularly when you identify someone who is extensively at risk,” he said.

But suicide has a disproportionately high impact on young populations, and “identifying youth at risk for suicide identifies a group of young people who are at risk for a variety of threats to their health and well-being,” he said.

For youth aged 10-19 years in 2016, suicide was the second leading cause of death behind accidents, according to the Centers for Disease Control and Prevention (Natl Vital Stat Rep. 2018 Jun;67[4]:1-16). In fact, accidents, suicide, and homicide account for three-quarters of deaths among youth aged 10-24 years (Natl Vital Stat Rep. 2019 Jun;68[6]:1-77), yet it’s typically the other 25% that most physicians trained for in residency.

“Suicide kills more kids than cancer, heart disease, infections – all kinds, sepsis, meningitis, pneumonia, influenza, HIV, respiratory conditions. Suicide kills more young people every year than all of that [combined],” Dr. Campo said. “And yet, when you walk through a modern emergency department, we see all these specialized programs for those who present with physical trauma or chest pain or all these other things, but zero specialized mental health services. There’s a disconnect.”

There is some good news in the data, he said. Observational data have shown that suicide rates negatively correlate with indicators of better access to health and medical health services, and researchers increasingly are identifying proven strategies that help prevent suicide in young people – once they have been identified.

But that’s the problem, “and we all know it,” Dr. Campo continued. “Most youth who are at risk for suicide aren’t recognized, and those who are recognized most often are untreated or inadequately treated,” he said. Further, “the best predictor of future behavior is past behavior,” but most adolescents die by suicide on their first attempt.

Again, however, Dr. Campo pivoted to the good news. Data also have shown that most youth who die by suicide had at least one health contact in the previous year, which means there are opportunities for screening and intervention.

The most common risk factor for suicide is having a mental health or substance use condition, present in about 90% of completed suicides and affecting approximately one in five youth. Prevalence is even higher in those with physical health conditions and among those with Medicaid or no insurance (J Child Psychol Psychiatry. 2006 Mar-Apr;47[3-4]372-94).

Yet, “the majority of them have not been treated at all for mental disorder, which seems to be the most important remediable risk factor for suicide, and even fewer are in current treatment at the time of the death,” Dr. Campo said. Suicide also is correlated with a number of other high-risk behaviors or circumstances, such as “vulnerabilities to substance abuse, riding in a car with someone who is intoxicated, carrying a weapon to school, fighting, and meeting criteria for depression” (Pediatrics. 2010 May;125[5]:945-52). Screening for suicide risk therefore allows physicians to identify youth vulnerable to a wide range of risks, conditions, or death.

Overcoming barriers to suicide screening in primary care

Given the high prevalence of suicide and its link to so many other risks for youth, screening in primary care can send the message that suicide screening “really is a part of health care,” Dr. Campo said. Incorporating screening into primary care also can help overcome distrust of behavioral health specialists in the general public and stigma associated with behavioral health disorders.

Primary care screening emphasizes the importance and credibility of mental health and challenges attitudinal barriers to care, he said.

At the same time, however, he acknowledged that providers themselves often are uneasy about addressing behavioral health. Therefore, “having the guideline and the expectation [of suicide risk screening] really drives home the point that this needs to be integrated into the rest of primary care,” he said. “It’s also consistent with the idea of the medical home.” With suicide the second leading cause of death among youth, “if there’s anything that we’re going to be thinking about screening for, one would think suicide would be high on the list.”

In fact, observational evidence has shown that educating and training primary care providers to recognize people with depression or a high risk for suicide can reduce suicide attempts and the suicide rate, Dr. Campo said (JAMA Psychiatry. 2017 Jun 1;74[6]:563-70). It also can help with the mismatch between where at-risk patients are and where behavioral health specialists are. About 90% of behavioral health specialists work only in specialty settings, and only 5% typically work in general medical settings, he said. Yet “most people who are in mental distress or in crisis don’t present in specialty behavioral health settings. They present in general medical settings.”

More data are needed to demonstrate more definitively whether and how much suicide risk screening changes outcomes, but we know a few things, Dr. Campo said, summing up his key points: “We know suicide’s a major source of mortality in youth that’s been relatively neglected in pediatric health care. Second, we know that suicide risk is associated with risk for other important causes of death, for mental disorders, and for alcohol and substance use.

“We know that most suicide decedents are unrecognized prior to the time of death, and those who are recognized often are not treated. We know that the majority of suicide deaths occur on the very first attempt. We also know that we increasingly have treatments, mental disorders that can be identified, and remediable risk factors, and [that at-risk youth] typically present at general medical settings. Beyond that, focusing on the general medical setting has both conceptual and practical advantages as a site for really helping us to detect patients at risk and then managing them.”

No funding was used for the presentations. Dr. Horowitz and Dr. Campo had no relevant financial disclosures.

Screening youth to identify those at risk for suicide is particularly important in medical settings, given the increasing rates of adolescent suicide, and screening can take as little as 20 seconds, according to Lisa Horowitz, PhD, MPH, a staff scientist and clinical psychologist at the National Institute of Mental Health, Bethesda, Md.

Steve Debenport/Getty Images

But clinicians need to use validated screening instruments that are both population specific and site specific, and they need practice guidelines to treat patients screening positive.

Currently, many practitioners use depression screens – such as question #9 on suicide ideation and self harm on the Patient Health Questionnaire for Adolescents (PHQ-A) – to identify suicide risk, but preliminary data suggest these screens often are inadequate, Dr. Horowitz said. Just one question, especially one without precise language, does not appear to identify as many at-risk youths as more direct questions about suicidal thoughts and behaviors.

A Pathways to Clinical Care suicide risk screening work group therefore designed a three-tiered clinical pathway for suicide risk screenings in emergency departments, inpatient care, and outpatient primary care. It begins with the Ask Suicide-Screening Questions (ASQ), which takes about 20 seconds and was specifically developed for pediatric patients in the emergency department and validated in both inpatient and outpatient settings.

Dr Horowitz, also the lead principal investigator for development of the ASQ, currently is leading six National Institute of Mental Health studies to validate and implement the screening tool in medical settings. She explained the three-tiered system during a session on youth suicide screening at the Pediatric Academic Societies annual meeting in Baltimore this year.

If a patient screens positive on the ASQ, a trained clinician should conduct a brief suicide safety assessment (BSSA), which takes approximately 10 minutes, Dr Horowitz said. Those who screen positive on the BSSA should receive the Patient Resource List and then be referred for a full mental health and safety evaluation, which takes about 30 minutes. Resources, such as nurse scripts and parent/guardian flyers, are available at the NIMH website, as well as translations of the ASQ in Arabic, Chinese, Dutch, French, Hebrew, Italian, Japanese, Korean, Portuguese, Russian, Somali, Spanish, and Vietnamese.

Acknowledging the importance of suicide screening

During the same session, John V. Campo, MD, an assistant dean for behavioral health and professor of behavioral medicine and psychiatry at West Virginia University in Morgantown, discussed why suicide risk screening is so crucial in general medical settings. As someone who trained as a pediatrician before crossing over to behavioral health, he acknowledged that primary care physicians already have many priorities to cover in short visits, and that the national answer to most public health problems is to deal with it in primary care.

“Anyone who has done primary care pediatrics understands the challenges involved with screening for anything – particularly when you identify someone who is extensively at risk,” he said.

But suicide has a disproportionately high impact on young populations, and “identifying youth at risk for suicide identifies a group of young people who are at risk for a variety of threats to their health and well-being,” he said.

For youth aged 10-19 years in 2016, suicide was the second leading cause of death behind accidents, according to the Centers for Disease Control and Prevention (Natl Vital Stat Rep. 2018 Jun;67[4]:1-16). In fact, accidents, suicide, and homicide account for three-quarters of deaths among youth aged 10-24 years (Natl Vital Stat Rep. 2019 Jun;68[6]:1-77), yet it’s typically the other 25% that most physicians trained for in residency.

“Suicide kills more kids than cancer, heart disease, infections – all kinds, sepsis, meningitis, pneumonia, influenza, HIV, respiratory conditions. Suicide kills more young people every year than all of that [combined],” Dr. Campo said. “And yet, when you walk through a modern emergency department, we see all these specialized programs for those who present with physical trauma or chest pain or all these other things, but zero specialized mental health services. There’s a disconnect.”

There is some good news in the data, he said. Observational data have shown that suicide rates negatively correlate with indicators of better access to health and medical health services, and researchers increasingly are identifying proven strategies that help prevent suicide in young people – once they have been identified.

But that’s the problem, “and we all know it,” Dr. Campo continued. “Most youth who are at risk for suicide aren’t recognized, and those who are recognized most often are untreated or inadequately treated,” he said. Further, “the best predictor of future behavior is past behavior,” but most adolescents die by suicide on their first attempt.

Again, however, Dr. Campo pivoted to the good news. Data also have shown that most youth who die by suicide had at least one health contact in the previous year, which means there are opportunities for screening and intervention.

The most common risk factor for suicide is having a mental health or substance use condition, present in about 90% of completed suicides and affecting approximately one in five youth. Prevalence is even higher in those with physical health conditions and among those with Medicaid or no insurance (J Child Psychol Psychiatry. 2006 Mar-Apr;47[3-4]372-94).

Yet, “the majority of them have not been treated at all for mental disorder, which seems to be the most important remediable risk factor for suicide, and even fewer are in current treatment at the time of the death,” Dr. Campo said. Suicide also is correlated with a number of other high-risk behaviors or circumstances, such as “vulnerabilities to substance abuse, riding in a car with someone who is intoxicated, carrying a weapon to school, fighting, and meeting criteria for depression” (Pediatrics. 2010 May;125[5]:945-52). Screening for suicide risk therefore allows physicians to identify youth vulnerable to a wide range of risks, conditions, or death.

Overcoming barriers to suicide screening in primary care

Given the high prevalence of suicide and its link to so many other risks for youth, screening in primary care can send the message that suicide screening “really is a part of health care,” Dr. Campo said. Incorporating screening into primary care also can help overcome distrust of behavioral health specialists in the general public and stigma associated with behavioral health disorders.

Primary care screening emphasizes the importance and credibility of mental health and challenges attitudinal barriers to care, he said.

At the same time, however, he acknowledged that providers themselves often are uneasy about addressing behavioral health. Therefore, “having the guideline and the expectation [of suicide risk screening] really drives home the point that this needs to be integrated into the rest of primary care,” he said. “It’s also consistent with the idea of the medical home.” With suicide the second leading cause of death among youth, “if there’s anything that we’re going to be thinking about screening for, one would think suicide would be high on the list.”

In fact, observational evidence has shown that educating and training primary care providers to recognize people with depression or a high risk for suicide can reduce suicide attempts and the suicide rate, Dr. Campo said (JAMA Psychiatry. 2017 Jun 1;74[6]:563-70). It also can help with the mismatch between where at-risk patients are and where behavioral health specialists are. About 90% of behavioral health specialists work only in specialty settings, and only 5% typically work in general medical settings, he said. Yet “most people who are in mental distress or in crisis don’t present in specialty behavioral health settings. They present in general medical settings.”

More data are needed to demonstrate more definitively whether and how much suicide risk screening changes outcomes, but we know a few things, Dr. Campo said, summing up his key points: “We know suicide’s a major source of mortality in youth that’s been relatively neglected in pediatric health care. Second, we know that suicide risk is associated with risk for other important causes of death, for mental disorders, and for alcohol and substance use.

“We know that most suicide decedents are unrecognized prior to the time of death, and those who are recognized often are not treated. We know that the majority of suicide deaths occur on the very first attempt. We also know that we increasingly have treatments, mental disorders that can be identified, and remediable risk factors, and [that at-risk youth] typically present at general medical settings. Beyond that, focusing on the general medical setting has both conceptual and practical advantages as a site for really helping us to detect patients at risk and then managing them.”

No funding was used for the presentations. Dr. Horowitz and Dr. Campo had no relevant financial disclosures.

China’s National Medical Products Administration has approved a new therapy for patients with mild to moderate Alzheimer’s disease – a seaweed extract thought to alter the gut microbiome profile and subsequently decrease microbiome-driven neuroinflammation.

Sodium oligomannate – dubbed GV-971 – won approval based on a 36-week, placebo-controlled, phase 3 study of 818 patients with mild to moderate Alzheimer’s disease (AD). The study hit its primary endpoint of change on the Alzheimer’s Disease Assessment Scale cognitive portion (ADAS-cog12). It did not meet any of the trial’s other cognitive or functional secondary endpoints.

A portion of the data were presented last year at the Clinical Trials on Alzheimer’s Disease meeting in Barcelona. But the full study has never appeared in a peer-reviewed journal. A truncated version is publicly available on the website of Shanghai Green Valley Pharmaceuticals, the company developing the molecule.

Shanghai Green Valley contends that it reduces neuroinflammation by improving a proinflammatory microbiome profile that it says is characteristic of AD. However, the mechanism by which GV-971 alters intestinal bacterial composition is unclear – or at least it is not fully described in the public literature.

In the United States, some key researchers appraised the news with a cautiously optimistic eye, while others pointed noted that the AD-microbiome link is an unproven concept, and that it was evaluated in a study of questionable worth.

“The company has presented data that suggest there is a modest cognitive benefit to this treatment,” Paul S. Aisen, MD, said in an interview. “The key secondary endpoint was missed, and the other secondary endpoints showed no benefit. It’s a single trial and the mechanism is still unclear.”

“We do need to pursue all possible leads, and I’m glad the company is pursuing additional studies, but I wouldn’t draw a firm conclusion from these data. And they certainly would not be enough to win approval in the U.S.,” said Dr. Aisen, founding director Alzheimer’s Therapeutic Research Institute at the University of Southern California, Los Angeles.

Preclinical findings on GV-971

In commenting on preclinical findings of GV-971 published in Cell Research in September 2019, David Holtzman, MD, associate director of the Alzheimer’s disease research center at Washington University, St. Louis, and coauthors observed that the data support research exploring treatments that modulate the gut microbiome but leave it unclear as to whether GV-971 has AD-specific effects.

“[The company shows] that GV-971 decreases amyloid beta-related pathologies by reconditioning the gut microbiota, providing further evidence that gut-targeted interventions may serve as novel strategies to tackle AD,” Dr. Holtzman and coauthors wrote. “Whether this potential mechanism represents an AD-specific process is not clear, since there is great overlap in immunological changes and gut dysbiosis with other diseases. … In addition, although this study reveals that gut reconditioning may be one mechanism of action of the drug GV-971, it does not rule out other possible mechanisms. For example, GV-971 may attenuate AD pathogenesis by directly inhibiting neuroinflammation or amyloid-beta fibril formation. However, there is no question that [these] data further [support] the emerging idea that modulation of the gut microbiome via treatments such as GV-971 or other strategies should be further explored as novel strategies to slow the progression of AD.”

Sodium oligomannate is a long-chain saccharide extracted from brown sea algae and consists of acidic linear oligosaccharides with structures ranging from dimers to decamers. Related molecules without the sugar backbone were inactive, suggesting that the saccharides are the active portion, Xinyi Wang of Shanghai Green Valley and colleagues wrote in the Cell Research paper.

Based on these studies, the company contends that Alzheimer’s progression is accompanied by a characteristic microbiome change to a proinflammatory profile. And indeed, two transgenic Alzheimer’s mouse models – one with five familial AD mutations (5xFAD) and one with mutations of amyloid precursor protein and presenilin 1 (APP/PS1) – showed similar gradual age- and progression-related decreases of Bacteroides and Verrucomicrobia, two components of a normal microbiome. Bacteroides species perform key functions necessary for survival, including sensing and adapting to nutrient variability, expelling toxins, and stimulating the immune system). Species of the Verrucomicrobia phylum are important in glucose homeostasis. The decline in Bacteroides and Verrucomicrobia species is accompanied by an increase in concomitant proinflammatory species.

The investigators then explored the relationship between the microbiome composition and cognitive function in both transgenic models and a wild-type mouse.

First, they showed that the bacterial populations shifted as the mice aged and their AD pathology developed. This was accompanied by an uptick in activated microglia and, in turn, proinflammatory T1 helper cells that migrated through the intestinal membranes and into the periphery, then cross the blood-brain barrier to enter the brain.

Then the investigators used a cocktail of powerful antibiotics to disturb the intestinal flora in both transgenic and wild-type mice. After this, the 5xFAD mice showed fewer activated microglia and fewer infiltrating T cells. Later, they gave wild-type mice a fecal transplant from the 5xFAD mice. The wild-type mice developed more activated and infiltrating cells and their microbiome began to resemble that of the transgenic mice. Conversely, when the transgenic mice received a transplant from the wild-type mice, their microbiome changed to resemble the donors’, and their activated and infiltrating cells declined.

After this, the team gave GV-971 to the mice. The APP/PS1 mice improved cognitively, and the 5xFAD mice had fewer activated and infiltrating cells, fewer amyloid brain plaques, and less tau phosphorylation. These changes were accompanied by higher levels of two amino acids, phenylalanine and isoleucine. These proteins appear to act on T-cell proliferation and differentiation, they said.

“Taken together, these analyses suggest the idea that gut dysbiosis contributes to [phenylalanine and isoleucine] elevation, which drives the proliferation/differentiation and brain infiltration of [T1 helper] cells,” Dr. Holtzman and coauthors wrote. “These infiltrating Th1 cells may then further activate microglia and contribute to amyloid-related pathogenesis.”

The phase 3 study

The approval of GV-971 was based on the subsequent 36-week phase 3, placebo-controlled study of 818 patients with mild to moderate AD, which was reported last year. Patients were randomized to placebo or to GV-971 450 mg twice daily. Amyloid PET imaging was not required at entrance to the study, so there was no measure of baseline amyloid load. However, all patients showed MRI evidence of cortical atrophy. The Mini Mental State Exam (MMSE) ranged from 11 to 26, indicating mild to moderate AD.

Secondary endpoints included change on the Alzheimer’s Disease Cooperative Study Activities of Daily Living, the Clinician’s Interview-Based Impression of Change–Plus, and the Neuropsychiatric Index.

Patients taking GV-971 experienced a statistically significant 2.54-point difference on the ADAS-cog12, compared with placebo. The difference was apparent by week 4 and was seen at every clinical visit. When patients were grouped according to baseline MMSE (11-14, 15-19, and 20-26), the drug performed similarly.

Michele G Sullivan/MDedge News

But none of the secondary endpoints significantly favored of GV-971. And the placebo group behaved in an unexpected way, which could throw the data interpretation off-kilter somewhat, David Knopman, MD, said in an interview.

“It was a very weird and unusual-looking trajectory of the placebo and treated groups,” said Dr. Knopman of the Mayo Clinic, Rochester, Minn., with those taking placebo staying relatively stable for some time before the cognitive scores dropped precipitously. “The data were unconvincing to me.”

He also pointed out that although the extensive preclinical data appeared in the recent peer-reviewed Cell Research paper, the phase 3 data has not appeared in any peer-reviewed forum, “even though the trial has been completed for some time now. Furthermore, the duration of the study was inadequate.”

Finally, none of the study subjects were taking the standard-of-care cholinesterase inhibitors, which virtually every AD patient in the United States does take.

“This makes it almost completely inapplicable to the U.S.,” he said. “It’s not bad news. I’m just not convinced.”

Dr. Holtzman is a cofounder of C2N Diagnostics. He is on the scientific advisory board of Genentech, Denali, and C2N Diagnostics. He consults for Idorsia. Dr. Knopman is a consultant for the Bluefield Project to Cure Frontotemporal Dementia and for Lundbeck.

China’s National Medical Products Administration has approved a new therapy for patients with mild to moderate Alzheimer’s disease – a seaweed extract thought to alter the gut microbiome profile and subsequently decrease microbiome-driven neuroinflammation.

Sodium oligomannate – dubbed GV-971 – won approval based on a 36-week, placebo-controlled, phase 3 study of 818 patients with mild to moderate Alzheimer’s disease (AD). The study hit its primary endpoint of change on the Alzheimer’s Disease Assessment Scale cognitive portion (ADAS-cog12). It did not meet any of the trial’s other cognitive or functional secondary endpoints.

A portion of the data were presented last year at the Clinical Trials on Alzheimer’s Disease meeting in Barcelona. But the full study has never appeared in a peer-reviewed journal. A truncated version is publicly available on the website of Shanghai Green Valley Pharmaceuticals, the company developing the molecule.

Shanghai Green Valley contends that it reduces neuroinflammation by improving a proinflammatory microbiome profile that it says is characteristic of AD. However, the mechanism by which GV-971 alters intestinal bacterial composition is unclear – or at least it is not fully described in the public literature.

In the United States, some key researchers appraised the news with a cautiously optimistic eye, while others pointed noted that the AD-microbiome link is an unproven concept, and that it was evaluated in a study of questionable worth.

“The company has presented data that suggest there is a modest cognitive benefit to this treatment,” Paul S. Aisen, MD, said in an interview. “The key secondary endpoint was missed, and the other secondary endpoints showed no benefit. It’s a single trial and the mechanism is still unclear.”

“We do need to pursue all possible leads, and I’m glad the company is pursuing additional studies, but I wouldn’t draw a firm conclusion from these data. And they certainly would not be enough to win approval in the U.S.,” said Dr. Aisen, founding director Alzheimer’s Therapeutic Research Institute at the University of Southern California, Los Angeles.

Preclinical findings on GV-971

In commenting on preclinical findings of GV-971 published in Cell Research in September 2019, David Holtzman, MD, associate director of the Alzheimer’s disease research center at Washington University, St. Louis, and coauthors observed that the data support research exploring treatments that modulate the gut microbiome but leave it unclear as to whether GV-971 has AD-specific effects.

“[The company shows] that GV-971 decreases amyloid beta-related pathologies by reconditioning the gut microbiota, providing further evidence that gut-targeted interventions may serve as novel strategies to tackle AD,” Dr. Holtzman and coauthors wrote. “Whether this potential mechanism represents an AD-specific process is not clear, since there is great overlap in immunological changes and gut dysbiosis with other diseases. … In addition, although this study reveals that gut reconditioning may be one mechanism of action of the drug GV-971, it does not rule out other possible mechanisms. For example, GV-971 may attenuate AD pathogenesis by directly inhibiting neuroinflammation or amyloid-beta fibril formation. However, there is no question that [these] data further [support] the emerging idea that modulation of the gut microbiome via treatments such as GV-971 or other strategies should be further explored as novel strategies to slow the progression of AD.”

Sodium oligomannate is a long-chain saccharide extracted from brown sea algae and consists of acidic linear oligosaccharides with structures ranging from dimers to decamers. Related molecules without the sugar backbone were inactive, suggesting that the saccharides are the active portion, Xinyi Wang of Shanghai Green Valley and colleagues wrote in the Cell Research paper.

Based on these studies, the company contends that Alzheimer’s progression is accompanied by a characteristic microbiome change to a proinflammatory profile. And indeed, two transgenic Alzheimer’s mouse models – one with five familial AD mutations (5xFAD) and one with mutations of amyloid precursor protein and presenilin 1 (APP/PS1) – showed similar gradual age- and progression-related decreases of Bacteroides and Verrucomicrobia, two components of a normal microbiome. Bacteroides species perform key functions necessary for survival, including sensing and adapting to nutrient variability, expelling toxins, and stimulating the immune system). Species of the Verrucomicrobia phylum are important in glucose homeostasis. The decline in Bacteroides and Verrucomicrobia species is accompanied by an increase in concomitant proinflammatory species.

The investigators then explored the relationship between the microbiome composition and cognitive function in both transgenic models and a wild-type mouse.

First, they showed that the bacterial populations shifted as the mice aged and their AD pathology developed. This was accompanied by an uptick in activated microglia and, in turn, proinflammatory T1 helper cells that migrated through the intestinal membranes and into the periphery, then cross the blood-brain barrier to enter the brain.

Then the investigators used a cocktail of powerful antibiotics to disturb the intestinal flora in both transgenic and wild-type mice. After this, the 5xFAD mice showed fewer activated microglia and fewer infiltrating T cells. Later, they gave wild-type mice a fecal transplant from the 5xFAD mice. The wild-type mice developed more activated and infiltrating cells and their microbiome began to resemble that of the transgenic mice. Conversely, when the transgenic mice received a transplant from the wild-type mice, their microbiome changed to resemble the donors’, and their activated and infiltrating cells declined.

After this, the team gave GV-971 to the mice. The APP/PS1 mice improved cognitively, and the 5xFAD mice had fewer activated and infiltrating cells, fewer amyloid brain plaques, and less tau phosphorylation. These changes were accompanied by higher levels of two amino acids, phenylalanine and isoleucine. These proteins appear to act on T-cell proliferation and differentiation, they said.

“Taken together, these analyses suggest the idea that gut dysbiosis contributes to [phenylalanine and isoleucine] elevation, which drives the proliferation/differentiation and brain infiltration of [T1 helper] cells,” Dr. Holtzman and coauthors wrote. “These infiltrating Th1 cells may then further activate microglia and contribute to amyloid-related pathogenesis.”

The phase 3 study

The approval of GV-971 was based on the subsequent 36-week phase 3, placebo-controlled study of 818 patients with mild to moderate AD, which was reported last year. Patients were randomized to placebo or to GV-971 450 mg twice daily. Amyloid PET imaging was not required at entrance to the study, so there was no measure of baseline amyloid load. However, all patients showed MRI evidence of cortical atrophy. The Mini Mental State Exam (MMSE) ranged from 11 to 26, indicating mild to moderate AD.

Secondary endpoints included change on the Alzheimer’s Disease Cooperative Study Activities of Daily Living, the Clinician’s Interview-Based Impression of Change–Plus, and the Neuropsychiatric Index.

Patients taking GV-971 experienced a statistically significant 2.54-point difference on the ADAS-cog12, compared with placebo. The difference was apparent by week 4 and was seen at every clinical visit. When patients were grouped according to baseline MMSE (11-14, 15-19, and 20-26), the drug performed similarly.

Michele G Sullivan/MDedge News

But none of the secondary endpoints significantly favored of GV-971. And the placebo group behaved in an unexpected way, which could throw the data interpretation off-kilter somewhat, David Knopman, MD, said in an interview.

“It was a very weird and unusual-looking trajectory of the placebo and treated groups,” said Dr. Knopman of the Mayo Clinic, Rochester, Minn., with those taking placebo staying relatively stable for some time before the cognitive scores dropped precipitously. “The data were unconvincing to me.”

He also pointed out that although the extensive preclinical data appeared in the recent peer-reviewed Cell Research paper, the phase 3 data has not appeared in any peer-reviewed forum, “even though the trial has been completed for some time now. Furthermore, the duration of the study was inadequate.”

Finally, none of the study subjects were taking the standard-of-care cholinesterase inhibitors, which virtually every AD patient in the United States does take.

“This makes it almost completely inapplicable to the U.S.,” he said. “It’s not bad news. I’m just not convinced.”

Dr. Holtzman is a cofounder of C2N Diagnostics. He is on the scientific advisory board of Genentech, Denali, and C2N Diagnostics. He consults for Idorsia. Dr. Knopman is a consultant for the Bluefield Project to Cure Frontotemporal Dementia and for Lundbeck.

China’s National Medical Products Administration has approved a new therapy for patients with mild to moderate Alzheimer’s disease – a seaweed extract thought to alter the gut microbiome profile and subsequently decrease microbiome-driven neuroinflammation.

Sodium oligomannate – dubbed GV-971 – won approval based on a 36-week, placebo-controlled, phase 3 study of 818 patients with mild to moderate Alzheimer’s disease (AD). The study hit its primary endpoint of change on the Alzheimer’s Disease Assessment Scale cognitive portion (ADAS-cog12). It did not meet any of the trial’s other cognitive or functional secondary endpoints.

A portion of the data were presented last year at the Clinical Trials on Alzheimer’s Disease meeting in Barcelona. But the full study has never appeared in a peer-reviewed journal. A truncated version is publicly available on the website of Shanghai Green Valley Pharmaceuticals, the company developing the molecule.

Shanghai Green Valley contends that it reduces neuroinflammation by improving a proinflammatory microbiome profile that it says is characteristic of AD. However, the mechanism by which GV-971 alters intestinal bacterial composition is unclear – or at least it is not fully described in the public literature.

In the United States, some key researchers appraised the news with a cautiously optimistic eye, while others pointed noted that the AD-microbiome link is an unproven concept, and that it was evaluated in a study of questionable worth.

“The company has presented data that suggest there is a modest cognitive benefit to this treatment,” Paul S. Aisen, MD, said in an interview. “The key secondary endpoint was missed, and the other secondary endpoints showed no benefit. It’s a single trial and the mechanism is still unclear.”

“We do need to pursue all possible leads, and I’m glad the company is pursuing additional studies, but I wouldn’t draw a firm conclusion from these data. And they certainly would not be enough to win approval in the U.S.,” said Dr. Aisen, founding director Alzheimer’s Therapeutic Research Institute at the University of Southern California, Los Angeles.

Preclinical findings on GV-971

In commenting on preclinical findings of GV-971 published in Cell Research in September 2019, David Holtzman, MD, associate director of the Alzheimer’s disease research center at Washington University, St. Louis, and coauthors observed that the data support research exploring treatments that modulate the gut microbiome but leave it unclear as to whether GV-971 has AD-specific effects.

“[The company shows] that GV-971 decreases amyloid beta-related pathologies by reconditioning the gut microbiota, providing further evidence that gut-targeted interventions may serve as novel strategies to tackle AD,” Dr. Holtzman and coauthors wrote. “Whether this potential mechanism represents an AD-specific process is not clear, since there is great overlap in immunological changes and gut dysbiosis with other diseases. … In addition, although this study reveals that gut reconditioning may be one mechanism of action of the drug GV-971, it does not rule out other possible mechanisms. For example, GV-971 may attenuate AD pathogenesis by directly inhibiting neuroinflammation or amyloid-beta fibril formation. However, there is no question that [these] data further [support] the emerging idea that modulation of the gut microbiome via treatments such as GV-971 or other strategies should be further explored as novel strategies to slow the progression of AD.”

Sodium oligomannate is a long-chain saccharide extracted from brown sea algae and consists of acidic linear oligosaccharides with structures ranging from dimers to decamers. Related molecules without the sugar backbone were inactive, suggesting that the saccharides are the active portion, Xinyi Wang of Shanghai Green Valley and colleagues wrote in the Cell Research paper.

Based on these studies, the company contends that Alzheimer’s progression is accompanied by a characteristic microbiome change to a proinflammatory profile. And indeed, two transgenic Alzheimer’s mouse models – one with five familial AD mutations (5xFAD) and one with mutations of amyloid precursor protein and presenilin 1 (APP/PS1) – showed similar gradual age- and progression-related decreases of Bacteroides and Verrucomicrobia, two components of a normal microbiome. Bacteroides species perform key functions necessary for survival, including sensing and adapting to nutrient variability, expelling toxins, and stimulating the immune system). Species of the Verrucomicrobia phylum are important in glucose homeostasis. The decline in Bacteroides and Verrucomicrobia species is accompanied by an increase in concomitant proinflammatory species.

The investigators then explored the relationship between the microbiome composition and cognitive function in both transgenic models and a wild-type mouse.

First, they showed that the bacterial populations shifted as the mice aged and their AD pathology developed. This was accompanied by an uptick in activated microglia and, in turn, proinflammatory T1 helper cells that migrated through the intestinal membranes and into the periphery, then cross the blood-brain barrier to enter the brain.

Then the investigators used a cocktail of powerful antibiotics to disturb the intestinal flora in both transgenic and wild-type mice. After this, the 5xFAD mice showed fewer activated microglia and fewer infiltrating T cells. Later, they gave wild-type mice a fecal transplant from the 5xFAD mice. The wild-type mice developed more activated and infiltrating cells and their microbiome began to resemble that of the transgenic mice. Conversely, when the transgenic mice received a transplant from the wild-type mice, their microbiome changed to resemble the donors’, and their activated and infiltrating cells declined.

After this, the team gave GV-971 to the mice. The APP/PS1 mice improved cognitively, and the 5xFAD mice had fewer activated and infiltrating cells, fewer amyloid brain plaques, and less tau phosphorylation. These changes were accompanied by higher levels of two amino acids, phenylalanine and isoleucine. These proteins appear to act on T-cell proliferation and differentiation, they said.

“Taken together, these analyses suggest the idea that gut dysbiosis contributes to [phenylalanine and isoleucine] elevation, which drives the proliferation/differentiation and brain infiltration of [T1 helper] cells,” Dr. Holtzman and coauthors wrote. “These infiltrating Th1 cells may then further activate microglia and contribute to amyloid-related pathogenesis.”

The phase 3 study

The approval of GV-971 was based on the subsequent 36-week phase 3, placebo-controlled study of 818 patients with mild to moderate AD, which was reported last year. Patients were randomized to placebo or to GV-971 450 mg twice daily. Amyloid PET imaging was not required at entrance to the study, so there was no measure of baseline amyloid load. However, all patients showed MRI evidence of cortical atrophy. The Mini Mental State Exam (MMSE) ranged from 11 to 26, indicating mild to moderate AD.

Secondary endpoints included change on the Alzheimer’s Disease Cooperative Study Activities of Daily Living, the Clinician’s Interview-Based Impression of Change–Plus, and the Neuropsychiatric Index.

Patients taking GV-971 experienced a statistically significant 2.54-point difference on the ADAS-cog12, compared with placebo. The difference was apparent by week 4 and was seen at every clinical visit. When patients were grouped according to baseline MMSE (11-14, 15-19, and 20-26), the drug performed similarly.

Michele G Sullivan/MDedge News

But none of the secondary endpoints significantly favored of GV-971. And the placebo group behaved in an unexpected way, which could throw the data interpretation off-kilter somewhat, David Knopman, MD, said in an interview.

“It was a very weird and unusual-looking trajectory of the placebo and treated groups,” said Dr. Knopman of the Mayo Clinic, Rochester, Minn., with those taking placebo staying relatively stable for some time before the cognitive scores dropped precipitously. “The data were unconvincing to me.”

He also pointed out that although the extensive preclinical data appeared in the recent peer-reviewed Cell Research paper, the phase 3 data has not appeared in any peer-reviewed forum, “even though the trial has been completed for some time now. Furthermore, the duration of the study was inadequate.”

Finally, none of the study subjects were taking the standard-of-care cholinesterase inhibitors, which virtually every AD patient in the United States does take.

“This makes it almost completely inapplicable to the U.S.,” he said. “It’s not bad news. I’m just not convinced.”

Dr. Holtzman is a cofounder of C2N Diagnostics. He is on the scientific advisory board of Genentech, Denali, and C2N Diagnostics. He consults for Idorsia. Dr. Knopman is a consultant for the Bluefield Project to Cure Frontotemporal Dementia and for Lundbeck.

The Food and Drug Administration has approved crizanlizumab-tmca (Adakveo) to reduce the frequency of vaso-occlusive crisis, a common complication of sickle cell disease.

The drug is approved for patients aged 16 years and older. It was approved on the strength of the SUSTAIN trial, which randomized 198 patients with sickle cell disease and a history of vaso-occlusive crisis to crizanlizumab or placebo. Patients who received crizanlizumab had a median annual rate of 1.63 health care visits for vaso-occlusive crises, compared with patients who received placebo and had a median annual rate of 2.98 visits. The drug also delayed the first vaso-occlusive crisis after starting treatment from 1.4 months to 4.1 months, according to the FDA.

“Adakveo is the first targeted therapy approved for sickle cell disease, specifically inhibiting selectin, a substance that contributes to cells sticking together and leads to vaso-occlusive crisis,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement. “Vaso-occlusive crisis can be extremely painful and is a frequent reason for emergency department visits and hospitalization for patients with sickle cell disease.”

Common adverse events associated with crizanlizumab included back pain, nausea, pyrexia, and arthralgia. The FDA advised physicians to monitor patients for infusion-related reactions.

mschneider@mdedge.com

The Food and Drug Administration has approved crizanlizumab-tmca (Adakveo) to reduce the frequency of vaso-occlusive crisis, a common complication of sickle cell disease.

The drug is approved for patients aged 16 years and older. It was approved on the strength of the SUSTAIN trial, which randomized 198 patients with sickle cell disease and a history of vaso-occlusive crisis to crizanlizumab or placebo. Patients who received crizanlizumab had a median annual rate of 1.63 health care visits for vaso-occlusive crises, compared with patients who received placebo and had a median annual rate of 2.98 visits. The drug also delayed the first vaso-occlusive crisis after starting treatment from 1.4 months to 4.1 months, according to the FDA.

“Adakveo is the first targeted therapy approved for sickle cell disease, specifically inhibiting selectin, a substance that contributes to cells sticking together and leads to vaso-occlusive crisis,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement. “Vaso-occlusive crisis can be extremely painful and is a frequent reason for emergency department visits and hospitalization for patients with sickle cell disease.”

Common adverse events associated with crizanlizumab included back pain, nausea, pyrexia, and arthralgia. The FDA advised physicians to monitor patients for infusion-related reactions.

mschneider@mdedge.com

The Food and Drug Administration has approved crizanlizumab-tmca (Adakveo) to reduce the frequency of vaso-occlusive crisis, a common complication of sickle cell disease.

The drug is approved for patients aged 16 years and older. It was approved on the strength of the SUSTAIN trial, which randomized 198 patients with sickle cell disease and a history of vaso-occlusive crisis to crizanlizumab or placebo. Patients who received crizanlizumab had a median annual rate of 1.63 health care visits for vaso-occlusive crises, compared with patients who received placebo and had a median annual rate of 2.98 visits. The drug also delayed the first vaso-occlusive crisis after starting treatment from 1.4 months to 4.1 months, according to the FDA.

“Adakveo is the first targeted therapy approved for sickle cell disease, specifically inhibiting selectin, a substance that contributes to cells sticking together and leads to vaso-occlusive crisis,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement. “Vaso-occlusive crisis can be extremely painful and is a frequent reason for emergency department visits and hospitalization for patients with sickle cell disease.”

Common adverse events associated with crizanlizumab included back pain, nausea, pyrexia, and arthralgia. The FDA advised physicians to monitor patients for infusion-related reactions.

mschneider@mdedge.com

LAS VEGAS – Be alert for hidden cases of hyperhidrosis in patients, Seemal R. Desai, MD, said during a presentation on this topic at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

During an examination for another condition, he said, patients may be “sweating and dripping.” However, “you look over that diagnosis because that’s not what they’re there for,” said Dr. Desai, a dermatologist at the University of Texas Southwestern Medical Center in Dallas.

He described one of his patients, who only revealed that she suffered from “horrible, devastating” hyperhidrosis after he’d treated her for years for melasma. The sweating especially affected her because it prevented her from wearing the skin-exposing clothing of her Indian culture.

Delays in treatment are common in hyperhidrosis, which is believed to affect 5% of the world’s population. According to Dr. Desai, research suggests that 85% of patients with hyperhidrosis wait more than 3 years to bring it up with doctors, and half wait more than a decade.

There are many treatments for hyperhidrosis. Some are fairly simple: over-the-counter or prescription antiperspirants, said Dr. Desai, who likes the over-the-counter brand Certain Dri), iontophoresis (application of electric current), topical anticholinergics (including glycopyrronium tosylate cloth wipes, recently approved by the FDA for topical treatment of primary axillary hyperhidrosis for ages 9 years and older), and systemic management. Others are minimally invasive: Botox injections and the miraDry medical device (which relies on thermolysis). And surgical strategies may be an option for severe cases.

On its website, the International Hyperhidrosis Society provides a chart of options for hyperhidrosis in various parts of the body. Treatments tend to focus on the underarms, however, and “we’ve got huge unmet needs for patient options,” Dr. Desai said.
 

• During his presentation, he provided the following pearls regarding hyperhidrosis treatments:
• Distinguish between antiperspirants, which block sweating, and deodorants, which cover up body odor. “Sometimes I get caught up in the middle of a busy office visit and use these terms interchangeably. They’re really different, but patients and the public tend to equate those together,” he commented.
• Make sure patients understand how to properly use antiperspirants and explain that antiperspirants must be applied to dry skin. “Antiperspirant is forming a clog in the drain” to prevent the release of sweat, he said. “If you apply it to wet skin, you will block that chemical reaction in the duct.”
• Massage in the antiperspirant, he advises, and don’t occlude the skin. Apply twice daily, including before bedtime. “They can use antiperspirant on the hands and the bottom of the feet,”Dr. Desai said. “You want to ensure that they’re using the spray on the surface and in the web space. They can also use antiperspirants on the face, but avoid contact with the eyes.”
• Be careful if you prescribe glycopyrronium cloths off label. These wipes are helpful and they can be used outside the FDA-approved use in the underarms, said Dr. Desai, who said he has palmar hyperhidrosis and has successfully used them on his palms, but he hasn’t found them to be helpful on the soles of his feet.

Dr. Desai recommends 5-minute applications on the palms because the treatment can irritate the face and eyes.

Linda F. Stein Gold, MD, of Henry Ford Health System in Detroit, told the audience about the case of a teacher who touched his eyes after applying the treatment. He went to school, felt ill, and ended up in an emergency department because he had an enlarged pupil. “You just have to tell people this can happen,” she said.

Dr. Desai reported no relevant disclosures.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Be alert for hidden cases of hyperhidrosis in patients, Seemal R. Desai, MD, said during a presentation on this topic at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

During an examination for another condition, he said, patients may be “sweating and dripping.” However, “you look over that diagnosis because that’s not what they’re there for,” said Dr. Desai, a dermatologist at the University of Texas Southwestern Medical Center in Dallas.

He described one of his patients, who only revealed that she suffered from “horrible, devastating” hyperhidrosis after he’d treated her for years for melasma. The sweating especially affected her because it prevented her from wearing the skin-exposing clothing of her Indian culture.

Delays in treatment are common in hyperhidrosis, which is believed to affect 5% of the world’s population. According to Dr. Desai, research suggests that 85% of patients with hyperhidrosis wait more than 3 years to bring it up with doctors, and half wait more than a decade.

There are many treatments for hyperhidrosis. Some are fairly simple: over-the-counter or prescription antiperspirants, said Dr. Desai, who likes the over-the-counter brand Certain Dri), iontophoresis (application of electric current), topical anticholinergics (including glycopyrronium tosylate cloth wipes, recently approved by the FDA for topical treatment of primary axillary hyperhidrosis for ages 9 years and older), and systemic management. Others are minimally invasive: Botox injections and the miraDry medical device (which relies on thermolysis). And surgical strategies may be an option for severe cases.

On its website, the International Hyperhidrosis Society provides a chart of options for hyperhidrosis in various parts of the body. Treatments tend to focus on the underarms, however, and “we’ve got huge unmet needs for patient options,” Dr. Desai said.
 

• During his presentation, he provided the following pearls regarding hyperhidrosis treatments:
• Distinguish between antiperspirants, which block sweating, and deodorants, which cover up body odor. “Sometimes I get caught up in the middle of a busy office visit and use these terms interchangeably. They’re really different, but patients and the public tend to equate those together,” he commented.
• Make sure patients understand how to properly use antiperspirants and explain that antiperspirants must be applied to dry skin. “Antiperspirant is forming a clog in the drain” to prevent the release of sweat, he said. “If you apply it to wet skin, you will block that chemical reaction in the duct.”
• Massage in the antiperspirant, he advises, and don’t occlude the skin. Apply twice daily, including before bedtime. “They can use antiperspirant on the hands and the bottom of the feet,”Dr. Desai said. “You want to ensure that they’re using the spray on the surface and in the web space. They can also use antiperspirants on the face, but avoid contact with the eyes.”
• Be careful if you prescribe glycopyrronium cloths off label. These wipes are helpful and they can be used outside the FDA-approved use in the underarms, said Dr. Desai, who said he has palmar hyperhidrosis and has successfully used them on his palms, but he hasn’t found them to be helpful on the soles of his feet.

Dr. Desai recommends 5-minute applications on the palms because the treatment can irritate the face and eyes.

Linda F. Stein Gold, MD, of Henry Ford Health System in Detroit, told the audience about the case of a teacher who touched his eyes after applying the treatment. He went to school, felt ill, and ended up in an emergency department because he had an enlarged pupil. “You just have to tell people this can happen,” she said.

Dr. Desai reported no relevant disclosures.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Be alert for hidden cases of hyperhidrosis in patients, Seemal R. Desai, MD, said during a presentation on this topic at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

During an examination for another condition, he said, patients may be “sweating and dripping.” However, “you look over that diagnosis because that’s not what they’re there for,” said Dr. Desai, a dermatologist at the University of Texas Southwestern Medical Center in Dallas.

He described one of his patients, who only revealed that she suffered from “horrible, devastating” hyperhidrosis after he’d treated her for years for melasma. The sweating especially affected her because it prevented her from wearing the skin-exposing clothing of her Indian culture.

Delays in treatment are common in hyperhidrosis, which is believed to affect 5% of the world’s population. According to Dr. Desai, research suggests that 85% of patients with hyperhidrosis wait more than 3 years to bring it up with doctors, and half wait more than a decade.

There are many treatments for hyperhidrosis. Some are fairly simple: over-the-counter or prescription antiperspirants, said Dr. Desai, who likes the over-the-counter brand Certain Dri), iontophoresis (application of electric current), topical anticholinergics (including glycopyrronium tosylate cloth wipes, recently approved by the FDA for topical treatment of primary axillary hyperhidrosis for ages 9 years and older), and systemic management. Others are minimally invasive: Botox injections and the miraDry medical device (which relies on thermolysis). And surgical strategies may be an option for severe cases.

On its website, the International Hyperhidrosis Society provides a chart of options for hyperhidrosis in various parts of the body. Treatments tend to focus on the underarms, however, and “we’ve got huge unmet needs for patient options,” Dr. Desai said.
 

• During his presentation, he provided the following pearls regarding hyperhidrosis treatments:
• Distinguish between antiperspirants, which block sweating, and deodorants, which cover up body odor. “Sometimes I get caught up in the middle of a busy office visit and use these terms interchangeably. They’re really different, but patients and the public tend to equate those together,” he commented.
• Make sure patients understand how to properly use antiperspirants and explain that antiperspirants must be applied to dry skin. “Antiperspirant is forming a clog in the drain” to prevent the release of sweat, he said. “If you apply it to wet skin, you will block that chemical reaction in the duct.”
• Massage in the antiperspirant, he advises, and don’t occlude the skin. Apply twice daily, including before bedtime. “They can use antiperspirant on the hands and the bottom of the feet,”Dr. Desai said. “You want to ensure that they’re using the spray on the surface and in the web space. They can also use antiperspirants on the face, but avoid contact with the eyes.”
• Be careful if you prescribe glycopyrronium cloths off label. These wipes are helpful and they can be used outside the FDA-approved use in the underarms, said Dr. Desai, who said he has palmar hyperhidrosis and has successfully used them on his palms, but he hasn’t found them to be helpful on the soles of his feet.

Dr. Desai recommends 5-minute applications on the palms because the treatment can irritate the face and eyes.

Linda F. Stein Gold, MD, of Henry Ford Health System in Detroit, told the audience about the case of a teacher who touched his eyes after applying the treatment. He went to school, felt ill, and ended up in an emergency department because he had an enlarged pupil. “You just have to tell people this can happen,” she said.

Dr. Desai reported no relevant disclosures.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – It is important to think outside the box and consider whether secondary causes of hyperhidrosis are at play when a patient complains of sweating too much, a dermatologist told his colleagues.

“Look at where the patient fits into the sweating paradigm,” advised Seemal R. Desai, MD, of University of Texas Southwestern Medical Center in Dallas, and consider factors such as where and how often patients are oversweating.

In cases of secondary hyperhidrosis – those that are caused by another condition – “the key is to really find the underlying cause of the problem and not just try to treat the sweating,” said Dr. Desai, who spoke in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

According to Dr. Desai, the answers to several questions can help pinpoint a diagnosis of primary hyperhidrosis (also known as focal or primary focal hyperhidrosis) or secondary hyperhidrosis:

• Where does the sweating occur?

Sweating occurs over large parts of the body in patients with secondary hyperhidrosis, Dr. Desai said, although it is typically limited to certain areas, such as the armpits, palms, or soles in the primary form.

• When did the sweating begin?

When sweating begins in adulthood, he said, there’s a good chance that it has a secondary cause. Sweating that began in childhood is more likely to be the primary form.

• How does sweating occur at night?

Dr. Desai advised: “Ask about sleep patterns. Do you sweat during your sleep or wake up feeling like you’re sweating?” Sweating throughout a sleep cycle – not “night sweats” that are brief in nature – indicate a probable secondary cause, he said.

According to Dr. Desai, the causes of secondary hyperhidrosis are numerous, including hypoglycemia, neural tumors, and cardiovascular conditions. “Typically, if I’m trying to figure out why a patient is having generalized sweating, the No. 1 cause is medications.”

Dr. Desai reported no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – It is important to think outside the box and consider whether secondary causes of hyperhidrosis are at play when a patient complains of sweating too much, a dermatologist told his colleagues.

“Look at where the patient fits into the sweating paradigm,” advised Seemal R. Desai, MD, of University of Texas Southwestern Medical Center in Dallas, and consider factors such as where and how often patients are oversweating.

In cases of secondary hyperhidrosis – those that are caused by another condition – “the key is to really find the underlying cause of the problem and not just try to treat the sweating,” said Dr. Desai, who spoke in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

According to Dr. Desai, the answers to several questions can help pinpoint a diagnosis of primary hyperhidrosis (also known as focal or primary focal hyperhidrosis) or secondary hyperhidrosis:

• Where does the sweating occur?

Sweating occurs over large parts of the body in patients with secondary hyperhidrosis, Dr. Desai said, although it is typically limited to certain areas, such as the armpits, palms, or soles in the primary form.

• When did the sweating begin?

When sweating begins in adulthood, he said, there’s a good chance that it has a secondary cause. Sweating that began in childhood is more likely to be the primary form.

• How does sweating occur at night?

Dr. Desai advised: “Ask about sleep patterns. Do you sweat during your sleep or wake up feeling like you’re sweating?” Sweating throughout a sleep cycle – not “night sweats” that are brief in nature – indicate a probable secondary cause, he said.

According to Dr. Desai, the causes of secondary hyperhidrosis are numerous, including hypoglycemia, neural tumors, and cardiovascular conditions. “Typically, if I’m trying to figure out why a patient is having generalized sweating, the No. 1 cause is medications.”

Dr. Desai reported no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – It is important to think outside the box and consider whether secondary causes of hyperhidrosis are at play when a patient complains of sweating too much, a dermatologist told his colleagues.

“Look at where the patient fits into the sweating paradigm,” advised Seemal R. Desai, MD, of University of Texas Southwestern Medical Center in Dallas, and consider factors such as where and how often patients are oversweating.

In cases of secondary hyperhidrosis – those that are caused by another condition – “the key is to really find the underlying cause of the problem and not just try to treat the sweating,” said Dr. Desai, who spoke in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

According to Dr. Desai, the answers to several questions can help pinpoint a diagnosis of primary hyperhidrosis (also known as focal or primary focal hyperhidrosis) or secondary hyperhidrosis:

• Where does the sweating occur?

Sweating occurs over large parts of the body in patients with secondary hyperhidrosis, Dr. Desai said, although it is typically limited to certain areas, such as the armpits, palms, or soles in the primary form.

• When did the sweating begin?

When sweating begins in adulthood, he said, there’s a good chance that it has a secondary cause. Sweating that began in childhood is more likely to be the primary form.

• How does sweating occur at night?

Dr. Desai advised: “Ask about sleep patterns. Do you sweat during your sleep or wake up feeling like you’re sweating?” Sweating throughout a sleep cycle – not “night sweats” that are brief in nature – indicate a probable secondary cause, he said.

According to Dr. Desai, the causes of secondary hyperhidrosis are numerous, including hypoglycemia, neural tumors, and cardiovascular conditions. “Typically, if I’m trying to figure out why a patient is having generalized sweating, the No. 1 cause is medications.”

Dr. Desai reported no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Merkel cell carcinoma, an extremely rare form of skin cancer, is often caused by a subclinical virus that routinely inhabits the skin. Now, a serum test of virus antibody levels is offering insight into the state of the disease, according to one dermatologist.

“If you have these antibodies, you have a better prognosis. You can follow those antibodies to test for recurrence or progression,” Isaac Brownell, MD, PhD, of the Dermatology Branch of the National Institutes of Health said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

The cancer appears in the skin’s Merkel cells, which contribute to our sense of touch by helping us to discriminate textures. “When you put your hand in your pocket, and you can tell the difference between the front and back of a quarter,” he said, “you’re using the Merkel cells in your fingertips.”

Only about 2,500 cases of Merkel cell carcinoma appear in the United States each year, Dr. Brownell said. It appears more often in elderly white patients, is more common in men than women, and is more likely among immunosuppressed patients, whose risk is increased 15- to 20-fold. Cases are more common in sunnier regions – at least in men – and lesions frequently appear on the head, face, and neck.

Five-year survival is estimated at 51% if the cancer is localized, according to a 2016 study of 9,387 cases that Dr. Brownell highlighted. But survival declines dramatically if it has spread to lymph nodes or distant sites (Ann Surg Oncol. 2016 Oct;23[11]:3564-71).

In recent years, researchers have linked 80% of Merkel cell carcinoma cases to the Merkel cell polyomavirus, he said. The virus normally inhabits our skin with no ill effects, he said. “We all have this virus on our skin. It’s everywhere, and even children have antibodies,” he said. But mutations can lead to Merkel cell carcinoma.

Does it matter if cases are polyomavirus positive or polyomavirus negative? Not really, Dr. Brownell said, since the presence of the virus doesn’t appear to affect overall prognosis. However, he said, serum antibody testing can be helpful in polyomavirus-positive patients because it offers insight into prognosis and tumor burden. For example, “if the baseline titer falls and then starts to go up, they’re likely to have a recurrence, and you’ll want to look out for that,” he said.

Dr. Brownell offered another bit of advice: Be prepared to respond to patients who worry that they have a contagious virus and could be a danger to others. The proper answer, he said, is this: “You don’t have to worry about infecting people. Your tumor is not making the virus, you’re not infectious, and we have the virus on us already.”

For more information about the antibody test, visit merkelcell.org/sero.

Dr. Brownell reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Merkel cell carcinoma, an extremely rare form of skin cancer, is often caused by a subclinical virus that routinely inhabits the skin. Now, a serum test of virus antibody levels is offering insight into the state of the disease, according to one dermatologist.

“If you have these antibodies, you have a better prognosis. You can follow those antibodies to test for recurrence or progression,” Isaac Brownell, MD, PhD, of the Dermatology Branch of the National Institutes of Health said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

The cancer appears in the skin’s Merkel cells, which contribute to our sense of touch by helping us to discriminate textures. “When you put your hand in your pocket, and you can tell the difference between the front and back of a quarter,” he said, “you’re using the Merkel cells in your fingertips.”

Only about 2,500 cases of Merkel cell carcinoma appear in the United States each year, Dr. Brownell said. It appears more often in elderly white patients, is more common in men than women, and is more likely among immunosuppressed patients, whose risk is increased 15- to 20-fold. Cases are more common in sunnier regions – at least in men – and lesions frequently appear on the head, face, and neck.

Five-year survival is estimated at 51% if the cancer is localized, according to a 2016 study of 9,387 cases that Dr. Brownell highlighted. But survival declines dramatically if it has spread to lymph nodes or distant sites (Ann Surg Oncol. 2016 Oct;23[11]:3564-71).

In recent years, researchers have linked 80% of Merkel cell carcinoma cases to the Merkel cell polyomavirus, he said. The virus normally inhabits our skin with no ill effects, he said. “We all have this virus on our skin. It’s everywhere, and even children have antibodies,” he said. But mutations can lead to Merkel cell carcinoma.

Does it matter if cases are polyomavirus positive or polyomavirus negative? Not really, Dr. Brownell said, since the presence of the virus doesn’t appear to affect overall prognosis. However, he said, serum antibody testing can be helpful in polyomavirus-positive patients because it offers insight into prognosis and tumor burden. For example, “if the baseline titer falls and then starts to go up, they’re likely to have a recurrence, and you’ll want to look out for that,” he said.

Dr. Brownell offered another bit of advice: Be prepared to respond to patients who worry that they have a contagious virus and could be a danger to others. The proper answer, he said, is this: “You don’t have to worry about infecting people. Your tumor is not making the virus, you’re not infectious, and we have the virus on us already.”

For more information about the antibody test, visit merkelcell.org/sero.

Dr. Brownell reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Merkel cell carcinoma, an extremely rare form of skin cancer, is often caused by a subclinical virus that routinely inhabits the skin. Now, a serum test of virus antibody levels is offering insight into the state of the disease, according to one dermatologist.

“If you have these antibodies, you have a better prognosis. You can follow those antibodies to test for recurrence or progression,” Isaac Brownell, MD, PhD, of the Dermatology Branch of the National Institutes of Health said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

The cancer appears in the skin’s Merkel cells, which contribute to our sense of touch by helping us to discriminate textures. “When you put your hand in your pocket, and you can tell the difference between the front and back of a quarter,” he said, “you’re using the Merkel cells in your fingertips.”

Only about 2,500 cases of Merkel cell carcinoma appear in the United States each year, Dr. Brownell said. It appears more often in elderly white patients, is more common in men than women, and is more likely among immunosuppressed patients, whose risk is increased 15- to 20-fold. Cases are more common in sunnier regions – at least in men – and lesions frequently appear on the head, face, and neck.

Five-year survival is estimated at 51% if the cancer is localized, according to a 2016 study of 9,387 cases that Dr. Brownell highlighted. But survival declines dramatically if it has spread to lymph nodes or distant sites (Ann Surg Oncol. 2016 Oct;23[11]:3564-71).

In recent years, researchers have linked 80% of Merkel cell carcinoma cases to the Merkel cell polyomavirus, he said. The virus normally inhabits our skin with no ill effects, he said. “We all have this virus on our skin. It’s everywhere, and even children have antibodies,” he said. But mutations can lead to Merkel cell carcinoma.

Does it matter if cases are polyomavirus positive or polyomavirus negative? Not really, Dr. Brownell said, since the presence of the virus doesn’t appear to affect overall prognosis. However, he said, serum antibody testing can be helpful in polyomavirus-positive patients because it offers insight into prognosis and tumor burden. For example, “if the baseline titer falls and then starts to go up, they’re likely to have a recurrence, and you’ll want to look out for that,” he said.

Dr. Brownell offered another bit of advice: Be prepared to respond to patients who worry that they have a contagious virus and could be a danger to others. The proper answer, he said, is this: “You don’t have to worry about infecting people. Your tumor is not making the virus, you’re not infectious, and we have the virus on us already.”

For more information about the antibody test, visit merkelcell.org/sero.

Dr. Brownell reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

mlesney@mdedge.com

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

mlesney@mdedge.com

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

mlesney@mdedge.com

As wildfires increase the likelihood of respiratory illnesses for residents in California and Queensland, Australia, a new report from the Lancet warns that such health risks will become increasingly common without action to address climate change. But, the authors stressed, it’s still possible to prevent some health effects and mitigate others.

Given the magnitude of the issue, lead author Nick Watts, MBBS, MA, framed the issue in terms of what an individual child born today will face in his or her future. If the world continues on its current trajectory, such a child will eventually live in a world at least 4º C above average preindustrial temperatures.

“We roughly know what that looks like from a climate perspective,” said Dr. Watts, executive director of The Lancet Countdown: Tracking Progress on Health and Climate Change, during a telebriefing on the report.

“We have no idea of what that looks like from a public health perspective, but we know it is catastrophic,” he continued. “We know that it has the potential to undermine the last 50 years of gains in public health and overwhelm the health systems that we rely on.”

Health sector a significant, growing contributor

The report described the changes to which climate change has already contributed and addresses both the health threats and the way institutions and states are currently responding to those threats. It also included policy briefs specific to individual countries and an extensive appendix with projections data.

The authors noted that progress in mitigating fossil fuel combustion – the biggest driver of rising temperatures – is “intermittent at best,” with carbon dioxide emissions continuing to rise in 2018. The past decade has included 8 of the 10 hottest years on record. “Many of the indicators contained in this report suggest the world is following this ‘business as usual’ pathway,” the authors wrote.

In fact, the trend of coal-produced energy that had been declining actually increased 1.7% between 2016 and 2018. Perhaps ironically, given the focus of the report, “the health­care sector is responsible for about 4.6% of global emissions, a value which is steadily rising across most major economies,” Dr. Watts and colleagues reported.

The potential health risks from climate change range from increased chronic illness, such as asthma and cardiovascular disease, to the increased spread of infectious diseases, especially vector-borne diseases, including dengue fever, malaria, and chikungunya. Increases in the frequency and intensity of severe weather events can lead to increased acute and longer-term morbidity and mortality.

Though children will suffer the brunt of negative health impact from climate change, the effects will touch people at every stage of life, from in utero development through old age, the authors emphasized.

“Downward trends in global yield potential for all major crops tracked since 1960 threaten food production and food security, with infants often the worst affected by the potentially permanent effects of undernutrition,” the authors reported. Children are also most susceptible to diarrheal disease and infectious diseases, particularly dengue.

Mitigating actions available

But the report focused as much on solutions and mitigation strategies as it did on the worst-case scenario without action. Speakers during the telebriefing emphasized the responsibility of all people, including physicians and other health care providers, to play a role in countering the public health disaster that could result from inaction on climate.

“Thankfully, here we have the treatment for climate change, solutions to shift away from the carbon pollution and towards clean energy and working to find the best way to protect ourselves and each other from climate change,” Renee N. Salas, MD, MPH, lead author of the 2019 Lancet Countdown U.S. Policy Brief and a Harvard C-CHANGE Fellow, said during the press briefing. “All we need is political will.”

Salas compared the present moment to that period when a physician still has the ability to save a critically ill patient’s life with fast action.

“If I don’t act quickly, the patient may still die even though that treatment would have saved their life earlier,” she said. “We are in that narrow window.”

Physicians have a responsibility to speak to patients and families frankly about not only specific conditions, such as asthma, but also the climate-related causes of those conditions, such as increasing air pollution, said Gina McCarthy, director of the Harvard Center for Climate, Health and the Global Environment and the 13th administrator U.S. Environmental Policy Administration. Physicians are trusted advisers and therefore need to speak up because climate change is “about the health and well-being and the future of children,” she said.

Political polarization is one of the biggest challenges to addressing climate change and stymies efforts to take action, according to Richard Carmona, MD, who served as the 17th U.S. Surgeon General.

“The thing that frustrated me as a surgeon general and continues to frustrate me today is that these very scientifically vetted issues are reduced to political currency that creates divisiveness, and things don’t get done,” he said during the briefing.

“We have to move beyond that and elevate this discussion to one of the survival of our civilization and the health and safety and security of all nations in the world,” continued Dr. Carmona, who is also a professor of public health at the University of Arizona in Tucson.

The report notes that the warming is already “occurring faster than governments are able, or willing, to respond,” likely contributing to the increased outcry across the world from youth about the need to act.

And anyone can take some kind of action, Ms. McCarthy said. Her aim is to make the reality of climate change effects personal so that people understand its impact on them as well as what they can do.

“The report provides a list of actions that policy makers can take today to reduce the threat of climate change” as well as information on “how we can adapt and be more resilient as communities” while facing climate change’s challenges, she said.

Ms. McCarthy encouraged people to pay particular attention to the report’s mitigation and adaptation recommendations, “because I want them to know that climate change isn’t a lost cause,” she said. The actions people can demand of policymakers will not only avoid the worst-case health scenario but can also improve health today, she added.

“We can do better than to dwell on the problem,” Ms. McCarthy said. “We need people now to be hopeful about climate change, to do as others have suggested and demand action and take action in their own lives. We can use that to really drive solutions.”

Annual report assesses numerous indicators

The Lancet Countdown is an annual report supported by the Wellcome Trust that pulls together research from 35 academic institutions and United Nations agencies across the world to provide an update on what the authors described as “41 health indicators across five key domains: climate change impacts, exposures and vulnerability; adaptation, planning, and resilience for health; mitigation action and health cobenefits; economics and finance; [and] public and political engagement.”

Given the complexity of the issue of climate change and the wide range of possible effects and preventive measures, contributing researchers included not just climate scientists but also ecologists, mathematicians, engineers, hydrologists, social and political scientists, physicians and other public health professionals, and experts in energy, food, and transportation.

The research was supported by the Wellcome Trust. Multiple authors also received support from a range of government institutions and public and private foundations and fellowships. No relevant financial relationships were noted.
 

SOURCE: Watts N et al. Lancet. 2019 Nov 13. doi: 10.1016/S0140-6736(19)32596-6.

This story first appeared in Medscape.com.

As wildfires increase the likelihood of respiratory illnesses for residents in California and Queensland, Australia, a new report from the Lancet warns that such health risks will become increasingly common without action to address climate change. But, the authors stressed, it’s still possible to prevent some health effects and mitigate others.

Given the magnitude of the issue, lead author Nick Watts, MBBS, MA, framed the issue in terms of what an individual child born today will face in his or her future. If the world continues on its current trajectory, such a child will eventually live in a world at least 4º C above average preindustrial temperatures.

“We roughly know what that looks like from a climate perspective,” said Dr. Watts, executive director of The Lancet Countdown: Tracking Progress on Health and Climate Change, during a telebriefing on the report.

“We have no idea of what that looks like from a public health perspective, but we know it is catastrophic,” he continued. “We know that it has the potential to undermine the last 50 years of gains in public health and overwhelm the health systems that we rely on.”

Health sector a significant, growing contributor

The report described the changes to which climate change has already contributed and addresses both the health threats and the way institutions and states are currently responding to those threats. It also included policy briefs specific to individual countries and an extensive appendix with projections data.

The authors noted that progress in mitigating fossil fuel combustion – the biggest driver of rising temperatures – is “intermittent at best,” with carbon dioxide emissions continuing to rise in 2018. The past decade has included 8 of the 10 hottest years on record. “Many of the indicators contained in this report suggest the world is following this ‘business as usual’ pathway,” the authors wrote.

In fact, the trend of coal-produced energy that had been declining actually increased 1.7% between 2016 and 2018. Perhaps ironically, given the focus of the report, “the health­care sector is responsible for about 4.6% of global emissions, a value which is steadily rising across most major economies,” Dr. Watts and colleagues reported.

The potential health risks from climate change range from increased chronic illness, such as asthma and cardiovascular disease, to the increased spread of infectious diseases, especially vector-borne diseases, including dengue fever, malaria, and chikungunya. Increases in the frequency and intensity of severe weather events can lead to increased acute and longer-term morbidity and mortality.

Though children will suffer the brunt of negative health impact from climate change, the effects will touch people at every stage of life, from in utero development through old age, the authors emphasized.

“Downward trends in global yield potential for all major crops tracked since 1960 threaten food production and food security, with infants often the worst affected by the potentially permanent effects of undernutrition,” the authors reported. Children are also most susceptible to diarrheal disease and infectious diseases, particularly dengue.

Mitigating actions available

But the report focused as much on solutions and mitigation strategies as it did on the worst-case scenario without action. Speakers during the telebriefing emphasized the responsibility of all people, including physicians and other health care providers, to play a role in countering the public health disaster that could result from inaction on climate.

“Thankfully, here we have the treatment for climate change, solutions to shift away from the carbon pollution and towards clean energy and working to find the best way to protect ourselves and each other from climate change,” Renee N. Salas, MD, MPH, lead author of the 2019 Lancet Countdown U.S. Policy Brief and a Harvard C-CHANGE Fellow, said during the press briefing. “All we need is political will.”

Salas compared the present moment to that period when a physician still has the ability to save a critically ill patient’s life with fast action.

“If I don’t act quickly, the patient may still die even though that treatment would have saved their life earlier,” she said. “We are in that narrow window.”

Physicians have a responsibility to speak to patients and families frankly about not only specific conditions, such as asthma, but also the climate-related causes of those conditions, such as increasing air pollution, said Gina McCarthy, director of the Harvard Center for Climate, Health and the Global Environment and the 13th administrator U.S. Environmental Policy Administration. Physicians are trusted advisers and therefore need to speak up because climate change is “about the health and well-being and the future of children,” she said.

Political polarization is one of the biggest challenges to addressing climate change and stymies efforts to take action, according to Richard Carmona, MD, who served as the 17th U.S. Surgeon General.

“The thing that frustrated me as a surgeon general and continues to frustrate me today is that these very scientifically vetted issues are reduced to political currency that creates divisiveness, and things don’t get done,” he said during the briefing.

“We have to move beyond that and elevate this discussion to one of the survival of our civilization and the health and safety and security of all nations in the world,” continued Dr. Carmona, who is also a professor of public health at the University of Arizona in Tucson.

The report notes that the warming is already “occurring faster than governments are able, or willing, to respond,” likely contributing to the increased outcry across the world from youth about the need to act.

And anyone can take some kind of action, Ms. McCarthy said. Her aim is to make the reality of climate change effects personal so that people understand its impact on them as well as what they can do.

“The report provides a list of actions that policy makers can take today to reduce the threat of climate change” as well as information on “how we can adapt and be more resilient as communities” while facing climate change’s challenges, she said.

Ms. McCarthy encouraged people to pay particular attention to the report’s mitigation and adaptation recommendations, “because I want them to know that climate change isn’t a lost cause,” she said. The actions people can demand of policymakers will not only avoid the worst-case health scenario but can also improve health today, she added.

“We can do better than to dwell on the problem,” Ms. McCarthy said. “We need people now to be hopeful about climate change, to do as others have suggested and demand action and take action in their own lives. We can use that to really drive solutions.”

Annual report assesses numerous indicators

The Lancet Countdown is an annual report supported by the Wellcome Trust that pulls together research from 35 academic institutions and United Nations agencies across the world to provide an update on what the authors described as “41 health indicators across five key domains: climate change impacts, exposures and vulnerability; adaptation, planning, and resilience for health; mitigation action and health cobenefits; economics and finance; [and] public and political engagement.”

Given the complexity of the issue of climate change and the wide range of possible effects and preventive measures, contributing researchers included not just climate scientists but also ecologists, mathematicians, engineers, hydrologists, social and political scientists, physicians and other public health professionals, and experts in energy, food, and transportation.

The research was supported by the Wellcome Trust. Multiple authors also received support from a range of government institutions and public and private foundations and fellowships. No relevant financial relationships were noted.
 

SOURCE: Watts N et al. Lancet. 2019 Nov 13. doi: 10.1016/S0140-6736(19)32596-6.

This story first appeared in Medscape.com.

As wildfires increase the likelihood of respiratory illnesses for residents in California and Queensland, Australia, a new report from the Lancet warns that such health risks will become increasingly common without action to address climate change. But, the authors stressed, it’s still possible to prevent some health effects and mitigate others.

Given the magnitude of the issue, lead author Nick Watts, MBBS, MA, framed the issue in terms of what an individual child born today will face in his or her future. If the world continues on its current trajectory, such a child will eventually live in a world at least 4º C above average preindustrial temperatures.

“We roughly know what that looks like from a climate perspective,” said Dr. Watts, executive director of The Lancet Countdown: Tracking Progress on Health and Climate Change, during a telebriefing on the report.

“We have no idea of what that looks like from a public health perspective, but we know it is catastrophic,” he continued. “We know that it has the potential to undermine the last 50 years of gains in public health and overwhelm the health systems that we rely on.”

Health sector a significant, growing contributor

The report described the changes to which climate change has already contributed and addresses both the health threats and the way institutions and states are currently responding to those threats. It also included policy briefs specific to individual countries and an extensive appendix with projections data.

The authors noted that progress in mitigating fossil fuel combustion – the biggest driver of rising temperatures – is “intermittent at best,” with carbon dioxide emissions continuing to rise in 2018. The past decade has included 8 of the 10 hottest years on record. “Many of the indicators contained in this report suggest the world is following this ‘business as usual’ pathway,” the authors wrote.

In fact, the trend of coal-produced energy that had been declining actually increased 1.7% between 2016 and 2018. Perhaps ironically, given the focus of the report, “the health­care sector is responsible for about 4.6% of global emissions, a value which is steadily rising across most major economies,” Dr. Watts and colleagues reported.

The potential health risks from climate change range from increased chronic illness, such as asthma and cardiovascular disease, to the increased spread of infectious diseases, especially vector-borne diseases, including dengue fever, malaria, and chikungunya. Increases in the frequency and intensity of severe weather events can lead to increased acute and longer-term morbidity and mortality.

Though children will suffer the brunt of negative health impact from climate change, the effects will touch people at every stage of life, from in utero development through old age, the authors emphasized.

“Downward trends in global yield potential for all major crops tracked since 1960 threaten food production and food security, with infants often the worst affected by the potentially permanent effects of undernutrition,” the authors reported. Children are also most susceptible to diarrheal disease and infectious diseases, particularly dengue.

Mitigating actions available

But the report focused as much on solutions and mitigation strategies as it did on the worst-case scenario without action. Speakers during the telebriefing emphasized the responsibility of all people, including physicians and other health care providers, to play a role in countering the public health disaster that could result from inaction on climate.

“Thankfully, here we have the treatment for climate change, solutions to shift away from the carbon pollution and towards clean energy and working to find the best way to protect ourselves and each other from climate change,” Renee N. Salas, MD, MPH, lead author of the 2019 Lancet Countdown U.S. Policy Brief and a Harvard C-CHANGE Fellow, said during the press briefing. “All we need is political will.”

Salas compared the present moment to that period when a physician still has the ability to save a critically ill patient’s life with fast action.

“If I don’t act quickly, the patient may still die even though that treatment would have saved their life earlier,” she said. “We are in that narrow window.”

Physicians have a responsibility to speak to patients and families frankly about not only specific conditions, such as asthma, but also the climate-related causes of those conditions, such as increasing air pollution, said Gina McCarthy, director of the Harvard Center for Climate, Health and the Global Environment and the 13th administrator U.S. Environmental Policy Administration. Physicians are trusted advisers and therefore need to speak up because climate change is “about the health and well-being and the future of children,” she said.

Political polarization is one of the biggest challenges to addressing climate change and stymies efforts to take action, according to Richard Carmona, MD, who served as the 17th U.S. Surgeon General.

“The thing that frustrated me as a surgeon general and continues to frustrate me today is that these very scientifically vetted issues are reduced to political currency that creates divisiveness, and things don’t get done,” he said during the briefing.

“We have to move beyond that and elevate this discussion to one of the survival of our civilization and the health and safety and security of all nations in the world,” continued Dr. Carmona, who is also a professor of public health at the University of Arizona in Tucson.

The report notes that the warming is already “occurring faster than governments are able, or willing, to respond,” likely contributing to the increased outcry across the world from youth about the need to act.

And anyone can take some kind of action, Ms. McCarthy said. Her aim is to make the reality of climate change effects personal so that people understand its impact on them as well as what they can do.

“The report provides a list of actions that policy makers can take today to reduce the threat of climate change” as well as information on “how we can adapt and be more resilient as communities” while facing climate change’s challenges, she said.

Ms. McCarthy encouraged people to pay particular attention to the report’s mitigation and adaptation recommendations, “because I want them to know that climate change isn’t a lost cause,” she said. The actions people can demand of policymakers will not only avoid the worst-case health scenario but can also improve health today, she added.

“We can do better than to dwell on the problem,” Ms. McCarthy said. “We need people now to be hopeful about climate change, to do as others have suggested and demand action and take action in their own lives. We can use that to really drive solutions.”

Annual report assesses numerous indicators

The Lancet Countdown is an annual report supported by the Wellcome Trust that pulls together research from 35 academic institutions and United Nations agencies across the world to provide an update on what the authors described as “41 health indicators across five key domains: climate change impacts, exposures and vulnerability; adaptation, planning, and resilience for health; mitigation action and health cobenefits; economics and finance; [and] public and political engagement.”

Given the complexity of the issue of climate change and the wide range of possible effects and preventive measures, contributing researchers included not just climate scientists but also ecologists, mathematicians, engineers, hydrologists, social and political scientists, physicians and other public health professionals, and experts in energy, food, and transportation.

The research was supported by the Wellcome Trust. Multiple authors also received support from a range of government institutions and public and private foundations and fellowships. No relevant financial relationships were noted.
 

SOURCE: Watts N et al. Lancet. 2019 Nov 13. doi: 10.1016/S0140-6736(19)32596-6.

This story first appeared in Medscape.com.

Adults worried about dementia are far more likely to do crossword puzzles and take fish oil than they are to talk to their doctor about risk, Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.

More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.

Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.

The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.

A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.

People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.

“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”

Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).

Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.

“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.

Dr. Maust had no financial disclosures.

msullivan@mdedge.com

SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946

Adults worried about dementia are far more likely to do crossword puzzles and take fish oil than they are to talk to their doctor about risk, Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.

More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.

Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.

The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.

A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.

People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.

“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”

Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).

Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.

“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.

Dr. Maust had no financial disclosures.

msullivan@mdedge.com

SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946

Adults worried about dementia are far more likely to do crossword puzzles and take fish oil than they are to talk to their doctor about risk, Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.

More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.

Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.

The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.

A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.

People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.

“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”

Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).

Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.

“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.

Dr. Maust had no financial disclosures.

msullivan@mdedge.com

SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946

COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.

He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.

This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.

If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.

The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.

“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.

In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.

“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.

Dr. Guinart reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.

He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.

This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.

If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.

The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.

“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.

In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.

“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.

Dr. Guinart reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.

He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.

This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.

If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.

The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.

“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.

In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.

“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.

Dr. Guinart reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com