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Study Highlights Atopic Dermatitis Features, Treatments Among Older Patients
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The researchers reviewed charts of patients aged 60 years and older who were seen at either a private or county dermatology clinic in Houston between 2009 and 2020 and had been diagnosed with AD by a dermatologist. The findings of their cross-sectional study further supports that AD in this age group “presents as a unique phenotype compared to AD in younger ages, which may inform dermatologists’ diagnosis of AD in these patients” they wrote.
The 791 patients in the study had an average age of 69.3 years, were predominantly women (60.1%), and were racially diverse, with almost 40% being non-Hispanic White individuals. Others were non-Hispanic Black individuals (21.8%), Hispanics (20.4%), and non-Hispanic Asian/Pacific Islanders (11.7%).
Use of topicals, mainly topical corticosteroids (92.2%), was the most frequent treatment prescribed. Oral corticosteroids and antihistamines were “frequent systemic treatments” in this population, prescribed to 10.4% and 12.1%, respectively, “likely due to management prior to a diagnosis of AD by a dermatologist,” wrote first author Hannah Y. Wang, Baylor College of Medicine, Houston, and her coauthors, including Soo Jung Kim, MD, PhD, of the department of dermatology at Baylor.
Other treatments included dupilumab in 5.4%, systemic immunosuppressants (including methotrexate, cyclosporine, and mycophenolate) in 5.4%, and UVB-phototherapy in 2.7%.
Approximately 40% of the patients had a history of allergic rhinitis, while 20% had a history of asthma. Lichenification was noted in 14.5% of patients and nummular lesions in almost 13%. Other rash characteristics — ichthyosis and hyperpigmented patches — were less frequent, seen in 9.7% and 9.1%, respectively.
AD in this older population was most commonly documented on the extensors (49.9%) and the trunk (46%) and less commonly on the hands (19.8%) and feet (9%) — a distribution that is similar to past reports, the authors wrote.
Asked to comment on the findings, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization that the data relating to clinical morphology are consistent with past reports and with his own experiences. Lichenification is a “tell-tale sign of chronic disease” and may indicate undertreatment, and the frequency of nummular plaques is unsurprising because “nummular dermatitis as an independent eczema tends to occur more so in the elderly.”
More important, he said, was the finding regarding the use of oral corticosteroid and antihistamine, “both of which are advocated against in the management of AD.”
More research is “needed to elucidate the unique features of elderly AD in pathophysiology and optimal treatments,” the authors wrote, noting that age-related factors potentially affecting AD in this population include reduced skin barrier function, immune dysregulation, and environmental exposures.
The study, Dr. Friedman said, “shines a spotlight on this demographic — they exist, they suffer, and they are at times being managed with less-than-optimal options.” Clinical trials of “the welcome additions to our historically limited armament often lack a substantial elderly study population,” he said, and Medicare makes it “painful to get these game-changing drugs for this large patient population.”
The study authors and Dr. Friedman, who was not involved with the study, reported no conflicts of interest.
A version of this article appeared on Medscape.com.
.
The researchers reviewed charts of patients aged 60 years and older who were seen at either a private or county dermatology clinic in Houston between 2009 and 2020 and had been diagnosed with AD by a dermatologist. The findings of their cross-sectional study further supports that AD in this age group “presents as a unique phenotype compared to AD in younger ages, which may inform dermatologists’ diagnosis of AD in these patients” they wrote.
The 791 patients in the study had an average age of 69.3 years, were predominantly women (60.1%), and were racially diverse, with almost 40% being non-Hispanic White individuals. Others were non-Hispanic Black individuals (21.8%), Hispanics (20.4%), and non-Hispanic Asian/Pacific Islanders (11.7%).
Use of topicals, mainly topical corticosteroids (92.2%), was the most frequent treatment prescribed. Oral corticosteroids and antihistamines were “frequent systemic treatments” in this population, prescribed to 10.4% and 12.1%, respectively, “likely due to management prior to a diagnosis of AD by a dermatologist,” wrote first author Hannah Y. Wang, Baylor College of Medicine, Houston, and her coauthors, including Soo Jung Kim, MD, PhD, of the department of dermatology at Baylor.
Other treatments included dupilumab in 5.4%, systemic immunosuppressants (including methotrexate, cyclosporine, and mycophenolate) in 5.4%, and UVB-phototherapy in 2.7%.
Approximately 40% of the patients had a history of allergic rhinitis, while 20% had a history of asthma. Lichenification was noted in 14.5% of patients and nummular lesions in almost 13%. Other rash characteristics — ichthyosis and hyperpigmented patches — were less frequent, seen in 9.7% and 9.1%, respectively.
AD in this older population was most commonly documented on the extensors (49.9%) and the trunk (46%) and less commonly on the hands (19.8%) and feet (9%) — a distribution that is similar to past reports, the authors wrote.
Asked to comment on the findings, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization that the data relating to clinical morphology are consistent with past reports and with his own experiences. Lichenification is a “tell-tale sign of chronic disease” and may indicate undertreatment, and the frequency of nummular plaques is unsurprising because “nummular dermatitis as an independent eczema tends to occur more so in the elderly.”
More important, he said, was the finding regarding the use of oral corticosteroid and antihistamine, “both of which are advocated against in the management of AD.”
More research is “needed to elucidate the unique features of elderly AD in pathophysiology and optimal treatments,” the authors wrote, noting that age-related factors potentially affecting AD in this population include reduced skin barrier function, immune dysregulation, and environmental exposures.
The study, Dr. Friedman said, “shines a spotlight on this demographic — they exist, they suffer, and they are at times being managed with less-than-optimal options.” Clinical trials of “the welcome additions to our historically limited armament often lack a substantial elderly study population,” he said, and Medicare makes it “painful to get these game-changing drugs for this large patient population.”
The study authors and Dr. Friedman, who was not involved with the study, reported no conflicts of interest.
A version of this article appeared on Medscape.com.
.
The researchers reviewed charts of patients aged 60 years and older who were seen at either a private or county dermatology clinic in Houston between 2009 and 2020 and had been diagnosed with AD by a dermatologist. The findings of their cross-sectional study further supports that AD in this age group “presents as a unique phenotype compared to AD in younger ages, which may inform dermatologists’ diagnosis of AD in these patients” they wrote.
The 791 patients in the study had an average age of 69.3 years, were predominantly women (60.1%), and were racially diverse, with almost 40% being non-Hispanic White individuals. Others were non-Hispanic Black individuals (21.8%), Hispanics (20.4%), and non-Hispanic Asian/Pacific Islanders (11.7%).
Use of topicals, mainly topical corticosteroids (92.2%), was the most frequent treatment prescribed. Oral corticosteroids and antihistamines were “frequent systemic treatments” in this population, prescribed to 10.4% and 12.1%, respectively, “likely due to management prior to a diagnosis of AD by a dermatologist,” wrote first author Hannah Y. Wang, Baylor College of Medicine, Houston, and her coauthors, including Soo Jung Kim, MD, PhD, of the department of dermatology at Baylor.
Other treatments included dupilumab in 5.4%, systemic immunosuppressants (including methotrexate, cyclosporine, and mycophenolate) in 5.4%, and UVB-phototherapy in 2.7%.
Approximately 40% of the patients had a history of allergic rhinitis, while 20% had a history of asthma. Lichenification was noted in 14.5% of patients and nummular lesions in almost 13%. Other rash characteristics — ichthyosis and hyperpigmented patches — were less frequent, seen in 9.7% and 9.1%, respectively.
AD in this older population was most commonly documented on the extensors (49.9%) and the trunk (46%) and less commonly on the hands (19.8%) and feet (9%) — a distribution that is similar to past reports, the authors wrote.
Asked to comment on the findings, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization that the data relating to clinical morphology are consistent with past reports and with his own experiences. Lichenification is a “tell-tale sign of chronic disease” and may indicate undertreatment, and the frequency of nummular plaques is unsurprising because “nummular dermatitis as an independent eczema tends to occur more so in the elderly.”
More important, he said, was the finding regarding the use of oral corticosteroid and antihistamine, “both of which are advocated against in the management of AD.”
More research is “needed to elucidate the unique features of elderly AD in pathophysiology and optimal treatments,” the authors wrote, noting that age-related factors potentially affecting AD in this population include reduced skin barrier function, immune dysregulation, and environmental exposures.
The study, Dr. Friedman said, “shines a spotlight on this demographic — they exist, they suffer, and they are at times being managed with less-than-optimal options.” Clinical trials of “the welcome additions to our historically limited armament often lack a substantial elderly study population,” he said, and Medicare makes it “painful to get these game-changing drugs for this large patient population.”
The study authors and Dr. Friedman, who was not involved with the study, reported no conflicts of interest.
A version of this article appeared on Medscape.com.
FROM JAAD INTERNATIONAL
Three Keys to Longevity in Older Adults?
TOPLINE:
Physical performance significantly correlates with increased survival rates in individuals aged over 80 years.
METHODOLOGY:
- Researchers analyzed data from 195 participants in the ilSIRENTE study, a prospective cohort study in L’Aquila, Italy, that included men and women born before 1924. The analysis focused on participants aged < 85 years at the time of enrollment (mean age, 82 years).
- Physical performance was assessed via the Short Physical Performance Battery (SPPB), which tests balance, gait speed, and leg strength based on the ability to stand from a seated position in a chair.
- Based on SPPB scores, participants were classified as having severe, moderate, mild, or no functional impairment.
TAKEAWAY:
- About 21% of the participants lived to 95 years of age.
- Higher scores on the SPPB and faster gait speed were linked to a lower risk for mortality before that age.
- The average gait speed was 0.88 m/s among participants who lived to 95 years of age and 0.78 m/s for those who died at younger ages.
IN PRACTICE:
“Physical performance is ... a reliable metric for assessing mortality risk in octogenarians,” the authors of the study wrote. “Our findings, together with available evidence, support the view that physical performance is a primary target for interventions to enhance longevity and extend health span.”
SOURCE:
Stefano Cacciatore, MD, with Universita Cattolica del Sacro Cuore, in Rome, was the corresponding author on the paper. The study was published online on May 2, 2024, in Journal of the American Geriatrics Society.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Physical performance significantly correlates with increased survival rates in individuals aged over 80 years.
METHODOLOGY:
- Researchers analyzed data from 195 participants in the ilSIRENTE study, a prospective cohort study in L’Aquila, Italy, that included men and women born before 1924. The analysis focused on participants aged < 85 years at the time of enrollment (mean age, 82 years).
- Physical performance was assessed via the Short Physical Performance Battery (SPPB), which tests balance, gait speed, and leg strength based on the ability to stand from a seated position in a chair.
- Based on SPPB scores, participants were classified as having severe, moderate, mild, or no functional impairment.
TAKEAWAY:
- About 21% of the participants lived to 95 years of age.
- Higher scores on the SPPB and faster gait speed were linked to a lower risk for mortality before that age.
- The average gait speed was 0.88 m/s among participants who lived to 95 years of age and 0.78 m/s for those who died at younger ages.
IN PRACTICE:
“Physical performance is ... a reliable metric for assessing mortality risk in octogenarians,” the authors of the study wrote. “Our findings, together with available evidence, support the view that physical performance is a primary target for interventions to enhance longevity and extend health span.”
SOURCE:
Stefano Cacciatore, MD, with Universita Cattolica del Sacro Cuore, in Rome, was the corresponding author on the paper. The study was published online on May 2, 2024, in Journal of the American Geriatrics Society.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Physical performance significantly correlates with increased survival rates in individuals aged over 80 years.
METHODOLOGY:
- Researchers analyzed data from 195 participants in the ilSIRENTE study, a prospective cohort study in L’Aquila, Italy, that included men and women born before 1924. The analysis focused on participants aged < 85 years at the time of enrollment (mean age, 82 years).
- Physical performance was assessed via the Short Physical Performance Battery (SPPB), which tests balance, gait speed, and leg strength based on the ability to stand from a seated position in a chair.
- Based on SPPB scores, participants were classified as having severe, moderate, mild, or no functional impairment.
TAKEAWAY:
- About 21% of the participants lived to 95 years of age.
- Higher scores on the SPPB and faster gait speed were linked to a lower risk for mortality before that age.
- The average gait speed was 0.88 m/s among participants who lived to 95 years of age and 0.78 m/s for those who died at younger ages.
IN PRACTICE:
“Physical performance is ... a reliable metric for assessing mortality risk in octogenarians,” the authors of the study wrote. “Our findings, together with available evidence, support the view that physical performance is a primary target for interventions to enhance longevity and extend health span.”
SOURCE:
Stefano Cacciatore, MD, with Universita Cattolica del Sacro Cuore, in Rome, was the corresponding author on the paper. The study was published online on May 2, 2024, in Journal of the American Geriatrics Society.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Protecting Patients From Cybercrime: Advice for Mental Health Clinicians
Seniors are increasingly targeted in ever-sophisticated online financial cybercrimes, but mental health clinicians can play a key role in protecting their patients.
Elizabeth J. Santos, MD, clinical chief, Division of Geriatric Mental Health & Memory Care, and associate professor of psychiatry, neurology & medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, provided tips to attendees of the American Psychiatric Association (APA) 2024 Annual Meeting, and elaborated on these for this news organization.
Cybercrimes targeting seniors are common. A 2023 University of Michigan National Poll on Healthy Aging found 75% of adults aged 50-80 years experienced a fraud attempt either online or by phone, text, email, or mail in the past 2 years.
The poll found about 30% of respondents reported experiencing financial fraud, which could involve compromising credit cards, hacking bank accounts, or identity theft.
Older age is a risk factor for cybercrime. Seniors may have lower cognitive functioning and/or impaired decision-making. In addition, they are often socially isolated, dependent on others, and have poor health and financial literacy.
Romance Scams Common
Romance scams are another common financial fraud. Stephanie Garayalde, MD, a geriatric psychiatrist at the University of Florida, Gainesville, Florida, and another presenter at the APA session, used the example of Mr. L, a 74-year-old outpatient under treatment for depression who was unable to pay his rent.
Mr. L was giving money to his “girlfriend” he met online. Their relationship was totally virtual; she always had constant excuses for not meeting in person. He was funneling increasing funds to pay what he believed were medical bills and to bail her out of various other emergencies.
Once the fraud was discovered, Mr. L not only felt the loneliness of a lost romantic connection but also grappled with feelings of embarrassment and guilt.
“I see older patients who have been scammed who feel ashamed that they haven’t left enough money for their families,” said Dr. Santos.
Another well-known scam targets grandparents. Fraudsters sometimes use an artificial intelligence–generated voice mimicking a young family member and pretend to need money right away for bail or another problem.
In such situations, Dr. Santos advises patients to “hang up and call your family” to verify the call “no matter what the person says or who they sound like.”
Scammers may impersonate government officials to try to get social insurance information. Dr. Santos stresses the importance of never giving out this information. “If someone says they’re from your bank or a government agency like the IRS, hang up and call the bank or agency yourself.”
Evidence suggests this and other cybercrimes are on the rise. The Federal Bureau of Investigation’s Internet Crime Complaint Center received 888,000 complaints in 2023, a 10% increase from 2022, and losses of about $12.5 billion, which is a 22% increase over 2022.
It’s not that uncommon for the same older person to be scammed by numerous people and fall for it again and again, said Dr. Santos.
To mitigate the risk to this vulnerable group, researchers at the University of Central Florida, Orlando, Florida, are developing a scam screener for the elderly that will provide tools to help doctors screen older adults. The screen will focus on identifying factors that make victims most vulnerable, including seniors’ ability to think critically, a necessary skill for guarding against cybercrime.
Red Flags
In the meantime, Dr. Santos identified red flags for clinicians. Patients may show deviations in their typical behaviors; for example, they may seem sadder, more subdued, or more withdrawn than usual.
As loneliness and isolation can be a signal of victimization, “ask patients about their connectedness and be suspicious if the connectedness is all virtual,” she said.
Learning about the quality of their relationships is also important. “Instead of asking the superficial question of ‘Do you have friends’, ask ‘How do you talk to your friends? Are you actually getting out and meeting them?’”
If patients report they have never actually seen these so-called friends in-person, it should raise a red flag.
Another clue something may be amiss is “needing to be on their device or be home to get a call at a certain time.” Dr. Santos recalled a patient whose cell phone rang constantly during an evaluation, even after she had changed her phone number several times. “The scammers kept tracking her down,” she said.
Patients who are victims of cybercrime may stop taking their medications, fail to follow up on ordered tests, or miss paying for medical services.
Dr. Santos recommended screening for conditions known to be linked to cybercrime victimization such as depression. One of her patients was attending her memory clinic, but their cognitive issues were due to depression, not dementia.
It is important to identify subtle cognitive impairments. Dr. Santos recommended using the Saint Louis University Mental Status Examination, which she says is easier to use than the Montreal Cognitive Assessment.
Avoid Shaming
When managing patients who are potential cybercrime victims, she also suggests doctors be careful about their tone and their attitude. “Don’t shame someone for becoming a victim because it happens to everyone.”
When patients show signs of victimization, physicians could consider asking about their Internet use, social media practices, and general safety surrounding their finances.
They should emphasize the importance of protecting accounts through strong passwords, multifactor authentication when possible, and avoidance of sharing personal information with anyone who calls, emails, or texts.
Clinicians might also consider asking patients to review bills for new or unusual charges, check their bank account statements for withdrawals they didn’t make, and review credit reports for accounts in their name they don’t recognize.
Clinicians should also encourage patients to have a healthcare proxy, power of attorney, and advanced directives and recommend resources that can help victims. These include:
Federal Trade Commission (to report identity theft): https://reportfraud.ftc.gov; https://www.identitytheft.gov
Federal Bureau of Investigation – Internet Crime and Complaint Center https://www.ic3.gov
National Elder Fraud Hotline (1-833-372-8311) or 1-833-FRAUD-11
http://ovc.ojp.gov/program/stop-elder-fraud/providing-help-restoring-hope
A version of this article appeared on Medscape.com.
Seniors are increasingly targeted in ever-sophisticated online financial cybercrimes, but mental health clinicians can play a key role in protecting their patients.
Elizabeth J. Santos, MD, clinical chief, Division of Geriatric Mental Health & Memory Care, and associate professor of psychiatry, neurology & medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, provided tips to attendees of the American Psychiatric Association (APA) 2024 Annual Meeting, and elaborated on these for this news organization.
Cybercrimes targeting seniors are common. A 2023 University of Michigan National Poll on Healthy Aging found 75% of adults aged 50-80 years experienced a fraud attempt either online or by phone, text, email, or mail in the past 2 years.
The poll found about 30% of respondents reported experiencing financial fraud, which could involve compromising credit cards, hacking bank accounts, or identity theft.
Older age is a risk factor for cybercrime. Seniors may have lower cognitive functioning and/or impaired decision-making. In addition, they are often socially isolated, dependent on others, and have poor health and financial literacy.
Romance Scams Common
Romance scams are another common financial fraud. Stephanie Garayalde, MD, a geriatric psychiatrist at the University of Florida, Gainesville, Florida, and another presenter at the APA session, used the example of Mr. L, a 74-year-old outpatient under treatment for depression who was unable to pay his rent.
Mr. L was giving money to his “girlfriend” he met online. Their relationship was totally virtual; she always had constant excuses for not meeting in person. He was funneling increasing funds to pay what he believed were medical bills and to bail her out of various other emergencies.
Once the fraud was discovered, Mr. L not only felt the loneliness of a lost romantic connection but also grappled with feelings of embarrassment and guilt.
“I see older patients who have been scammed who feel ashamed that they haven’t left enough money for their families,” said Dr. Santos.
Another well-known scam targets grandparents. Fraudsters sometimes use an artificial intelligence–generated voice mimicking a young family member and pretend to need money right away for bail or another problem.
In such situations, Dr. Santos advises patients to “hang up and call your family” to verify the call “no matter what the person says or who they sound like.”
Scammers may impersonate government officials to try to get social insurance information. Dr. Santos stresses the importance of never giving out this information. “If someone says they’re from your bank or a government agency like the IRS, hang up and call the bank or agency yourself.”
Evidence suggests this and other cybercrimes are on the rise. The Federal Bureau of Investigation’s Internet Crime Complaint Center received 888,000 complaints in 2023, a 10% increase from 2022, and losses of about $12.5 billion, which is a 22% increase over 2022.
It’s not that uncommon for the same older person to be scammed by numerous people and fall for it again and again, said Dr. Santos.
To mitigate the risk to this vulnerable group, researchers at the University of Central Florida, Orlando, Florida, are developing a scam screener for the elderly that will provide tools to help doctors screen older adults. The screen will focus on identifying factors that make victims most vulnerable, including seniors’ ability to think critically, a necessary skill for guarding against cybercrime.
Red Flags
In the meantime, Dr. Santos identified red flags for clinicians. Patients may show deviations in their typical behaviors; for example, they may seem sadder, more subdued, or more withdrawn than usual.
As loneliness and isolation can be a signal of victimization, “ask patients about their connectedness and be suspicious if the connectedness is all virtual,” she said.
Learning about the quality of their relationships is also important. “Instead of asking the superficial question of ‘Do you have friends’, ask ‘How do you talk to your friends? Are you actually getting out and meeting them?’”
If patients report they have never actually seen these so-called friends in-person, it should raise a red flag.
Another clue something may be amiss is “needing to be on their device or be home to get a call at a certain time.” Dr. Santos recalled a patient whose cell phone rang constantly during an evaluation, even after she had changed her phone number several times. “The scammers kept tracking her down,” she said.
Patients who are victims of cybercrime may stop taking their medications, fail to follow up on ordered tests, or miss paying for medical services.
Dr. Santos recommended screening for conditions known to be linked to cybercrime victimization such as depression. One of her patients was attending her memory clinic, but their cognitive issues were due to depression, not dementia.
It is important to identify subtle cognitive impairments. Dr. Santos recommended using the Saint Louis University Mental Status Examination, which she says is easier to use than the Montreal Cognitive Assessment.
Avoid Shaming
When managing patients who are potential cybercrime victims, she also suggests doctors be careful about their tone and their attitude. “Don’t shame someone for becoming a victim because it happens to everyone.”
When patients show signs of victimization, physicians could consider asking about their Internet use, social media practices, and general safety surrounding their finances.
They should emphasize the importance of protecting accounts through strong passwords, multifactor authentication when possible, and avoidance of sharing personal information with anyone who calls, emails, or texts.
Clinicians might also consider asking patients to review bills for new or unusual charges, check their bank account statements for withdrawals they didn’t make, and review credit reports for accounts in their name they don’t recognize.
Clinicians should also encourage patients to have a healthcare proxy, power of attorney, and advanced directives and recommend resources that can help victims. These include:
Federal Trade Commission (to report identity theft): https://reportfraud.ftc.gov; https://www.identitytheft.gov
Federal Bureau of Investigation – Internet Crime and Complaint Center https://www.ic3.gov
National Elder Fraud Hotline (1-833-372-8311) or 1-833-FRAUD-11
http://ovc.ojp.gov/program/stop-elder-fraud/providing-help-restoring-hope
A version of this article appeared on Medscape.com.
Seniors are increasingly targeted in ever-sophisticated online financial cybercrimes, but mental health clinicians can play a key role in protecting their patients.
Elizabeth J. Santos, MD, clinical chief, Division of Geriatric Mental Health & Memory Care, and associate professor of psychiatry, neurology & medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, provided tips to attendees of the American Psychiatric Association (APA) 2024 Annual Meeting, and elaborated on these for this news organization.
Cybercrimes targeting seniors are common. A 2023 University of Michigan National Poll on Healthy Aging found 75% of adults aged 50-80 years experienced a fraud attempt either online or by phone, text, email, or mail in the past 2 years.
The poll found about 30% of respondents reported experiencing financial fraud, which could involve compromising credit cards, hacking bank accounts, or identity theft.
Older age is a risk factor for cybercrime. Seniors may have lower cognitive functioning and/or impaired decision-making. In addition, they are often socially isolated, dependent on others, and have poor health and financial literacy.
Romance Scams Common
Romance scams are another common financial fraud. Stephanie Garayalde, MD, a geriatric psychiatrist at the University of Florida, Gainesville, Florida, and another presenter at the APA session, used the example of Mr. L, a 74-year-old outpatient under treatment for depression who was unable to pay his rent.
Mr. L was giving money to his “girlfriend” he met online. Their relationship was totally virtual; she always had constant excuses for not meeting in person. He was funneling increasing funds to pay what he believed were medical bills and to bail her out of various other emergencies.
Once the fraud was discovered, Mr. L not only felt the loneliness of a lost romantic connection but also grappled with feelings of embarrassment and guilt.
“I see older patients who have been scammed who feel ashamed that they haven’t left enough money for their families,” said Dr. Santos.
Another well-known scam targets grandparents. Fraudsters sometimes use an artificial intelligence–generated voice mimicking a young family member and pretend to need money right away for bail or another problem.
In such situations, Dr. Santos advises patients to “hang up and call your family” to verify the call “no matter what the person says or who they sound like.”
Scammers may impersonate government officials to try to get social insurance information. Dr. Santos stresses the importance of never giving out this information. “If someone says they’re from your bank or a government agency like the IRS, hang up and call the bank or agency yourself.”
Evidence suggests this and other cybercrimes are on the rise. The Federal Bureau of Investigation’s Internet Crime Complaint Center received 888,000 complaints in 2023, a 10% increase from 2022, and losses of about $12.5 billion, which is a 22% increase over 2022.
It’s not that uncommon for the same older person to be scammed by numerous people and fall for it again and again, said Dr. Santos.
To mitigate the risk to this vulnerable group, researchers at the University of Central Florida, Orlando, Florida, are developing a scam screener for the elderly that will provide tools to help doctors screen older adults. The screen will focus on identifying factors that make victims most vulnerable, including seniors’ ability to think critically, a necessary skill for guarding against cybercrime.
Red Flags
In the meantime, Dr. Santos identified red flags for clinicians. Patients may show deviations in their typical behaviors; for example, they may seem sadder, more subdued, or more withdrawn than usual.
As loneliness and isolation can be a signal of victimization, “ask patients about their connectedness and be suspicious if the connectedness is all virtual,” she said.
Learning about the quality of their relationships is also important. “Instead of asking the superficial question of ‘Do you have friends’, ask ‘How do you talk to your friends? Are you actually getting out and meeting them?’”
If patients report they have never actually seen these so-called friends in-person, it should raise a red flag.
Another clue something may be amiss is “needing to be on their device or be home to get a call at a certain time.” Dr. Santos recalled a patient whose cell phone rang constantly during an evaluation, even after she had changed her phone number several times. “The scammers kept tracking her down,” she said.
Patients who are victims of cybercrime may stop taking their medications, fail to follow up on ordered tests, or miss paying for medical services.
Dr. Santos recommended screening for conditions known to be linked to cybercrime victimization such as depression. One of her patients was attending her memory clinic, but their cognitive issues were due to depression, not dementia.
It is important to identify subtle cognitive impairments. Dr. Santos recommended using the Saint Louis University Mental Status Examination, which she says is easier to use than the Montreal Cognitive Assessment.
Avoid Shaming
When managing patients who are potential cybercrime victims, she also suggests doctors be careful about their tone and their attitude. “Don’t shame someone for becoming a victim because it happens to everyone.”
When patients show signs of victimization, physicians could consider asking about their Internet use, social media practices, and general safety surrounding their finances.
They should emphasize the importance of protecting accounts through strong passwords, multifactor authentication when possible, and avoidance of sharing personal information with anyone who calls, emails, or texts.
Clinicians might also consider asking patients to review bills for new or unusual charges, check their bank account statements for withdrawals they didn’t make, and review credit reports for accounts in their name they don’t recognize.
Clinicians should also encourage patients to have a healthcare proxy, power of attorney, and advanced directives and recommend resources that can help victims. These include:
Federal Trade Commission (to report identity theft): https://reportfraud.ftc.gov; https://www.identitytheft.gov
Federal Bureau of Investigation – Internet Crime and Complaint Center https://www.ic3.gov
National Elder Fraud Hotline (1-833-372-8311) or 1-833-FRAUD-11
http://ovc.ojp.gov/program/stop-elder-fraud/providing-help-restoring-hope
A version of this article appeared on Medscape.com.
Resource Menu Gives Choice to Caregivers Struggling to Meet Basic Needs
Screenings may not be the way to get needed resources to children and their caregivers, according to new research presented at the annual meeting of the Pediatric Academic Societies (PAS).
Caregivers and parents who were asked if they wanted assistance in several areas of need, including transportation and childcare, were nearly twice as likely to say they wanted such help than those who received a screening on current hardships. Generally, each questionnaire is administered in front of their children in primary care or pediatric hospital settings.
“Families have a lot of concern about being seen a different way by their healthcare team, being seen as unfit, and having child protective services involved in their childcare for issues related to poverty,” said Danielle Cullen, MD, a pediatric emergency medicine specialist at Children’s Hospital of Philadelphia (CHOP) and assistant professor of pediatrics at the University of Pennsylvania in Philadelphia.
Dr. Cullen and her colleagues analyzed data from nearly 4000 caregivers of children up to age 21 at emergency departments or primary care clinics at CHOP between 2021 and 2023.
Caregivers were randomly assigned to one of three arms — screening with a version of WE CARE (Well Child Care, Evaluation, Community Resources, Advocacy, Referral, Education), use of an online menu of options for help in areas like housing, or neither approach.
Caregivers in all three arms received a map of resources and a follow-up text from a resource navigator to assist them as needed.
Nearly 40% of caregivers who presented with the digital menu said they wanted resources compared with 29% of those who were screened (P < .001). Non-native English speakers given the menu were 2.5 times more likely to say yes to resources compared with those who were screened.
“We need to be thoughtful about these mandates to screen for social determinants of health: It’s not that straightforward,” said Esther K. Chung, MD, a pediatrician and professor of pediatrics at the University of Washington Medicine in Seattle, who was not involved in the study. “What we’re getting from this study is that patients want choice, and the menu provides them choice.”
Dr. Cullen said the menu option allows caregivers to make choices based on their priorities and not on whether they meet the screening thresholds for need.
While some health clinics utilize tablet forms for screenings to offer more privacy with questions, asking direct questions about income, food insecurity, and housing stability can be stigmatizing, Dr. Cullen said.
“Screening positive for social risk doesn’t mean that you actually want resources, and on the flip side, the literature shows that about half of the people who screen negative want resources,” she said.
Dr. Cullen and her team also conducted follow-up interviews with caregivers and found many feared that their clinician would assume a medical condition was connected to living conditions. They also had concerns about insurance companies gaining access to the data and using it to deny coverage or raise costs.
Spanish-speaking caregivers cited fears about their immigration status, experiences of discrimination, and language barriers when trying to access resources.
Participants said a few key strategies could make screening less intimidating, such as abstaining from screening during a serious medical visit, asking for consent to record answers in medical records, and communicating in an empathetic manner.
“Some families are a bit surprised when we ask about things like housing and food insecurity, but I think as long as we contextualize it, we can minimize the stigma associated with it,” Dr. Chung said. “That takes quite a bit of nuance and skill.”
The study was funded by the William T. Grant Foundation and the Emergency Medicine Foundation. The authors reported no disclosures.
A version of this article appeared on Medscape.com.
Screenings may not be the way to get needed resources to children and their caregivers, according to new research presented at the annual meeting of the Pediatric Academic Societies (PAS).
Caregivers and parents who were asked if they wanted assistance in several areas of need, including transportation and childcare, were nearly twice as likely to say they wanted such help than those who received a screening on current hardships. Generally, each questionnaire is administered in front of their children in primary care or pediatric hospital settings.
“Families have a lot of concern about being seen a different way by their healthcare team, being seen as unfit, and having child protective services involved in their childcare for issues related to poverty,” said Danielle Cullen, MD, a pediatric emergency medicine specialist at Children’s Hospital of Philadelphia (CHOP) and assistant professor of pediatrics at the University of Pennsylvania in Philadelphia.
Dr. Cullen and her colleagues analyzed data from nearly 4000 caregivers of children up to age 21 at emergency departments or primary care clinics at CHOP between 2021 and 2023.
Caregivers were randomly assigned to one of three arms — screening with a version of WE CARE (Well Child Care, Evaluation, Community Resources, Advocacy, Referral, Education), use of an online menu of options for help in areas like housing, or neither approach.
Caregivers in all three arms received a map of resources and a follow-up text from a resource navigator to assist them as needed.
Nearly 40% of caregivers who presented with the digital menu said they wanted resources compared with 29% of those who were screened (P < .001). Non-native English speakers given the menu were 2.5 times more likely to say yes to resources compared with those who were screened.
“We need to be thoughtful about these mandates to screen for social determinants of health: It’s not that straightforward,” said Esther K. Chung, MD, a pediatrician and professor of pediatrics at the University of Washington Medicine in Seattle, who was not involved in the study. “What we’re getting from this study is that patients want choice, and the menu provides them choice.”
Dr. Cullen said the menu option allows caregivers to make choices based on their priorities and not on whether they meet the screening thresholds for need.
While some health clinics utilize tablet forms for screenings to offer more privacy with questions, asking direct questions about income, food insecurity, and housing stability can be stigmatizing, Dr. Cullen said.
“Screening positive for social risk doesn’t mean that you actually want resources, and on the flip side, the literature shows that about half of the people who screen negative want resources,” she said.
Dr. Cullen and her team also conducted follow-up interviews with caregivers and found many feared that their clinician would assume a medical condition was connected to living conditions. They also had concerns about insurance companies gaining access to the data and using it to deny coverage or raise costs.
Spanish-speaking caregivers cited fears about their immigration status, experiences of discrimination, and language barriers when trying to access resources.
Participants said a few key strategies could make screening less intimidating, such as abstaining from screening during a serious medical visit, asking for consent to record answers in medical records, and communicating in an empathetic manner.
“Some families are a bit surprised when we ask about things like housing and food insecurity, but I think as long as we contextualize it, we can minimize the stigma associated with it,” Dr. Chung said. “That takes quite a bit of nuance and skill.”
The study was funded by the William T. Grant Foundation and the Emergency Medicine Foundation. The authors reported no disclosures.
A version of this article appeared on Medscape.com.
Screenings may not be the way to get needed resources to children and their caregivers, according to new research presented at the annual meeting of the Pediatric Academic Societies (PAS).
Caregivers and parents who were asked if they wanted assistance in several areas of need, including transportation and childcare, were nearly twice as likely to say they wanted such help than those who received a screening on current hardships. Generally, each questionnaire is administered in front of their children in primary care or pediatric hospital settings.
“Families have a lot of concern about being seen a different way by their healthcare team, being seen as unfit, and having child protective services involved in their childcare for issues related to poverty,” said Danielle Cullen, MD, a pediatric emergency medicine specialist at Children’s Hospital of Philadelphia (CHOP) and assistant professor of pediatrics at the University of Pennsylvania in Philadelphia.
Dr. Cullen and her colleagues analyzed data from nearly 4000 caregivers of children up to age 21 at emergency departments or primary care clinics at CHOP between 2021 and 2023.
Caregivers were randomly assigned to one of three arms — screening with a version of WE CARE (Well Child Care, Evaluation, Community Resources, Advocacy, Referral, Education), use of an online menu of options for help in areas like housing, or neither approach.
Caregivers in all three arms received a map of resources and a follow-up text from a resource navigator to assist them as needed.
Nearly 40% of caregivers who presented with the digital menu said they wanted resources compared with 29% of those who were screened (P < .001). Non-native English speakers given the menu were 2.5 times more likely to say yes to resources compared with those who were screened.
“We need to be thoughtful about these mandates to screen for social determinants of health: It’s not that straightforward,” said Esther K. Chung, MD, a pediatrician and professor of pediatrics at the University of Washington Medicine in Seattle, who was not involved in the study. “What we’re getting from this study is that patients want choice, and the menu provides them choice.”
Dr. Cullen said the menu option allows caregivers to make choices based on their priorities and not on whether they meet the screening thresholds for need.
While some health clinics utilize tablet forms for screenings to offer more privacy with questions, asking direct questions about income, food insecurity, and housing stability can be stigmatizing, Dr. Cullen said.
“Screening positive for social risk doesn’t mean that you actually want resources, and on the flip side, the literature shows that about half of the people who screen negative want resources,” she said.
Dr. Cullen and her team also conducted follow-up interviews with caregivers and found many feared that their clinician would assume a medical condition was connected to living conditions. They also had concerns about insurance companies gaining access to the data and using it to deny coverage or raise costs.
Spanish-speaking caregivers cited fears about their immigration status, experiences of discrimination, and language barriers when trying to access resources.
Participants said a few key strategies could make screening less intimidating, such as abstaining from screening during a serious medical visit, asking for consent to record answers in medical records, and communicating in an empathetic manner.
“Some families are a bit surprised when we ask about things like housing and food insecurity, but I think as long as we contextualize it, we can minimize the stigma associated with it,” Dr. Chung said. “That takes quite a bit of nuance and skill.”
The study was funded by the William T. Grant Foundation and the Emergency Medicine Foundation. The authors reported no disclosures.
A version of this article appeared on Medscape.com.
FROM PAS 2024
Do Antipsychotic Overprescribing Warning Letters Work?
Warning letters to primary care physicians (PCPs) regarding overprescription of quetiapine were helpful in reducing overprescribing of this agent, new research suggested.
Investigators analyzed data from an earlier trial that compared prescribing patterns in 5055 PCPs who receive a placebo letter or three warning letters informing them that their prescribing of quetiapine was high and under review by Medicare. Patients in question all had dementia and were either living in nursing homes or in the community.
The intervention reduced quetiapine use among all patients with dementia, with no detectable adverse effects on cognitive function, behavioral symptoms, depression, metabolic diagnoses, hospitalization, or death.
“This study found that overprescribing warning letters to PCPs safely reduced quetiapine prescribing to their patients with dementia,” wrote investigators led by Adam Sacarny, PhD, of the Department of Health Policy and Management, Mailman School of Public Health, Columbia University, New York.
“This intervention and other[s] like it may be useful for future efforts to promote guideline-concordant care,” they added.
The study was published online in JAMA Network Open.
Off-Label Prescribing Common
The off-label use of antipsychotics in patients with dementia is fairly common, the investigators noted, affecting roughly one in seven nursing home residents and a similar number of community-dwelling older adults with dementia.
The agents are often prescribed to treat behavioral symptoms associated with dementia, including agitation and aggression. Although some evidence supports this use, antipsychotics in dementia patients can also cause an increased risk for weight gain, cognitive decline, falls and other injuries, cerebrovascular events, and mortality.
While some professional societies have called for “judicious use of antipsychotics in dementia care,” there is little evidence that reducing antipsychotic use in people with dementia might result in a benefit, investigators wrote.
The researchers analyzed data from a previous trial that focused on quetiapine, which is the most prescribed antipsychotic in the United States and is frequently used for patients with dementia.
In the original study, 2528 PCPs received a placebo letter and 2527 received three warning letters sent by the Centers for Medicare & Medicaid Services (CMS), which identified the highest-volume PCP prescribers of quetiapine.
The warning letters stated that the recipient’s quetiapine prescribing was high relative to their peers and was under review by Medicare. The placebo letter clarified an unrelated regulation.
The current secondary analysis followed the providers and a cohort of their patients from their first receipt of the letters in 2015 through April 2017. The current evaluation analyzes patients’ outcomes through December 2018, utilizing Medicare fee-for-service claims, Minimum Data Set nursing home assessment, and Medicare enrollment data.
Low-Cost, Effective Intervention
While the original study focused on total quetiapine prescribing by study PCPs, the current analysis focused on patients’ total quetiapine use per 90-day period. Additional secondary outcomes included measures of cognitive function and behavioral symptoms, indicators of depression, metabolic diagnoses, indicators of use of hospital and healthcare services, and death.
PCPs in the study had a total of 84,881 patients with dementia living in nursing homes and 261,288 living in the community. At baseline, there were 92,874 patients (mean age, 82 years; 69% female).
The warning letters were associated with reduced quetiapine use among both nursing home patients and community-dwelling patients (adjusted difference, –0.7 days; P = .02 and adjusted difference, −1.5 days; P < .001, respectively).
Among nursing home patients, there were no statistically significant adverse changes in cognitive of behavioral health measures that coincided with reduction in quetiapine use.
Although a higher percentage of treatment vs control patients reported weight loss, the difference was not significant, and rates of metabolic diagnoses were similar in both groups. There were also no significant differences between the groups in emergency department use, inpatient hospital admission, or use of restraints.
Results were similar for patients living in the community.
Additionally, no adverse effects on more severe health endpoints, including rates of hospital use or entry to nursing facilities, were detected. Importantly, the risk for death was statistically significantly lower for patients whose PCPs had received warning letters vs control patients (P = .04).
The analysis “provides evidence that a low-cost letter intervention informed by behavioral science can reduce prescribing of quetiapine to patients with dementia in nursing home and community settings,” the authors wrote.
Researchers did not directly observe the administration of the medication but instead used prescription drug fills as a proxy. Moreover, they could not observe results for patients enrolled in Medicare Advantage, and claims-based and assessment-based outcomes might have been subject to measurement errors and under-ascertainment of diagnoses.
The authors received support from the National Institute on Aging. They reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Warning letters to primary care physicians (PCPs) regarding overprescription of quetiapine were helpful in reducing overprescribing of this agent, new research suggested.
Investigators analyzed data from an earlier trial that compared prescribing patterns in 5055 PCPs who receive a placebo letter or three warning letters informing them that their prescribing of quetiapine was high and under review by Medicare. Patients in question all had dementia and were either living in nursing homes or in the community.
The intervention reduced quetiapine use among all patients with dementia, with no detectable adverse effects on cognitive function, behavioral symptoms, depression, metabolic diagnoses, hospitalization, or death.
“This study found that overprescribing warning letters to PCPs safely reduced quetiapine prescribing to their patients with dementia,” wrote investigators led by Adam Sacarny, PhD, of the Department of Health Policy and Management, Mailman School of Public Health, Columbia University, New York.
“This intervention and other[s] like it may be useful for future efforts to promote guideline-concordant care,” they added.
The study was published online in JAMA Network Open.
Off-Label Prescribing Common
The off-label use of antipsychotics in patients with dementia is fairly common, the investigators noted, affecting roughly one in seven nursing home residents and a similar number of community-dwelling older adults with dementia.
The agents are often prescribed to treat behavioral symptoms associated with dementia, including agitation and aggression. Although some evidence supports this use, antipsychotics in dementia patients can also cause an increased risk for weight gain, cognitive decline, falls and other injuries, cerebrovascular events, and mortality.
While some professional societies have called for “judicious use of antipsychotics in dementia care,” there is little evidence that reducing antipsychotic use in people with dementia might result in a benefit, investigators wrote.
The researchers analyzed data from a previous trial that focused on quetiapine, which is the most prescribed antipsychotic in the United States and is frequently used for patients with dementia.
In the original study, 2528 PCPs received a placebo letter and 2527 received three warning letters sent by the Centers for Medicare & Medicaid Services (CMS), which identified the highest-volume PCP prescribers of quetiapine.
The warning letters stated that the recipient’s quetiapine prescribing was high relative to their peers and was under review by Medicare. The placebo letter clarified an unrelated regulation.
The current secondary analysis followed the providers and a cohort of their patients from their first receipt of the letters in 2015 through April 2017. The current evaluation analyzes patients’ outcomes through December 2018, utilizing Medicare fee-for-service claims, Minimum Data Set nursing home assessment, and Medicare enrollment data.
Low-Cost, Effective Intervention
While the original study focused on total quetiapine prescribing by study PCPs, the current analysis focused on patients’ total quetiapine use per 90-day period. Additional secondary outcomes included measures of cognitive function and behavioral symptoms, indicators of depression, metabolic diagnoses, indicators of use of hospital and healthcare services, and death.
PCPs in the study had a total of 84,881 patients with dementia living in nursing homes and 261,288 living in the community. At baseline, there were 92,874 patients (mean age, 82 years; 69% female).
The warning letters were associated with reduced quetiapine use among both nursing home patients and community-dwelling patients (adjusted difference, –0.7 days; P = .02 and adjusted difference, −1.5 days; P < .001, respectively).
Among nursing home patients, there were no statistically significant adverse changes in cognitive of behavioral health measures that coincided with reduction in quetiapine use.
Although a higher percentage of treatment vs control patients reported weight loss, the difference was not significant, and rates of metabolic diagnoses were similar in both groups. There were also no significant differences between the groups in emergency department use, inpatient hospital admission, or use of restraints.
Results were similar for patients living in the community.
Additionally, no adverse effects on more severe health endpoints, including rates of hospital use or entry to nursing facilities, were detected. Importantly, the risk for death was statistically significantly lower for patients whose PCPs had received warning letters vs control patients (P = .04).
The analysis “provides evidence that a low-cost letter intervention informed by behavioral science can reduce prescribing of quetiapine to patients with dementia in nursing home and community settings,” the authors wrote.
Researchers did not directly observe the administration of the medication but instead used prescription drug fills as a proxy. Moreover, they could not observe results for patients enrolled in Medicare Advantage, and claims-based and assessment-based outcomes might have been subject to measurement errors and under-ascertainment of diagnoses.
The authors received support from the National Institute on Aging. They reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Warning letters to primary care physicians (PCPs) regarding overprescription of quetiapine were helpful in reducing overprescribing of this agent, new research suggested.
Investigators analyzed data from an earlier trial that compared prescribing patterns in 5055 PCPs who receive a placebo letter or three warning letters informing them that their prescribing of quetiapine was high and under review by Medicare. Patients in question all had dementia and were either living in nursing homes or in the community.
The intervention reduced quetiapine use among all patients with dementia, with no detectable adverse effects on cognitive function, behavioral symptoms, depression, metabolic diagnoses, hospitalization, or death.
“This study found that overprescribing warning letters to PCPs safely reduced quetiapine prescribing to their patients with dementia,” wrote investigators led by Adam Sacarny, PhD, of the Department of Health Policy and Management, Mailman School of Public Health, Columbia University, New York.
“This intervention and other[s] like it may be useful for future efforts to promote guideline-concordant care,” they added.
The study was published online in JAMA Network Open.
Off-Label Prescribing Common
The off-label use of antipsychotics in patients with dementia is fairly common, the investigators noted, affecting roughly one in seven nursing home residents and a similar number of community-dwelling older adults with dementia.
The agents are often prescribed to treat behavioral symptoms associated with dementia, including agitation and aggression. Although some evidence supports this use, antipsychotics in dementia patients can also cause an increased risk for weight gain, cognitive decline, falls and other injuries, cerebrovascular events, and mortality.
While some professional societies have called for “judicious use of antipsychotics in dementia care,” there is little evidence that reducing antipsychotic use in people with dementia might result in a benefit, investigators wrote.
The researchers analyzed data from a previous trial that focused on quetiapine, which is the most prescribed antipsychotic in the United States and is frequently used for patients with dementia.
In the original study, 2528 PCPs received a placebo letter and 2527 received three warning letters sent by the Centers for Medicare & Medicaid Services (CMS), which identified the highest-volume PCP prescribers of quetiapine.
The warning letters stated that the recipient’s quetiapine prescribing was high relative to their peers and was under review by Medicare. The placebo letter clarified an unrelated regulation.
The current secondary analysis followed the providers and a cohort of their patients from their first receipt of the letters in 2015 through April 2017. The current evaluation analyzes patients’ outcomes through December 2018, utilizing Medicare fee-for-service claims, Minimum Data Set nursing home assessment, and Medicare enrollment data.
Low-Cost, Effective Intervention
While the original study focused on total quetiapine prescribing by study PCPs, the current analysis focused on patients’ total quetiapine use per 90-day period. Additional secondary outcomes included measures of cognitive function and behavioral symptoms, indicators of depression, metabolic diagnoses, indicators of use of hospital and healthcare services, and death.
PCPs in the study had a total of 84,881 patients with dementia living in nursing homes and 261,288 living in the community. At baseline, there were 92,874 patients (mean age, 82 years; 69% female).
The warning letters were associated with reduced quetiapine use among both nursing home patients and community-dwelling patients (adjusted difference, –0.7 days; P = .02 and adjusted difference, −1.5 days; P < .001, respectively).
Among nursing home patients, there were no statistically significant adverse changes in cognitive of behavioral health measures that coincided with reduction in quetiapine use.
Although a higher percentage of treatment vs control patients reported weight loss, the difference was not significant, and rates of metabolic diagnoses were similar in both groups. There were also no significant differences between the groups in emergency department use, inpatient hospital admission, or use of restraints.
Results were similar for patients living in the community.
Additionally, no adverse effects on more severe health endpoints, including rates of hospital use or entry to nursing facilities, were detected. Importantly, the risk for death was statistically significantly lower for patients whose PCPs had received warning letters vs control patients (P = .04).
The analysis “provides evidence that a low-cost letter intervention informed by behavioral science can reduce prescribing of quetiapine to patients with dementia in nursing home and community settings,” the authors wrote.
Researchers did not directly observe the administration of the medication but instead used prescription drug fills as a proxy. Moreover, they could not observe results for patients enrolled in Medicare Advantage, and claims-based and assessment-based outcomes might have been subject to measurement errors and under-ascertainment of diagnoses.
The authors received support from the National Institute on Aging. They reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Does Racism in Black Americans Boost Alzheimer’s Risk?
Racial discrimination in Black Americans is associated with an increased risk of developing Alzheimer’s disease (AD) in later life, new findings showed.
Researchers found that Black Americans who experience racism in their 40s and 50s are more likely to have increased serum levels of AD biomarkers p-tau181 and neurofilament light (NfL) more than a decade later.
“We know that Black Americans are at an elevated risk of Alzheimer’s disease and other dementias compared to non-Hispanic White Americans, but we don’t fully understand all the factors that contribute to this disproportionate risk,” Michelle Mielke, PhD, co-author and professor of epidemiology and prevention at Wake Forest University School of Medicine, Winston-Salem, North Carolina, said in a press release.
Recent data show AD is twice as prevalent in Black Americans as in Whites, at 18.6% and 10%, respectively. Dr. Mielke said this level of disparity cannot be attributed solely to genetic differences, and evidence suggests that racism and its related stress may play a role.
The findings were published online in Alzheimer’s and Dementia.
AD Biomarker Testing
To further explore a possible link between exposure to racism and AD risk, investigators analyzed data from the Family and Community Health Study, a multisite, longitudinal investigation that included more than 800 families in the United States.
Blood samples and information on racial discrimination were collected from 255 middle-aged Black Americans between 2002 and 2005.
Blood samples were tested for serum phosphorylated tau181 (p-Tau181), a marker of AD pathology; NfL, a nonspecific marker of neurodegeneration; and glial fibrillary acidic protein (GFAP), a marker of brain inflammation.
Participants answered questions about racial discrimination, which included whether they have been subjected to disrespectful treatment including racial slurs, harassment from law enforcement, or if they had ever been excluded from social activities because of their race.
The sample included 212 females and 43 males with a mean age of 46. Most participants (70%) lived in urban areas.
Stress-Related?
Investigators found no correlation between racial discrimination and increased levels of AD blood biomarkers in 2008 when participants were a mean age of 46 years. However, 11 years later, when participants were roughly 57 years old, investigators found experiencing racism in middle age was significantly correlated with higher levels of both p-Tau181 (r = 0.158; P ≤ .012) and NfL (r = 0.143; P ≤ .023). There was no significant association between reported discrimination and GFAP.
“These findings support the hypothesis that unique life stressors encountered by Black Americans in midlife become biologically embedded and contribute to AD pathology and neurodegeneration later in life,” the authors wrote.
Investigators speculated based on previous research that the stress related to discrimination may be associated with reductions in hippocampal and prefrontal cortex volumes and neurodegeneration in general.
Dr. Mielke also said it’s clear that future studies should focus on racism experienced by Black Americans to further understand their risk for dementia.
“This research can help inform policies and interventions to reduce racial disparities and reduce dementia risk,” she said.
Study limitations include the absence of amyloid biomarkers. Investigators noted that participants had non-detectable levels of amyloid, likely due to the use of serum vs cerebrospinal fluid.
The study was funded by the National Institute on Aging and the National Heart, Lung, and Blood Institute. Mielke reported serving on scientific advisory boards and/or having consulted for Acadia, Biogen, Eisai, LabCorp, Lilly, Merck, PeerView Institute, Roche, Siemens Healthineers, and Sunbird Bio.
A version of this article appeared on Medscape.com.
Racial discrimination in Black Americans is associated with an increased risk of developing Alzheimer’s disease (AD) in later life, new findings showed.
Researchers found that Black Americans who experience racism in their 40s and 50s are more likely to have increased serum levels of AD biomarkers p-tau181 and neurofilament light (NfL) more than a decade later.
“We know that Black Americans are at an elevated risk of Alzheimer’s disease and other dementias compared to non-Hispanic White Americans, but we don’t fully understand all the factors that contribute to this disproportionate risk,” Michelle Mielke, PhD, co-author and professor of epidemiology and prevention at Wake Forest University School of Medicine, Winston-Salem, North Carolina, said in a press release.
Recent data show AD is twice as prevalent in Black Americans as in Whites, at 18.6% and 10%, respectively. Dr. Mielke said this level of disparity cannot be attributed solely to genetic differences, and evidence suggests that racism and its related stress may play a role.
The findings were published online in Alzheimer’s and Dementia.
AD Biomarker Testing
To further explore a possible link between exposure to racism and AD risk, investigators analyzed data from the Family and Community Health Study, a multisite, longitudinal investigation that included more than 800 families in the United States.
Blood samples and information on racial discrimination were collected from 255 middle-aged Black Americans between 2002 and 2005.
Blood samples were tested for serum phosphorylated tau181 (p-Tau181), a marker of AD pathology; NfL, a nonspecific marker of neurodegeneration; and glial fibrillary acidic protein (GFAP), a marker of brain inflammation.
Participants answered questions about racial discrimination, which included whether they have been subjected to disrespectful treatment including racial slurs, harassment from law enforcement, or if they had ever been excluded from social activities because of their race.
The sample included 212 females and 43 males with a mean age of 46. Most participants (70%) lived in urban areas.
Stress-Related?
Investigators found no correlation between racial discrimination and increased levels of AD blood biomarkers in 2008 when participants were a mean age of 46 years. However, 11 years later, when participants were roughly 57 years old, investigators found experiencing racism in middle age was significantly correlated with higher levels of both p-Tau181 (r = 0.158; P ≤ .012) and NfL (r = 0.143; P ≤ .023). There was no significant association between reported discrimination and GFAP.
“These findings support the hypothesis that unique life stressors encountered by Black Americans in midlife become biologically embedded and contribute to AD pathology and neurodegeneration later in life,” the authors wrote.
Investigators speculated based on previous research that the stress related to discrimination may be associated with reductions in hippocampal and prefrontal cortex volumes and neurodegeneration in general.
Dr. Mielke also said it’s clear that future studies should focus on racism experienced by Black Americans to further understand their risk for dementia.
“This research can help inform policies and interventions to reduce racial disparities and reduce dementia risk,” she said.
Study limitations include the absence of amyloid biomarkers. Investigators noted that participants had non-detectable levels of amyloid, likely due to the use of serum vs cerebrospinal fluid.
The study was funded by the National Institute on Aging and the National Heart, Lung, and Blood Institute. Mielke reported serving on scientific advisory boards and/or having consulted for Acadia, Biogen, Eisai, LabCorp, Lilly, Merck, PeerView Institute, Roche, Siemens Healthineers, and Sunbird Bio.
A version of this article appeared on Medscape.com.
Racial discrimination in Black Americans is associated with an increased risk of developing Alzheimer’s disease (AD) in later life, new findings showed.
Researchers found that Black Americans who experience racism in their 40s and 50s are more likely to have increased serum levels of AD biomarkers p-tau181 and neurofilament light (NfL) more than a decade later.
“We know that Black Americans are at an elevated risk of Alzheimer’s disease and other dementias compared to non-Hispanic White Americans, but we don’t fully understand all the factors that contribute to this disproportionate risk,” Michelle Mielke, PhD, co-author and professor of epidemiology and prevention at Wake Forest University School of Medicine, Winston-Salem, North Carolina, said in a press release.
Recent data show AD is twice as prevalent in Black Americans as in Whites, at 18.6% and 10%, respectively. Dr. Mielke said this level of disparity cannot be attributed solely to genetic differences, and evidence suggests that racism and its related stress may play a role.
The findings were published online in Alzheimer’s and Dementia.
AD Biomarker Testing
To further explore a possible link between exposure to racism and AD risk, investigators analyzed data from the Family and Community Health Study, a multisite, longitudinal investigation that included more than 800 families in the United States.
Blood samples and information on racial discrimination were collected from 255 middle-aged Black Americans between 2002 and 2005.
Blood samples were tested for serum phosphorylated tau181 (p-Tau181), a marker of AD pathology; NfL, a nonspecific marker of neurodegeneration; and glial fibrillary acidic protein (GFAP), a marker of brain inflammation.
Participants answered questions about racial discrimination, which included whether they have been subjected to disrespectful treatment including racial slurs, harassment from law enforcement, or if they had ever been excluded from social activities because of their race.
The sample included 212 females and 43 males with a mean age of 46. Most participants (70%) lived in urban areas.
Stress-Related?
Investigators found no correlation between racial discrimination and increased levels of AD blood biomarkers in 2008 when participants were a mean age of 46 years. However, 11 years later, when participants were roughly 57 years old, investigators found experiencing racism in middle age was significantly correlated with higher levels of both p-Tau181 (r = 0.158; P ≤ .012) and NfL (r = 0.143; P ≤ .023). There was no significant association between reported discrimination and GFAP.
“These findings support the hypothesis that unique life stressors encountered by Black Americans in midlife become biologically embedded and contribute to AD pathology and neurodegeneration later in life,” the authors wrote.
Investigators speculated based on previous research that the stress related to discrimination may be associated with reductions in hippocampal and prefrontal cortex volumes and neurodegeneration in general.
Dr. Mielke also said it’s clear that future studies should focus on racism experienced by Black Americans to further understand their risk for dementia.
“This research can help inform policies and interventions to reduce racial disparities and reduce dementia risk,” she said.
Study limitations include the absence of amyloid biomarkers. Investigators noted that participants had non-detectable levels of amyloid, likely due to the use of serum vs cerebrospinal fluid.
The study was funded by the National Institute on Aging and the National Heart, Lung, and Blood Institute. Mielke reported serving on scientific advisory boards and/or having consulted for Acadia, Biogen, Eisai, LabCorp, Lilly, Merck, PeerView Institute, Roche, Siemens Healthineers, and Sunbird Bio.
A version of this article appeared on Medscape.com.
Lecanemab’s Promise and Peril: Alzheimer’s Treatment Dilemma
Clinicians interested in treating patients with symptoms of mild cognitive impairment or mild dementia should carefully analyze the potential benefits and harms of monoclonal amyloid beta therapy, including likelihood of side effects and overall burden on the patient, according to researchers at the annual meeting of the American Geriatrics Society (AGS).
Lecanemab (Leqembi) may help some patients by lowering the level of beta-amyloid protein in the brain. Results from a phase 3 trial presented at the conference showed participants with Alzheimer’s disease had a 27% slower progression of the disease compared with placebo.
But clinicians must weigh that advantage against risks and contraindications, according to Esther Oh, MD, PhD, an associate professor in the Division of Geriatric Medicine and Gerontology and co-director of the Johns Hopkins Memory and Alzheimer’s Treatment Center, Johns Hopkins University, Baltimore, Maryland, who spoke during a plenary session. Lecanemab gained accelerated approval by the US Food and Drug Administration in January 2023 and full approval in July 2023.
The results from CLARITY, an 18-month, multicenter, double-blind trial involving 1795 participants aged 50-90 years, showed that the variation between treatment and placebo did not meet the criteria for a minimum clinically important difference for mild cognitive impairment or mild Alzheimer’s disease.
Even more concerning to Dr. Oh was the rate of amyloid-related abnormalities on brain imaging, which can cause brain edema and hemorrhage (12.6% and 17.3%, respectively). Almost 85% of cases were asymptomatic.
The risk for abnormalities indicates that thrombolytics are contraindicated for patients taking the drug, according to Dr. Oh.
“Appropriate use recommendations exclude vitamin K antagonists such as warfarin, direct oral anticoagulants and heparin, although aspirin and other antiplatelet agents are allowed,” Dr. Oh said during the presentation.
Blood biomarkers, PET imaging, and levels of amyloid-beta proteins in cerebrospinal fluid are used to determine eligibility for lecanemab. However, tau biomarkers may indicate signs of cognitive impairment decades prior to symptoms. Some evidence indicates that the drug may be more effective in individuals with low tau levels that are evident in earlier stages of disease. Tau can also be determined from cerebrospinal fluid, however, “we do not factor in tau protein as a biomarker for treatment eligibility, but this may become an important biomarker in the future,” Dr. Oh said.
Lecanemab is cost-prohibitive for many patients, with an annual price tag of $26,000. Treatment also requires monthly infusions, a PET, intravenous administration, lab work, multiple MRIs, and potentially an APOE4 serum test.
Medicare covers the majority of services, but patients are responsible for deductibles and copays, an estimated $7000 annually, according to Shari Ling, MD, deputy chief medical officer with the US Centers for Medicare & Medicaid Services, who also spoke during the session. Supplemental or other insurance such as Medicaid are also not included in this estimate.
The Medicare population is growing more complex over time, Dr. Ling said. In 2021, 54% of beneficiaries had five or more comorbidities, which can affect eligibility for lecanemab.
“Across the healthcare system, we are learning what is necessary for coordination of delivery, for evaluation of people who receive these treatments, and for the care that is not anticipated,” Dr. Ling noted.
Neither speaker reported any financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Clinicians interested in treating patients with symptoms of mild cognitive impairment or mild dementia should carefully analyze the potential benefits and harms of monoclonal amyloid beta therapy, including likelihood of side effects and overall burden on the patient, according to researchers at the annual meeting of the American Geriatrics Society (AGS).
Lecanemab (Leqembi) may help some patients by lowering the level of beta-amyloid protein in the brain. Results from a phase 3 trial presented at the conference showed participants with Alzheimer’s disease had a 27% slower progression of the disease compared with placebo.
But clinicians must weigh that advantage against risks and contraindications, according to Esther Oh, MD, PhD, an associate professor in the Division of Geriatric Medicine and Gerontology and co-director of the Johns Hopkins Memory and Alzheimer’s Treatment Center, Johns Hopkins University, Baltimore, Maryland, who spoke during a plenary session. Lecanemab gained accelerated approval by the US Food and Drug Administration in January 2023 and full approval in July 2023.
The results from CLARITY, an 18-month, multicenter, double-blind trial involving 1795 participants aged 50-90 years, showed that the variation between treatment and placebo did not meet the criteria for a minimum clinically important difference for mild cognitive impairment or mild Alzheimer’s disease.
Even more concerning to Dr. Oh was the rate of amyloid-related abnormalities on brain imaging, which can cause brain edema and hemorrhage (12.6% and 17.3%, respectively). Almost 85% of cases were asymptomatic.
The risk for abnormalities indicates that thrombolytics are contraindicated for patients taking the drug, according to Dr. Oh.
“Appropriate use recommendations exclude vitamin K antagonists such as warfarin, direct oral anticoagulants and heparin, although aspirin and other antiplatelet agents are allowed,” Dr. Oh said during the presentation.
Blood biomarkers, PET imaging, and levels of amyloid-beta proteins in cerebrospinal fluid are used to determine eligibility for lecanemab. However, tau biomarkers may indicate signs of cognitive impairment decades prior to symptoms. Some evidence indicates that the drug may be more effective in individuals with low tau levels that are evident in earlier stages of disease. Tau can also be determined from cerebrospinal fluid, however, “we do not factor in tau protein as a biomarker for treatment eligibility, but this may become an important biomarker in the future,” Dr. Oh said.
Lecanemab is cost-prohibitive for many patients, with an annual price tag of $26,000. Treatment also requires monthly infusions, a PET, intravenous administration, lab work, multiple MRIs, and potentially an APOE4 serum test.
Medicare covers the majority of services, but patients are responsible for deductibles and copays, an estimated $7000 annually, according to Shari Ling, MD, deputy chief medical officer with the US Centers for Medicare & Medicaid Services, who also spoke during the session. Supplemental or other insurance such as Medicaid are also not included in this estimate.
The Medicare population is growing more complex over time, Dr. Ling said. In 2021, 54% of beneficiaries had five or more comorbidities, which can affect eligibility for lecanemab.
“Across the healthcare system, we are learning what is necessary for coordination of delivery, for evaluation of people who receive these treatments, and for the care that is not anticipated,” Dr. Ling noted.
Neither speaker reported any financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Clinicians interested in treating patients with symptoms of mild cognitive impairment or mild dementia should carefully analyze the potential benefits and harms of monoclonal amyloid beta therapy, including likelihood of side effects and overall burden on the patient, according to researchers at the annual meeting of the American Geriatrics Society (AGS).
Lecanemab (Leqembi) may help some patients by lowering the level of beta-amyloid protein in the brain. Results from a phase 3 trial presented at the conference showed participants with Alzheimer’s disease had a 27% slower progression of the disease compared with placebo.
But clinicians must weigh that advantage against risks and contraindications, according to Esther Oh, MD, PhD, an associate professor in the Division of Geriatric Medicine and Gerontology and co-director of the Johns Hopkins Memory and Alzheimer’s Treatment Center, Johns Hopkins University, Baltimore, Maryland, who spoke during a plenary session. Lecanemab gained accelerated approval by the US Food and Drug Administration in January 2023 and full approval in July 2023.
The results from CLARITY, an 18-month, multicenter, double-blind trial involving 1795 participants aged 50-90 years, showed that the variation between treatment and placebo did not meet the criteria for a minimum clinically important difference for mild cognitive impairment or mild Alzheimer’s disease.
Even more concerning to Dr. Oh was the rate of amyloid-related abnormalities on brain imaging, which can cause brain edema and hemorrhage (12.6% and 17.3%, respectively). Almost 85% of cases were asymptomatic.
The risk for abnormalities indicates that thrombolytics are contraindicated for patients taking the drug, according to Dr. Oh.
“Appropriate use recommendations exclude vitamin K antagonists such as warfarin, direct oral anticoagulants and heparin, although aspirin and other antiplatelet agents are allowed,” Dr. Oh said during the presentation.
Blood biomarkers, PET imaging, and levels of amyloid-beta proteins in cerebrospinal fluid are used to determine eligibility for lecanemab. However, tau biomarkers may indicate signs of cognitive impairment decades prior to symptoms. Some evidence indicates that the drug may be more effective in individuals with low tau levels that are evident in earlier stages of disease. Tau can also be determined from cerebrospinal fluid, however, “we do not factor in tau protein as a biomarker for treatment eligibility, but this may become an important biomarker in the future,” Dr. Oh said.
Lecanemab is cost-prohibitive for many patients, with an annual price tag of $26,000. Treatment also requires monthly infusions, a PET, intravenous administration, lab work, multiple MRIs, and potentially an APOE4 serum test.
Medicare covers the majority of services, but patients are responsible for deductibles and copays, an estimated $7000 annually, according to Shari Ling, MD, deputy chief medical officer with the US Centers for Medicare & Medicaid Services, who also spoke during the session. Supplemental or other insurance such as Medicaid are also not included in this estimate.
The Medicare population is growing more complex over time, Dr. Ling said. In 2021, 54% of beneficiaries had five or more comorbidities, which can affect eligibility for lecanemab.
“Across the healthcare system, we are learning what is necessary for coordination of delivery, for evaluation of people who receive these treatments, and for the care that is not anticipated,” Dr. Ling noted.
Neither speaker reported any financial conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM AGS 2024
Nocturnal Hot Flashes and Alzheimer’s Risk
In a recent article in the American Journal of Obstetrics & Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menopause’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).
Hot flashes are known to be associated with changes in brain white matter, carotid atherosclerosis, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of Alzheimer’s disease biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.
A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.
Previous research has found that menopausal hormone therapy is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who initiate hormone therapy in their late perimenopausal or early postmenopausal years and continue such therapy long term.
The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.
Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.
A version of this article appeared on Medscape.com.
In a recent article in the American Journal of Obstetrics & Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menopause’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).
Hot flashes are known to be associated with changes in brain white matter, carotid atherosclerosis, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of Alzheimer’s disease biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.
A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.
Previous research has found that menopausal hormone therapy is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who initiate hormone therapy in their late perimenopausal or early postmenopausal years and continue such therapy long term.
The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.
Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.
A version of this article appeared on Medscape.com.
In a recent article in the American Journal of Obstetrics & Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menopause’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).
Hot flashes are known to be associated with changes in brain white matter, carotid atherosclerosis, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of Alzheimer’s disease biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.
A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.
Previous research has found that menopausal hormone therapy is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who initiate hormone therapy in their late perimenopausal or early postmenopausal years and continue such therapy long term.
The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.
Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.
A version of this article appeared on Medscape.com.
Lower Urinary Tract Symptoms Associated With Poorer Cognition in Older Adults
Lower urinary tract symptoms were significantly associated with lower scores on measures of cognitive impairment in older adults, based on data from approximately 10,000 individuals.
“We know that lower urinary tract symptoms are very common in aging men and women;” however, older adults often underreport symptoms and avoid seeking treatment, Belinda Williams, MD, of the University of Alabama, Birmingham, said in a presentation at the annual meeting of the American Geriatrics Society.
“Evidence also shows us that the incidence of lower urinary tract symptoms (LUTS) is higher in patients with dementia,” she said. However, the association between cognitive impairment and LUTS has not been well studied, she said.
To address this knowledge gap, Dr. Williams and colleagues reviewed data from older adults with and without LUTS who were enrolled in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, a cohort study including 30,239 Black or White adults aged 45 years and older who completed telephone or in-home assessments in 2003-2007 and in 2013-2017.
The study population included 6062 women and 4438 men who responded to questionnaires about LUTS and completed several cognitive tests via telephone in 2019-2010. The tests evaluated verbal fluency, executive function, and memory, and included the Six-Item Screener, Animal Naming, Letter F naming, and word list learning; lower scores indicated poorer cognitive performance.
Participants who met the criteria for LUTS were categorized as having mild, moderate, or severe symptoms.
The researchers controlled for age, race, education, income, and urban/rural setting in a multivariate analysis. The mean ages of the women and men were 69 years and 63 years, respectively; 41% and 32% were Black, 59% and 68% were White.
Overall, 70% of women and 62% of men reported LUTS; 6.2% and 8.2%, respectively, met criteria for cognitive impairment. The association between cognitive impairment and LUTS was statistically significant for all specific tests (P < .01), but not for the global cognitive domain tests.
Black men were more likely to report LUTS than White men, but LUTS reports were similar between Black and White women.
Moderate LUTS was the most common degree of severity for men and women (54% and 64%, respectively).
The most common symptom overall was pre-toilet leakage (urge urinary incontinence), reported by 94% of women and 91% of men. The next most common symptoms for men and women were nocturia and urgency.
“We found that, across the board, in all the cognitive tests, LUTS were associated with lower cognitive test scores,” Dr. Williams said in her presentation. Little differences were seen on the Six-Item Screener, she noted, but when they further analyzed the data using scores lower than 4 to indicate cognitive impairment, they found significant association with LUTS, she said.
The results showing that the presence of LUTS was consistently associated with lower cognitive test scores of verbal fluency, executive function, and memory, are applicable in clinical practice, Dr. Williams said in her presentation.
“Recognizing the subtle changes in cognition among older adults with LUTS may impact treatment decisions,” she said. “For example, we can encourage and advise our patients to be physically and cognitively active and to avoid anticholinergic medications.”
Next steps for research include analyzing longitudinal changes in cognition among participants with and without LUTS, said Dr. Williams.
During a question-and-answer session, Dr. Williams agreed with a comment that incorporating cognitive screening strategies in to LUTS clinical pathways might be helpful, such as conducting a baseline Montreal Cognitive Assessment Test (MoCA) in patients with LUTS. “Periodic repeat MoCAs thereafter can help assess decline in cognition,” she said.
The study was supported by the National Institutes of Neurological Disorders and Stroke and the National Institute on Aging. The researchers had no financial conflicts to disclose.
Lower urinary tract symptoms were significantly associated with lower scores on measures of cognitive impairment in older adults, based on data from approximately 10,000 individuals.
“We know that lower urinary tract symptoms are very common in aging men and women;” however, older adults often underreport symptoms and avoid seeking treatment, Belinda Williams, MD, of the University of Alabama, Birmingham, said in a presentation at the annual meeting of the American Geriatrics Society.
“Evidence also shows us that the incidence of lower urinary tract symptoms (LUTS) is higher in patients with dementia,” she said. However, the association between cognitive impairment and LUTS has not been well studied, she said.
To address this knowledge gap, Dr. Williams and colleagues reviewed data from older adults with and without LUTS who were enrolled in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, a cohort study including 30,239 Black or White adults aged 45 years and older who completed telephone or in-home assessments in 2003-2007 and in 2013-2017.
The study population included 6062 women and 4438 men who responded to questionnaires about LUTS and completed several cognitive tests via telephone in 2019-2010. The tests evaluated verbal fluency, executive function, and memory, and included the Six-Item Screener, Animal Naming, Letter F naming, and word list learning; lower scores indicated poorer cognitive performance.
Participants who met the criteria for LUTS were categorized as having mild, moderate, or severe symptoms.
The researchers controlled for age, race, education, income, and urban/rural setting in a multivariate analysis. The mean ages of the women and men were 69 years and 63 years, respectively; 41% and 32% were Black, 59% and 68% were White.
Overall, 70% of women and 62% of men reported LUTS; 6.2% and 8.2%, respectively, met criteria for cognitive impairment. The association between cognitive impairment and LUTS was statistically significant for all specific tests (P < .01), but not for the global cognitive domain tests.
Black men were more likely to report LUTS than White men, but LUTS reports were similar between Black and White women.
Moderate LUTS was the most common degree of severity for men and women (54% and 64%, respectively).
The most common symptom overall was pre-toilet leakage (urge urinary incontinence), reported by 94% of women and 91% of men. The next most common symptoms for men and women were nocturia and urgency.
“We found that, across the board, in all the cognitive tests, LUTS were associated with lower cognitive test scores,” Dr. Williams said in her presentation. Little differences were seen on the Six-Item Screener, she noted, but when they further analyzed the data using scores lower than 4 to indicate cognitive impairment, they found significant association with LUTS, she said.
The results showing that the presence of LUTS was consistently associated with lower cognitive test scores of verbal fluency, executive function, and memory, are applicable in clinical practice, Dr. Williams said in her presentation.
“Recognizing the subtle changes in cognition among older adults with LUTS may impact treatment decisions,” she said. “For example, we can encourage and advise our patients to be physically and cognitively active and to avoid anticholinergic medications.”
Next steps for research include analyzing longitudinal changes in cognition among participants with and without LUTS, said Dr. Williams.
During a question-and-answer session, Dr. Williams agreed with a comment that incorporating cognitive screening strategies in to LUTS clinical pathways might be helpful, such as conducting a baseline Montreal Cognitive Assessment Test (MoCA) in patients with LUTS. “Periodic repeat MoCAs thereafter can help assess decline in cognition,” she said.
The study was supported by the National Institutes of Neurological Disorders and Stroke and the National Institute on Aging. The researchers had no financial conflicts to disclose.
Lower urinary tract symptoms were significantly associated with lower scores on measures of cognitive impairment in older adults, based on data from approximately 10,000 individuals.
“We know that lower urinary tract symptoms are very common in aging men and women;” however, older adults often underreport symptoms and avoid seeking treatment, Belinda Williams, MD, of the University of Alabama, Birmingham, said in a presentation at the annual meeting of the American Geriatrics Society.
“Evidence also shows us that the incidence of lower urinary tract symptoms (LUTS) is higher in patients with dementia,” she said. However, the association between cognitive impairment and LUTS has not been well studied, she said.
To address this knowledge gap, Dr. Williams and colleagues reviewed data from older adults with and without LUTS who were enrolled in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, a cohort study including 30,239 Black or White adults aged 45 years and older who completed telephone or in-home assessments in 2003-2007 and in 2013-2017.
The study population included 6062 women and 4438 men who responded to questionnaires about LUTS and completed several cognitive tests via telephone in 2019-2010. The tests evaluated verbal fluency, executive function, and memory, and included the Six-Item Screener, Animal Naming, Letter F naming, and word list learning; lower scores indicated poorer cognitive performance.
Participants who met the criteria for LUTS were categorized as having mild, moderate, or severe symptoms.
The researchers controlled for age, race, education, income, and urban/rural setting in a multivariate analysis. The mean ages of the women and men were 69 years and 63 years, respectively; 41% and 32% were Black, 59% and 68% were White.
Overall, 70% of women and 62% of men reported LUTS; 6.2% and 8.2%, respectively, met criteria for cognitive impairment. The association between cognitive impairment and LUTS was statistically significant for all specific tests (P < .01), but not for the global cognitive domain tests.
Black men were more likely to report LUTS than White men, but LUTS reports were similar between Black and White women.
Moderate LUTS was the most common degree of severity for men and women (54% and 64%, respectively).
The most common symptom overall was pre-toilet leakage (urge urinary incontinence), reported by 94% of women and 91% of men. The next most common symptoms for men and women were nocturia and urgency.
“We found that, across the board, in all the cognitive tests, LUTS were associated with lower cognitive test scores,” Dr. Williams said in her presentation. Little differences were seen on the Six-Item Screener, she noted, but when they further analyzed the data using scores lower than 4 to indicate cognitive impairment, they found significant association with LUTS, she said.
The results showing that the presence of LUTS was consistently associated with lower cognitive test scores of verbal fluency, executive function, and memory, are applicable in clinical practice, Dr. Williams said in her presentation.
“Recognizing the subtle changes in cognition among older adults with LUTS may impact treatment decisions,” she said. “For example, we can encourage and advise our patients to be physically and cognitively active and to avoid anticholinergic medications.”
Next steps for research include analyzing longitudinal changes in cognition among participants with and without LUTS, said Dr. Williams.
During a question-and-answer session, Dr. Williams agreed with a comment that incorporating cognitive screening strategies in to LUTS clinical pathways might be helpful, such as conducting a baseline Montreal Cognitive Assessment Test (MoCA) in patients with LUTS. “Periodic repeat MoCAs thereafter can help assess decline in cognition,” she said.
The study was supported by the National Institutes of Neurological Disorders and Stroke and the National Institute on Aging. The researchers had no financial conflicts to disclose.
FROM AGS 2024
Clinicians Call for Easing FDA Warnings on Low-Dose Estrogen
Charles Powell, MD, said he sometimes has a hard time persuading patients to start on low-dose vaginal estrogen, which can help prevent urinary tract infections and ease other symptoms of menopause.
Many women fear taking these vaginal products because of what Dr. Powell considers excessively strong warnings about the risk for cancer and cardiovascular disease linked to daily estrogen pills that were issued in the early 2000s.
He is advocating for the US Food and Drug Administration (FDA) to remove the boxed warning on low-dose estrogen. His efforts are separate from his roles as an associate professor of urology at the Indiana University School of Medicine, and as a member of the American Urological Association (AUA), Dr. Powell said.
In his quest to find out how to change labeling, Dr. Powell has gained a quick education about drug regulation. He has enlisted Representative Jim Baird (R-IN) and Senator Mike Braun (R-IN) to contact the FDA on his behalf, while congressional staff guided him through the hurdles of getting the warning label changed. For instance, a manufacturer of low-dose estrogen may need to become involved.
“You don’t learn this in med school,” Dr. Powell said in an interview.
With this work, Dr. Powell is wading into a long-standing argument between the FDA and some clinicians and researchers about the potential harms of low-dose estrogen.
He is doing so at a time of increased interest in understanding genitourinary syndrome of menopause (GSM), a term coined a decade ago by the International Society for the Study of Women’s Sexual Health and the North American Menopause Society to cover “a constellation of conditions” related to urogenital atrophy.
Symptoms of GSM include vaginal dryness and burning and recurrent urinary tract infections.
The federal government in 2022 began a project budgeted with nearly $1 million to review evidence on treatments, including vaginal and low-dose estrogen. The aim is to eventually help the AUA develop clinical guidelines for addressing GSM.
In addition, a bipartisan Senate bill introduced in May calls for authorizing $125 million over 5 years for the National Institutes of Health (NIH) to fund research on menopause. Senator Patty Murray (D-WA), the lead sponsor of the bill, is a longtime advocate for women’s health and serves as chairwoman for the Senate Appropriations Committee, which largely sets the NIH budget.
“The bottom line is, for too long, menopause has been overlooked, underinvested in and left behind,” Sen. Murray said during a May 2 press conference. “It is well past time to stop treating menopause like some kind of secret and start treating it like the major mainstream public health issue it is.”
Evidence Demands
Increased federal funding for menopause research could help efforts to change the warning label on low-dose estrogen, according to JoAnn Manson, MD, chief of preventive medicine at Brigham and Women’s Hospital in Boston.
Dr. Manson was a leader of the Women’s Health Initiative (WHI), a major federally funded research project launched in 1991 to investigate if hormone therapy and diet could protect older women from chronic diseases related to aging.
Before the WHI, clinicians prescribed hormones to prevent cardiovascular disease, based on evidence from earlier research.
But in 2002, a WHI trial that compared estrogen-progestin tablets with placebo was halted early because of disturbing findings, including an association with higher risk for breast cancer and cardiovascular disease.
Compared with placebo, for every 10,000 women taking estrogen plus progestin annually, incidences of cardiovascular disease, stroke, pulmonary embolism, and invasive breast cancer were seven to eight times higher.
In January 2003, the FDA announced it would put a boxed warning about cardiovascular risk and cancer risk on estrogen products, reflecting the WHI finding.
The agency at the time said clinicians should work with patients to assess risks and benefits of these products to manage the effects of menopause.
But more news on the potential harms of estrogen followed in 2004: A WHI study comparing estrogen-only pills with placebo produced signals of a small increased risk for stroke, although it also indicated no excess risk for breast cancer for at least 6.8 years of use.
Dr. Manson and the North American Menopause Society in 2016 filed a petition with the FDA to remove the boxed warning that appears on the front of low-dose estrogen products. The group wanted the information on risks moved to the usual warning section of the label.
Two years later, the FDA rejected the petition, citing the absence of “well-controlled studies,” to prove low-dose topical estrogen poses less risk to women than the high-dose pills studied in the WHI.
The FDA told this news organization that it stands by the decisions in its rejection of the petition.
Persuading the FDA to revise the labels on low-dose estrogen products likely will require evidence from randomized, large-scale studies, Dr. Manson said. The agency has not been satisfied to date with findings from other kinds of studies, including observational research.
“Once that evidence is available that the benefit-risk profile is different for different formulations and the evidence is compelling and definitive, that warning should change,” Dr. Manson told this news organization.
But the warning continues to have a chilling effect on patient willingness to use low-dose vaginal estrogen, even with the FDA’s continued endorsement of estrogen for menopause symptoms, clinicians told this news organization.
Risa Kagan, MD, a gynecologist at Sutter Health in Berkeley, California, said in many cases her patients’ partners also need to be reassured. Dr. Kagan said she still sees women who have had to discontinue sexual intercourse because of pain. In some cases, the patients will bring the medicine home only to find that the warnings frighten their spouses.
“The spouse says, ‘Oh my God, I don’t want you to get dementia, to get breast cancer, it’s not worth it, so let’s keep doing outercourse’,” meaning sexual relations without penetration, Dr. Kagan said.
Difficult Messaging
From the initial unveiling of disappointing WHI results, clinicians and researchers have stressed that women could continue using estrogen products for managing symptoms of menopause, even while advising strongly against their continued use with the intention of preventing heart disease.
Newly published findings from follow-ups of WHI participants may give clinicians and patients even more confidence for the use of estrogen products in early menopause.
According to the study, which Dr. Manson coauthored, younger women have a low risk for cardiovascular disease and other associated conditions when taking hormone therapy. Risks attributed to these drugs were less than one additional adverse event per 1000 women annually. This population may also derive significant quality-of-life benefits for symptom relief.
Dr. Manson told this news organization that estrogen in lower doses and delivered through the skin as a patch or gel may further reduce risks.
“The WHI findings should never be used as a reason to deny hormone therapy to women in early menopause with bothersome menopausal symptoms,” Dr. Manson said. “Many women are good candidates for treatment and, in shared decision-making with their clinicians, should be able to receive appropriate and personalized healthcare for their needs.”
But the current FDA warning label makes it difficult to help women understand the risk and benefits of low-dose estrogen, according to Stephanie Faubion, MD, MBA, medical director at the North American Menopause Society and director of Mayo Clinic’s Center for Women’s Health in Jacksonville, Florida.
Clinicians now must set aside time to explain the warnings to women when they prescribe low-dose estrogen, Dr. Faubion said.
“The package insert is going to look scary: I prepare women for that because otherwise they often won’t even fill it or use it.”
A version of this article appeared on Medscape.com .
Charles Powell, MD, said he sometimes has a hard time persuading patients to start on low-dose vaginal estrogen, which can help prevent urinary tract infections and ease other symptoms of menopause.
Many women fear taking these vaginal products because of what Dr. Powell considers excessively strong warnings about the risk for cancer and cardiovascular disease linked to daily estrogen pills that were issued in the early 2000s.
He is advocating for the US Food and Drug Administration (FDA) to remove the boxed warning on low-dose estrogen. His efforts are separate from his roles as an associate professor of urology at the Indiana University School of Medicine, and as a member of the American Urological Association (AUA), Dr. Powell said.
In his quest to find out how to change labeling, Dr. Powell has gained a quick education about drug regulation. He has enlisted Representative Jim Baird (R-IN) and Senator Mike Braun (R-IN) to contact the FDA on his behalf, while congressional staff guided him through the hurdles of getting the warning label changed. For instance, a manufacturer of low-dose estrogen may need to become involved.
“You don’t learn this in med school,” Dr. Powell said in an interview.
With this work, Dr. Powell is wading into a long-standing argument between the FDA and some clinicians and researchers about the potential harms of low-dose estrogen.
He is doing so at a time of increased interest in understanding genitourinary syndrome of menopause (GSM), a term coined a decade ago by the International Society for the Study of Women’s Sexual Health and the North American Menopause Society to cover “a constellation of conditions” related to urogenital atrophy.
Symptoms of GSM include vaginal dryness and burning and recurrent urinary tract infections.
The federal government in 2022 began a project budgeted with nearly $1 million to review evidence on treatments, including vaginal and low-dose estrogen. The aim is to eventually help the AUA develop clinical guidelines for addressing GSM.
In addition, a bipartisan Senate bill introduced in May calls for authorizing $125 million over 5 years for the National Institutes of Health (NIH) to fund research on menopause. Senator Patty Murray (D-WA), the lead sponsor of the bill, is a longtime advocate for women’s health and serves as chairwoman for the Senate Appropriations Committee, which largely sets the NIH budget.
“The bottom line is, for too long, menopause has been overlooked, underinvested in and left behind,” Sen. Murray said during a May 2 press conference. “It is well past time to stop treating menopause like some kind of secret and start treating it like the major mainstream public health issue it is.”
Evidence Demands
Increased federal funding for menopause research could help efforts to change the warning label on low-dose estrogen, according to JoAnn Manson, MD, chief of preventive medicine at Brigham and Women’s Hospital in Boston.
Dr. Manson was a leader of the Women’s Health Initiative (WHI), a major federally funded research project launched in 1991 to investigate if hormone therapy and diet could protect older women from chronic diseases related to aging.
Before the WHI, clinicians prescribed hormones to prevent cardiovascular disease, based on evidence from earlier research.
But in 2002, a WHI trial that compared estrogen-progestin tablets with placebo was halted early because of disturbing findings, including an association with higher risk for breast cancer and cardiovascular disease.
Compared with placebo, for every 10,000 women taking estrogen plus progestin annually, incidences of cardiovascular disease, stroke, pulmonary embolism, and invasive breast cancer were seven to eight times higher.
In January 2003, the FDA announced it would put a boxed warning about cardiovascular risk and cancer risk on estrogen products, reflecting the WHI finding.
The agency at the time said clinicians should work with patients to assess risks and benefits of these products to manage the effects of menopause.
But more news on the potential harms of estrogen followed in 2004: A WHI study comparing estrogen-only pills with placebo produced signals of a small increased risk for stroke, although it also indicated no excess risk for breast cancer for at least 6.8 years of use.
Dr. Manson and the North American Menopause Society in 2016 filed a petition with the FDA to remove the boxed warning that appears on the front of low-dose estrogen products. The group wanted the information on risks moved to the usual warning section of the label.
Two years later, the FDA rejected the petition, citing the absence of “well-controlled studies,” to prove low-dose topical estrogen poses less risk to women than the high-dose pills studied in the WHI.
The FDA told this news organization that it stands by the decisions in its rejection of the petition.
Persuading the FDA to revise the labels on low-dose estrogen products likely will require evidence from randomized, large-scale studies, Dr. Manson said. The agency has not been satisfied to date with findings from other kinds of studies, including observational research.
“Once that evidence is available that the benefit-risk profile is different for different formulations and the evidence is compelling and definitive, that warning should change,” Dr. Manson told this news organization.
But the warning continues to have a chilling effect on patient willingness to use low-dose vaginal estrogen, even with the FDA’s continued endorsement of estrogen for menopause symptoms, clinicians told this news organization.
Risa Kagan, MD, a gynecologist at Sutter Health in Berkeley, California, said in many cases her patients’ partners also need to be reassured. Dr. Kagan said she still sees women who have had to discontinue sexual intercourse because of pain. In some cases, the patients will bring the medicine home only to find that the warnings frighten their spouses.
“The spouse says, ‘Oh my God, I don’t want you to get dementia, to get breast cancer, it’s not worth it, so let’s keep doing outercourse’,” meaning sexual relations without penetration, Dr. Kagan said.
Difficult Messaging
From the initial unveiling of disappointing WHI results, clinicians and researchers have stressed that women could continue using estrogen products for managing symptoms of menopause, even while advising strongly against their continued use with the intention of preventing heart disease.
Newly published findings from follow-ups of WHI participants may give clinicians and patients even more confidence for the use of estrogen products in early menopause.
According to the study, which Dr. Manson coauthored, younger women have a low risk for cardiovascular disease and other associated conditions when taking hormone therapy. Risks attributed to these drugs were less than one additional adverse event per 1000 women annually. This population may also derive significant quality-of-life benefits for symptom relief.
Dr. Manson told this news organization that estrogen in lower doses and delivered through the skin as a patch or gel may further reduce risks.
“The WHI findings should never be used as a reason to deny hormone therapy to women in early menopause with bothersome menopausal symptoms,” Dr. Manson said. “Many women are good candidates for treatment and, in shared decision-making with their clinicians, should be able to receive appropriate and personalized healthcare for their needs.”
But the current FDA warning label makes it difficult to help women understand the risk and benefits of low-dose estrogen, according to Stephanie Faubion, MD, MBA, medical director at the North American Menopause Society and director of Mayo Clinic’s Center for Women’s Health in Jacksonville, Florida.
Clinicians now must set aside time to explain the warnings to women when they prescribe low-dose estrogen, Dr. Faubion said.
“The package insert is going to look scary: I prepare women for that because otherwise they often won’t even fill it or use it.”
A version of this article appeared on Medscape.com .
Charles Powell, MD, said he sometimes has a hard time persuading patients to start on low-dose vaginal estrogen, which can help prevent urinary tract infections and ease other symptoms of menopause.
Many women fear taking these vaginal products because of what Dr. Powell considers excessively strong warnings about the risk for cancer and cardiovascular disease linked to daily estrogen pills that were issued in the early 2000s.
He is advocating for the US Food and Drug Administration (FDA) to remove the boxed warning on low-dose estrogen. His efforts are separate from his roles as an associate professor of urology at the Indiana University School of Medicine, and as a member of the American Urological Association (AUA), Dr. Powell said.
In his quest to find out how to change labeling, Dr. Powell has gained a quick education about drug regulation. He has enlisted Representative Jim Baird (R-IN) and Senator Mike Braun (R-IN) to contact the FDA on his behalf, while congressional staff guided him through the hurdles of getting the warning label changed. For instance, a manufacturer of low-dose estrogen may need to become involved.
“You don’t learn this in med school,” Dr. Powell said in an interview.
With this work, Dr. Powell is wading into a long-standing argument between the FDA and some clinicians and researchers about the potential harms of low-dose estrogen.
He is doing so at a time of increased interest in understanding genitourinary syndrome of menopause (GSM), a term coined a decade ago by the International Society for the Study of Women’s Sexual Health and the North American Menopause Society to cover “a constellation of conditions” related to urogenital atrophy.
Symptoms of GSM include vaginal dryness and burning and recurrent urinary tract infections.
The federal government in 2022 began a project budgeted with nearly $1 million to review evidence on treatments, including vaginal and low-dose estrogen. The aim is to eventually help the AUA develop clinical guidelines for addressing GSM.
In addition, a bipartisan Senate bill introduced in May calls for authorizing $125 million over 5 years for the National Institutes of Health (NIH) to fund research on menopause. Senator Patty Murray (D-WA), the lead sponsor of the bill, is a longtime advocate for women’s health and serves as chairwoman for the Senate Appropriations Committee, which largely sets the NIH budget.
“The bottom line is, for too long, menopause has been overlooked, underinvested in and left behind,” Sen. Murray said during a May 2 press conference. “It is well past time to stop treating menopause like some kind of secret and start treating it like the major mainstream public health issue it is.”
Evidence Demands
Increased federal funding for menopause research could help efforts to change the warning label on low-dose estrogen, according to JoAnn Manson, MD, chief of preventive medicine at Brigham and Women’s Hospital in Boston.
Dr. Manson was a leader of the Women’s Health Initiative (WHI), a major federally funded research project launched in 1991 to investigate if hormone therapy and diet could protect older women from chronic diseases related to aging.
Before the WHI, clinicians prescribed hormones to prevent cardiovascular disease, based on evidence from earlier research.
But in 2002, a WHI trial that compared estrogen-progestin tablets with placebo was halted early because of disturbing findings, including an association with higher risk for breast cancer and cardiovascular disease.
Compared with placebo, for every 10,000 women taking estrogen plus progestin annually, incidences of cardiovascular disease, stroke, pulmonary embolism, and invasive breast cancer were seven to eight times higher.
In January 2003, the FDA announced it would put a boxed warning about cardiovascular risk and cancer risk on estrogen products, reflecting the WHI finding.
The agency at the time said clinicians should work with patients to assess risks and benefits of these products to manage the effects of menopause.
But more news on the potential harms of estrogen followed in 2004: A WHI study comparing estrogen-only pills with placebo produced signals of a small increased risk for stroke, although it also indicated no excess risk for breast cancer for at least 6.8 years of use.
Dr. Manson and the North American Menopause Society in 2016 filed a petition with the FDA to remove the boxed warning that appears on the front of low-dose estrogen products. The group wanted the information on risks moved to the usual warning section of the label.
Two years later, the FDA rejected the petition, citing the absence of “well-controlled studies,” to prove low-dose topical estrogen poses less risk to women than the high-dose pills studied in the WHI.
The FDA told this news organization that it stands by the decisions in its rejection of the petition.
Persuading the FDA to revise the labels on low-dose estrogen products likely will require evidence from randomized, large-scale studies, Dr. Manson said. The agency has not been satisfied to date with findings from other kinds of studies, including observational research.
“Once that evidence is available that the benefit-risk profile is different for different formulations and the evidence is compelling and definitive, that warning should change,” Dr. Manson told this news organization.
But the warning continues to have a chilling effect on patient willingness to use low-dose vaginal estrogen, even with the FDA’s continued endorsement of estrogen for menopause symptoms, clinicians told this news organization.
Risa Kagan, MD, a gynecologist at Sutter Health in Berkeley, California, said in many cases her patients’ partners also need to be reassured. Dr. Kagan said she still sees women who have had to discontinue sexual intercourse because of pain. In some cases, the patients will bring the medicine home only to find that the warnings frighten their spouses.
“The spouse says, ‘Oh my God, I don’t want you to get dementia, to get breast cancer, it’s not worth it, so let’s keep doing outercourse’,” meaning sexual relations without penetration, Dr. Kagan said.
Difficult Messaging
From the initial unveiling of disappointing WHI results, clinicians and researchers have stressed that women could continue using estrogen products for managing symptoms of menopause, even while advising strongly against their continued use with the intention of preventing heart disease.
Newly published findings from follow-ups of WHI participants may give clinicians and patients even more confidence for the use of estrogen products in early menopause.
According to the study, which Dr. Manson coauthored, younger women have a low risk for cardiovascular disease and other associated conditions when taking hormone therapy. Risks attributed to these drugs were less than one additional adverse event per 1000 women annually. This population may also derive significant quality-of-life benefits for symptom relief.
Dr. Manson told this news organization that estrogen in lower doses and delivered through the skin as a patch or gel may further reduce risks.
“The WHI findings should never be used as a reason to deny hormone therapy to women in early menopause with bothersome menopausal symptoms,” Dr. Manson said. “Many women are good candidates for treatment and, in shared decision-making with their clinicians, should be able to receive appropriate and personalized healthcare for their needs.”
But the current FDA warning label makes it difficult to help women understand the risk and benefits of low-dose estrogen, according to Stephanie Faubion, MD, MBA, medical director at the North American Menopause Society and director of Mayo Clinic’s Center for Women’s Health in Jacksonville, Florida.
Clinicians now must set aside time to explain the warnings to women when they prescribe low-dose estrogen, Dr. Faubion said.
“The package insert is going to look scary: I prepare women for that because otherwise they often won’t even fill it or use it.”
A version of this article appeared on Medscape.com .