Geriatrics

Wisdom increases with age, and although this personality trait is regarded as nebulous by many, there is evidence that it has biological and neuropsychiatric underpinnings. It could even hold the key to reducing loneliness and burnout among older people.

Courtesy Dr. Tanya T. Nguyen

Those were some of the key messages delivered by Tanya T. Nguyen, PhD, of the department of psychiatry at the University of California, San Diego, who spoke at a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

“To many people, wisdom remains a fuzzy concept that’s difficult to operationalize and measure. It’s analogous to the concepts of consciousness, emotions, and cognitions, which at one point were considered nonscientific, but today we accept them as biological and scientific entities,” Dr. Nguyen said during her talk at the meeting presented by MedscapeLive. MedscapeLive and this news organization are owned by the same parent company.

Interest in quantifying and studying wisdom has picked up in recent years, and Dr. Nguyen gave a definition with six elements that includes prosocial behaviors such as empathy and compassion, as well as emotional regulation, self-reflection, decisiveness, and social decision-making. She also included a spirituality component, though she conceded that this is controversial.

She noted that there are cultural variations in the definition of wisdom, but it has changed little over time, suggesting that it may be biological rather than cultural in nature, and therefore may have a neuropsychiatric underpinning.

Loss of some or all characteristics of wisdom occurs in some behaviors and disorders, including most markedly in the neurodegenerative disorder frontotemporal dementia (FTD), which is characterized by damage only in the prefrontal cortex and anterior temporal lobes. It usually occurs before age 60, and patients exhibit poor social awareness, impulsivity, antisocial behavior, and a lack of insight and empathy.

This and other lines of evidence have led to the suggestion that wisdom may be governed by processes in the prefrontal cortex and the limbic striatum. The prefrontal cortex controls executive functions such as planning, predicting, and anticipating events, as well as managing emotional reactions and impulses. “Thus, wisdom involves parts of the brain that balance cold, hard analytical reasoning with primitive desires and drives, which ultimately leads to self-regulation, social insight, theory of mind, and empathy,” said Dr. Nguyen.

Wisdom has long been associated with age, but age is also linked to cognitive decline. A recent discovery that the brain does not stop evolving at older age may help explain this contradiction. Brains develop in a back to front order, so that the prefrontal cortex is the last to mature. As we age, neural activity shifts from the occipital lobes to the prefrontal cortex and its executive decision-making power.

“The brain may recruit higher-order networks to the prefrontal cortex that are associated with wisdom development,” said Dr. Nguyen. She also pointed out that asymmetry between the left and right hemisphere is reduced with age, as tasks that relied on circuits from one hemisphere or another more often call upon both. “In order to make up for lost synapses and neurons with aging, active older adults use more neuronal networks from both hemispheres to perform the same mental activity,” Dr. Nguyen said.

Some interventions can improve scores in traits associated with wisdom in older adults, and could be an important contributor to improvements in health and longevity, said Dr. Nguyen. Randomized, controlled trials have demonstrated that psychosocial or behavioral interventions can improve elements of wisdom such as prosocial behaviors and emotional regulation, both in people with mental illness and in the general population, with moderate to large effect sizes. But such studies don’t prove an effect on overall wisdom.

Dr. Nguyen’s group tested a manualized intervention called Raise Your Resilience, which attempts to improve wisdom, resilience, and perceived stress through engagement in value-based activities. The intervention achieved positive results in 89 participants in senior housing communities, though the effect sizes were small, possibly because of high baseline resilience. A subanalysis suggested that reduction in loneliness was mediated by an increase in compassion.

“One of the most striking findings from our research on wisdom is this consistent and very strongly negative correlation between wisdom and loneliness,” Dr. Nguyen said. She highlighted other U.S. nationwide and cross-cultural studies that showed inverse relationships between loneliness and wisdom.

Loneliness is an important topic because it can contribute to burnout and suicide rates.

“Loneliness has a profound effect on how we show up in the workplace, in school, and in our communities. And that leads to anxiety, depression, depersonalization, and emotional fatigue. All are key features of burnout. And together loneliness and burnout have contributed to increased rates of suicide by 30%, and opioid-related deaths almost sixfold since the late 1990s,” Dr. Nguyen said.

Loneliness also is associated with worse physical health, and it may be linked to wisdom. “Loneliness can be conceptualized as being caused and maintained by objective circumstances, such as physical or social distancing, and by thoughts, behaviors, and feelings surrounding those experiences, including biased perceptions of social relations, and a negative assessment of one’s social skills, which then results in a discrepancy between one’s desired and perceived social relationships, which then can contribute to social withdrawal,” Dr. Nguyen said.

Dr. Nguyen highlighted the AARP Foundation’s Experience Corps program, which recruits older adults to act as mentors and tutors for children in kindergarten through third grade. It involves 15 hours per week over an entire school year, with a focus on child literacy, development, and behavioral management skills. A study revealed a significant impact. “It showed improvements in children’s grades and happiness, as well as seniors’ mental and physical health,” Dr. Nguyen said.

Dr. Nguyen concluded that wisdom “may be a vaccine against compassion fatigue and burnout that drive today’s behavioral epidemics of loneliness, opioid abuse, and suicide. It’s a tool for our times. It’s nuanced, flexible, pragmatic, compassionate, and it presents a reasonable framework for getting along in the often messy world that we all share.”
 

Implications for psychiatrists

Henry A. Nasrallah, MD, who organized the conference, suggested that the benefits of wisdom may not be limited to patients. He pointed out that surgeons often retire at age 60 or 65 because of declining physical skills, while psychiatrists continue to practice.

“We develop more wisdom and better skills, and we can practice into our 60s and 70s. I know psychiatrists who practice sometimes into their 80s. It’s really a wonderful thing to know that what you do in life develops or enhances the neuroplasticity of certain brain regions. In our case, in psychiatry, it is the brain regions involved in wisdom,” commented Dr. Nasrallah, who is a professor of psychiatry, neurology, and neuroscience at the University of Cincinnati.

Dr. Nguyen has no financial disclosures. Dr. Nasrallah has received grants from Abbott, AstraZeneca, Forest, Janssen, Lilly, Pfizer, and Shire, and advises Abbott, AstraZeneca, and Shire.

Wisdom increases with age, and although this personality trait is regarded as nebulous by many, there is evidence that it has biological and neuropsychiatric underpinnings. It could even hold the key to reducing loneliness and burnout among older people.

Courtesy Dr. Tanya T. Nguyen

Those were some of the key messages delivered by Tanya T. Nguyen, PhD, of the department of psychiatry at the University of California, San Diego, who spoke at a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

“To many people, wisdom remains a fuzzy concept that’s difficult to operationalize and measure. It’s analogous to the concepts of consciousness, emotions, and cognitions, which at one point were considered nonscientific, but today we accept them as biological and scientific entities,” Dr. Nguyen said during her talk at the meeting presented by MedscapeLive. MedscapeLive and this news organization are owned by the same parent company.

Interest in quantifying and studying wisdom has picked up in recent years, and Dr. Nguyen gave a definition with six elements that includes prosocial behaviors such as empathy and compassion, as well as emotional regulation, self-reflection, decisiveness, and social decision-making. She also included a spirituality component, though she conceded that this is controversial.

She noted that there are cultural variations in the definition of wisdom, but it has changed little over time, suggesting that it may be biological rather than cultural in nature, and therefore may have a neuropsychiatric underpinning.

Loss of some or all characteristics of wisdom occurs in some behaviors and disorders, including most markedly in the neurodegenerative disorder frontotemporal dementia (FTD), which is characterized by damage only in the prefrontal cortex and anterior temporal lobes. It usually occurs before age 60, and patients exhibit poor social awareness, impulsivity, antisocial behavior, and a lack of insight and empathy.

This and other lines of evidence have led to the suggestion that wisdom may be governed by processes in the prefrontal cortex and the limbic striatum. The prefrontal cortex controls executive functions such as planning, predicting, and anticipating events, as well as managing emotional reactions and impulses. “Thus, wisdom involves parts of the brain that balance cold, hard analytical reasoning with primitive desires and drives, which ultimately leads to self-regulation, social insight, theory of mind, and empathy,” said Dr. Nguyen.

Wisdom has long been associated with age, but age is also linked to cognitive decline. A recent discovery that the brain does not stop evolving at older age may help explain this contradiction. Brains develop in a back to front order, so that the prefrontal cortex is the last to mature. As we age, neural activity shifts from the occipital lobes to the prefrontal cortex and its executive decision-making power.

“The brain may recruit higher-order networks to the prefrontal cortex that are associated with wisdom development,” said Dr. Nguyen. She also pointed out that asymmetry between the left and right hemisphere is reduced with age, as tasks that relied on circuits from one hemisphere or another more often call upon both. “In order to make up for lost synapses and neurons with aging, active older adults use more neuronal networks from both hemispheres to perform the same mental activity,” Dr. Nguyen said.

Some interventions can improve scores in traits associated with wisdom in older adults, and could be an important contributor to improvements in health and longevity, said Dr. Nguyen. Randomized, controlled trials have demonstrated that psychosocial or behavioral interventions can improve elements of wisdom such as prosocial behaviors and emotional regulation, both in people with mental illness and in the general population, with moderate to large effect sizes. But such studies don’t prove an effect on overall wisdom.

Dr. Nguyen’s group tested a manualized intervention called Raise Your Resilience, which attempts to improve wisdom, resilience, and perceived stress through engagement in value-based activities. The intervention achieved positive results in 89 participants in senior housing communities, though the effect sizes were small, possibly because of high baseline resilience. A subanalysis suggested that reduction in loneliness was mediated by an increase in compassion.

“One of the most striking findings from our research on wisdom is this consistent and very strongly negative correlation between wisdom and loneliness,” Dr. Nguyen said. She highlighted other U.S. nationwide and cross-cultural studies that showed inverse relationships between loneliness and wisdom.

Loneliness is an important topic because it can contribute to burnout and suicide rates.

“Loneliness has a profound effect on how we show up in the workplace, in school, and in our communities. And that leads to anxiety, depression, depersonalization, and emotional fatigue. All are key features of burnout. And together loneliness and burnout have contributed to increased rates of suicide by 30%, and opioid-related deaths almost sixfold since the late 1990s,” Dr. Nguyen said.

Loneliness also is associated with worse physical health, and it may be linked to wisdom. “Loneliness can be conceptualized as being caused and maintained by objective circumstances, such as physical or social distancing, and by thoughts, behaviors, and feelings surrounding those experiences, including biased perceptions of social relations, and a negative assessment of one’s social skills, which then results in a discrepancy between one’s desired and perceived social relationships, which then can contribute to social withdrawal,” Dr. Nguyen said.

Dr. Nguyen highlighted the AARP Foundation’s Experience Corps program, which recruits older adults to act as mentors and tutors for children in kindergarten through third grade. It involves 15 hours per week over an entire school year, with a focus on child literacy, development, and behavioral management skills. A study revealed a significant impact. “It showed improvements in children’s grades and happiness, as well as seniors’ mental and physical health,” Dr. Nguyen said.

Dr. Nguyen concluded that wisdom “may be a vaccine against compassion fatigue and burnout that drive today’s behavioral epidemics of loneliness, opioid abuse, and suicide. It’s a tool for our times. It’s nuanced, flexible, pragmatic, compassionate, and it presents a reasonable framework for getting along in the often messy world that we all share.”
 

Implications for psychiatrists

Henry A. Nasrallah, MD, who organized the conference, suggested that the benefits of wisdom may not be limited to patients. He pointed out that surgeons often retire at age 60 or 65 because of declining physical skills, while psychiatrists continue to practice.

“We develop more wisdom and better skills, and we can practice into our 60s and 70s. I know psychiatrists who practice sometimes into their 80s. It’s really a wonderful thing to know that what you do in life develops or enhances the neuroplasticity of certain brain regions. In our case, in psychiatry, it is the brain regions involved in wisdom,” commented Dr. Nasrallah, who is a professor of psychiatry, neurology, and neuroscience at the University of Cincinnati.

Dr. Nguyen has no financial disclosures. Dr. Nasrallah has received grants from Abbott, AstraZeneca, Forest, Janssen, Lilly, Pfizer, and Shire, and advises Abbott, AstraZeneca, and Shire.

Wisdom increases with age, and although this personality trait is regarded as nebulous by many, there is evidence that it has biological and neuropsychiatric underpinnings. It could even hold the key to reducing loneliness and burnout among older people.

Courtesy Dr. Tanya T. Nguyen

Those were some of the key messages delivered by Tanya T. Nguyen, PhD, of the department of psychiatry at the University of California, San Diego, who spoke at a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

“To many people, wisdom remains a fuzzy concept that’s difficult to operationalize and measure. It’s analogous to the concepts of consciousness, emotions, and cognitions, which at one point were considered nonscientific, but today we accept them as biological and scientific entities,” Dr. Nguyen said during her talk at the meeting presented by MedscapeLive. MedscapeLive and this news organization are owned by the same parent company.

Interest in quantifying and studying wisdom has picked up in recent years, and Dr. Nguyen gave a definition with six elements that includes prosocial behaviors such as empathy and compassion, as well as emotional regulation, self-reflection, decisiveness, and social decision-making. She also included a spirituality component, though she conceded that this is controversial.

She noted that there are cultural variations in the definition of wisdom, but it has changed little over time, suggesting that it may be biological rather than cultural in nature, and therefore may have a neuropsychiatric underpinning.

Loss of some or all characteristics of wisdom occurs in some behaviors and disorders, including most markedly in the neurodegenerative disorder frontotemporal dementia (FTD), which is characterized by damage only in the prefrontal cortex and anterior temporal lobes. It usually occurs before age 60, and patients exhibit poor social awareness, impulsivity, antisocial behavior, and a lack of insight and empathy.

This and other lines of evidence have led to the suggestion that wisdom may be governed by processes in the prefrontal cortex and the limbic striatum. The prefrontal cortex controls executive functions such as planning, predicting, and anticipating events, as well as managing emotional reactions and impulses. “Thus, wisdom involves parts of the brain that balance cold, hard analytical reasoning with primitive desires and drives, which ultimately leads to self-regulation, social insight, theory of mind, and empathy,” said Dr. Nguyen.

Wisdom has long been associated with age, but age is also linked to cognitive decline. A recent discovery that the brain does not stop evolving at older age may help explain this contradiction. Brains develop in a back to front order, so that the prefrontal cortex is the last to mature. As we age, neural activity shifts from the occipital lobes to the prefrontal cortex and its executive decision-making power.

“The brain may recruit higher-order networks to the prefrontal cortex that are associated with wisdom development,” said Dr. Nguyen. She also pointed out that asymmetry between the left and right hemisphere is reduced with age, as tasks that relied on circuits from one hemisphere or another more often call upon both. “In order to make up for lost synapses and neurons with aging, active older adults use more neuronal networks from both hemispheres to perform the same mental activity,” Dr. Nguyen said.

Some interventions can improve scores in traits associated with wisdom in older adults, and could be an important contributor to improvements in health and longevity, said Dr. Nguyen. Randomized, controlled trials have demonstrated that psychosocial or behavioral interventions can improve elements of wisdom such as prosocial behaviors and emotional regulation, both in people with mental illness and in the general population, with moderate to large effect sizes. But such studies don’t prove an effect on overall wisdom.

Dr. Nguyen’s group tested a manualized intervention called Raise Your Resilience, which attempts to improve wisdom, resilience, and perceived stress through engagement in value-based activities. The intervention achieved positive results in 89 participants in senior housing communities, though the effect sizes were small, possibly because of high baseline resilience. A subanalysis suggested that reduction in loneliness was mediated by an increase in compassion.

“One of the most striking findings from our research on wisdom is this consistent and very strongly negative correlation between wisdom and loneliness,” Dr. Nguyen said. She highlighted other U.S. nationwide and cross-cultural studies that showed inverse relationships between loneliness and wisdom.

Loneliness is an important topic because it can contribute to burnout and suicide rates.

“Loneliness has a profound effect on how we show up in the workplace, in school, and in our communities. And that leads to anxiety, depression, depersonalization, and emotional fatigue. All are key features of burnout. And together loneliness and burnout have contributed to increased rates of suicide by 30%, and opioid-related deaths almost sixfold since the late 1990s,” Dr. Nguyen said.

Loneliness also is associated with worse physical health, and it may be linked to wisdom. “Loneliness can be conceptualized as being caused and maintained by objective circumstances, such as physical or social distancing, and by thoughts, behaviors, and feelings surrounding those experiences, including biased perceptions of social relations, and a negative assessment of one’s social skills, which then results in a discrepancy between one’s desired and perceived social relationships, which then can contribute to social withdrawal,” Dr. Nguyen said.

Dr. Nguyen highlighted the AARP Foundation’s Experience Corps program, which recruits older adults to act as mentors and tutors for children in kindergarten through third grade. It involves 15 hours per week over an entire school year, with a focus on child literacy, development, and behavioral management skills. A study revealed a significant impact. “It showed improvements in children’s grades and happiness, as well as seniors’ mental and physical health,” Dr. Nguyen said.

Dr. Nguyen concluded that wisdom “may be a vaccine against compassion fatigue and burnout that drive today’s behavioral epidemics of loneliness, opioid abuse, and suicide. It’s a tool for our times. It’s nuanced, flexible, pragmatic, compassionate, and it presents a reasonable framework for getting along in the often messy world that we all share.”
 

Implications for psychiatrists

Henry A. Nasrallah, MD, who organized the conference, suggested that the benefits of wisdom may not be limited to patients. He pointed out that surgeons often retire at age 60 or 65 because of declining physical skills, while psychiatrists continue to practice.

“We develop more wisdom and better skills, and we can practice into our 60s and 70s. I know psychiatrists who practice sometimes into their 80s. It’s really a wonderful thing to know that what you do in life develops or enhances the neuroplasticity of certain brain regions. In our case, in psychiatry, it is the brain regions involved in wisdom,” commented Dr. Nasrallah, who is a professor of psychiatry, neurology, and neuroscience at the University of Cincinnati.

Dr. Nguyen has no financial disclosures. Dr. Nasrallah has received grants from Abbott, AstraZeneca, Forest, Janssen, Lilly, Pfizer, and Shire, and advises Abbott, AstraZeneca, and Shire.

About one in six patients with heart failure in the United States are skipping doctors’ appointments, not taking their medications as directed, or forgoing some other type of care, and their recalcitrance actually ends up costing the health care system 20%-30% more per patient.

That’s according to a cross-sectional study using data from a large public database reported in JACC: Heart Failure on Aug. 11.

The investigators pooled data on 2,050 patients with HF enrolled in the Medical Expenditure Panel Survey, a public database sponsored by the Agency for Healthcare Research and Quality, from 2004 to 2015. Some 339 of those HF patients were classified in the forgone or delayed (F/D) care group. This is the first study to describe the cost impact of missed care in heart failure, lead author Alexander Thomas, MD, and colleagues wrote.

“I think we make a pretty strong case linking forgone care to higher cost,” Dr. Thomas said in an interview. “Obviously this is a prospective study, so causality is not made based on this study, but there’s a strong association, it appears.” He acknowledged that prospective studies would need to confirm these findings, but added, “I think even this is enough to give us cause to look at the somewhat granular reasons as to why patients are forgoing care.”

Average annual total costs for adults who skipped care were $8,027 higher than for those heart failure patients who kept up with their regimen (P = .02). However, for people 65 and older, the cost differential was even higher: $10,581 (P = .02), which translates into a 50% premium over average costs for compliant elderly patients, noted Dr. Thomas, a cardiovascular medicine fellow at Yale University, New Haven, Conn.

In the nonelderly F/D group, average per-patient costs were $27,000 annually; in the elderly, it was a little over $30,000.

However, nonelderly patients were more likely to forgo care. While 16% of all patients in the study were considered F/D, 27% of nonelderly patients were classified as such vs. 10% of the elderly.
 

Elderly forgoing care drives cost

But, Dr. Thomas said, elderly patients forgoing care drive higher costs because they’re more fragile, have more comorbidities and more advanced heart failure, and tend to decompensate more quickly. “For them, missing one appointment or missing some medications is not nearly as well tolerated as it is in the younger population,” he said. In these elderly patients, inpatient costs accounted for 75% of the increased expense, Dr. Thomas added.

Reasons for forgoing care range from the obvious, such as cost or insurance issues – 191 individuals cited the former, 69 the latter – to more granular reasons, such as transportation issues or lack of time.

The study also found a number of demographic features that were associated with forgone or delayed care: non-Hispanic Black race; lack of insurance; low-income; and worse cardiovascular risk factor profiles.

The study’s call to action is for further research and policy changes aimed at better understanding barriers to care and improving access. “It’s a really great driver for policy interventions to attack this problem and to have the financial backing also to put money and resources into fixing this problem – which is probably not only going to decrease costs and allow more cost-effective care, but lead to better outcomes in this population as well,” Dr. Thomas said.

The sentiment for policy changes was echoed in an accompanying editorial by Khadijah Breathett, MD, MS, a heart failure/transplant cardiologist at the Sarver Heart Center, University of Arizona, Tucson. But she also noted the study exposed insufficiencies with Medicare. In an interview, she expanded on that. 

“Our system is failing this population,” she said of the elderly with heart failure who have forgone care. “I think that’s because of the complexity of our system: One person’s Medicare is different from another’s. There are multiple parts to Medicare that provide different forms of care – hospital care, prescription care, and so forth – and everyone does not necessarily have the same parts.” Also, many Medicare beneficiaries are still working, and “they’re still trying to figure out how to make ends meet,” Dr. Breathett added.

The study also showed that the pre-Medicare population requires the attention of policymakers. “How do we help the younger population so that they don’t develop the comorbidities that worsen their quality of life and contribute to rising hospital costs?” Dr. Breathett said.

Dr. Thomas had no financial relationships to disclose. Dr. Breathett has received grants from the National Heart, Lung, and Blood Institute.

About one in six patients with heart failure in the United States are skipping doctors’ appointments, not taking their medications as directed, or forgoing some other type of care, and their recalcitrance actually ends up costing the health care system 20%-30% more per patient.

That’s according to a cross-sectional study using data from a large public database reported in JACC: Heart Failure on Aug. 11.

The investigators pooled data on 2,050 patients with HF enrolled in the Medical Expenditure Panel Survey, a public database sponsored by the Agency for Healthcare Research and Quality, from 2004 to 2015. Some 339 of those HF patients were classified in the forgone or delayed (F/D) care group. This is the first study to describe the cost impact of missed care in heart failure, lead author Alexander Thomas, MD, and colleagues wrote.

“I think we make a pretty strong case linking forgone care to higher cost,” Dr. Thomas said in an interview. “Obviously this is a prospective study, so causality is not made based on this study, but there’s a strong association, it appears.” He acknowledged that prospective studies would need to confirm these findings, but added, “I think even this is enough to give us cause to look at the somewhat granular reasons as to why patients are forgoing care.”

Average annual total costs for adults who skipped care were $8,027 higher than for those heart failure patients who kept up with their regimen (P = .02). However, for people 65 and older, the cost differential was even higher: $10,581 (P = .02), which translates into a 50% premium over average costs for compliant elderly patients, noted Dr. Thomas, a cardiovascular medicine fellow at Yale University, New Haven, Conn.

In the nonelderly F/D group, average per-patient costs were $27,000 annually; in the elderly, it was a little over $30,000.

However, nonelderly patients were more likely to forgo care. While 16% of all patients in the study were considered F/D, 27% of nonelderly patients were classified as such vs. 10% of the elderly.
 

Elderly forgoing care drives cost

But, Dr. Thomas said, elderly patients forgoing care drive higher costs because they’re more fragile, have more comorbidities and more advanced heart failure, and tend to decompensate more quickly. “For them, missing one appointment or missing some medications is not nearly as well tolerated as it is in the younger population,” he said. In these elderly patients, inpatient costs accounted for 75% of the increased expense, Dr. Thomas added.

Reasons for forgoing care range from the obvious, such as cost or insurance issues – 191 individuals cited the former, 69 the latter – to more granular reasons, such as transportation issues or lack of time.

The study also found a number of demographic features that were associated with forgone or delayed care: non-Hispanic Black race; lack of insurance; low-income; and worse cardiovascular risk factor profiles.

The study’s call to action is for further research and policy changes aimed at better understanding barriers to care and improving access. “It’s a really great driver for policy interventions to attack this problem and to have the financial backing also to put money and resources into fixing this problem – which is probably not only going to decrease costs and allow more cost-effective care, but lead to better outcomes in this population as well,” Dr. Thomas said.

The sentiment for policy changes was echoed in an accompanying editorial by Khadijah Breathett, MD, MS, a heart failure/transplant cardiologist at the Sarver Heart Center, University of Arizona, Tucson. But she also noted the study exposed insufficiencies with Medicare. In an interview, she expanded on that. 

“Our system is failing this population,” she said of the elderly with heart failure who have forgone care. “I think that’s because of the complexity of our system: One person’s Medicare is different from another’s. There are multiple parts to Medicare that provide different forms of care – hospital care, prescription care, and so forth – and everyone does not necessarily have the same parts.” Also, many Medicare beneficiaries are still working, and “they’re still trying to figure out how to make ends meet,” Dr. Breathett added.

The study also showed that the pre-Medicare population requires the attention of policymakers. “How do we help the younger population so that they don’t develop the comorbidities that worsen their quality of life and contribute to rising hospital costs?” Dr. Breathett said.

Dr. Thomas had no financial relationships to disclose. Dr. Breathett has received grants from the National Heart, Lung, and Blood Institute.

About one in six patients with heart failure in the United States are skipping doctors’ appointments, not taking their medications as directed, or forgoing some other type of care, and their recalcitrance actually ends up costing the health care system 20%-30% more per patient.

That’s according to a cross-sectional study using data from a large public database reported in JACC: Heart Failure on Aug. 11.

The investigators pooled data on 2,050 patients with HF enrolled in the Medical Expenditure Panel Survey, a public database sponsored by the Agency for Healthcare Research and Quality, from 2004 to 2015. Some 339 of those HF patients were classified in the forgone or delayed (F/D) care group. This is the first study to describe the cost impact of missed care in heart failure, lead author Alexander Thomas, MD, and colleagues wrote.

“I think we make a pretty strong case linking forgone care to higher cost,” Dr. Thomas said in an interview. “Obviously this is a prospective study, so causality is not made based on this study, but there’s a strong association, it appears.” He acknowledged that prospective studies would need to confirm these findings, but added, “I think even this is enough to give us cause to look at the somewhat granular reasons as to why patients are forgoing care.”

Average annual total costs for adults who skipped care were $8,027 higher than for those heart failure patients who kept up with their regimen (P = .02). However, for people 65 and older, the cost differential was even higher: $10,581 (P = .02), which translates into a 50% premium over average costs for compliant elderly patients, noted Dr. Thomas, a cardiovascular medicine fellow at Yale University, New Haven, Conn.

In the nonelderly F/D group, average per-patient costs were $27,000 annually; in the elderly, it was a little over $30,000.

However, nonelderly patients were more likely to forgo care. While 16% of all patients in the study were considered F/D, 27% of nonelderly patients were classified as such vs. 10% of the elderly.
 

Elderly forgoing care drives cost

But, Dr. Thomas said, elderly patients forgoing care drive higher costs because they’re more fragile, have more comorbidities and more advanced heart failure, and tend to decompensate more quickly. “For them, missing one appointment or missing some medications is not nearly as well tolerated as it is in the younger population,” he said. In these elderly patients, inpatient costs accounted for 75% of the increased expense, Dr. Thomas added.

Reasons for forgoing care range from the obvious, such as cost or insurance issues – 191 individuals cited the former, 69 the latter – to more granular reasons, such as transportation issues or lack of time.

The study also found a number of demographic features that were associated with forgone or delayed care: non-Hispanic Black race; lack of insurance; low-income; and worse cardiovascular risk factor profiles.

The study’s call to action is for further research and policy changes aimed at better understanding barriers to care and improving access. “It’s a really great driver for policy interventions to attack this problem and to have the financial backing also to put money and resources into fixing this problem – which is probably not only going to decrease costs and allow more cost-effective care, but lead to better outcomes in this population as well,” Dr. Thomas said.

The sentiment for policy changes was echoed in an accompanying editorial by Khadijah Breathett, MD, MS, a heart failure/transplant cardiologist at the Sarver Heart Center, University of Arizona, Tucson. But she also noted the study exposed insufficiencies with Medicare. In an interview, she expanded on that. 

“Our system is failing this population,” she said of the elderly with heart failure who have forgone care. “I think that’s because of the complexity of our system: One person’s Medicare is different from another’s. There are multiple parts to Medicare that provide different forms of care – hospital care, prescription care, and so forth – and everyone does not necessarily have the same parts.” Also, many Medicare beneficiaries are still working, and “they’re still trying to figure out how to make ends meet,” Dr. Breathett added.

The study also showed that the pre-Medicare population requires the attention of policymakers. “How do we help the younger population so that they don’t develop the comorbidities that worsen their quality of life and contribute to rising hospital costs?” Dr. Breathett said.

Dr. Thomas had no financial relationships to disclose. Dr. Breathett has received grants from the National Heart, Lung, and Blood Institute.

Study Overview

Objective. To update national trends in the treatment and risk factor control of diabetic patients from 1999 through 2018 in the US using data from the National Health and Nutrition Examination Survey (NHANES) with the goal of identifying population subgroups with the highest probability of having untreated risk factors.

Design. The authors conducted a cross-sectional analysis of data from NHANES focusing on adults with diabetes. They examined patient characteristics and medication use over time and estimated the prevalence of risk factor control and medication use. To minimize the effects of a small sample size, the survey years were pooled into 4-year intervals. The variables studied included glycated hemoglobin (HbA_1c), blood pressure, serum cholesterol, medication use, sociodemographic characteristics, and weight status. For statistical analysis, logistic and multinomial logistic regression models were used to examine factors associated with treatment in participants who did not achieve targets for glycemic, blood pressure, and lipid control. Temporal trends were estimated using 2-piece linear spline models with 1 knot at inflection points.

Setting and participants. The NHANES program began in the early 1960s to monitor the health of the US population. In 1999, the survey became a continuous program combining interviews and physical examinations. The survey examines a nationally representative sample of about 5000 persons each year. This study included 6653 participants who were nonpregnant, aged older than 20 years, reported a diagnosis of diabetes from a physician, and participated in NHANES from 1999 through 2018.

Main outcome measures. The main outcome measures were temporal trends in risk factor control (glycemic, blood pressure, or lipid levels) and medication use (glucose lowering, blood pressure lowering, or lipid lowering medications), and number as well as class of drug used, from 1999 through 2018 in diabetic adults from the US participating in NHANES.

Results. Sociodemographic characteristics of the studied diabetes population—The age and racial or ethnic distribution of participants with diabetes were stable from 1999 through 2018, whereas participants with a college degree, higher income, health insurance, obesity, or long-standing diabetes increased during the same period.

Trends in diabetes risk factor control—The trends for glycemic, blood pressure, and lipid control were nonlinear, with an inflection point around 2010. Glycemic control was defined as HbA_1c less than 7%, blood pressure was considered controlled if less than 140/90 mmHg, and lipid was controlled if non-HDL cholesterol level was less than 130 mg/dL. Although these chosen targets were based on the most recent clinical guidelines, the authors declared that they observed similar trends when alternative targets were used. The level of risk factor control improved in all diabetic patients from 1999 through 2010. However, the percentage of adult diabetic participants for whom glycemic control was achieved declined from 57.4% (95% CI, 52.9-61.8) in 2007-2010 to 50.5% (95% CI, 45.8-55.3) in 2015-2018. Blood pressure control was achieved in 74.2% of participants (95% CI, 70.7-77.4) in 2011-2014 but declined to 70.4% (95% CI, 66.7-73.8) in 2015-2018. Control in lipid levels improved during the entire study period; however, the rate of improvement heavily declined after 2007 with lipid target levels attained in 52.3% of participants (95% CI, 49.2-55.3) in 2007-2014 and 55.7% (95% CI, 50.8-60.5) in 2015-2018. Finally, the percentage of participants in whom targets for all 3 risk factors were simultaneously achieved plateaued after 2010 and was 22.2% (95% CI, 17.9-27.3) in 2015-2018.

Trends in diabetes treatment—The use of glucose lowering drugs increased from 74.1% in 1999-2002 to 82.7% in 2007-2010 and then stabilized. A shift toward a safer glucose lowering treatment choice was observed with a decline in the use of older glucose lowering medications such as sulfonylureas, which increases the risk of hypoglycemia, and an increase in the use of metformin, insulin, and newer agents such as sodium-glucose cotransporter 2 inhibitors.

Similarly, blood pressure lowering medication use rose from 1999-2002 to 2007-2010 and then stabilized, with increased use of first-line recommended treatments including angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers. Likewise, statin use rose from 28.4% in 1999-2002 to 56% in 2011-2014 and then stabilized. The total number of drugs used culminated in 2011-2014 with 60% of participants using more than 5 drugs and then leveled off to 57.2% in 2015-2018. Lastly, health insurance status and race or ethnicity impacted the likelihood of receiving monotherapy or combination drug therapy when targets for glycemic, blood pressure, or lipid control were not achieved.

Conclusion. Despite great progress in the control of diabetes and its associated risk factors between 1999 and 2010, this trend declined for glycemic and blood pressure control and leveled off for lipid control in adult NHANES participants with diabetes after 2010. First-line treatments for diabetes and associated risk factors remain underused, and treatment intensification may not be sufficiently considered in patients with uncontrolled risk factors despite clinical guideline recommendations. The findings of this study may portend a possible population-level increase in diabetes-related illnesses in the years to come.

Commentary

The thorough understanding of trends in management of diseases is critical to inform public health policies and planning. Well designed clinical studies heavily influence the development of public health policies and clinical guidelines, which in turn drive real-world clinical practice. In a recent analysis utilizing data from NHANES, Fang et al¹ showed evidence of a general shift toward less intensive treatment of diabetes, hypertension, and hypercholesterolemia in adults living in the US during the last decade.

Similarly, in a separate study using NHANES data collected between 1999 and 2018 published in JAMA just 2 weeks after the current report, Wang et al² confirms this declining trend in diabetes management with only 21.2% of diabetic adults simultaneously attaining glycemic, blood pressure, and lipid level targets during the same period. What led to the decline in more stringent risk factor and diabetes management since 2010 observed in these studies? One possible explanation, as suggested by Fang et al, is that major clinical trials from the late 2000s­—including Action to Control Cardiovascular Risk in Diabetes, UK Prospective Diabetes Study, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, and Veterans Affairs Diabetes Trial—that assessed the effects of intensive glycemic control (with target HbA_1c < 6.5%) found that intensive treatment of diabetes compared to standard care had no cardiovascular benefit albeit increasing the risk of hypoglycemia. Thus, these trial findings may have translated into suboptimal diabetes treatment observed in some NHANES participants. Wang et al propose that effective tailored approaches are needed to improve risk factor control in diabetic patients, such as enhance and maintain adherence to medications and healthy lifestyle behaviors, as well as better access to health care and therapeutic education.

The changes in recent trends in diabetes management have immense clinical implications. The authors of this study suggest a link between the recent relaxation of glycemic targets, as well as risk factor control, and a resurgence of diabetic complications such as lower limb amputation or stroke. Indeed, several recent studies indicate an upward trend or plateau in diabetic complications which had been decreasing in prevalence prior to 2010.³ For example, lower extremity amputation has surged by more than 25% between 2010 and 2015, especially in young and middle-aged adults.⁴ Among the arguments brought forward that this recent resurgence in amputations is directly linked to worsening glycemic control is the fact that between 2007 and 2010, when glucose levels were best controlled within the previous 30-year period, amputations were also at the lowest levels. Moreover, data from the Centers for Disease Control and Prevention also show a 55% increase in mortality (from 15.7 to 24.2 per 1000) among diabetic patients between 2010 and 2015.¹⁴ On the other hand, a growing number of studies show that an increase of inappropriate treatment intensification—reaching HbA_1c levels that are way below the recommended targets—is associated with adverse consequences in diabetic patients particularly in those aged more than 65 years.^5-7 These seemingly contradictory findings highlight the importance of a personalized and thoughtful approach to the management of diabetes and its risk factors. As an example, an increase in the use of newer and safer glucose lowering drugs (eg, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase 4 inhibitors) can help achieve better HbA_1c goals with a reduced risk of hypoglycemic episodes as recently shown by a Danish study.⁸ In this study, the authors concluded that the reduction of the rate of hypoglycemic episodes leading to hospitalization in Denmark was directly linked to the use of these safer and newer glucose lowering drugs.

A discussion on the specifics of trends in diabetes treatment and control must include considerations in older adults aged more than 65 years who constitute more than 40% of the diabetic population. Despite the high prevalence of diabetes in this vulnerable population, such data are still insufficient in the literature and are critically needed to inform public health policies and clinical guidelines. In epidemiological studies focusing on diabetic complications from the last 10 years, concerning increases have been observed in younger⁹ and middle-aged adults while remaining stable in older adults. However, the risk of hypoglycemia or severe hypoglycemia remains high in older adults living in nursing facilities, even in those with an elevated HbA_1c of greater than 8%.⁷ Moreover, in light of more relaxed HbA_1c treatment goals for older frail adults as recommended by international guidelines since 2010,^10,11 recent findings from the French GERODIAB cohort show an increased mortality (hazard ratio, 1.76) in type 2 diabetics aged 70 years and older with HbA_1c greater than or equal to 8.6%.¹² Similarly, a 5-year retrospective British study from 2018 which included patients aged 70 years and older, shows an increased overall mortality in those with HbA_1c greater than 8.5%.¹³ Taken together, further age-stratified analysis utilizing data from large cohort studies including NHANES may help to clarify national trends in diabetes treatment and risk factor control as well as diabetic complications specific to the geriatric population. By being better informed of such trends, clinicians could then develop treatment strategies that minimize complications (eg, hypoglycemia, falls) while achieving favorable outcomes (eg, reduce hyperglycemic emergencies, improve survival) in frail older patients.

Applications for Clinical Practice

The understanding of population-wide trends in diabetes control is critical to planning public health approaches for the prevention and treatment of this disease and its complications. In older adults, the high risk of hypoglycemic events and insufficient epidemiological data on trends of diabetes control hinder diabetes management. Personalized treatment targets taking into account geriatric syndromes and general health status, as well as multidisciplinary management involving endocrinologists, geriatricians, and clinical pharmacists, are necessary to optimize care in older adults with diabetes.

Study Overview

Objective. To update national trends in the treatment and risk factor control of diabetic patients from 1999 through 2018 in the US using data from the National Health and Nutrition Examination Survey (NHANES) with the goal of identifying population subgroups with the highest probability of having untreated risk factors.

Design. The authors conducted a cross-sectional analysis of data from NHANES focusing on adults with diabetes. They examined patient characteristics and medication use over time and estimated the prevalence of risk factor control and medication use. To minimize the effects of a small sample size, the survey years were pooled into 4-year intervals. The variables studied included glycated hemoglobin (HbA_1c), blood pressure, serum cholesterol, medication use, sociodemographic characteristics, and weight status. For statistical analysis, logistic and multinomial logistic regression models were used to examine factors associated with treatment in participants who did not achieve targets for glycemic, blood pressure, and lipid control. Temporal trends were estimated using 2-piece linear spline models with 1 knot at inflection points.

Setting and participants. The NHANES program began in the early 1960s to monitor the health of the US population. In 1999, the survey became a continuous program combining interviews and physical examinations. The survey examines a nationally representative sample of about 5000 persons each year. This study included 6653 participants who were nonpregnant, aged older than 20 years, reported a diagnosis of diabetes from a physician, and participated in NHANES from 1999 through 2018.

Main outcome measures. The main outcome measures were temporal trends in risk factor control (glycemic, blood pressure, or lipid levels) and medication use (glucose lowering, blood pressure lowering, or lipid lowering medications), and number as well as class of drug used, from 1999 through 2018 in diabetic adults from the US participating in NHANES.

Results. Sociodemographic characteristics of the studied diabetes population—The age and racial or ethnic distribution of participants with diabetes were stable from 1999 through 2018, whereas participants with a college degree, higher income, health insurance, obesity, or long-standing diabetes increased during the same period.

Trends in diabetes risk factor control—The trends for glycemic, blood pressure, and lipid control were nonlinear, with an inflection point around 2010. Glycemic control was defined as HbA_1c less than 7%, blood pressure was considered controlled if less than 140/90 mmHg, and lipid was controlled if non-HDL cholesterol level was less than 130 mg/dL. Although these chosen targets were based on the most recent clinical guidelines, the authors declared that they observed similar trends when alternative targets were used. The level of risk factor control improved in all diabetic patients from 1999 through 2010. However, the percentage of adult diabetic participants for whom glycemic control was achieved declined from 57.4% (95% CI, 52.9-61.8) in 2007-2010 to 50.5% (95% CI, 45.8-55.3) in 2015-2018. Blood pressure control was achieved in 74.2% of participants (95% CI, 70.7-77.4) in 2011-2014 but declined to 70.4% (95% CI, 66.7-73.8) in 2015-2018. Control in lipid levels improved during the entire study period; however, the rate of improvement heavily declined after 2007 with lipid target levels attained in 52.3% of participants (95% CI, 49.2-55.3) in 2007-2014 and 55.7% (95% CI, 50.8-60.5) in 2015-2018. Finally, the percentage of participants in whom targets for all 3 risk factors were simultaneously achieved plateaued after 2010 and was 22.2% (95% CI, 17.9-27.3) in 2015-2018.

Trends in diabetes treatment—The use of glucose lowering drugs increased from 74.1% in 1999-2002 to 82.7% in 2007-2010 and then stabilized. A shift toward a safer glucose lowering treatment choice was observed with a decline in the use of older glucose lowering medications such as sulfonylureas, which increases the risk of hypoglycemia, and an increase in the use of metformin, insulin, and newer agents such as sodium-glucose cotransporter 2 inhibitors.

Similarly, blood pressure lowering medication use rose from 1999-2002 to 2007-2010 and then stabilized, with increased use of first-line recommended treatments including angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers. Likewise, statin use rose from 28.4% in 1999-2002 to 56% in 2011-2014 and then stabilized. The total number of drugs used culminated in 2011-2014 with 60% of participants using more than 5 drugs and then leveled off to 57.2% in 2015-2018. Lastly, health insurance status and race or ethnicity impacted the likelihood of receiving monotherapy or combination drug therapy when targets for glycemic, blood pressure, or lipid control were not achieved.

Conclusion. Despite great progress in the control of diabetes and its associated risk factors between 1999 and 2010, this trend declined for glycemic and blood pressure control and leveled off for lipid control in adult NHANES participants with diabetes after 2010. First-line treatments for diabetes and associated risk factors remain underused, and treatment intensification may not be sufficiently considered in patients with uncontrolled risk factors despite clinical guideline recommendations. The findings of this study may portend a possible population-level increase in diabetes-related illnesses in the years to come.

Commentary

The thorough understanding of trends in management of diseases is critical to inform public health policies and planning. Well designed clinical studies heavily influence the development of public health policies and clinical guidelines, which in turn drive real-world clinical practice. In a recent analysis utilizing data from NHANES, Fang et al¹ showed evidence of a general shift toward less intensive treatment of diabetes, hypertension, and hypercholesterolemia in adults living in the US during the last decade.

Similarly, in a separate study using NHANES data collected between 1999 and 2018 published in JAMA just 2 weeks after the current report, Wang et al² confirms this declining trend in diabetes management with only 21.2% of diabetic adults simultaneously attaining glycemic, blood pressure, and lipid level targets during the same period. What led to the decline in more stringent risk factor and diabetes management since 2010 observed in these studies? One possible explanation, as suggested by Fang et al, is that major clinical trials from the late 2000s­—including Action to Control Cardiovascular Risk in Diabetes, UK Prospective Diabetes Study, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, and Veterans Affairs Diabetes Trial—that assessed the effects of intensive glycemic control (with target HbA_1c < 6.5%) found that intensive treatment of diabetes compared to standard care had no cardiovascular benefit albeit increasing the risk of hypoglycemia. Thus, these trial findings may have translated into suboptimal diabetes treatment observed in some NHANES participants. Wang et al propose that effective tailored approaches are needed to improve risk factor control in diabetic patients, such as enhance and maintain adherence to medications and healthy lifestyle behaviors, as well as better access to health care and therapeutic education.

The changes in recent trends in diabetes management have immense clinical implications. The authors of this study suggest a link between the recent relaxation of glycemic targets, as well as risk factor control, and a resurgence of diabetic complications such as lower limb amputation or stroke. Indeed, several recent studies indicate an upward trend or plateau in diabetic complications which had been decreasing in prevalence prior to 2010.³ For example, lower extremity amputation has surged by more than 25% between 2010 and 2015, especially in young and middle-aged adults.⁴ Among the arguments brought forward that this recent resurgence in amputations is directly linked to worsening glycemic control is the fact that between 2007 and 2010, when glucose levels were best controlled within the previous 30-year period, amputations were also at the lowest levels. Moreover, data from the Centers for Disease Control and Prevention also show a 55% increase in mortality (from 15.7 to 24.2 per 1000) among diabetic patients between 2010 and 2015.¹⁴ On the other hand, a growing number of studies show that an increase of inappropriate treatment intensification—reaching HbA_1c levels that are way below the recommended targets—is associated with adverse consequences in diabetic patients particularly in those aged more than 65 years.^5-7 These seemingly contradictory findings highlight the importance of a personalized and thoughtful approach to the management of diabetes and its risk factors. As an example, an increase in the use of newer and safer glucose lowering drugs (eg, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase 4 inhibitors) can help achieve better HbA_1c goals with a reduced risk of hypoglycemic episodes as recently shown by a Danish study.⁸ In this study, the authors concluded that the reduction of the rate of hypoglycemic episodes leading to hospitalization in Denmark was directly linked to the use of these safer and newer glucose lowering drugs.

A discussion on the specifics of trends in diabetes treatment and control must include considerations in older adults aged more than 65 years who constitute more than 40% of the diabetic population. Despite the high prevalence of diabetes in this vulnerable population, such data are still insufficient in the literature and are critically needed to inform public health policies and clinical guidelines. In epidemiological studies focusing on diabetic complications from the last 10 years, concerning increases have been observed in younger⁹ and middle-aged adults while remaining stable in older adults. However, the risk of hypoglycemia or severe hypoglycemia remains high in older adults living in nursing facilities, even in those with an elevated HbA_1c of greater than 8%.⁷ Moreover, in light of more relaxed HbA_1c treatment goals for older frail adults as recommended by international guidelines since 2010,^10,11 recent findings from the French GERODIAB cohort show an increased mortality (hazard ratio, 1.76) in type 2 diabetics aged 70 years and older with HbA_1c greater than or equal to 8.6%.¹² Similarly, a 5-year retrospective British study from 2018 which included patients aged 70 years and older, shows an increased overall mortality in those with HbA_1c greater than 8.5%.¹³ Taken together, further age-stratified analysis utilizing data from large cohort studies including NHANES may help to clarify national trends in diabetes treatment and risk factor control as well as diabetic complications specific to the geriatric population. By being better informed of such trends, clinicians could then develop treatment strategies that minimize complications (eg, hypoglycemia, falls) while achieving favorable outcomes (eg, reduce hyperglycemic emergencies, improve survival) in frail older patients.

Applications for Clinical Practice

The understanding of population-wide trends in diabetes control is critical to planning public health approaches for the prevention and treatment of this disease and its complications. In older adults, the high risk of hypoglycemic events and insufficient epidemiological data on trends of diabetes control hinder diabetes management. Personalized treatment targets taking into account geriatric syndromes and general health status, as well as multidisciplinary management involving endocrinologists, geriatricians, and clinical pharmacists, are necessary to optimize care in older adults with diabetes.

Study Overview

Objective. To update national trends in the treatment and risk factor control of diabetic patients from 1999 through 2018 in the US using data from the National Health and Nutrition Examination Survey (NHANES) with the goal of identifying population subgroups with the highest probability of having untreated risk factors.

Design. The authors conducted a cross-sectional analysis of data from NHANES focusing on adults with diabetes. They examined patient characteristics and medication use over time and estimated the prevalence of risk factor control and medication use. To minimize the effects of a small sample size, the survey years were pooled into 4-year intervals. The variables studied included glycated hemoglobin (HbA_1c), blood pressure, serum cholesterol, medication use, sociodemographic characteristics, and weight status. For statistical analysis, logistic and multinomial logistic regression models were used to examine factors associated with treatment in participants who did not achieve targets for glycemic, blood pressure, and lipid control. Temporal trends were estimated using 2-piece linear spline models with 1 knot at inflection points.

Setting and participants. The NHANES program began in the early 1960s to monitor the health of the US population. In 1999, the survey became a continuous program combining interviews and physical examinations. The survey examines a nationally representative sample of about 5000 persons each year. This study included 6653 participants who were nonpregnant, aged older than 20 years, reported a diagnosis of diabetes from a physician, and participated in NHANES from 1999 through 2018.

Main outcome measures. The main outcome measures were temporal trends in risk factor control (glycemic, blood pressure, or lipid levels) and medication use (glucose lowering, blood pressure lowering, or lipid lowering medications), and number as well as class of drug used, from 1999 through 2018 in diabetic adults from the US participating in NHANES.

Results. Sociodemographic characteristics of the studied diabetes population—The age and racial or ethnic distribution of participants with diabetes were stable from 1999 through 2018, whereas participants with a college degree, higher income, health insurance, obesity, or long-standing diabetes increased during the same period.

Trends in diabetes risk factor control—The trends for glycemic, blood pressure, and lipid control were nonlinear, with an inflection point around 2010. Glycemic control was defined as HbA_1c less than 7%, blood pressure was considered controlled if less than 140/90 mmHg, and lipid was controlled if non-HDL cholesterol level was less than 130 mg/dL. Although these chosen targets were based on the most recent clinical guidelines, the authors declared that they observed similar trends when alternative targets were used. The level of risk factor control improved in all diabetic patients from 1999 through 2010. However, the percentage of adult diabetic participants for whom glycemic control was achieved declined from 57.4% (95% CI, 52.9-61.8) in 2007-2010 to 50.5% (95% CI, 45.8-55.3) in 2015-2018. Blood pressure control was achieved in 74.2% of participants (95% CI, 70.7-77.4) in 2011-2014 but declined to 70.4% (95% CI, 66.7-73.8) in 2015-2018. Control in lipid levels improved during the entire study period; however, the rate of improvement heavily declined after 2007 with lipid target levels attained in 52.3% of participants (95% CI, 49.2-55.3) in 2007-2014 and 55.7% (95% CI, 50.8-60.5) in 2015-2018. Finally, the percentage of participants in whom targets for all 3 risk factors were simultaneously achieved plateaued after 2010 and was 22.2% (95% CI, 17.9-27.3) in 2015-2018.

Trends in diabetes treatment—The use of glucose lowering drugs increased from 74.1% in 1999-2002 to 82.7% in 2007-2010 and then stabilized. A shift toward a safer glucose lowering treatment choice was observed with a decline in the use of older glucose lowering medications such as sulfonylureas, which increases the risk of hypoglycemia, and an increase in the use of metformin, insulin, and newer agents such as sodium-glucose cotransporter 2 inhibitors.

Similarly, blood pressure lowering medication use rose from 1999-2002 to 2007-2010 and then stabilized, with increased use of first-line recommended treatments including angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers. Likewise, statin use rose from 28.4% in 1999-2002 to 56% in 2011-2014 and then stabilized. The total number of drugs used culminated in 2011-2014 with 60% of participants using more than 5 drugs and then leveled off to 57.2% in 2015-2018. Lastly, health insurance status and race or ethnicity impacted the likelihood of receiving monotherapy or combination drug therapy when targets for glycemic, blood pressure, or lipid control were not achieved.

Conclusion. Despite great progress in the control of diabetes and its associated risk factors between 1999 and 2010, this trend declined for glycemic and blood pressure control and leveled off for lipid control in adult NHANES participants with diabetes after 2010. First-line treatments for diabetes and associated risk factors remain underused, and treatment intensification may not be sufficiently considered in patients with uncontrolled risk factors despite clinical guideline recommendations. The findings of this study may portend a possible population-level increase in diabetes-related illnesses in the years to come.

Commentary

The thorough understanding of trends in management of diseases is critical to inform public health policies and planning. Well designed clinical studies heavily influence the development of public health policies and clinical guidelines, which in turn drive real-world clinical practice. In a recent analysis utilizing data from NHANES, Fang et al¹ showed evidence of a general shift toward less intensive treatment of diabetes, hypertension, and hypercholesterolemia in adults living in the US during the last decade.

Similarly, in a separate study using NHANES data collected between 1999 and 2018 published in JAMA just 2 weeks after the current report, Wang et al² confirms this declining trend in diabetes management with only 21.2% of diabetic adults simultaneously attaining glycemic, blood pressure, and lipid level targets during the same period. What led to the decline in more stringent risk factor and diabetes management since 2010 observed in these studies? One possible explanation, as suggested by Fang et al, is that major clinical trials from the late 2000s­—including Action to Control Cardiovascular Risk in Diabetes, UK Prospective Diabetes Study, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, and Veterans Affairs Diabetes Trial—that assessed the effects of intensive glycemic control (with target HbA_1c < 6.5%) found that intensive treatment of diabetes compared to standard care had no cardiovascular benefit albeit increasing the risk of hypoglycemia. Thus, these trial findings may have translated into suboptimal diabetes treatment observed in some NHANES participants. Wang et al propose that effective tailored approaches are needed to improve risk factor control in diabetic patients, such as enhance and maintain adherence to medications and healthy lifestyle behaviors, as well as better access to health care and therapeutic education.

The changes in recent trends in diabetes management have immense clinical implications. The authors of this study suggest a link between the recent relaxation of glycemic targets, as well as risk factor control, and a resurgence of diabetic complications such as lower limb amputation or stroke. Indeed, several recent studies indicate an upward trend or plateau in diabetic complications which had been decreasing in prevalence prior to 2010.³ For example, lower extremity amputation has surged by more than 25% between 2010 and 2015, especially in young and middle-aged adults.⁴ Among the arguments brought forward that this recent resurgence in amputations is directly linked to worsening glycemic control is the fact that between 2007 and 2010, when glucose levels were best controlled within the previous 30-year period, amputations were also at the lowest levels. Moreover, data from the Centers for Disease Control and Prevention also show a 55% increase in mortality (from 15.7 to 24.2 per 1000) among diabetic patients between 2010 and 2015.¹⁴ On the other hand, a growing number of studies show that an increase of inappropriate treatment intensification—reaching HbA_1c levels that are way below the recommended targets—is associated with adverse consequences in diabetic patients particularly in those aged more than 65 years.^5-7 These seemingly contradictory findings highlight the importance of a personalized and thoughtful approach to the management of diabetes and its risk factors. As an example, an increase in the use of newer and safer glucose lowering drugs (eg, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase 4 inhibitors) can help achieve better HbA_1c goals with a reduced risk of hypoglycemic episodes as recently shown by a Danish study.⁸ In this study, the authors concluded that the reduction of the rate of hypoglycemic episodes leading to hospitalization in Denmark was directly linked to the use of these safer and newer glucose lowering drugs.

A discussion on the specifics of trends in diabetes treatment and control must include considerations in older adults aged more than 65 years who constitute more than 40% of the diabetic population. Despite the high prevalence of diabetes in this vulnerable population, such data are still insufficient in the literature and are critically needed to inform public health policies and clinical guidelines. In epidemiological studies focusing on diabetic complications from the last 10 years, concerning increases have been observed in younger⁹ and middle-aged adults while remaining stable in older adults. However, the risk of hypoglycemia or severe hypoglycemia remains high in older adults living in nursing facilities, even in those with an elevated HbA_1c of greater than 8%.⁷ Moreover, in light of more relaxed HbA_1c treatment goals for older frail adults as recommended by international guidelines since 2010,^10,11 recent findings from the French GERODIAB cohort show an increased mortality (hazard ratio, 1.76) in type 2 diabetics aged 70 years and older with HbA_1c greater than or equal to 8.6%.¹² Similarly, a 5-year retrospective British study from 2018 which included patients aged 70 years and older, shows an increased overall mortality in those with HbA_1c greater than 8.5%.¹³ Taken together, further age-stratified analysis utilizing data from large cohort studies including NHANES may help to clarify national trends in diabetes treatment and risk factor control as well as diabetic complications specific to the geriatric population. By being better informed of such trends, clinicians could then develop treatment strategies that minimize complications (eg, hypoglycemia, falls) while achieving favorable outcomes (eg, reduce hyperglycemic emergencies, improve survival) in frail older patients.

Applications for Clinical Practice

The understanding of population-wide trends in diabetes control is critical to planning public health approaches for the prevention and treatment of this disease and its complications. In older adults, the high risk of hypoglycemic events and insufficient epidemiological data on trends of diabetes control hinder diabetes management. Personalized treatment targets taking into account geriatric syndromes and general health status, as well as multidisciplinary management involving endocrinologists, geriatricians, and clinical pharmacists, are necessary to optimize care in older adults with diabetes.

When it comes to dieting and heart health in patients who are also exercising, less is more, suggests a new study.

The authors of the paper, published in Circulation, found a link between greater vascular benefits and exercise with modest – rather than intense – calorie restriction (CR) in elderly individuals with obesity.

“The finding that higher-intensity calorie restriction may not be necessary or advised has important implications for weight loss recommendations,” noted Tina E. Brinkley, Ph.D., lead author of the study and associate professor of gerontology and geriatric medicine at the Sticht Center for Healthy Aging and Alzheimer’s Prevention at Wake Forest University in Winston-Salem, N.C.

It’s “not entirely clear” why greater calorie restriction did not translate to greater vascular benefit, but it “could be related in part to potentially adverse effects of severe CR on vascular function,” she noted. “These findings have important implications for reducing cardiovascular risk with nonpharmacological interventions in high-risk populations.”

Methods and findings

The study included 160 men and women aged 65-79 years, with a body mass index (BMI) of 30 to 45 kg/m². The subjects were randomized to one of three groups for 20 weeks of aerobic exercise only, aerobic exercise plus moderate CR, or aerobic exercise plus more intensive CR. Their exercise regimen involved 30 minutes of supervised treadmill walking for 4 days per week at 65%-70% of heart rate reserve.

Subjects in the moderate CR group decreased caloric intake by 250 kcals a day, while the intense calorie reduction group cut 600 kcals per day. Their meals contained less than 30% of calories from fat and at least 0.8 g of protein per kg of ideal body weight. They were also provided with supplemental calcium (1,200 mg/day) and vitamin D (800 IU/day).

Cardiovascular magnetic resonance imaging was used to assess various aspects of aortic structure and function, including aortic arch pulse wave velocity, aortic distensibility and dimensions, and periaortic fat.

Weight loss was greater among subjects with CR plus exercise, compared with that of patients in the exercise-only group. The degree of weight loss was not significantly different between those with moderate versus intense CR ( 8.02 kg vs. 8.98 kg).

Among the exercise-only group, researchers observed no changes in aortic stiffness. However, adding moderate CR significantly improved this measure, while intense CR did not.

Specifically, subjects in the moderate-CR group had a “robust” 21% increase in distensibility in the descending aorta (DA), and an 8% decrease in aortic arch pulse wave velocity, whereas there were no significant vascular changes in the intense-CR group.

Bests results seen in exercise plus modest CR group

“Collectively, these data suggest that combining exercise with modest CR (as opposed to more intensive CR or no CR) provides the greatest benefit for proximal aortic stiffness, while also optimizing weight loss and improvements in body composition and body fat distribution,” noted the authors in their paper.

“Our data support the growing number of studies indicating that intentional weight loss can be safe for older adults with obesity and extend our previous findings, suggesting that obesity may blunt the beneficial effects of exercise for not only cardiorespiratory fitness, but likely vascular health as well.”

William E. Kraus, MD, professor in the Department of Medicine, Division of Cardiology at Duke University Medical Center, in Durham, NC, described the study as important and interesting for several reasons.

“First, it demonstrates one can change aortic vascular function with a combined diet and exercise program, even in older, obese Americans. This implies it is never too late to make meaningful lifestyle changes that will benefit cardiovascular health,” he said. “Second, it is among an increasing number of studies demonstrating that more is not always better than less in exercise and diet lifestyle changes - and in fact the converse is true.” 

“This gives hope that more people can benefit from modest lifestyle changes - in this case following guidelines for physical activity and only a modest reduction of 250 kilocalories per day resulted in benefit,” Dr. Kraus added.

The authors of the paper and Dr. Kraus disclosed no conflicts of interest.

When it comes to dieting and heart health in patients who are also exercising, less is more, suggests a new study.

The authors of the paper, published in Circulation, found a link between greater vascular benefits and exercise with modest – rather than intense – calorie restriction (CR) in elderly individuals with obesity.

“The finding that higher-intensity calorie restriction may not be necessary or advised has important implications for weight loss recommendations,” noted Tina E. Brinkley, Ph.D., lead author of the study and associate professor of gerontology and geriatric medicine at the Sticht Center for Healthy Aging and Alzheimer’s Prevention at Wake Forest University in Winston-Salem, N.C.

It’s “not entirely clear” why greater calorie restriction did not translate to greater vascular benefit, but it “could be related in part to potentially adverse effects of severe CR on vascular function,” she noted. “These findings have important implications for reducing cardiovascular risk with nonpharmacological interventions in high-risk populations.”

Methods and findings

The study included 160 men and women aged 65-79 years, with a body mass index (BMI) of 30 to 45 kg/m². The subjects were randomized to one of three groups for 20 weeks of aerobic exercise only, aerobic exercise plus moderate CR, or aerobic exercise plus more intensive CR. Their exercise regimen involved 30 minutes of supervised treadmill walking for 4 days per week at 65%-70% of heart rate reserve.

Subjects in the moderate CR group decreased caloric intake by 250 kcals a day, while the intense calorie reduction group cut 600 kcals per day. Their meals contained less than 30% of calories from fat and at least 0.8 g of protein per kg of ideal body weight. They were also provided with supplemental calcium (1,200 mg/day) and vitamin D (800 IU/day).

Cardiovascular magnetic resonance imaging was used to assess various aspects of aortic structure and function, including aortic arch pulse wave velocity, aortic distensibility and dimensions, and periaortic fat.

Weight loss was greater among subjects with CR plus exercise, compared with that of patients in the exercise-only group. The degree of weight loss was not significantly different between those with moderate versus intense CR ( 8.02 kg vs. 8.98 kg).

Among the exercise-only group, researchers observed no changes in aortic stiffness. However, adding moderate CR significantly improved this measure, while intense CR did not.

Specifically, subjects in the moderate-CR group had a “robust” 21% increase in distensibility in the descending aorta (DA), and an 8% decrease in aortic arch pulse wave velocity, whereas there were no significant vascular changes in the intense-CR group.

Bests results seen in exercise plus modest CR group

“Collectively, these data suggest that combining exercise with modest CR (as opposed to more intensive CR or no CR) provides the greatest benefit for proximal aortic stiffness, while also optimizing weight loss and improvements in body composition and body fat distribution,” noted the authors in their paper.

“Our data support the growing number of studies indicating that intentional weight loss can be safe for older adults with obesity and extend our previous findings, suggesting that obesity may blunt the beneficial effects of exercise for not only cardiorespiratory fitness, but likely vascular health as well.”

William E. Kraus, MD, professor in the Department of Medicine, Division of Cardiology at Duke University Medical Center, in Durham, NC, described the study as important and interesting for several reasons.

“First, it demonstrates one can change aortic vascular function with a combined diet and exercise program, even in older, obese Americans. This implies it is never too late to make meaningful lifestyle changes that will benefit cardiovascular health,” he said. “Second, it is among an increasing number of studies demonstrating that more is not always better than less in exercise and diet lifestyle changes - and in fact the converse is true.” 

“This gives hope that more people can benefit from modest lifestyle changes - in this case following guidelines for physical activity and only a modest reduction of 250 kilocalories per day resulted in benefit,” Dr. Kraus added.

The authors of the paper and Dr. Kraus disclosed no conflicts of interest.

When it comes to dieting and heart health in patients who are also exercising, less is more, suggests a new study.

The authors of the paper, published in Circulation, found a link between greater vascular benefits and exercise with modest – rather than intense – calorie restriction (CR) in elderly individuals with obesity.

“The finding that higher-intensity calorie restriction may not be necessary or advised has important implications for weight loss recommendations,” noted Tina E. Brinkley, Ph.D., lead author of the study and associate professor of gerontology and geriatric medicine at the Sticht Center for Healthy Aging and Alzheimer’s Prevention at Wake Forest University in Winston-Salem, N.C.

It’s “not entirely clear” why greater calorie restriction did not translate to greater vascular benefit, but it “could be related in part to potentially adverse effects of severe CR on vascular function,” she noted. “These findings have important implications for reducing cardiovascular risk with nonpharmacological interventions in high-risk populations.”

Methods and findings

The study included 160 men and women aged 65-79 years, with a body mass index (BMI) of 30 to 45 kg/m². The subjects were randomized to one of three groups for 20 weeks of aerobic exercise only, aerobic exercise plus moderate CR, or aerobic exercise plus more intensive CR. Their exercise regimen involved 30 minutes of supervised treadmill walking for 4 days per week at 65%-70% of heart rate reserve.

Subjects in the moderate CR group decreased caloric intake by 250 kcals a day, while the intense calorie reduction group cut 600 kcals per day. Their meals contained less than 30% of calories from fat and at least 0.8 g of protein per kg of ideal body weight. They were also provided with supplemental calcium (1,200 mg/day) and vitamin D (800 IU/day).

Cardiovascular magnetic resonance imaging was used to assess various aspects of aortic structure and function, including aortic arch pulse wave velocity, aortic distensibility and dimensions, and periaortic fat.

Weight loss was greater among subjects with CR plus exercise, compared with that of patients in the exercise-only group. The degree of weight loss was not significantly different between those with moderate versus intense CR ( 8.02 kg vs. 8.98 kg).

Among the exercise-only group, researchers observed no changes in aortic stiffness. However, adding moderate CR significantly improved this measure, while intense CR did not.

Specifically, subjects in the moderate-CR group had a “robust” 21% increase in distensibility in the descending aorta (DA), and an 8% decrease in aortic arch pulse wave velocity, whereas there were no significant vascular changes in the intense-CR group.

Bests results seen in exercise plus modest CR group

“Collectively, these data suggest that combining exercise with modest CR (as opposed to more intensive CR or no CR) provides the greatest benefit for proximal aortic stiffness, while also optimizing weight loss and improvements in body composition and body fat distribution,” noted the authors in their paper.

“Our data support the growing number of studies indicating that intentional weight loss can be safe for older adults with obesity and extend our previous findings, suggesting that obesity may blunt the beneficial effects of exercise for not only cardiorespiratory fitness, but likely vascular health as well.”

William E. Kraus, MD, professor in the Department of Medicine, Division of Cardiology at Duke University Medical Center, in Durham, NC, described the study as important and interesting for several reasons.

“First, it demonstrates one can change aortic vascular function with a combined diet and exercise program, even in older, obese Americans. This implies it is never too late to make meaningful lifestyle changes that will benefit cardiovascular health,” he said. “Second, it is among an increasing number of studies demonstrating that more is not always better than less in exercise and diet lifestyle changes - and in fact the converse is true.” 

“This gives hope that more people can benefit from modest lifestyle changes - in this case following guidelines for physical activity and only a modest reduction of 250 kilocalories per day resulted in benefit,” Dr. Kraus added.

The authors of the paper and Dr. Kraus disclosed no conflicts of interest.

Around the world, cases of dementia are projected to hit 153 million in 2050, up from around 57 million in 2019, new global prevalence data show. “These extreme increases are due largely to demographic trends, including population growth and aging,” said study investigator Emma Nichols, MPH, a researcher at the Institute for Health Metrics and Evaluation at the University of Washington in Seattle.

“Our estimates of expected increases can and should inform policy and planning efforts that will be needed to address the needs of the growing number of individuals with dementia in the future,” Ms. Nichols said.

The latest global prevalence data were reported at the 2021 Alzheimer’s Association International Conference.

“The numbers are staggering: Nearly 153 million cases of dementia are predicted worldwide by the year 2050. To put that in context, that number is equal to approximately half of the U.S. population in 2020,” Heather M. Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said in a statement.
 

Prevalence by country

To more accurately forecast global dementia prevalence and produce country-level estimates, the investigators leveraged data from 1999 to 2019 from the Global Burden of Disease study, a comprehensive set of estimates of worldwide health trends.

These data suggest global dementia cases will increase from 57.4 million (50.4 to 65.1) in 2019 to 152.8 million (130.8 to 175.9) in 2050.

Regions that will experience the worst of the increase are eastern Sub-Saharan Africa, North Africa, and the Middle East.

The researchers also factored into the forecasts expected trends in obesity, diabetes, smoking, and educational attainment.

Increases in better education around the world are projected to decrease dementia prevalence by 6.2 million cases worldwide by 2050. However, anticipated trends in smoking, high body mass index, and diabetes will offset this gain, increasing global dementia cases by 6.8 million cases.

“A reversal of these expected trends in cardiovascular risks would be necessary to alter the anticipated trends,” Ms. Nichols said. “Interventions targeted at modifiable risk factors for dementia represent a viable strategy to help address the anticipated trends in dementia burden,” she added.
 

Need for effective prevention, treatment

Commenting on the research, Rebecca M. Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said the global increase in dementia cases is something the association has been following for many years. “We know that if we do not find effective treatments that are going to stop, slow, or prevent Alzheimer’s disease, this number will continue to grow and it will continue to impact people globally,” Dr. Edelmayer said.

She noted that although there are some positive trends, including the fact that increased education may drive down dementia risk, other factors, such as smoking, high body mass index, and high blood sugar level, are predicted to increase in prevalence.

“Some of these factors are actually counterbalancing each other, and in the end, if we don’t continue to develop culturally tailored interventions or even risk reduction strategies for individuals across the globe, we will continue to see those numbers rise overall,” Dr. Edelmayer said.

A version of this article first appeared on Medscape.com.

Around the world, cases of dementia are projected to hit 153 million in 2050, up from around 57 million in 2019, new global prevalence data show. “These extreme increases are due largely to demographic trends, including population growth and aging,” said study investigator Emma Nichols, MPH, a researcher at the Institute for Health Metrics and Evaluation at the University of Washington in Seattle.

“Our estimates of expected increases can and should inform policy and planning efforts that will be needed to address the needs of the growing number of individuals with dementia in the future,” Ms. Nichols said.

The latest global prevalence data were reported at the 2021 Alzheimer’s Association International Conference.

“The numbers are staggering: Nearly 153 million cases of dementia are predicted worldwide by the year 2050. To put that in context, that number is equal to approximately half of the U.S. population in 2020,” Heather M. Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said in a statement.
 

Prevalence by country

To more accurately forecast global dementia prevalence and produce country-level estimates, the investigators leveraged data from 1999 to 2019 from the Global Burden of Disease study, a comprehensive set of estimates of worldwide health trends.

These data suggest global dementia cases will increase from 57.4 million (50.4 to 65.1) in 2019 to 152.8 million (130.8 to 175.9) in 2050.

Regions that will experience the worst of the increase are eastern Sub-Saharan Africa, North Africa, and the Middle East.

The researchers also factored into the forecasts expected trends in obesity, diabetes, smoking, and educational attainment.

Increases in better education around the world are projected to decrease dementia prevalence by 6.2 million cases worldwide by 2050. However, anticipated trends in smoking, high body mass index, and diabetes will offset this gain, increasing global dementia cases by 6.8 million cases.

“A reversal of these expected trends in cardiovascular risks would be necessary to alter the anticipated trends,” Ms. Nichols said. “Interventions targeted at modifiable risk factors for dementia represent a viable strategy to help address the anticipated trends in dementia burden,” she added.
 

Need for effective prevention, treatment

Commenting on the research, Rebecca M. Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said the global increase in dementia cases is something the association has been following for many years. “We know that if we do not find effective treatments that are going to stop, slow, or prevent Alzheimer’s disease, this number will continue to grow and it will continue to impact people globally,” Dr. Edelmayer said.

She noted that although there are some positive trends, including the fact that increased education may drive down dementia risk, other factors, such as smoking, high body mass index, and high blood sugar level, are predicted to increase in prevalence.

“Some of these factors are actually counterbalancing each other, and in the end, if we don’t continue to develop culturally tailored interventions or even risk reduction strategies for individuals across the globe, we will continue to see those numbers rise overall,” Dr. Edelmayer said.

A version of this article first appeared on Medscape.com.

Around the world, cases of dementia are projected to hit 153 million in 2050, up from around 57 million in 2019, new global prevalence data show. “These extreme increases are due largely to demographic trends, including population growth and aging,” said study investigator Emma Nichols, MPH, a researcher at the Institute for Health Metrics and Evaluation at the University of Washington in Seattle.

“Our estimates of expected increases can and should inform policy and planning efforts that will be needed to address the needs of the growing number of individuals with dementia in the future,” Ms. Nichols said.

The latest global prevalence data were reported at the 2021 Alzheimer’s Association International Conference.

“The numbers are staggering: Nearly 153 million cases of dementia are predicted worldwide by the year 2050. To put that in context, that number is equal to approximately half of the U.S. population in 2020,” Heather M. Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said in a statement.
 

Prevalence by country

To more accurately forecast global dementia prevalence and produce country-level estimates, the investigators leveraged data from 1999 to 2019 from the Global Burden of Disease study, a comprehensive set of estimates of worldwide health trends.

These data suggest global dementia cases will increase from 57.4 million (50.4 to 65.1) in 2019 to 152.8 million (130.8 to 175.9) in 2050.

Regions that will experience the worst of the increase are eastern Sub-Saharan Africa, North Africa, and the Middle East.

The researchers also factored into the forecasts expected trends in obesity, diabetes, smoking, and educational attainment.

Increases in better education around the world are projected to decrease dementia prevalence by 6.2 million cases worldwide by 2050. However, anticipated trends in smoking, high body mass index, and diabetes will offset this gain, increasing global dementia cases by 6.8 million cases.

“A reversal of these expected trends in cardiovascular risks would be necessary to alter the anticipated trends,” Ms. Nichols said. “Interventions targeted at modifiable risk factors for dementia represent a viable strategy to help address the anticipated trends in dementia burden,” she added.
 

Need for effective prevention, treatment

Commenting on the research, Rebecca M. Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said the global increase in dementia cases is something the association has been following for many years. “We know that if we do not find effective treatments that are going to stop, slow, or prevent Alzheimer’s disease, this number will continue to grow and it will continue to impact people globally,” Dr. Edelmayer said.

She noted that although there are some positive trends, including the fact that increased education may drive down dementia risk, other factors, such as smoking, high body mass index, and high blood sugar level, are predicted to increase in prevalence.

“Some of these factors are actually counterbalancing each other, and in the end, if we don’t continue to develop culturally tailored interventions or even risk reduction strategies for individuals across the globe, we will continue to see those numbers rise overall,” Dr. Edelmayer said.

A version of this article first appeared on Medscape.com.

Mt. Sinai Hospital in New York, was No. 1 this year in geriatric care, according to rankings by U.S. News & World Report. The Cleveland Clinic in Ohio, and the Mayo Clinic in Rochester, Minn., followed.

Rounding out the top 10 hospitals in caring for patients older than age 75 were (4) UCLA Medical Center, Los Angeles; (5) NYU Langone Hospitals in New York; (6) Johns Hopkins Hospital in Baltimore; (7) New York–Presbyterian Hospital–Columbia and Cornell, New York; (8) Northwestern Memorial Hospital, Chicago; (9) UCSF Medical Center, San Francisco; and (10) Cedars-Sinai Medical Center, Los Angeles.

Those were followed by (11) Keck Medical Center of USC, Los Angeles; (12) University of Michigan Hospitals–Michigan Medicine, Ann Arbor; (13) UC San Diego Health–Jacobs Medical Center, San Diego; (14) Massachusetts General Hospital, Boston; (15) Stanford Health Care–Stanford Hospital, Palo Alto, Calif.; (16) Rush University Medical Center, Chicago; (17) Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia; (18) Brigham and Women’s Hospital, Boston; (19) Barnes-Jewish Hospital, St. Louis, Mo.; (tied for 19) UPMC Presbyterian Shadyside, Pittsburgh.

Data for the 2021-2022 edition of the “Best Hospitals” were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

U.S. News also investigated racial disparities in health care and debuted health equity measures alongside each hospital’s rankings. Among other aspects of health equity, the new measures examine whether the patients each hospital treated reflect the racial and ethnic diversity of its community.

Ben Harder, managing editor and chief of health analysis, said in a statement, “At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery, and common heart procedures. Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents.”

U.S. News compared more than 4,750 medical centers nationwide in 15 specialties. Of those, 531 were recognized as Best Regional Hospitals on the basis of their strong performance in multiple areas of care.

The top 20 hospitals overall were also named to the Honor Roll.

Mayo Clinic was again No. 1 on the honor roll, a ranking it has held for 6 years in a row, according to a press release. The Cleveland Clinic ranked No. 2, followed by UCLA Medical Center at No. 3.

In other top specialties, the University of Texas MD Anderson Cancer Center in Houston ranked No. 1 in cancer; the Cleveland Clinic is No. 1 in cardiology and heart surgery; and the Hospital for Special Surgery in New York is No. 1 in orthopedics.

A full list of rankings is available on the website.

In 12 of the 15 specialty areas, including geriatrics, rankings are derived from data sources such as Medicare. In the other three specialties – ophthalmology, psychiatry, and rheumatology – ranking is determined by expert opinion based on responses from 3 years of surveys of physician specialists who were asked to name the hospitals to which they would likely refer their sickest patients.

This year’s analysis adds seven new procedures and conditions: Heart attack, stroke, pneumonia, diabetes, kidney failure, hip fracture, and back surgery (spinal fusion).

The expanded list will help patients, in consultation with their physicians, choose their hospital on the basis of the specific type of care they need with consideration of distance to a facility and insurance coverage.

A version of this article first appeared on Medscape.com.

Mt. Sinai Hospital in New York, was No. 1 this year in geriatric care, according to rankings by U.S. News & World Report. The Cleveland Clinic in Ohio, and the Mayo Clinic in Rochester, Minn., followed.

Rounding out the top 10 hospitals in caring for patients older than age 75 were (4) UCLA Medical Center, Los Angeles; (5) NYU Langone Hospitals in New York; (6) Johns Hopkins Hospital in Baltimore; (7) New York–Presbyterian Hospital–Columbia and Cornell, New York; (8) Northwestern Memorial Hospital, Chicago; (9) UCSF Medical Center, San Francisco; and (10) Cedars-Sinai Medical Center, Los Angeles.

Those were followed by (11) Keck Medical Center of USC, Los Angeles; (12) University of Michigan Hospitals–Michigan Medicine, Ann Arbor; (13) UC San Diego Health–Jacobs Medical Center, San Diego; (14) Massachusetts General Hospital, Boston; (15) Stanford Health Care–Stanford Hospital, Palo Alto, Calif.; (16) Rush University Medical Center, Chicago; (17) Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia; (18) Brigham and Women’s Hospital, Boston; (19) Barnes-Jewish Hospital, St. Louis, Mo.; (tied for 19) UPMC Presbyterian Shadyside, Pittsburgh.

Data for the 2021-2022 edition of the “Best Hospitals” were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

U.S. News also investigated racial disparities in health care and debuted health equity measures alongside each hospital’s rankings. Among other aspects of health equity, the new measures examine whether the patients each hospital treated reflect the racial and ethnic diversity of its community.

Ben Harder, managing editor and chief of health analysis, said in a statement, “At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery, and common heart procedures. Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents.”

U.S. News compared more than 4,750 medical centers nationwide in 15 specialties. Of those, 531 were recognized as Best Regional Hospitals on the basis of their strong performance in multiple areas of care.

The top 20 hospitals overall were also named to the Honor Roll.

Mayo Clinic was again No. 1 on the honor roll, a ranking it has held for 6 years in a row, according to a press release. The Cleveland Clinic ranked No. 2, followed by UCLA Medical Center at No. 3.

In other top specialties, the University of Texas MD Anderson Cancer Center in Houston ranked No. 1 in cancer; the Cleveland Clinic is No. 1 in cardiology and heart surgery; and the Hospital for Special Surgery in New York is No. 1 in orthopedics.

A full list of rankings is available on the website.

In 12 of the 15 specialty areas, including geriatrics, rankings are derived from data sources such as Medicare. In the other three specialties – ophthalmology, psychiatry, and rheumatology – ranking is determined by expert opinion based on responses from 3 years of surveys of physician specialists who were asked to name the hospitals to which they would likely refer their sickest patients.

This year’s analysis adds seven new procedures and conditions: Heart attack, stroke, pneumonia, diabetes, kidney failure, hip fracture, and back surgery (spinal fusion).

The expanded list will help patients, in consultation with their physicians, choose their hospital on the basis of the specific type of care they need with consideration of distance to a facility and insurance coverage.

A version of this article first appeared on Medscape.com.

Mt. Sinai Hospital in New York, was No. 1 this year in geriatric care, according to rankings by U.S. News & World Report. The Cleveland Clinic in Ohio, and the Mayo Clinic in Rochester, Minn., followed.

Rounding out the top 10 hospitals in caring for patients older than age 75 were (4) UCLA Medical Center, Los Angeles; (5) NYU Langone Hospitals in New York; (6) Johns Hopkins Hospital in Baltimore; (7) New York–Presbyterian Hospital–Columbia and Cornell, New York; (8) Northwestern Memorial Hospital, Chicago; (9) UCSF Medical Center, San Francisco; and (10) Cedars-Sinai Medical Center, Los Angeles.

Those were followed by (11) Keck Medical Center of USC, Los Angeles; (12) University of Michigan Hospitals–Michigan Medicine, Ann Arbor; (13) UC San Diego Health–Jacobs Medical Center, San Diego; (14) Massachusetts General Hospital, Boston; (15) Stanford Health Care–Stanford Hospital, Palo Alto, Calif.; (16) Rush University Medical Center, Chicago; (17) Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia; (18) Brigham and Women’s Hospital, Boston; (19) Barnes-Jewish Hospital, St. Louis, Mo.; (tied for 19) UPMC Presbyterian Shadyside, Pittsburgh.

Data for the 2021-2022 edition of the “Best Hospitals” were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

U.S. News also investigated racial disparities in health care and debuted health equity measures alongside each hospital’s rankings. Among other aspects of health equity, the new measures examine whether the patients each hospital treated reflect the racial and ethnic diversity of its community.

Ben Harder, managing editor and chief of health analysis, said in a statement, “At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery, and common heart procedures. Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents.”

U.S. News compared more than 4,750 medical centers nationwide in 15 specialties. Of those, 531 were recognized as Best Regional Hospitals on the basis of their strong performance in multiple areas of care.

The top 20 hospitals overall were also named to the Honor Roll.

Mayo Clinic was again No. 1 on the honor roll, a ranking it has held for 6 years in a row, according to a press release. The Cleveland Clinic ranked No. 2, followed by UCLA Medical Center at No. 3.

In other top specialties, the University of Texas MD Anderson Cancer Center in Houston ranked No. 1 in cancer; the Cleveland Clinic is No. 1 in cardiology and heart surgery; and the Hospital for Special Surgery in New York is No. 1 in orthopedics.

A full list of rankings is available on the website.

In 12 of the 15 specialty areas, including geriatrics, rankings are derived from data sources such as Medicare. In the other three specialties – ophthalmology, psychiatry, and rheumatology – ranking is determined by expert opinion based on responses from 3 years of surveys of physician specialists who were asked to name the hospitals to which they would likely refer their sickest patients.

This year’s analysis adds seven new procedures and conditions: Heart attack, stroke, pneumonia, diabetes, kidney failure, hip fracture, and back surgery (spinal fusion).

The expanded list will help patients, in consultation with their physicians, choose their hospital on the basis of the specific type of care they need with consideration of distance to a facility and insurance coverage.

A version of this article first appeared on Medscape.com.

In April 2021, the US Preventive Services Task Force (USPSTF) published an updated recommendation on screening for vitamin D deficiency in adults. It reaffirmed an “I” statement first made in 2014: evidence is insufficient to balance the benefits and harms of screening.¹ This recommendation applies to asymptomatic, community-dwelling, nonpregnant adults without conditions treatable with vitamin D. It’s important to remember that screening refers to testing asymptomatic individuals to detect a condition early before it causes illness. Testing performed to determine whether symptoms are evidence of an underlying condition is not screening but diagnostic testing.

The Task Force statement explains the problems they found with the current level of knowledge about screening for vitamin D deficiency. First, while 25-hydroxyvitamin D [25(OH)D] is considered the best test for vitamin D levels, it is hard to measure accurately and test results vary by the method used and laboratories doing the testing. There also is uncertainty about how best to measure vitamin D status in different racial and ethnic groups, especially those with dark skin pigmentation. In addition, 25(OH)D in the blood is predominantly the bound form, with only 10% to 15% being unbound and bioavailable. Current tests do not determine the amount of bound vs unbound 25(OH)D.^1-3

There is no consensus about the optimal blood level of vitamin D or the level that defines deficiency. The Institute of Medicine (now the National Academy of Medicine—NAM) stated that serum 25(OH)D levels ≥ 20 ng/mL are adequate to meet the ­metabolic needs of 97.5% of people, and that levels of 12 to 20 ng/mL pose a risk of deficiency, with levels < 12 considered to be very low.⁴ The Endocrine Society defines deficiency as < 20 ng/mL and insufficiency as 21 to 29 ng/mL.⁵

The rate of testing for vitamin D deficiency in primary care in unknown, but there is evidence that since 2000, it has increased 80 fold at least among those with Medicare.⁶ Data from the 2011-2014 National Health and Nutrition Examination Survey showed that 5% of the population had 25(OH)D levels < 12 ng/mL and 18% had levels between 12 and 19 ng/mL.⁷ Some have estimated that as many as half of all adults would be considered vitamin D deficient or insufficient using current less conservative definitions, with higher rates in racial/ethnic minorities.^2,8

There are no firm data on the frequency, or benefits, of screening for vitamin D levels in asymptomatic adults (and treating those found to have vitamin D deficiency). The Task Force looked for indirect evidence by examining the effect of treating vitamin D deficiency in a number of conditions and found that for some, there was adequate evidence of no benefit and for others there was inadequate evidence for possible benefits.⁹ No benefit was found for incidence of fractures, type 2 diabetes, and overall mortality.⁹ Inadequate evidence was found for incidence of cancer, cardiovascular disease, scores on measures of depression and physical functioning, and urinary tract infections in those with impaired fasting glucose.⁹

Known risk factors for low vitamin D levels include low vitamin D intake, older age, obesity, low UVB exposure or absorption due to long winter seasons in northern latitudes, sun avoidance, and dark skin pigmentation.¹ In addition, certain medical conditions contribute to, or are caused by, low vitamin D levels—eg, osteoporosis, chronic kidney disease, malabsorption syndromes, and medication use (ie, glucocorticoids).^1-3

The Task Force recommendation on screening for vitamin D deficiency differs from those of some other organizations. However, none recommend universal population-based screening. The Endocrine Society and the American Association of Clinical Endocrinologists recommend screening but only in those at risk for vitamin D deficiency.^5,10 The American Academy of Family Physicians endorses the USPSTF recommendation.¹¹

Continue to: Specific USPSTF topics related to vitamin D

The Task Force has specifically addressed 3 topics pertaining to vitamin D. In each instance, the recommendation relates not to providing vitamin D to those who have vitamin D deficiency, but to providing vitamin D supplementation universally to specific groups at risk of a particular condition (TABLE 1).

Prevention of falls in the elderly. In 2018 the Task Force recommended against the use of vitamin D to prevent falls in ­community-dwelling adults ≥ 65 years.¹² This reversed its 2012 recommendation advising vitamin D supplementation to prevent falls. The Task Force re-examined the old evidence and looked at newer studies and concluded that their previous conclusion was wrong and that the evidence showed no benefit from vitamin D in preventing falls in the elderly. The reversal of a prior recommendation is rare for the USPSTF because of the rigor of its evidence reviews and its policy of not making a recommendation unless solid evidence for or against exists.

Prevention of cardiovascular disease and cancer. The Task Force concludes that current evidence is insufficient to assess the balance of benefits and harms in the use of single- or paired-nutrient supplements to prevent cardiovascular disease or cancer.¹³ (The exceptions are beta-carotene and vitamin E, which the Task Force recommends against.) This statement is consistent with the lack of evidence the Task Force found regarding prevention of these conditions by vitamin D supplementation in those who are vitamin D deficient.

Prevention of fractures in men and in premenopausal and postmenopausal women. For men and premenopausal women, the Task Force concludes that evidence is insufficient to assess the benefits and harms of vitamin D and calcium supplementation, alone or in combination, to prevent fractures.¹⁴ For prevention of fractures in postmenopausal women, there are 2 recommendations. The first one advises against the use of ≤ 400 IU of vitamin D and ≤ 1000 mg of calcium because the evidence indicates ineffectiveness. The second one is another “I” statement for the use of doses > 400 IU of vitamin D and > 1000 mg of calcium. These 3 recommendations apply to adults who live in the community and not in nursing homes or other institutional care facilities; they do not apply to those who have osteoporosis.

What should the family physician do?

Encourage all patients to take the recommended dietary allowances (RDA) of vitamin D. The RDA is the average daily level of intake sufficient to meet the nutrient requirements of nearly all (97%-98%) healthy individuals. Most professional organizations recommend that adults ≥ 50 years consume 800 to 1000 IU of vitamin D daily. TABLE 2 lists the RDA for vitamin D by age and sex.¹⁵ The amount of vitamin D in selected food products is listed in TABLE 3.¹⁵ Some increase in levels of vitamin D can occur as a result of sun exposure, but current practices of sun avoidance make it difficult to achieve a significant contribution to vitamin D requirements.¹⁵

Continue to: Alternatives to universal screening

Alternatives to universal screening. Screening for vitamin D deficiency might benefit some patients, although there is no evidence to support it. Universal screening will likely lead to overdiagnosis and overtreatment based on what is essentially a poorly understood blood test. This was the concern expressed by the NAM.^4,16 An editorial accompanying publication of the recent USPSTF recommendation suggested not measuring vitamin D levels but instead advising patients to consume the age-based RDA of vitamin D.³ For those at increased risk for vitamin D deficiency, advise a higher dose of vitamin D (eg, 2000 IU/d, which is still lower than the upper daily limit).³

Evidence is insufficient to recommend vitamin D and calcium supplementation, alone or in combination, to prevent fractures in men or premenopausal women.

Other options are to screen for vitamin D deficiency only in those at high risk for low vitamin D levels, and to test for vitamin D deficiency in those with symptoms associated with deficiency such as bone pain and muscle weakness. These options would be consistent with recommendations from the Endocrine Society.⁵ Some have recommended that if testing is ordered, it should be performed by a laboratory that uses liquid chromatography-mass spectrometry because it is the criterion standard.²

Treatment options. Vitamin D deficiency can be treated with either ergocalciferol (vitamin D₂) or cholecalciferol (vitamin D₃). These treatments can also be recommended for those whose diets may not provide the RDA for vitamin D. Both are readily available over the counter and by prescription. The Task Force found that the harms of treating vitamin D deficiency with vitamin D at recommended doses are small to none.¹ There is possibly a small increase in kidney stones with the combined use of 1000 mg/d calcium and 10 mcg (400 IU)/d vitamin D.¹⁷ Large doses of vitamin D can cause toxicity including marked hypercalcemia, nausea, vomiting, muscle weakness, neuropsychiatric disturbances, pain, loss of appetite, dehydration, polyuria, excessive thirst, and kidney stones.¹⁵A cautious evidence-based approach would be to selectively screen for vitamin D deficiency, conduct diagnostic testing when indicated, and advise vitamin D supplementation as needed.

In April 2021, the US Preventive Services Task Force (USPSTF) published an updated recommendation on screening for vitamin D deficiency in adults. It reaffirmed an “I” statement first made in 2014: evidence is insufficient to balance the benefits and harms of screening.¹ This recommendation applies to asymptomatic, community-dwelling, nonpregnant adults without conditions treatable with vitamin D. It’s important to remember that screening refers to testing asymptomatic individuals to detect a condition early before it causes illness. Testing performed to determine whether symptoms are evidence of an underlying condition is not screening but diagnostic testing.

The Task Force statement explains the problems they found with the current level of knowledge about screening for vitamin D deficiency. First, while 25-hydroxyvitamin D [25(OH)D] is considered the best test for vitamin D levels, it is hard to measure accurately and test results vary by the method used and laboratories doing the testing. There also is uncertainty about how best to measure vitamin D status in different racial and ethnic groups, especially those with dark skin pigmentation. In addition, 25(OH)D in the blood is predominantly the bound form, with only 10% to 15% being unbound and bioavailable. Current tests do not determine the amount of bound vs unbound 25(OH)D.^1-3

There is no consensus about the optimal blood level of vitamin D or the level that defines deficiency. The Institute of Medicine (now the National Academy of Medicine—NAM) stated that serum 25(OH)D levels ≥ 20 ng/mL are adequate to meet the ­metabolic needs of 97.5% of people, and that levels of 12 to 20 ng/mL pose a risk of deficiency, with levels < 12 considered to be very low.⁴ The Endocrine Society defines deficiency as < 20 ng/mL and insufficiency as 21 to 29 ng/mL.⁵

The rate of testing for vitamin D deficiency in primary care in unknown, but there is evidence that since 2000, it has increased 80 fold at least among those with Medicare.⁶ Data from the 2011-2014 National Health and Nutrition Examination Survey showed that 5% of the population had 25(OH)D levels < 12 ng/mL and 18% had levels between 12 and 19 ng/mL.⁷ Some have estimated that as many as half of all adults would be considered vitamin D deficient or insufficient using current less conservative definitions, with higher rates in racial/ethnic minorities.^2,8

There are no firm data on the frequency, or benefits, of screening for vitamin D levels in asymptomatic adults (and treating those found to have vitamin D deficiency). The Task Force looked for indirect evidence by examining the effect of treating vitamin D deficiency in a number of conditions and found that for some, there was adequate evidence of no benefit and for others there was inadequate evidence for possible benefits.⁹ No benefit was found for incidence of fractures, type 2 diabetes, and overall mortality.⁹ Inadequate evidence was found for incidence of cancer, cardiovascular disease, scores on measures of depression and physical functioning, and urinary tract infections in those with impaired fasting glucose.⁹

Known risk factors for low vitamin D levels include low vitamin D intake, older age, obesity, low UVB exposure or absorption due to long winter seasons in northern latitudes, sun avoidance, and dark skin pigmentation.¹ In addition, certain medical conditions contribute to, or are caused by, low vitamin D levels—eg, osteoporosis, chronic kidney disease, malabsorption syndromes, and medication use (ie, glucocorticoids).^1-3

The Task Force recommendation on screening for vitamin D deficiency differs from those of some other organizations. However, none recommend universal population-based screening. The Endocrine Society and the American Association of Clinical Endocrinologists recommend screening but only in those at risk for vitamin D deficiency.^5,10 The American Academy of Family Physicians endorses the USPSTF recommendation.¹¹

Continue to: Specific USPSTF topics related to vitamin D

The Task Force has specifically addressed 3 topics pertaining to vitamin D. In each instance, the recommendation relates not to providing vitamin D to those who have vitamin D deficiency, but to providing vitamin D supplementation universally to specific groups at risk of a particular condition (TABLE 1).

Prevention of falls in the elderly. In 2018 the Task Force recommended against the use of vitamin D to prevent falls in ­community-dwelling adults ≥ 65 years.¹² This reversed its 2012 recommendation advising vitamin D supplementation to prevent falls. The Task Force re-examined the old evidence and looked at newer studies and concluded that their previous conclusion was wrong and that the evidence showed no benefit from vitamin D in preventing falls in the elderly. The reversal of a prior recommendation is rare for the USPSTF because of the rigor of its evidence reviews and its policy of not making a recommendation unless solid evidence for or against exists.

Prevention of cardiovascular disease and cancer. The Task Force concludes that current evidence is insufficient to assess the balance of benefits and harms in the use of single- or paired-nutrient supplements to prevent cardiovascular disease or cancer.¹³ (The exceptions are beta-carotene and vitamin E, which the Task Force recommends against.) This statement is consistent with the lack of evidence the Task Force found regarding prevention of these conditions by vitamin D supplementation in those who are vitamin D deficient.

Prevention of fractures in men and in premenopausal and postmenopausal women. For men and premenopausal women, the Task Force concludes that evidence is insufficient to assess the benefits and harms of vitamin D and calcium supplementation, alone or in combination, to prevent fractures.¹⁴ For prevention of fractures in postmenopausal women, there are 2 recommendations. The first one advises against the use of ≤ 400 IU of vitamin D and ≤ 1000 mg of calcium because the evidence indicates ineffectiveness. The second one is another “I” statement for the use of doses > 400 IU of vitamin D and > 1000 mg of calcium. These 3 recommendations apply to adults who live in the community and not in nursing homes or other institutional care facilities; they do not apply to those who have osteoporosis.

What should the family physician do?

Encourage all patients to take the recommended dietary allowances (RDA) of vitamin D. The RDA is the average daily level of intake sufficient to meet the nutrient requirements of nearly all (97%-98%) healthy individuals. Most professional organizations recommend that adults ≥ 50 years consume 800 to 1000 IU of vitamin D daily. TABLE 2 lists the RDA for vitamin D by age and sex.¹⁵ The amount of vitamin D in selected food products is listed in TABLE 3.¹⁵ Some increase in levels of vitamin D can occur as a result of sun exposure, but current practices of sun avoidance make it difficult to achieve a significant contribution to vitamin D requirements.¹⁵

Continue to: Alternatives to universal screening

Alternatives to universal screening. Screening for vitamin D deficiency might benefit some patients, although there is no evidence to support it. Universal screening will likely lead to overdiagnosis and overtreatment based on what is essentially a poorly understood blood test. This was the concern expressed by the NAM.^4,16 An editorial accompanying publication of the recent USPSTF recommendation suggested not measuring vitamin D levels but instead advising patients to consume the age-based RDA of vitamin D.³ For those at increased risk for vitamin D deficiency, advise a higher dose of vitamin D (eg, 2000 IU/d, which is still lower than the upper daily limit).³

Evidence is insufficient to recommend vitamin D and calcium supplementation, alone or in combination, to prevent fractures in men or premenopausal women.

Other options are to screen for vitamin D deficiency only in those at high risk for low vitamin D levels, and to test for vitamin D deficiency in those with symptoms associated with deficiency such as bone pain and muscle weakness. These options would be consistent with recommendations from the Endocrine Society.⁵ Some have recommended that if testing is ordered, it should be performed by a laboratory that uses liquid chromatography-mass spectrometry because it is the criterion standard.²

Treatment options. Vitamin D deficiency can be treated with either ergocalciferol (vitamin D₂) or cholecalciferol (vitamin D₃). These treatments can also be recommended for those whose diets may not provide the RDA for vitamin D. Both are readily available over the counter and by prescription. The Task Force found that the harms of treating vitamin D deficiency with vitamin D at recommended doses are small to none.¹ There is possibly a small increase in kidney stones with the combined use of 1000 mg/d calcium and 10 mcg (400 IU)/d vitamin D.¹⁷ Large doses of vitamin D can cause toxicity including marked hypercalcemia, nausea, vomiting, muscle weakness, neuropsychiatric disturbances, pain, loss of appetite, dehydration, polyuria, excessive thirst, and kidney stones.¹⁵A cautious evidence-based approach would be to selectively screen for vitamin D deficiency, conduct diagnostic testing when indicated, and advise vitamin D supplementation as needed.

In April 2021, the US Preventive Services Task Force (USPSTF) published an updated recommendation on screening for vitamin D deficiency in adults. It reaffirmed an “I” statement first made in 2014: evidence is insufficient to balance the benefits and harms of screening.¹ This recommendation applies to asymptomatic, community-dwelling, nonpregnant adults without conditions treatable with vitamin D. It’s important to remember that screening refers to testing asymptomatic individuals to detect a condition early before it causes illness. Testing performed to determine whether symptoms are evidence of an underlying condition is not screening but diagnostic testing.

The Task Force statement explains the problems they found with the current level of knowledge about screening for vitamin D deficiency. First, while 25-hydroxyvitamin D [25(OH)D] is considered the best test for vitamin D levels, it is hard to measure accurately and test results vary by the method used and laboratories doing the testing. There also is uncertainty about how best to measure vitamin D status in different racial and ethnic groups, especially those with dark skin pigmentation. In addition, 25(OH)D in the blood is predominantly the bound form, with only 10% to 15% being unbound and bioavailable. Current tests do not determine the amount of bound vs unbound 25(OH)D.^1-3

There is no consensus about the optimal blood level of vitamin D or the level that defines deficiency. The Institute of Medicine (now the National Academy of Medicine—NAM) stated that serum 25(OH)D levels ≥ 20 ng/mL are adequate to meet the ­metabolic needs of 97.5% of people, and that levels of 12 to 20 ng/mL pose a risk of deficiency, with levels < 12 considered to be very low.⁴ The Endocrine Society defines deficiency as < 20 ng/mL and insufficiency as 21 to 29 ng/mL.⁵

The rate of testing for vitamin D deficiency in primary care in unknown, but there is evidence that since 2000, it has increased 80 fold at least among those with Medicare.⁶ Data from the 2011-2014 National Health and Nutrition Examination Survey showed that 5% of the population had 25(OH)D levels < 12 ng/mL and 18% had levels between 12 and 19 ng/mL.⁷ Some have estimated that as many as half of all adults would be considered vitamin D deficient or insufficient using current less conservative definitions, with higher rates in racial/ethnic minorities.^2,8

There are no firm data on the frequency, or benefits, of screening for vitamin D levels in asymptomatic adults (and treating those found to have vitamin D deficiency). The Task Force looked for indirect evidence by examining the effect of treating vitamin D deficiency in a number of conditions and found that for some, there was adequate evidence of no benefit and for others there was inadequate evidence for possible benefits.⁹ No benefit was found for incidence of fractures, type 2 diabetes, and overall mortality.⁹ Inadequate evidence was found for incidence of cancer, cardiovascular disease, scores on measures of depression and physical functioning, and urinary tract infections in those with impaired fasting glucose.⁹

Known risk factors for low vitamin D levels include low vitamin D intake, older age, obesity, low UVB exposure or absorption due to long winter seasons in northern latitudes, sun avoidance, and dark skin pigmentation.¹ In addition, certain medical conditions contribute to, or are caused by, low vitamin D levels—eg, osteoporosis, chronic kidney disease, malabsorption syndromes, and medication use (ie, glucocorticoids).^1-3

The Task Force recommendation on screening for vitamin D deficiency differs from those of some other organizations. However, none recommend universal population-based screening. The Endocrine Society and the American Association of Clinical Endocrinologists recommend screening but only in those at risk for vitamin D deficiency.^5,10 The American Academy of Family Physicians endorses the USPSTF recommendation.¹¹

Continue to: Specific USPSTF topics related to vitamin D

The Task Force has specifically addressed 3 topics pertaining to vitamin D. In each instance, the recommendation relates not to providing vitamin D to those who have vitamin D deficiency, but to providing vitamin D supplementation universally to specific groups at risk of a particular condition (TABLE 1).

Prevention of falls in the elderly. In 2018 the Task Force recommended against the use of vitamin D to prevent falls in ­community-dwelling adults ≥ 65 years.¹² This reversed its 2012 recommendation advising vitamin D supplementation to prevent falls. The Task Force re-examined the old evidence and looked at newer studies and concluded that their previous conclusion was wrong and that the evidence showed no benefit from vitamin D in preventing falls in the elderly. The reversal of a prior recommendation is rare for the USPSTF because of the rigor of its evidence reviews and its policy of not making a recommendation unless solid evidence for or against exists.

Prevention of cardiovascular disease and cancer. The Task Force concludes that current evidence is insufficient to assess the balance of benefits and harms in the use of single- or paired-nutrient supplements to prevent cardiovascular disease or cancer.¹³ (The exceptions are beta-carotene and vitamin E, which the Task Force recommends against.) This statement is consistent with the lack of evidence the Task Force found regarding prevention of these conditions by vitamin D supplementation in those who are vitamin D deficient.

Prevention of fractures in men and in premenopausal and postmenopausal women. For men and premenopausal women, the Task Force concludes that evidence is insufficient to assess the benefits and harms of vitamin D and calcium supplementation, alone or in combination, to prevent fractures.¹⁴ For prevention of fractures in postmenopausal women, there are 2 recommendations. The first one advises against the use of ≤ 400 IU of vitamin D and ≤ 1000 mg of calcium because the evidence indicates ineffectiveness. The second one is another “I” statement for the use of doses > 400 IU of vitamin D and > 1000 mg of calcium. These 3 recommendations apply to adults who live in the community and not in nursing homes or other institutional care facilities; they do not apply to those who have osteoporosis.

What should the family physician do?

Encourage all patients to take the recommended dietary allowances (RDA) of vitamin D. The RDA is the average daily level of intake sufficient to meet the nutrient requirements of nearly all (97%-98%) healthy individuals. Most professional organizations recommend that adults ≥ 50 years consume 800 to 1000 IU of vitamin D daily. TABLE 2 lists the RDA for vitamin D by age and sex.¹⁵ The amount of vitamin D in selected food products is listed in TABLE 3.¹⁵ Some increase in levels of vitamin D can occur as a result of sun exposure, but current practices of sun avoidance make it difficult to achieve a significant contribution to vitamin D requirements.¹⁵

Continue to: Alternatives to universal screening

Alternatives to universal screening. Screening for vitamin D deficiency might benefit some patients, although there is no evidence to support it. Universal screening will likely lead to overdiagnosis and overtreatment based on what is essentially a poorly understood blood test. This was the concern expressed by the NAM.^4,16 An editorial accompanying publication of the recent USPSTF recommendation suggested not measuring vitamin D levels but instead advising patients to consume the age-based RDA of vitamin D.³ For those at increased risk for vitamin D deficiency, advise a higher dose of vitamin D (eg, 2000 IU/d, which is still lower than the upper daily limit).³

Evidence is insufficient to recommend vitamin D and calcium supplementation, alone or in combination, to prevent fractures in men or premenopausal women.

Other options are to screen for vitamin D deficiency only in those at high risk for low vitamin D levels, and to test for vitamin D deficiency in those with symptoms associated with deficiency such as bone pain and muscle weakness. These options would be consistent with recommendations from the Endocrine Society.⁵ Some have recommended that if testing is ordered, it should be performed by a laboratory that uses liquid chromatography-mass spectrometry because it is the criterion standard.²

Treatment options. Vitamin D deficiency can be treated with either ergocalciferol (vitamin D₂) or cholecalciferol (vitamin D₃). These treatments can also be recommended for those whose diets may not provide the RDA for vitamin D. Both are readily available over the counter and by prescription. The Task Force found that the harms of treating vitamin D deficiency with vitamin D at recommended doses are small to none.¹ There is possibly a small increase in kidney stones with the combined use of 1000 mg/d calcium and 10 mcg (400 IU)/d vitamin D.¹⁷ Large doses of vitamin D can cause toxicity including marked hypercalcemia, nausea, vomiting, muscle weakness, neuropsychiatric disturbances, pain, loss of appetite, dehydration, polyuria, excessive thirst, and kidney stones.¹⁵A cautious evidence-based approach would be to selectively screen for vitamin D deficiency, conduct diagnostic testing when indicated, and advise vitamin D supplementation as needed.

An influential, independent panel unanimously voted that aducanumab (Aduhelm) offers no benefit for patients with Alzheimer’s disease (AD), adding to growing opposition from medical experts to the Food and Drug Administration’s approval of this controversial drug.

The Institute for Clinical and Economic Review asked one of its expert panels, the California Technology Assessment Forum, to consider the available data about aducanumab and requested that members vote on whether there was sufficient evidence of a net benefit of aducanumab plus supportive care versus supportive care alone. All 15 panelists voted no.

Several panelists, including ICER President Steven D. Pearson, MD, talked about their personal experience with family members who have the disease.

There was universal agreement among the panelists that there is an urgent need for effective medications to treat the disease. However, the panel of clinicians and researchers also agreed that the evidence to date does not show that the drug helps patients with this debilitating disease.

Panelist Sei Lee, MD, a geriatrician at the University of California, San Francisco, said he lost his mother to AD 6 years ago. In addition to his clinical work, Dr. Lee has conducted research focused on improving the targeting of preventive AD interventions for older adults to maximize benefits and minimize harms.

Dr. Lee said he frequently felt completely overwhelmed by the challenges of his mother’s disease.

“I absolutely hear everyone who is saying we need an effective therapy for this,” Dr. Lee said.

Dr. Lee added that, as an experienced researcher who has weighed the aducanumab data, he saw no clear proof of a benefit that would outweigh the drug’s documented side effects in the two phase 3 trials of the drug. Those side effects include temporary brain swelling. Dr. Lee suggested that Biogen do more to address concerns about this side effect, saying it should not be ignored.

“There’s clearly substantial uncertainty” about aducanumab, Dr. Lee said. “If I had to guess, I think the data is stronger for net harm than it is for that benefit.”

Questions persist about the data Biogen used in support of aducanumab after announcing that the drug had failed in a dual-track phase 3 program.

In March 2019, it was announced that two phase 3 clinical trials, EMERGE and ENGAGE, were scrapped because of disappointing results. The trials were intended to show that aducanumab could slow progression of cognitive and functional impairment, as measured by changes in scores on the Clinical Dementia Rating–Sum of Boxes (CDR-SB).

However, in October 2019, there was an about-face – Biogen announced that, in one of the studies, there were positive findings for a subset of patients who received a higher dose of aducanumab.

No treatment benefit was observed in either the high- or low-dose arms at week 78 in the ENGAGE trial. In the EMERGE trial, however, there was a statistically significant difference in change from baseline in CDR-SB score in the high-dose arm (difference vs. placebo, –0.39; 95% confidence interval, –0.69 to –0.09) but not in the low-dose arm, ICER noted in a draft report.

Still, there are questions about whether this difference would translate into clinical benefit. “Although statistically significant, the change in CDR-SB score in the high-dose group was less than the 1- to 2-point change that has been suggested as a minimal clinically important difference,” ICER staff wrote.
 

More push back

Other influential organizations also remain skeptical.

On July 14, the Cleveland Clinic announced it would not use aducanumab at this time, following a staff review of the evidence. Physicians from the clinic could prescribe it to appropriate patients, who would receive their infusions at external facilities, a spokeswoman for the clinic told this news organization. The Cleveland Clinic said it will reevaluate this position as additional data become available.

In addition, as reported by the New York Times, the Mount Sinai Health System in New York also decided not to administer the drug.

The drug received accelerated approval from the FDA. That approval was conditional upon Biogen’s conducting further research by 2030 that demonstrates that the drug has clinical benefit.

On July 14, the executive committee of the American Neurological Association issued a statement asking for a speedier timeline.

The FDA should ensure that Biogen completes the required confirmatory study “as soon as possible, preferably within 3 years, to confirm or not whether clinical efficacy is observed,” the ANA executive committee wrote in the letter.

The ANA executive committee also criticized the FDA’s decision to allow Biogen to begin sales of the drug. In light of the clinical evidence available at this time, aducanumab “should not have been approved” in the first place, the ANA executive committee stated.

ICER will release a final report on aducanumab on August 5, drawing from the discussion at the meeting and the panel’s votes. The work of the Boston-based group is used by private insurers to inform medication coverage decisions.

Lawmakers have taken an interest in aducanumab. On July 12, two top Democrats in the U.S. House of Representatives released a letter that they had sent to Biogen as part of their investigation into how the FDA handled the aducanumab approval and Biogen’s pricing for the drug.

In the letter, House Energy and Commerce Chairman Frank Pallone Jr. (D-N.J.) and Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) wrote that they had “significant questions about the drug’s clinical benefit, and the steep $56,000 annual price tag.”

At the ICER meeting on July 15, Dr. Lee said patients with AD and their caregivers would benefit more from increased spending on supportive services, such as home health care.

“There’s so many things we could do” with money that Biogen may get for aducanumab, Dr. Lee said. “To spend it on a medication that is more likely to do more harm than help seems really ill advised.”

A version of this article first appeared on Medscape.com.

An influential, independent panel unanimously voted that aducanumab (Aduhelm) offers no benefit for patients with Alzheimer’s disease (AD), adding to growing opposition from medical experts to the Food and Drug Administration’s approval of this controversial drug.

The Institute for Clinical and Economic Review asked one of its expert panels, the California Technology Assessment Forum, to consider the available data about aducanumab and requested that members vote on whether there was sufficient evidence of a net benefit of aducanumab plus supportive care versus supportive care alone. All 15 panelists voted no.

Several panelists, including ICER President Steven D. Pearson, MD, talked about their personal experience with family members who have the disease.

There was universal agreement among the panelists that there is an urgent need for effective medications to treat the disease. However, the panel of clinicians and researchers also agreed that the evidence to date does not show that the drug helps patients with this debilitating disease.

Panelist Sei Lee, MD, a geriatrician at the University of California, San Francisco, said he lost his mother to AD 6 years ago. In addition to his clinical work, Dr. Lee has conducted research focused on improving the targeting of preventive AD interventions for older adults to maximize benefits and minimize harms.

Dr. Lee said he frequently felt completely overwhelmed by the challenges of his mother’s disease.

“I absolutely hear everyone who is saying we need an effective therapy for this,” Dr. Lee said.

Dr. Lee added that, as an experienced researcher who has weighed the aducanumab data, he saw no clear proof of a benefit that would outweigh the drug’s documented side effects in the two phase 3 trials of the drug. Those side effects include temporary brain swelling. Dr. Lee suggested that Biogen do more to address concerns about this side effect, saying it should not be ignored.

“There’s clearly substantial uncertainty” about aducanumab, Dr. Lee said. “If I had to guess, I think the data is stronger for net harm than it is for that benefit.”

Questions persist about the data Biogen used in support of aducanumab after announcing that the drug had failed in a dual-track phase 3 program.

In March 2019, it was announced that two phase 3 clinical trials, EMERGE and ENGAGE, were scrapped because of disappointing results. The trials were intended to show that aducanumab could slow progression of cognitive and functional impairment, as measured by changes in scores on the Clinical Dementia Rating–Sum of Boxes (CDR-SB).

However, in October 2019, there was an about-face – Biogen announced that, in one of the studies, there were positive findings for a subset of patients who received a higher dose of aducanumab.

No treatment benefit was observed in either the high- or low-dose arms at week 78 in the ENGAGE trial. In the EMERGE trial, however, there was a statistically significant difference in change from baseline in CDR-SB score in the high-dose arm (difference vs. placebo, –0.39; 95% confidence interval, –0.69 to –0.09) but not in the low-dose arm, ICER noted in a draft report.

Still, there are questions about whether this difference would translate into clinical benefit. “Although statistically significant, the change in CDR-SB score in the high-dose group was less than the 1- to 2-point change that has been suggested as a minimal clinically important difference,” ICER staff wrote.
 

More push back

Other influential organizations also remain skeptical.

On July 14, the Cleveland Clinic announced it would not use aducanumab at this time, following a staff review of the evidence. Physicians from the clinic could prescribe it to appropriate patients, who would receive their infusions at external facilities, a spokeswoman for the clinic told this news organization. The Cleveland Clinic said it will reevaluate this position as additional data become available.

In addition, as reported by the New York Times, the Mount Sinai Health System in New York also decided not to administer the drug.

The drug received accelerated approval from the FDA. That approval was conditional upon Biogen’s conducting further research by 2030 that demonstrates that the drug has clinical benefit.

On July 14, the executive committee of the American Neurological Association issued a statement asking for a speedier timeline.

The FDA should ensure that Biogen completes the required confirmatory study “as soon as possible, preferably within 3 years, to confirm or not whether clinical efficacy is observed,” the ANA executive committee wrote in the letter.

The ANA executive committee also criticized the FDA’s decision to allow Biogen to begin sales of the drug. In light of the clinical evidence available at this time, aducanumab “should not have been approved” in the first place, the ANA executive committee stated.

ICER will release a final report on aducanumab on August 5, drawing from the discussion at the meeting and the panel’s votes. The work of the Boston-based group is used by private insurers to inform medication coverage decisions.

Lawmakers have taken an interest in aducanumab. On July 12, two top Democrats in the U.S. House of Representatives released a letter that they had sent to Biogen as part of their investigation into how the FDA handled the aducanumab approval and Biogen’s pricing for the drug.

In the letter, House Energy and Commerce Chairman Frank Pallone Jr. (D-N.J.) and Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) wrote that they had “significant questions about the drug’s clinical benefit, and the steep $56,000 annual price tag.”

At the ICER meeting on July 15, Dr. Lee said patients with AD and their caregivers would benefit more from increased spending on supportive services, such as home health care.

“There’s so many things we could do” with money that Biogen may get for aducanumab, Dr. Lee said. “To spend it on a medication that is more likely to do more harm than help seems really ill advised.”

A version of this article first appeared on Medscape.com.

An influential, independent panel unanimously voted that aducanumab (Aduhelm) offers no benefit for patients with Alzheimer’s disease (AD), adding to growing opposition from medical experts to the Food and Drug Administration’s approval of this controversial drug.

The Institute for Clinical and Economic Review asked one of its expert panels, the California Technology Assessment Forum, to consider the available data about aducanumab and requested that members vote on whether there was sufficient evidence of a net benefit of aducanumab plus supportive care versus supportive care alone. All 15 panelists voted no.

Several panelists, including ICER President Steven D. Pearson, MD, talked about their personal experience with family members who have the disease.

There was universal agreement among the panelists that there is an urgent need for effective medications to treat the disease. However, the panel of clinicians and researchers also agreed that the evidence to date does not show that the drug helps patients with this debilitating disease.

Panelist Sei Lee, MD, a geriatrician at the University of California, San Francisco, said he lost his mother to AD 6 years ago. In addition to his clinical work, Dr. Lee has conducted research focused on improving the targeting of preventive AD interventions for older adults to maximize benefits and minimize harms.

Dr. Lee said he frequently felt completely overwhelmed by the challenges of his mother’s disease.

“I absolutely hear everyone who is saying we need an effective therapy for this,” Dr. Lee said.

Dr. Lee added that, as an experienced researcher who has weighed the aducanumab data, he saw no clear proof of a benefit that would outweigh the drug’s documented side effects in the two phase 3 trials of the drug. Those side effects include temporary brain swelling. Dr. Lee suggested that Biogen do more to address concerns about this side effect, saying it should not be ignored.

“There’s clearly substantial uncertainty” about aducanumab, Dr. Lee said. “If I had to guess, I think the data is stronger for net harm than it is for that benefit.”

Questions persist about the data Biogen used in support of aducanumab after announcing that the drug had failed in a dual-track phase 3 program.

In March 2019, it was announced that two phase 3 clinical trials, EMERGE and ENGAGE, were scrapped because of disappointing results. The trials were intended to show that aducanumab could slow progression of cognitive and functional impairment, as measured by changes in scores on the Clinical Dementia Rating–Sum of Boxes (CDR-SB).

However, in October 2019, there was an about-face – Biogen announced that, in one of the studies, there were positive findings for a subset of patients who received a higher dose of aducanumab.

No treatment benefit was observed in either the high- or low-dose arms at week 78 in the ENGAGE trial. In the EMERGE trial, however, there was a statistically significant difference in change from baseline in CDR-SB score in the high-dose arm (difference vs. placebo, –0.39; 95% confidence interval, –0.69 to –0.09) but not in the low-dose arm, ICER noted in a draft report.

Still, there are questions about whether this difference would translate into clinical benefit. “Although statistically significant, the change in CDR-SB score in the high-dose group was less than the 1- to 2-point change that has been suggested as a minimal clinically important difference,” ICER staff wrote.
 

More push back

Other influential organizations also remain skeptical.

On July 14, the Cleveland Clinic announced it would not use aducanumab at this time, following a staff review of the evidence. Physicians from the clinic could prescribe it to appropriate patients, who would receive their infusions at external facilities, a spokeswoman for the clinic told this news organization. The Cleveland Clinic said it will reevaluate this position as additional data become available.

In addition, as reported by the New York Times, the Mount Sinai Health System in New York also decided not to administer the drug.

The drug received accelerated approval from the FDA. That approval was conditional upon Biogen’s conducting further research by 2030 that demonstrates that the drug has clinical benefit.

On July 14, the executive committee of the American Neurological Association issued a statement asking for a speedier timeline.

The FDA should ensure that Biogen completes the required confirmatory study “as soon as possible, preferably within 3 years, to confirm or not whether clinical efficacy is observed,” the ANA executive committee wrote in the letter.

The ANA executive committee also criticized the FDA’s decision to allow Biogen to begin sales of the drug. In light of the clinical evidence available at this time, aducanumab “should not have been approved” in the first place, the ANA executive committee stated.

ICER will release a final report on aducanumab on August 5, drawing from the discussion at the meeting and the panel’s votes. The work of the Boston-based group is used by private insurers to inform medication coverage decisions.

Lawmakers have taken an interest in aducanumab. On July 12, two top Democrats in the U.S. House of Representatives released a letter that they had sent to Biogen as part of their investigation into how the FDA handled the aducanumab approval and Biogen’s pricing for the drug.

In the letter, House Energy and Commerce Chairman Frank Pallone Jr. (D-N.J.) and Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) wrote that they had “significant questions about the drug’s clinical benefit, and the steep $56,000 annual price tag.”

At the ICER meeting on July 15, Dr. Lee said patients with AD and their caregivers would benefit more from increased spending on supportive services, such as home health care.

“There’s so many things we could do” with money that Biogen may get for aducanumab, Dr. Lee said. “To spend it on a medication that is more likely to do more harm than help seems really ill advised.”

A version of this article first appeared on Medscape.com.

On July 12, federal officials announced they are seeking to establish a national coverage policy for aducanumab (Aduhelm) for Alzheimer’s disease (AD), a process that will take until next year to complete.

The Centers for Medicare & Medicaid Services said it will accept public comments about how Medicare should cover aducanumab through Aug. 11. The agency intends to post a draft decision memo on its coverage approach by Jan. 12, 2022, and then finalize this policy by April 12. Coverage decisions about aducanumab now are being made at the local level by Medicare’s administrative contractors, CMS said in a press release.

The announcement followed separate public calls for such a review by America’s Health Insurance Plans (AHIP) and the Alzheimer’s Association.

On June 30, AHIP submitted a formal request to the CMS. In it, AHIP requests that CMS take “swift action” on a national coverage determination for aducanumab. In the request, the organization specifically urged CMS to use a policy known as coverage with evidence development (CED) for Aduhelm.

This CED approach would allow access for patients considered most likely to benefit from the drug while Biogen continues research needed to definitively show its clinical benefit, said AHIP chief executive Matt Eyles.

In June, the Food and Drug Administration approved aducanumab based on data suggesting the drug might slow AD progression using the surrogate marker of a reduction in amyloid plaque.

The FDA’s accelerated approval letter set a 2030 deadline for Biogen to produce evidence from a phase 3 clinical trial definitively proving the drug’s efficacy.
 

Hefty price tag

Even if Biogen meets the FDA’s deadline, patients with AD, their families, clinicians, and insurers likely will wrestle for years with questions about whether to use this costly drug without clear evidence of benefit. The drug is estimated to cost $56,000 per year.

In addition, patients taking the drug will be required to undergo MRI scans to monitor for brain swelling or bleeding, complications that were experienced by those participating in previous studies of the drug, Mr. Eyles noted in his letter to CMS, which AHIP provided to this news organization.

About 80% of those eligible for aducanumab in the United States are enrolled in Medicare, write James D. Chambers, PhD, MPharm, Tufts University, Boston, and coauthors in a June article in the journal Health Affairs. Like AHIP, these authors also recommended CMS consider the CED path for the drug.

CMS has used the CED approach since 2003 to evaluate interventions such as amyloid PET for clinical evaluation of AD to implantable cardioverter defibrillators.

Applying CED to aducanumab “would provide the medical community, patients, caregivers, and payers with additional information long before the FDA’s required postapproval studies are completed,” Dr. Chambers and coauthors wrote. “It would also ensure that data on every patient treated would add to the knowledge base about how aducanumab impacts patient outcomes such as cognition, function, and quality of life.”

In the AHIP request to CMS, Mr. Eyles also noted that an independent review organization, the Institute for Clinical and Economic Review, said the evidence from studies done to date on aducanumab is “insufficient” to show a net health benefit for patients with mild cognitive impairment because of AD or mild AD.

At the ICER meeting, which will take place July 15, one of ICER’s expert panels, the California Technology Assessment Forum, said it will further consider all of the available scientific data on aducanumab and vote on a series of questions about its efficacy and value.

ICER’s reports have clout because insurers use its recommendations to help determine how to cover drugs and medical treatments. Among the questions ICER has posted online ahead of the meeting is one about the relative effects of aducanumab plus supportive care versus supportive care alone.
 

‘Dark irony’

Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.

Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.

In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.

During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.

He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.

“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”

Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
 

Dr. Woodcock’s ‘personal commitment’

In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.

In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.

AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”

“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.

“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.

The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.

Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”

A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.

Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.

“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.

Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.

In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”

“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
 

A version of this article first appeared on Medscape.com.

On July 12, federal officials announced they are seeking to establish a national coverage policy for aducanumab (Aduhelm) for Alzheimer’s disease (AD), a process that will take until next year to complete.

The Centers for Medicare & Medicaid Services said it will accept public comments about how Medicare should cover aducanumab through Aug. 11. The agency intends to post a draft decision memo on its coverage approach by Jan. 12, 2022, and then finalize this policy by April 12. Coverage decisions about aducanumab now are being made at the local level by Medicare’s administrative contractors, CMS said in a press release.

The announcement followed separate public calls for such a review by America’s Health Insurance Plans (AHIP) and the Alzheimer’s Association.

On June 30, AHIP submitted a formal request to the CMS. In it, AHIP requests that CMS take “swift action” on a national coverage determination for aducanumab. In the request, the organization specifically urged CMS to use a policy known as coverage with evidence development (CED) for Aduhelm.

This CED approach would allow access for patients considered most likely to benefit from the drug while Biogen continues research needed to definitively show its clinical benefit, said AHIP chief executive Matt Eyles.

In June, the Food and Drug Administration approved aducanumab based on data suggesting the drug might slow AD progression using the surrogate marker of a reduction in amyloid plaque.

The FDA’s accelerated approval letter set a 2030 deadline for Biogen to produce evidence from a phase 3 clinical trial definitively proving the drug’s efficacy.
 

Hefty price tag

Even if Biogen meets the FDA’s deadline, patients with AD, their families, clinicians, and insurers likely will wrestle for years with questions about whether to use this costly drug without clear evidence of benefit. The drug is estimated to cost $56,000 per year.

In addition, patients taking the drug will be required to undergo MRI scans to monitor for brain swelling or bleeding, complications that were experienced by those participating in previous studies of the drug, Mr. Eyles noted in his letter to CMS, which AHIP provided to this news organization.

About 80% of those eligible for aducanumab in the United States are enrolled in Medicare, write James D. Chambers, PhD, MPharm, Tufts University, Boston, and coauthors in a June article in the journal Health Affairs. Like AHIP, these authors also recommended CMS consider the CED path for the drug.

CMS has used the CED approach since 2003 to evaluate interventions such as amyloid PET for clinical evaluation of AD to implantable cardioverter defibrillators.

Applying CED to aducanumab “would provide the medical community, patients, caregivers, and payers with additional information long before the FDA’s required postapproval studies are completed,” Dr. Chambers and coauthors wrote. “It would also ensure that data on every patient treated would add to the knowledge base about how aducanumab impacts patient outcomes such as cognition, function, and quality of life.”

In the AHIP request to CMS, Mr. Eyles also noted that an independent review organization, the Institute for Clinical and Economic Review, said the evidence from studies done to date on aducanumab is “insufficient” to show a net health benefit for patients with mild cognitive impairment because of AD or mild AD.

At the ICER meeting, which will take place July 15, one of ICER’s expert panels, the California Technology Assessment Forum, said it will further consider all of the available scientific data on aducanumab and vote on a series of questions about its efficacy and value.

ICER’s reports have clout because insurers use its recommendations to help determine how to cover drugs and medical treatments. Among the questions ICER has posted online ahead of the meeting is one about the relative effects of aducanumab plus supportive care versus supportive care alone.
 

‘Dark irony’

Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.

Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.

In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.

During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.

He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.

“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”

Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
 

Dr. Woodcock’s ‘personal commitment’

In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.

In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.

AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”

“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.

“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.

The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.

Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”

A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.

Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.

“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.

Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.

In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”

“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
 

A version of this article first appeared on Medscape.com.

On July 12, federal officials announced they are seeking to establish a national coverage policy for aducanumab (Aduhelm) for Alzheimer’s disease (AD), a process that will take until next year to complete.

The Centers for Medicare & Medicaid Services said it will accept public comments about how Medicare should cover aducanumab through Aug. 11. The agency intends to post a draft decision memo on its coverage approach by Jan. 12, 2022, and then finalize this policy by April 12. Coverage decisions about aducanumab now are being made at the local level by Medicare’s administrative contractors, CMS said in a press release.

The announcement followed separate public calls for such a review by America’s Health Insurance Plans (AHIP) and the Alzheimer’s Association.

On June 30, AHIP submitted a formal request to the CMS. In it, AHIP requests that CMS take “swift action” on a national coverage determination for aducanumab. In the request, the organization specifically urged CMS to use a policy known as coverage with evidence development (CED) for Aduhelm.

This CED approach would allow access for patients considered most likely to benefit from the drug while Biogen continues research needed to definitively show its clinical benefit, said AHIP chief executive Matt Eyles.

In June, the Food and Drug Administration approved aducanumab based on data suggesting the drug might slow AD progression using the surrogate marker of a reduction in amyloid plaque.

The FDA’s accelerated approval letter set a 2030 deadline for Biogen to produce evidence from a phase 3 clinical trial definitively proving the drug’s efficacy.
 

Hefty price tag

Even if Biogen meets the FDA’s deadline, patients with AD, their families, clinicians, and insurers likely will wrestle for years with questions about whether to use this costly drug without clear evidence of benefit. The drug is estimated to cost $56,000 per year.

In addition, patients taking the drug will be required to undergo MRI scans to monitor for brain swelling or bleeding, complications that were experienced by those participating in previous studies of the drug, Mr. Eyles noted in his letter to CMS, which AHIP provided to this news organization.

About 80% of those eligible for aducanumab in the United States are enrolled in Medicare, write James D. Chambers, PhD, MPharm, Tufts University, Boston, and coauthors in a June article in the journal Health Affairs. Like AHIP, these authors also recommended CMS consider the CED path for the drug.

CMS has used the CED approach since 2003 to evaluate interventions such as amyloid PET for clinical evaluation of AD to implantable cardioverter defibrillators.

Applying CED to aducanumab “would provide the medical community, patients, caregivers, and payers with additional information long before the FDA’s required postapproval studies are completed,” Dr. Chambers and coauthors wrote. “It would also ensure that data on every patient treated would add to the knowledge base about how aducanumab impacts patient outcomes such as cognition, function, and quality of life.”

In the AHIP request to CMS, Mr. Eyles also noted that an independent review organization, the Institute for Clinical and Economic Review, said the evidence from studies done to date on aducanumab is “insufficient” to show a net health benefit for patients with mild cognitive impairment because of AD or mild AD.

At the ICER meeting, which will take place July 15, one of ICER’s expert panels, the California Technology Assessment Forum, said it will further consider all of the available scientific data on aducanumab and vote on a series of questions about its efficacy and value.

ICER’s reports have clout because insurers use its recommendations to help determine how to cover drugs and medical treatments. Among the questions ICER has posted online ahead of the meeting is one about the relative effects of aducanumab plus supportive care versus supportive care alone.
 

‘Dark irony’

Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.

Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.

In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.

During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.

He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.

“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”

Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
 

Dr. Woodcock’s ‘personal commitment’

In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.

In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.

AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”

“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.

“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.

The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.

Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”

A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.

Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.

“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.

Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.

In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”

“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
 

A version of this article first appeared on Medscape.com.

Dancing helps slow the progression of motor and nonmotor symptoms and improves quality of life for patients with Parkinson’s disease (PD), new research shows.

Over 3 years, weekly participation in dance training classes “drastically” reduced the expected decline in motor function and significantly improved speech, tremors, balance, and stiffness, the researchers reported.

Dance training also appeared to have benefits regarding cognition, hallucinations, depression, and anxiety.

“These findings strongly suggest the benefits of dance for people with PD as a supplement to a normal treatment regimen,” the investigators noted.

Although the mechanism of benefit is unclear, dance training may help “train neural network nodes that helps either strengthen networks damaged or builds neural road maps that pass the damage,” study investigator Joseph DeSouza, PhD, principal investigator and associate professor, department of psychology, York University, Toronto, said in an interview.

The study was published online July 7, 2021, in Brain Sciences.
 

Multiple benefits

PD is a neurodegenerative disease associated with progression of motor dysfunction within the first 5 years of diagnosis. The annual rate of motor decline, as determined with the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), is between 5.2 and 8.9 points.

Prior studies that assessed various styles of dance by patients with PD showed beneficial effects regarding gait speed, balance, locomotion, and aspects of quality of life.

To investigate further, DeSouza and coauthor Karolina Bearss, a PhD candidate at York University, followed 16 patients with mild to moderate PD who participated in a weekly dance class at Canada’s National Ballet School and Trinity St. Paul’s church.

Dance for Parkinson’s Disease, which is an established dance curriculum, involves aerobic and anaerobic movements. The protocol begins with a seated warm-up, followed by barre work, and ends with moving across the floor. All participants learn choreography for an upcoming performance.

In the study, 16 patients with PD who did not participant in the dance classes served as control patients.

Over 3 years, the daily rate of motor decline, as indicated by scores on part III of the MDS-UPDRS, was zero among the dancers (slope = 0.000146), indicating no motor impairment, whereas among the nondancers, the motor decline during follow-up was as expected (P < .01), the researchers reported.

In modeling the data, the researchers determined that after completing 1,000 days of dance training, dancers will have a motor score of 19.07, compared with a score of 28.27 for nondancers.

“Our data further showed that training in dance will slow the rate of PD motor impairment progression, as measured by the UPDRS III, by close to 3 points annually in comparison to our PD subjects who did not train,” the researchers reported.

Dance training also had a beneficial effect on motor or nonmotor aspects of daily living and on motor complications, for which there was no significant decline among the PD dancers.

“For those with Parkinson’s disease, even when it’s mild, motor impairment can impact their daily functioning – how they feel about themselves. Many of these motor symptoms lead to isolation because once they get extreme, these people don’t want to go out,” Dr. DeSouza said in a news release.

“These motor symptoms lead to further psychological issues, depression, social isolation and eventually the symptoms do get worse over time. Our study shows that training with dance and music can slow this down and improve their daily living and daily function,” he added.
 

‘Great potential’

Reached for comment, Demian Kogutek, PhD, director of music therapy, University of Evansville (Indiana), said that these preliminary findings from a longitudinal study are “promising.”

“I believe that dance therapy has a great potential for PD. The longitudinal aspect of this study undoubtedly adds to the current literature. Although it is a standardized assessment, it is somewhat subjective,” Dr. Kogutek said in an interview.

Going forward, Dr. Kogutek said he’d like to see other objective outcomes measured, such as objective assessments of balance, gait, hand strength, and dexterity.

Also weighing in on the results, Karen Lee, PhD, president and CEO of Parkinson Canada, said her organization is “encouraged by these preliminary findings as exercise and healthy activities are important for people with Parkinson’s. This study is part of a growing body of research that explores the link between the impact of activities and both motor and nonmotor symptoms of Parkinson’s.

“This research adds to growing evidence about the importance of exercise as part of the management of Parkinson’s, and we encourage people living with Parkinson’s to incorporate exercise as part of their approach to managing their health,” Dr. Lee said in an interview.

Funding for the project is provided in part by a National Science and Engineering Research Council Discovery Grant and by donations from the Irpinia Club of Toronto and others. Dr. Dr. DeSouza, Ms. Bearss, Dr. Kogutek, and Dr. Lee disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Dancing helps slow the progression of motor and nonmotor symptoms and improves quality of life for patients with Parkinson’s disease (PD), new research shows.

Over 3 years, weekly participation in dance training classes “drastically” reduced the expected decline in motor function and significantly improved speech, tremors, balance, and stiffness, the researchers reported.

Dance training also appeared to have benefits regarding cognition, hallucinations, depression, and anxiety.

“These findings strongly suggest the benefits of dance for people with PD as a supplement to a normal treatment regimen,” the investigators noted.

Although the mechanism of benefit is unclear, dance training may help “train neural network nodes that helps either strengthen networks damaged or builds neural road maps that pass the damage,” study investigator Joseph DeSouza, PhD, principal investigator and associate professor, department of psychology, York University, Toronto, said in an interview.

The study was published online July 7, 2021, in Brain Sciences.
 

Multiple benefits

PD is a neurodegenerative disease associated with progression of motor dysfunction within the first 5 years of diagnosis. The annual rate of motor decline, as determined with the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), is between 5.2 and 8.9 points.

Prior studies that assessed various styles of dance by patients with PD showed beneficial effects regarding gait speed, balance, locomotion, and aspects of quality of life.

To investigate further, DeSouza and coauthor Karolina Bearss, a PhD candidate at York University, followed 16 patients with mild to moderate PD who participated in a weekly dance class at Canada’s National Ballet School and Trinity St. Paul’s church.

Dance for Parkinson’s Disease, which is an established dance curriculum, involves aerobic and anaerobic movements. The protocol begins with a seated warm-up, followed by barre work, and ends with moving across the floor. All participants learn choreography for an upcoming performance.

In the study, 16 patients with PD who did not participant in the dance classes served as control patients.

Over 3 years, the daily rate of motor decline, as indicated by scores on part III of the MDS-UPDRS, was zero among the dancers (slope = 0.000146), indicating no motor impairment, whereas among the nondancers, the motor decline during follow-up was as expected (P < .01), the researchers reported.

In modeling the data, the researchers determined that after completing 1,000 days of dance training, dancers will have a motor score of 19.07, compared with a score of 28.27 for nondancers.

“Our data further showed that training in dance will slow the rate of PD motor impairment progression, as measured by the UPDRS III, by close to 3 points annually in comparison to our PD subjects who did not train,” the researchers reported.

Dance training also had a beneficial effect on motor or nonmotor aspects of daily living and on motor complications, for which there was no significant decline among the PD dancers.

“For those with Parkinson’s disease, even when it’s mild, motor impairment can impact their daily functioning – how they feel about themselves. Many of these motor symptoms lead to isolation because once they get extreme, these people don’t want to go out,” Dr. DeSouza said in a news release.

“These motor symptoms lead to further psychological issues, depression, social isolation and eventually the symptoms do get worse over time. Our study shows that training with dance and music can slow this down and improve their daily living and daily function,” he added.
 

‘Great potential’

Reached for comment, Demian Kogutek, PhD, director of music therapy, University of Evansville (Indiana), said that these preliminary findings from a longitudinal study are “promising.”

“I believe that dance therapy has a great potential for PD. The longitudinal aspect of this study undoubtedly adds to the current literature. Although it is a standardized assessment, it is somewhat subjective,” Dr. Kogutek said in an interview.

Going forward, Dr. Kogutek said he’d like to see other objective outcomes measured, such as objective assessments of balance, gait, hand strength, and dexterity.

Also weighing in on the results, Karen Lee, PhD, president and CEO of Parkinson Canada, said her organization is “encouraged by these preliminary findings as exercise and healthy activities are important for people with Parkinson’s. This study is part of a growing body of research that explores the link between the impact of activities and both motor and nonmotor symptoms of Parkinson’s.

“This research adds to growing evidence about the importance of exercise as part of the management of Parkinson’s, and we encourage people living with Parkinson’s to incorporate exercise as part of their approach to managing their health,” Dr. Lee said in an interview.

Funding for the project is provided in part by a National Science and Engineering Research Council Discovery Grant and by donations from the Irpinia Club of Toronto and others. Dr. Dr. DeSouza, Ms. Bearss, Dr. Kogutek, and Dr. Lee disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Dancing helps slow the progression of motor and nonmotor symptoms and improves quality of life for patients with Parkinson’s disease (PD), new research shows.

Over 3 years, weekly participation in dance training classes “drastically” reduced the expected decline in motor function and significantly improved speech, tremors, balance, and stiffness, the researchers reported.

Dance training also appeared to have benefits regarding cognition, hallucinations, depression, and anxiety.

“These findings strongly suggest the benefits of dance for people with PD as a supplement to a normal treatment regimen,” the investigators noted.

Although the mechanism of benefit is unclear, dance training may help “train neural network nodes that helps either strengthen networks damaged or builds neural road maps that pass the damage,” study investigator Joseph DeSouza, PhD, principal investigator and associate professor, department of psychology, York University, Toronto, said in an interview.

The study was published online July 7, 2021, in Brain Sciences.
 

Multiple benefits

PD is a neurodegenerative disease associated with progression of motor dysfunction within the first 5 years of diagnosis. The annual rate of motor decline, as determined with the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), is between 5.2 and 8.9 points.

Prior studies that assessed various styles of dance by patients with PD showed beneficial effects regarding gait speed, balance, locomotion, and aspects of quality of life.

To investigate further, DeSouza and coauthor Karolina Bearss, a PhD candidate at York University, followed 16 patients with mild to moderate PD who participated in a weekly dance class at Canada’s National Ballet School and Trinity St. Paul’s church.

Dance for Parkinson’s Disease, which is an established dance curriculum, involves aerobic and anaerobic movements. The protocol begins with a seated warm-up, followed by barre work, and ends with moving across the floor. All participants learn choreography for an upcoming performance.

In the study, 16 patients with PD who did not participant in the dance classes served as control patients.

Over 3 years, the daily rate of motor decline, as indicated by scores on part III of the MDS-UPDRS, was zero among the dancers (slope = 0.000146), indicating no motor impairment, whereas among the nondancers, the motor decline during follow-up was as expected (P < .01), the researchers reported.

In modeling the data, the researchers determined that after completing 1,000 days of dance training, dancers will have a motor score of 19.07, compared with a score of 28.27 for nondancers.

“Our data further showed that training in dance will slow the rate of PD motor impairment progression, as measured by the UPDRS III, by close to 3 points annually in comparison to our PD subjects who did not train,” the researchers reported.

Dance training also had a beneficial effect on motor or nonmotor aspects of daily living and on motor complications, for which there was no significant decline among the PD dancers.

“For those with Parkinson’s disease, even when it’s mild, motor impairment can impact their daily functioning – how they feel about themselves. Many of these motor symptoms lead to isolation because once they get extreme, these people don’t want to go out,” Dr. DeSouza said in a news release.

“These motor symptoms lead to further psychological issues, depression, social isolation and eventually the symptoms do get worse over time. Our study shows that training with dance and music can slow this down and improve their daily living and daily function,” he added.
 

‘Great potential’

Reached for comment, Demian Kogutek, PhD, director of music therapy, University of Evansville (Indiana), said that these preliminary findings from a longitudinal study are “promising.”

“I believe that dance therapy has a great potential for PD. The longitudinal aspect of this study undoubtedly adds to the current literature. Although it is a standardized assessment, it is somewhat subjective,” Dr. Kogutek said in an interview.

Going forward, Dr. Kogutek said he’d like to see other objective outcomes measured, such as objective assessments of balance, gait, hand strength, and dexterity.

Also weighing in on the results, Karen Lee, PhD, president and CEO of Parkinson Canada, said her organization is “encouraged by these preliminary findings as exercise and healthy activities are important for people with Parkinson’s. This study is part of a growing body of research that explores the link between the impact of activities and both motor and nonmotor symptoms of Parkinson’s.

“This research adds to growing evidence about the importance of exercise as part of the management of Parkinson’s, and we encourage people living with Parkinson’s to incorporate exercise as part of their approach to managing their health,” Dr. Lee said in an interview.

Funding for the project is provided in part by a National Science and Engineering Research Council Discovery Grant and by donations from the Irpinia Club of Toronto and others. Dr. Dr. DeSouza, Ms. Bearss, Dr. Kogutek, and Dr. Lee disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.