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Why doctors should take end-of-life decisions back from insurers, says physician
Sadly, the medical business has descended to this: Some insurers are combing health records to find and target customers with a 50% chance of dying in the next 18 months. Those companies then work to persuade customers to switch into palliative and hospice care.
And more of this automated end-of-life medicine appears to be on the way.
What’s gained is cost savings. What’s lost is empathy and humanity.
Doctor colleagues have warned for decades about the rise of the bean-counters in medicine. Yes, health care is a business, but it should be a higher calling, too. We serve, we heal, we protect, and we comfort.
There are times, however, when the people who try to squeeze the most money out of medicine try to gain too much influence over the people who actually engage in medicine. I think the rise of phone bank boiler rooms, built on business incentives to move patients into cheaper hospice care, should be a bridge too far for our profession.
End-of-life care is one of the most sensitive and emotionally rewarding things a doctor can do. Hospice can be an excellent choice for fully informed patients and families, but we should not be turning over these decisions to artificial intelligence, spreadsheets, and crunchers of big data.
At the same time, we should realize that the end-of-life phone banks have not evolved from nowhere. The reality is that dying is expensive. The last year of life accounts for 13%-25% of all spending on Medicare, according to numerous studies. That’s more than $200 billion a year for just one part of one federal health care program. Much of that money goes to hospitals, where end-of-life patients amass average charges of $6,000 per day.
All this spending runs counter to the wishes of most Americans. According to a Kaiser Family Foundation poll, 9 out of 10 adults say they don’t want their families to be burdened financially by their end-of-life medical care. Given the choice, 7 out of 10 Americans say they want to die at home; fewer than 1 in 10 say they want to die in a hospital.
And far more people (71%) think it’s more important to die without pain or stress than to extend life as long as possible (19%).
It’s crucial for us to get this right. Within 11 years, the U.S. Census projects that seniors will outnumber kids for the first time in history: We’ll have 77 million people age 65 or older and 76.5 million age 18 or under. And many of those seniors have medical and functional conditions that signal they are nearing end of life.
As chief medical officer of a complete senior health company, and as a physician with more than 3 decades of personal experience in geriatrics, I know we can improve the final chapter of life for our older adults and our taxpayers. If medical professionals don’t do a better job with patients at the end of life, then key decisions increasingly will be driven by the money-centered phone banks.
The single biggest improvement is having a frank and direct talk with senior patients about end-of-life wishes. Remarkably, only 1 in 10 Americans say they’ve ever had an end-of-life conversation with their doctor or health care provider – no heartfelt talk about what quality of life looks like under different treatment options. Only half ever discussed the topic with a spouse or loved one.
As a result, the default end-of-life care regimen for many is to extend life at any cost, even though most Americans tell pollsters they don’t truly want that. Doctors must focus on thorough informed consent with patients before major medical crises hurt patient cognition.
Another key is for specialists and general care doctors to do a better job consulting with each other. Two of every 3 seniors have several chronic conditions, or multimorbidities; that status worsens to include 8 of every 10 seniors after age 80. That means seniors often have multiple doctors who work in their own silos and fail to communicate the competing risks and benefits of diagnostic and treatment options. The result is fragmented plans that are difficult to follow and often as likely to harm complex patients as help them.
We all know that 90-year-old people shouldn’t be on 15 drugs, and yet too many are. Big Pharma has made it easy for doctors to add new medications, but I don’t think there’s even a class in medical school to teach clinicians how to trim the medicine list. When a drug is causing side effects, the sad reality is that most doctors add another medication to treat the side effect, as opposed to removing the offending agent. We need to end this practice known as drug cascading.
Doctors need training on how to unwind prescriptions. For example, too many seniors are being prescribed atypical antipsychotics off label for dementia. Overtreatment of geriatric diabetes and hypertension causes weakness and falls. Overprescribing antibiotics for frail patients whose bladders are colonized with bacteria too often leads to colitis. We need to question why our seniors are on so many drugs.
Doctors, patients, and families should be discussing quality of life as much as quantity of life.
I’ve spent my career taking care of older people. It’s rare for me to get a phone call saying an older person died and nobody expected it. We all know that we will die, but we spend so little time talking about it and preparing for it. A great disservice will be done to patients, doctors, and the medical profession if we let the phone banks take over.
Dr. Schneeman is a geriatrician and chief medical officer for Lifespark, a senior health company based in Minneapolis.
A version of this article appeared on Medscape.com.
Sadly, the medical business has descended to this: Some insurers are combing health records to find and target customers with a 50% chance of dying in the next 18 months. Those companies then work to persuade customers to switch into palliative and hospice care.
And more of this automated end-of-life medicine appears to be on the way.
What’s gained is cost savings. What’s lost is empathy and humanity.
Doctor colleagues have warned for decades about the rise of the bean-counters in medicine. Yes, health care is a business, but it should be a higher calling, too. We serve, we heal, we protect, and we comfort.
There are times, however, when the people who try to squeeze the most money out of medicine try to gain too much influence over the people who actually engage in medicine. I think the rise of phone bank boiler rooms, built on business incentives to move patients into cheaper hospice care, should be a bridge too far for our profession.
End-of-life care is one of the most sensitive and emotionally rewarding things a doctor can do. Hospice can be an excellent choice for fully informed patients and families, but we should not be turning over these decisions to artificial intelligence, spreadsheets, and crunchers of big data.
At the same time, we should realize that the end-of-life phone banks have not evolved from nowhere. The reality is that dying is expensive. The last year of life accounts for 13%-25% of all spending on Medicare, according to numerous studies. That’s more than $200 billion a year for just one part of one federal health care program. Much of that money goes to hospitals, where end-of-life patients amass average charges of $6,000 per day.
All this spending runs counter to the wishes of most Americans. According to a Kaiser Family Foundation poll, 9 out of 10 adults say they don’t want their families to be burdened financially by their end-of-life medical care. Given the choice, 7 out of 10 Americans say they want to die at home; fewer than 1 in 10 say they want to die in a hospital.
And far more people (71%) think it’s more important to die without pain or stress than to extend life as long as possible (19%).
It’s crucial for us to get this right. Within 11 years, the U.S. Census projects that seniors will outnumber kids for the first time in history: We’ll have 77 million people age 65 or older and 76.5 million age 18 or under. And many of those seniors have medical and functional conditions that signal they are nearing end of life.
As chief medical officer of a complete senior health company, and as a physician with more than 3 decades of personal experience in geriatrics, I know we can improve the final chapter of life for our older adults and our taxpayers. If medical professionals don’t do a better job with patients at the end of life, then key decisions increasingly will be driven by the money-centered phone banks.
The single biggest improvement is having a frank and direct talk with senior patients about end-of-life wishes. Remarkably, only 1 in 10 Americans say they’ve ever had an end-of-life conversation with their doctor or health care provider – no heartfelt talk about what quality of life looks like under different treatment options. Only half ever discussed the topic with a spouse or loved one.
As a result, the default end-of-life care regimen for many is to extend life at any cost, even though most Americans tell pollsters they don’t truly want that. Doctors must focus on thorough informed consent with patients before major medical crises hurt patient cognition.
Another key is for specialists and general care doctors to do a better job consulting with each other. Two of every 3 seniors have several chronic conditions, or multimorbidities; that status worsens to include 8 of every 10 seniors after age 80. That means seniors often have multiple doctors who work in their own silos and fail to communicate the competing risks and benefits of diagnostic and treatment options. The result is fragmented plans that are difficult to follow and often as likely to harm complex patients as help them.
We all know that 90-year-old people shouldn’t be on 15 drugs, and yet too many are. Big Pharma has made it easy for doctors to add new medications, but I don’t think there’s even a class in medical school to teach clinicians how to trim the medicine list. When a drug is causing side effects, the sad reality is that most doctors add another medication to treat the side effect, as opposed to removing the offending agent. We need to end this practice known as drug cascading.
Doctors need training on how to unwind prescriptions. For example, too many seniors are being prescribed atypical antipsychotics off label for dementia. Overtreatment of geriatric diabetes and hypertension causes weakness and falls. Overprescribing antibiotics for frail patients whose bladders are colonized with bacteria too often leads to colitis. We need to question why our seniors are on so many drugs.
Doctors, patients, and families should be discussing quality of life as much as quantity of life.
I’ve spent my career taking care of older people. It’s rare for me to get a phone call saying an older person died and nobody expected it. We all know that we will die, but we spend so little time talking about it and preparing for it. A great disservice will be done to patients, doctors, and the medical profession if we let the phone banks take over.
Dr. Schneeman is a geriatrician and chief medical officer for Lifespark, a senior health company based in Minneapolis.
A version of this article appeared on Medscape.com.
Sadly, the medical business has descended to this: Some insurers are combing health records to find and target customers with a 50% chance of dying in the next 18 months. Those companies then work to persuade customers to switch into palliative and hospice care.
And more of this automated end-of-life medicine appears to be on the way.
What’s gained is cost savings. What’s lost is empathy and humanity.
Doctor colleagues have warned for decades about the rise of the bean-counters in medicine. Yes, health care is a business, but it should be a higher calling, too. We serve, we heal, we protect, and we comfort.
There are times, however, when the people who try to squeeze the most money out of medicine try to gain too much influence over the people who actually engage in medicine. I think the rise of phone bank boiler rooms, built on business incentives to move patients into cheaper hospice care, should be a bridge too far for our profession.
End-of-life care is one of the most sensitive and emotionally rewarding things a doctor can do. Hospice can be an excellent choice for fully informed patients and families, but we should not be turning over these decisions to artificial intelligence, spreadsheets, and crunchers of big data.
At the same time, we should realize that the end-of-life phone banks have not evolved from nowhere. The reality is that dying is expensive. The last year of life accounts for 13%-25% of all spending on Medicare, according to numerous studies. That’s more than $200 billion a year for just one part of one federal health care program. Much of that money goes to hospitals, where end-of-life patients amass average charges of $6,000 per day.
All this spending runs counter to the wishes of most Americans. According to a Kaiser Family Foundation poll, 9 out of 10 adults say they don’t want their families to be burdened financially by their end-of-life medical care. Given the choice, 7 out of 10 Americans say they want to die at home; fewer than 1 in 10 say they want to die in a hospital.
And far more people (71%) think it’s more important to die without pain or stress than to extend life as long as possible (19%).
It’s crucial for us to get this right. Within 11 years, the U.S. Census projects that seniors will outnumber kids for the first time in history: We’ll have 77 million people age 65 or older and 76.5 million age 18 or under. And many of those seniors have medical and functional conditions that signal they are nearing end of life.
As chief medical officer of a complete senior health company, and as a physician with more than 3 decades of personal experience in geriatrics, I know we can improve the final chapter of life for our older adults and our taxpayers. If medical professionals don’t do a better job with patients at the end of life, then key decisions increasingly will be driven by the money-centered phone banks.
The single biggest improvement is having a frank and direct talk with senior patients about end-of-life wishes. Remarkably, only 1 in 10 Americans say they’ve ever had an end-of-life conversation with their doctor or health care provider – no heartfelt talk about what quality of life looks like under different treatment options. Only half ever discussed the topic with a spouse or loved one.
As a result, the default end-of-life care regimen for many is to extend life at any cost, even though most Americans tell pollsters they don’t truly want that. Doctors must focus on thorough informed consent with patients before major medical crises hurt patient cognition.
Another key is for specialists and general care doctors to do a better job consulting with each other. Two of every 3 seniors have several chronic conditions, or multimorbidities; that status worsens to include 8 of every 10 seniors after age 80. That means seniors often have multiple doctors who work in their own silos and fail to communicate the competing risks and benefits of diagnostic and treatment options. The result is fragmented plans that are difficult to follow and often as likely to harm complex patients as help them.
We all know that 90-year-old people shouldn’t be on 15 drugs, and yet too many are. Big Pharma has made it easy for doctors to add new medications, but I don’t think there’s even a class in medical school to teach clinicians how to trim the medicine list. When a drug is causing side effects, the sad reality is that most doctors add another medication to treat the side effect, as opposed to removing the offending agent. We need to end this practice known as drug cascading.
Doctors need training on how to unwind prescriptions. For example, too many seniors are being prescribed atypical antipsychotics off label for dementia. Overtreatment of geriatric diabetes and hypertension causes weakness and falls. Overprescribing antibiotics for frail patients whose bladders are colonized with bacteria too often leads to colitis. We need to question why our seniors are on so many drugs.
Doctors, patients, and families should be discussing quality of life as much as quantity of life.
I’ve spent my career taking care of older people. It’s rare for me to get a phone call saying an older person died and nobody expected it. We all know that we will die, but we spend so little time talking about it and preparing for it. A great disservice will be done to patients, doctors, and the medical profession if we let the phone banks take over.
Dr. Schneeman is a geriatrician and chief medical officer for Lifespark, a senior health company based in Minneapolis.
A version of this article appeared on Medscape.com.
ACP sticks with 50 as age to start CRC screening
Not so fast with earlier screening for colorectal cancer (CRC), at least according to one professional group.
The American College of Physicians published updated clinical guidance maintaining 50 as the age when clinicians should start screening for CRC in patients who are asymptomatic and at average risk.
The recommendation conflicts with guidelines from the American Cancer Society and the U.S. Preventive Services Task Force, which lowered the recommended age to start screening to age 45.
Although the rate of CRC has increased among adults aged 45-49, the incidence is 35.1 cases per 100,000 people, much lower than among persons aged 50-64 (71.9 per 100,000) and those aged 65-74 (128.9 per 100,000), the guidance notes.
“The net benefit of screening is much less favorable in average-risk adults between ages 45 and 49 years than in those aged 50-75 years,” the authors wrote. “Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”
The ACP’s updated guidance is provocative and should be considered in the context of other groups’ recommendations, not as superseding them just because it is the most recently published document, according to Jeffrey A. Meyerhardt, MD, MPH, codirector of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, Boston.
“As with a lot of the things we do in medicine, it is balancing risk and potential benefit,” Dr. Meyerhardt said in an interview. “If a patient is informed that at a younger age doing screening is very likely not to find anything and there are some risks to screening, that patient could then weigh the risks and benefit with their provider.”
Three screening approaches
The new guidance statement is based on a critical review of existing clinical guidelines, evidence reviews, and modeling studies. The guidance does not apply to patients who have long-standing inflammatory bowel disease and those with a family history of CRC.
The guideline also addresses when clinicians should stop screening – at age 75 – and what types of tests patients should choose from.
After discussing the benefits, harms, cost, availability, and patient preferences, clinicians and patients should select one of three screening approaches, according to the ACP: a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years; colonoscopy every 10 years; or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years.
They should avoid CRC screening tests that use stool DNA, CT colonography, capsule endoscopy, urine, or serum, according to the guidance.
A balancing act
Some physicians view starting screenings at age 45 as a settled argument.
“The entire nation is now focused on increasing screening capacity and getting everyone screened,” said Richard C. Wender, MD, professor and chair of family medicine and community health at the University of Pennsylvania, Philadelphia, who was not involved in the new guidelines. “There is not a controversy about age to start, and I anticipate that this paper won’t create a new one.”
The epidemiology of CRC is changing rapidly, Dr. Wender said.
“While CRC mortality is going down in older age groups, mortality is now rising in younger people,” he said. “While cancer incidence is lower in the 45- to 49-years-old group, the precursors to cancer are present and can be found in a substantial percentage of patients – the same percentage as 50- to 55-year-olds.”
Dr. Meyerhardt said in an interview that the recommendation to start screening at age 45 was reasonable but that more people need to be screened to detect CRC than the older population.
“Ultimately, one’s going to have to consider the various recommendations from these different societies when having a patient in front of you as a primary care or other physician to discuss screening in someone who’s what we call average risk,” he said.
Younger patients who notice any possible symptoms of CRC such as blood in stool or changes in bowel habits should discuss them with a physician, he said.
The ACP also differs from other groups in not recommending stool DNA tests such as Cologuard (Exact Sciences). Dr. Wender said this test is the least cost effective based on comparing adherence for other options. “If Cologuard can lead to higher adherence and there are data suggesting it can, then relative cost-effectiveness looks better.”
Why 50
In weighing the risks and benefits of screening, the ACP noted that CRC screening can entail risk for serious bleeding and perforation in the case of colonoscopy.
Overdiagnosis and associated overtreatment, as well as costly follow-ups for findings that are clinically unimportant, are additional factors to consider with various cancer screening tests, said Amir Qaseem, MD, PhD, MHA, the ACP’s chief science officer and the corresponding author of the updated guidance.
Despite some differences between various groups’ recommendations, Dr. Qaseem saw important similarities.
“We need to get everyone between 50 and 75 screened,” Dr. Qaseem said. On that point, “there is no disagreement.”
One guideline author reported receiving salary from the ACP. Dr. Qaseem reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Not so fast with earlier screening for colorectal cancer (CRC), at least according to one professional group.
The American College of Physicians published updated clinical guidance maintaining 50 as the age when clinicians should start screening for CRC in patients who are asymptomatic and at average risk.
The recommendation conflicts with guidelines from the American Cancer Society and the U.S. Preventive Services Task Force, which lowered the recommended age to start screening to age 45.
Although the rate of CRC has increased among adults aged 45-49, the incidence is 35.1 cases per 100,000 people, much lower than among persons aged 50-64 (71.9 per 100,000) and those aged 65-74 (128.9 per 100,000), the guidance notes.
“The net benefit of screening is much less favorable in average-risk adults between ages 45 and 49 years than in those aged 50-75 years,” the authors wrote. “Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”
The ACP’s updated guidance is provocative and should be considered in the context of other groups’ recommendations, not as superseding them just because it is the most recently published document, according to Jeffrey A. Meyerhardt, MD, MPH, codirector of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, Boston.
“As with a lot of the things we do in medicine, it is balancing risk and potential benefit,” Dr. Meyerhardt said in an interview. “If a patient is informed that at a younger age doing screening is very likely not to find anything and there are some risks to screening, that patient could then weigh the risks and benefit with their provider.”
Three screening approaches
The new guidance statement is based on a critical review of existing clinical guidelines, evidence reviews, and modeling studies. The guidance does not apply to patients who have long-standing inflammatory bowel disease and those with a family history of CRC.
The guideline also addresses when clinicians should stop screening – at age 75 – and what types of tests patients should choose from.
After discussing the benefits, harms, cost, availability, and patient preferences, clinicians and patients should select one of three screening approaches, according to the ACP: a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years; colonoscopy every 10 years; or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years.
They should avoid CRC screening tests that use stool DNA, CT colonography, capsule endoscopy, urine, or serum, according to the guidance.
A balancing act
Some physicians view starting screenings at age 45 as a settled argument.
“The entire nation is now focused on increasing screening capacity and getting everyone screened,” said Richard C. Wender, MD, professor and chair of family medicine and community health at the University of Pennsylvania, Philadelphia, who was not involved in the new guidelines. “There is not a controversy about age to start, and I anticipate that this paper won’t create a new one.”
The epidemiology of CRC is changing rapidly, Dr. Wender said.
“While CRC mortality is going down in older age groups, mortality is now rising in younger people,” he said. “While cancer incidence is lower in the 45- to 49-years-old group, the precursors to cancer are present and can be found in a substantial percentage of patients – the same percentage as 50- to 55-year-olds.”
Dr. Meyerhardt said in an interview that the recommendation to start screening at age 45 was reasonable but that more people need to be screened to detect CRC than the older population.
“Ultimately, one’s going to have to consider the various recommendations from these different societies when having a patient in front of you as a primary care or other physician to discuss screening in someone who’s what we call average risk,” he said.
Younger patients who notice any possible symptoms of CRC such as blood in stool or changes in bowel habits should discuss them with a physician, he said.
The ACP also differs from other groups in not recommending stool DNA tests such as Cologuard (Exact Sciences). Dr. Wender said this test is the least cost effective based on comparing adherence for other options. “If Cologuard can lead to higher adherence and there are data suggesting it can, then relative cost-effectiveness looks better.”
Why 50
In weighing the risks and benefits of screening, the ACP noted that CRC screening can entail risk for serious bleeding and perforation in the case of colonoscopy.
Overdiagnosis and associated overtreatment, as well as costly follow-ups for findings that are clinically unimportant, are additional factors to consider with various cancer screening tests, said Amir Qaseem, MD, PhD, MHA, the ACP’s chief science officer and the corresponding author of the updated guidance.
Despite some differences between various groups’ recommendations, Dr. Qaseem saw important similarities.
“We need to get everyone between 50 and 75 screened,” Dr. Qaseem said. On that point, “there is no disagreement.”
One guideline author reported receiving salary from the ACP. Dr. Qaseem reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Not so fast with earlier screening for colorectal cancer (CRC), at least according to one professional group.
The American College of Physicians published updated clinical guidance maintaining 50 as the age when clinicians should start screening for CRC in patients who are asymptomatic and at average risk.
The recommendation conflicts with guidelines from the American Cancer Society and the U.S. Preventive Services Task Force, which lowered the recommended age to start screening to age 45.
Although the rate of CRC has increased among adults aged 45-49, the incidence is 35.1 cases per 100,000 people, much lower than among persons aged 50-64 (71.9 per 100,000) and those aged 65-74 (128.9 per 100,000), the guidance notes.
“The net benefit of screening is much less favorable in average-risk adults between ages 45 and 49 years than in those aged 50-75 years,” the authors wrote. “Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”
The ACP’s updated guidance is provocative and should be considered in the context of other groups’ recommendations, not as superseding them just because it is the most recently published document, according to Jeffrey A. Meyerhardt, MD, MPH, codirector of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, Boston.
“As with a lot of the things we do in medicine, it is balancing risk and potential benefit,” Dr. Meyerhardt said in an interview. “If a patient is informed that at a younger age doing screening is very likely not to find anything and there are some risks to screening, that patient could then weigh the risks and benefit with their provider.”
Three screening approaches
The new guidance statement is based on a critical review of existing clinical guidelines, evidence reviews, and modeling studies. The guidance does not apply to patients who have long-standing inflammatory bowel disease and those with a family history of CRC.
The guideline also addresses when clinicians should stop screening – at age 75 – and what types of tests patients should choose from.
After discussing the benefits, harms, cost, availability, and patient preferences, clinicians and patients should select one of three screening approaches, according to the ACP: a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years; colonoscopy every 10 years; or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years.
They should avoid CRC screening tests that use stool DNA, CT colonography, capsule endoscopy, urine, or serum, according to the guidance.
A balancing act
Some physicians view starting screenings at age 45 as a settled argument.
“The entire nation is now focused on increasing screening capacity and getting everyone screened,” said Richard C. Wender, MD, professor and chair of family medicine and community health at the University of Pennsylvania, Philadelphia, who was not involved in the new guidelines. “There is not a controversy about age to start, and I anticipate that this paper won’t create a new one.”
The epidemiology of CRC is changing rapidly, Dr. Wender said.
“While CRC mortality is going down in older age groups, mortality is now rising in younger people,” he said. “While cancer incidence is lower in the 45- to 49-years-old group, the precursors to cancer are present and can be found in a substantial percentage of patients – the same percentage as 50- to 55-year-olds.”
Dr. Meyerhardt said in an interview that the recommendation to start screening at age 45 was reasonable but that more people need to be screened to detect CRC than the older population.
“Ultimately, one’s going to have to consider the various recommendations from these different societies when having a patient in front of you as a primary care or other physician to discuss screening in someone who’s what we call average risk,” he said.
Younger patients who notice any possible symptoms of CRC such as blood in stool or changes in bowel habits should discuss them with a physician, he said.
The ACP also differs from other groups in not recommending stool DNA tests such as Cologuard (Exact Sciences). Dr. Wender said this test is the least cost effective based on comparing adherence for other options. “If Cologuard can lead to higher adherence and there are data suggesting it can, then relative cost-effectiveness looks better.”
Why 50
In weighing the risks and benefits of screening, the ACP noted that CRC screening can entail risk for serious bleeding and perforation in the case of colonoscopy.
Overdiagnosis and associated overtreatment, as well as costly follow-ups for findings that are clinically unimportant, are additional factors to consider with various cancer screening tests, said Amir Qaseem, MD, PhD, MHA, the ACP’s chief science officer and the corresponding author of the updated guidance.
Despite some differences between various groups’ recommendations, Dr. Qaseem saw important similarities.
“We need to get everyone between 50 and 75 screened,” Dr. Qaseem said. On that point, “there is no disagreement.”
One guideline author reported receiving salary from the ACP. Dr. Qaseem reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
Daily aspirin for stroke prevention in healthy elderly should be avoided
according to results from a large randomized trial.
The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.
Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
ASPEE findings
In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.
The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).
Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).
“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.
The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
Patients need to know their risk
In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.
“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”
Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”
A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”
The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.
according to results from a large randomized trial.
The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.
Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
ASPEE findings
In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.
The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).
Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).
“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.
The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
Patients need to know their risk
In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.
“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”
Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”
A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”
The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.
according to results from a large randomized trial.
The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.
Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
ASPEE findings
In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.
The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).
Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).
“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.
The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
Patients need to know their risk
In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.
“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”
Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”
A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”
The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.
FROM JAMA NETWORK OPEN
Research casts doubt on value of daily aspirin for healthy adults
Daily use of low-dose aspirin offers no significant protection against stroke and was linked to a higher rate of bleeding in the brain, according to new research published in JAMA.
The research matches other evidence advising that healthy older adults without a history of heart conditions or warning signs of stroke should not take low-dose aspirin.
The findings also support the recommendation from the U.S. Preventive Services Task Force that low-dose aspirin should not be prescribed for preventing a first heart attack or stroke in healthy older adults, The New York Times reported.
“We can be very emphatic that healthy people who are not on aspirin and do not have multiple risk factors should not be starting it now,” said Randall Stafford, MD, of Stanford (Calif.) University, who was not involved in the study, in the Times.
It’s not as clear for others, he said.
“The longer you’ve been on aspirin and the more risk factors you have for heart attacks and strokes, the murkier it gets,” he said.
Some cardiac and stroke experts say daily aspirin should remain part of the regimen for people who have had a heart attack or stroke.
The JAMA report was based on data from a randomized control trial of 19,000 people from Australia and America. Participants were over the age of 70 and did not have heart disease.
The data covered an average of almost 4.7 years and revealed that aspirin lowered the rate of ischemic stroke but not significantly. An ischemic stroke happens when a clot forms in a blood vessel that sends blood to the brain.
There was also a 38% higher rate of brain bleeds for people who took aspirin daily, compared with those who took a placebo.
The Times wrote, “In the past, some doctors regarded aspirin as something of a wonder drug, capable of protecting healthy patients against a future heart attack or stroke. But recent studies have shown that the powerful drug has limited protective power among people who have not yet had such an event, and it comes with dangerous side effects.”
A version of this article first appeared on WebMD.com.
Daily use of low-dose aspirin offers no significant protection against stroke and was linked to a higher rate of bleeding in the brain, according to new research published in JAMA.
The research matches other evidence advising that healthy older adults without a history of heart conditions or warning signs of stroke should not take low-dose aspirin.
The findings also support the recommendation from the U.S. Preventive Services Task Force that low-dose aspirin should not be prescribed for preventing a first heart attack or stroke in healthy older adults, The New York Times reported.
“We can be very emphatic that healthy people who are not on aspirin and do not have multiple risk factors should not be starting it now,” said Randall Stafford, MD, of Stanford (Calif.) University, who was not involved in the study, in the Times.
It’s not as clear for others, he said.
“The longer you’ve been on aspirin and the more risk factors you have for heart attacks and strokes, the murkier it gets,” he said.
Some cardiac and stroke experts say daily aspirin should remain part of the regimen for people who have had a heart attack or stroke.
The JAMA report was based on data from a randomized control trial of 19,000 people from Australia and America. Participants were over the age of 70 and did not have heart disease.
The data covered an average of almost 4.7 years and revealed that aspirin lowered the rate of ischemic stroke but not significantly. An ischemic stroke happens when a clot forms in a blood vessel that sends blood to the brain.
There was also a 38% higher rate of brain bleeds for people who took aspirin daily, compared with those who took a placebo.
The Times wrote, “In the past, some doctors regarded aspirin as something of a wonder drug, capable of protecting healthy patients against a future heart attack or stroke. But recent studies have shown that the powerful drug has limited protective power among people who have not yet had such an event, and it comes with dangerous side effects.”
A version of this article first appeared on WebMD.com.
Daily use of low-dose aspirin offers no significant protection against stroke and was linked to a higher rate of bleeding in the brain, according to new research published in JAMA.
The research matches other evidence advising that healthy older adults without a history of heart conditions or warning signs of stroke should not take low-dose aspirin.
The findings also support the recommendation from the U.S. Preventive Services Task Force that low-dose aspirin should not be prescribed for preventing a first heart attack or stroke in healthy older adults, The New York Times reported.
“We can be very emphatic that healthy people who are not on aspirin and do not have multiple risk factors should not be starting it now,” said Randall Stafford, MD, of Stanford (Calif.) University, who was not involved in the study, in the Times.
It’s not as clear for others, he said.
“The longer you’ve been on aspirin and the more risk factors you have for heart attacks and strokes, the murkier it gets,” he said.
Some cardiac and stroke experts say daily aspirin should remain part of the regimen for people who have had a heart attack or stroke.
The JAMA report was based on data from a randomized control trial of 19,000 people from Australia and America. Participants were over the age of 70 and did not have heart disease.
The data covered an average of almost 4.7 years and revealed that aspirin lowered the rate of ischemic stroke but not significantly. An ischemic stroke happens when a clot forms in a blood vessel that sends blood to the brain.
There was also a 38% higher rate of brain bleeds for people who took aspirin daily, compared with those who took a placebo.
The Times wrote, “In the past, some doctors regarded aspirin as something of a wonder drug, capable of protecting healthy patients against a future heart attack or stroke. But recent studies have shown that the powerful drug has limited protective power among people who have not yet had such an event, and it comes with dangerous side effects.”
A version of this article first appeared on WebMD.com.
FROM JAMA
Tooth loss, gum disease tied to hippocampal atrophy
Gum disease and tooth loss are linked to hippocampal atrophy and may have a more negative impact on the brain than aging, new research suggests.
Investigators found that in a late middle-aged and older cohort, among patients with mild periodontitis, having fewer teeth was linked to a faster rate of left hippocampal atrophy. For those with severe gum disease, each additional lost tooth was associated with a faster rate of brain shrinkage, equivalent to 1.3 years of brain aging.
“Tooth loss and gum disease, which is inflammation of the tissue around the teeth that can cause shrinkage of the gums and loosening of the teeth, are very common, so evaluating a potential link with dementia is incredibly important,” study investigator Satoshi Yamaguchi, PhD, DDS, of Tohoku University, in Sendai, Japan, said in a release.
“Our study found that these conditions may play a role in the health of the brain area that controls thinking and memory, giving people another reason to take better care of their teeth,” Dr. Yamaguchi noted.
The findings were published online in Neurology.
Greater effect than aging
Although previous research suggests that tooth loss and periodontitis are risk factors for Alzheimer’s disease, longitudinal research has not shown a significant correlation between these conditions and hippocampal atrophy.
To clarify this association, the investigators followed 172 men and women (average age, 67 years) who had undergone two MRI brain scans 4 years apart and had had a dental examination. None of the participants had any signs of cognitive decline at baseline.
At study outset, information on cerebrovascular and cardiovascular disease, alcohol consumption, smoking, depression history, and cognitive function was gathered. The Mini Mental State Exam and dental exams were administered at baseline and at 4-year follow-up.
For each participant, the number of teeth was counted, and all participants were assessed for gum disease via periodontal probing depth (PD).
Healthy gums typically measure between 1 and 3 mm in depth. Mild gum disease is signified by measurements of 3-4 mm in several areas. Severe gum disease involves measurements of 5-6 mm and is accompanied by greater bone loss, leading to potential tooth loss.
Multiple regression analysis was performed, with the annual symmetric percentage change (SPC) of hippocampal volume as the dependent variable. The analysis included an interaction term between the number of teeth present (NTP) and mean PD.
Over the 4-year study period, the investigators found that the qualitative interaction between NTP and mean PD was significant for the annual SPC in the left hippocampus.
Among those with mild periodontitis, having fewer teeth correlated with more rapid atrophy of the left hippocampus, such that every tooth lost was equivalent to nearly 1 year of brain aging.
In contrast, having more teeth was associated with a faster rate of left hippocampal atrophy among those with severe periodontitis and was equivalent to 1.3 years of brain aging.
For those with severe gum disease, each additional lost tooth corresponded to a faster rate of brain shrinkage, equivalent to 1.3 years of brain aging.
“This finding indicates that periodontitis may have a greater association with left hippocampal atrophy than the association exhibited by age. Furthermore, in cases of mild periodontitis, fewer teeth may be associated with a subsequent decline in cognitive function,” the investigators write.
The study’s results, they add, highlight the importance of preserving oral health, not just the retaining of teeth. “These findings suggest that retaining teeth with severe gum disease is associated with brain atrophy,” said Dr. Yamaguchi.
“Controlling the progression of gum disease through regular dental visits is crucial, and teeth with severe gum disease may need to be extracted and replaced with appropriate prosthetic devices,” he added.
The researchers note that further studies are needed to confirm these findings.
The study was supported the Japanese Ministry of Education, Culture, Sports, Science, and Technology; Kelo University; Japan Arteriosclerosis Prevention Fund; Japanese Ministry of Health, Labor, and Welfare; Teiko University; Pfizer Japan; Bayer Yakuhin; Chugai Pharmaceutical; Daiichi Sankyo; Astrellas Pharma; Takeda Pharmaceutical; the Health Care Science Institute; the Health Science Center; and the Takeda Science Foundation. The investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Gum disease and tooth loss are linked to hippocampal atrophy and may have a more negative impact on the brain than aging, new research suggests.
Investigators found that in a late middle-aged and older cohort, among patients with mild periodontitis, having fewer teeth was linked to a faster rate of left hippocampal atrophy. For those with severe gum disease, each additional lost tooth was associated with a faster rate of brain shrinkage, equivalent to 1.3 years of brain aging.
“Tooth loss and gum disease, which is inflammation of the tissue around the teeth that can cause shrinkage of the gums and loosening of the teeth, are very common, so evaluating a potential link with dementia is incredibly important,” study investigator Satoshi Yamaguchi, PhD, DDS, of Tohoku University, in Sendai, Japan, said in a release.
“Our study found that these conditions may play a role in the health of the brain area that controls thinking and memory, giving people another reason to take better care of their teeth,” Dr. Yamaguchi noted.
The findings were published online in Neurology.
Greater effect than aging
Although previous research suggests that tooth loss and periodontitis are risk factors for Alzheimer’s disease, longitudinal research has not shown a significant correlation between these conditions and hippocampal atrophy.
To clarify this association, the investigators followed 172 men and women (average age, 67 years) who had undergone two MRI brain scans 4 years apart and had had a dental examination. None of the participants had any signs of cognitive decline at baseline.
At study outset, information on cerebrovascular and cardiovascular disease, alcohol consumption, smoking, depression history, and cognitive function was gathered. The Mini Mental State Exam and dental exams were administered at baseline and at 4-year follow-up.
For each participant, the number of teeth was counted, and all participants were assessed for gum disease via periodontal probing depth (PD).
Healthy gums typically measure between 1 and 3 mm in depth. Mild gum disease is signified by measurements of 3-4 mm in several areas. Severe gum disease involves measurements of 5-6 mm and is accompanied by greater bone loss, leading to potential tooth loss.
Multiple regression analysis was performed, with the annual symmetric percentage change (SPC) of hippocampal volume as the dependent variable. The analysis included an interaction term between the number of teeth present (NTP) and mean PD.
Over the 4-year study period, the investigators found that the qualitative interaction between NTP and mean PD was significant for the annual SPC in the left hippocampus.
Among those with mild periodontitis, having fewer teeth correlated with more rapid atrophy of the left hippocampus, such that every tooth lost was equivalent to nearly 1 year of brain aging.
In contrast, having more teeth was associated with a faster rate of left hippocampal atrophy among those with severe periodontitis and was equivalent to 1.3 years of brain aging.
For those with severe gum disease, each additional lost tooth corresponded to a faster rate of brain shrinkage, equivalent to 1.3 years of brain aging.
“This finding indicates that periodontitis may have a greater association with left hippocampal atrophy than the association exhibited by age. Furthermore, in cases of mild periodontitis, fewer teeth may be associated with a subsequent decline in cognitive function,” the investigators write.
The study’s results, they add, highlight the importance of preserving oral health, not just the retaining of teeth. “These findings suggest that retaining teeth with severe gum disease is associated with brain atrophy,” said Dr. Yamaguchi.
“Controlling the progression of gum disease through regular dental visits is crucial, and teeth with severe gum disease may need to be extracted and replaced with appropriate prosthetic devices,” he added.
The researchers note that further studies are needed to confirm these findings.
The study was supported the Japanese Ministry of Education, Culture, Sports, Science, and Technology; Kelo University; Japan Arteriosclerosis Prevention Fund; Japanese Ministry of Health, Labor, and Welfare; Teiko University; Pfizer Japan; Bayer Yakuhin; Chugai Pharmaceutical; Daiichi Sankyo; Astrellas Pharma; Takeda Pharmaceutical; the Health Care Science Institute; the Health Science Center; and the Takeda Science Foundation. The investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Gum disease and tooth loss are linked to hippocampal atrophy and may have a more negative impact on the brain than aging, new research suggests.
Investigators found that in a late middle-aged and older cohort, among patients with mild periodontitis, having fewer teeth was linked to a faster rate of left hippocampal atrophy. For those with severe gum disease, each additional lost tooth was associated with a faster rate of brain shrinkage, equivalent to 1.3 years of brain aging.
“Tooth loss and gum disease, which is inflammation of the tissue around the teeth that can cause shrinkage of the gums and loosening of the teeth, are very common, so evaluating a potential link with dementia is incredibly important,” study investigator Satoshi Yamaguchi, PhD, DDS, of Tohoku University, in Sendai, Japan, said in a release.
“Our study found that these conditions may play a role in the health of the brain area that controls thinking and memory, giving people another reason to take better care of their teeth,” Dr. Yamaguchi noted.
The findings were published online in Neurology.
Greater effect than aging
Although previous research suggests that tooth loss and periodontitis are risk factors for Alzheimer’s disease, longitudinal research has not shown a significant correlation between these conditions and hippocampal atrophy.
To clarify this association, the investigators followed 172 men and women (average age, 67 years) who had undergone two MRI brain scans 4 years apart and had had a dental examination. None of the participants had any signs of cognitive decline at baseline.
At study outset, information on cerebrovascular and cardiovascular disease, alcohol consumption, smoking, depression history, and cognitive function was gathered. The Mini Mental State Exam and dental exams were administered at baseline and at 4-year follow-up.
For each participant, the number of teeth was counted, and all participants were assessed for gum disease via periodontal probing depth (PD).
Healthy gums typically measure between 1 and 3 mm in depth. Mild gum disease is signified by measurements of 3-4 mm in several areas. Severe gum disease involves measurements of 5-6 mm and is accompanied by greater bone loss, leading to potential tooth loss.
Multiple regression analysis was performed, with the annual symmetric percentage change (SPC) of hippocampal volume as the dependent variable. The analysis included an interaction term between the number of teeth present (NTP) and mean PD.
Over the 4-year study period, the investigators found that the qualitative interaction between NTP and mean PD was significant for the annual SPC in the left hippocampus.
Among those with mild periodontitis, having fewer teeth correlated with more rapid atrophy of the left hippocampus, such that every tooth lost was equivalent to nearly 1 year of brain aging.
In contrast, having more teeth was associated with a faster rate of left hippocampal atrophy among those with severe periodontitis and was equivalent to 1.3 years of brain aging.
For those with severe gum disease, each additional lost tooth corresponded to a faster rate of brain shrinkage, equivalent to 1.3 years of brain aging.
“This finding indicates that periodontitis may have a greater association with left hippocampal atrophy than the association exhibited by age. Furthermore, in cases of mild periodontitis, fewer teeth may be associated with a subsequent decline in cognitive function,” the investigators write.
The study’s results, they add, highlight the importance of preserving oral health, not just the retaining of teeth. “These findings suggest that retaining teeth with severe gum disease is associated with brain atrophy,” said Dr. Yamaguchi.
“Controlling the progression of gum disease through regular dental visits is crucial, and teeth with severe gum disease may need to be extracted and replaced with appropriate prosthetic devices,” he added.
The researchers note that further studies are needed to confirm these findings.
The study was supported the Japanese Ministry of Education, Culture, Sports, Science, and Technology; Kelo University; Japan Arteriosclerosis Prevention Fund; Japanese Ministry of Health, Labor, and Welfare; Teiko University; Pfizer Japan; Bayer Yakuhin; Chugai Pharmaceutical; Daiichi Sankyo; Astrellas Pharma; Takeda Pharmaceutical; the Health Care Science Institute; the Health Science Center; and the Takeda Science Foundation. The investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
New Alzheimer’s drugs: Setting realistic expectations
With the Food and Drug Administration’s full stamp of approval in hand, Leqembi (lecanemab) is poised to catapult us into a new era of treatment for Alzheimer’s disease. And now that the donanemab trial data are out, there’s another antiamyloid drug waiting in the wings.
To finally have true disease-modifying therapies for Alzheimer’s disease is a massive step forward for a field that’s been plagued with disappointment. But these drugs come with serious concerns and unknowns. They will require complex decision-making, putting doctors, patients, and their families in a medical quandary.
Striking the right balance between cautious optimism and realistic expectations will be a formidable challenge.
Managing patient and family expectations
These drugs are no magic bullet. They slow down the dementia’s progression, buying patients more time (on the order of months) before they begin to experience significant worsening. We’ll need a lot more information from research and clinical experience before we can understand how meaningful that treatment effect is. Right now, it is unclear whether eligible patients and their families will even perceive tangible differences.
In the CLARITY-AD trial, participants on lecanemab experienced a 27% slowing in the rate of cognitive decline over 18 months. Donanemab was shown to slow decline in memory and cognition by about 35% over the same time frame in the TRAILBLAZER-ALZ 2 trial. That translates to more time for patients and their families to enjoy independence, maintain normal life, and stave off the most distressing parts of the disease.
But what happens after 18 months of treatment – will the treatment effect magnify or dissipate? How much time are we really buying in the long run? Counseling patients and their families is made all the more difficult when the answers to important questions like these remain to be seen.
Only a sliver of Alzheimer’s patients are current candidates
The fact is that most patients living with Alzheimer’s disease will not qualify for treatment with these drugs. Lecanemab is approved for people with early-stage disease, meaning their dementia is mild or they have mild cognitive impairment, which is a precursor to full-blown Alzheimer’s disease. Of the 6 million people in the United States living with Alzheimer’s, about 1.5 million are estimated to fall into that category. We can expect to see a similar qualifier for donanemab if it receives FDA approval, especially because that trial suggested a more pronounced treatment effect for patients in the earliest stages of the disease.
Even if a patient hits the sweet spot where they have just enough cognitive impairment, but not too much, they aren’t technically therapeutic candidates until prerequisite testing confirms amyloid protein accumulation in the brain via PET scan or cerebrospinal fluid analysis.
Even then, the FDA’s boxed warning for lecanemab recommends that patients undergo genetic testing for the apo E4 mutation to identify those at a particularly high risk for severe adverse effects including brain bleeding and swelling. This recommendation is not unreasonable considering that 15% of the Alzheimer’s population has two copies of the apo E4 mutation and fall into that high-risk group.
Significant risks
Antiamyloid drugs are well-known to cause serious side effects. In the lecanemab trial, 13% of participants receiving Leqembi experienced brain swelling (vs. 2% of participants receiving placebo) and 17% of participants had brain bleeding (vs. 9% of participants on placebo). In the donanemab trial, brain bleeding occurred in 31.4% of participants on the drug (vs. 13.6% on placebo) and swelling occurred in 24% (vs. 2.1% receiving placebo). Thankfully, in both trials, most of these adverse events did not produce significant symptoms, but in rare cases these events caused severe or catastrophic neurologic injury, including death.
How can we best guide patients and their families to weigh the uncertain benefits against potentially serious risks? We can start by considering the patient characteristics most likely to portend increased risk for serious side effects: apo E4 mutations, blood thinner use, and the presence of microhemorrhages on brain imaging. But after that, we’re left with a lot of uncertainty in terms of which patients are most likely to see meaningful clinical improvements from the drug and unknown factors that may increase the risks of treatment.
A costly therapy
Medicare plans to cover 80% of lecanemab’s steep cost of $26,500 per year. Still, that will leave many patients with a hefty copay, potentially over $6,000 per year. But that only scratches the surface. Consider the frequent medical visits, repeated brain scans, laboratory tests, and infusion center appointments. It’s been estimated that all-in, the treatment will actually cost about $90,000 per year.
Yes, Medicare will reimburse a large portion of that cost, but it adds up to an estimated $2 billion per year for about 85,000 patients. This will probably spur increases to Medicare premiums, among other economic consequences for the health care system.
We’ll probably have to wait for an FDA approval decision before we know where donanemab will be priced.
Logistical challenges could be a rate-limiting step
Ask anyone who’s tried to see a neurologist recently, and they’ll tell you that the wait for a new patient appointment is months long. The shortage of neurologists in the United States is already a crisis, and there are even fewer cognitive neurologists. How long will patients be forced to wait for their diagnosis?
Many geriatricians will get comfortable prescribing these drugs, but will our already overburdened primary care providers have the bandwidth to do the same? It’s a tall order.
A new world of Alzheimer’s treatments also means that the infrastructure of our health care systems will need to be ramped up. Lecanemab infusions are administered every 2 weeks and donanemab every 4 weeks. Infusion centers will need to accommodate a lot more patients. And those patients will need frequent brain scans, so neuroimaging centers will need to increase their capacity to perform many more brain MRI and PET scans.
Antiamyloid drugs: An exciting first step
The bottom line is that these drugs aren’t the Alzheimer’s holy grail: An accessible treatment that could stop the disease in its tracks or reverse cognitive impairment. They are, however, a very promising breakthrough.
Yes, there are a ton of kinks to work out here, but this is an exciting start. Alzheimer’s research is entering a renaissance era that will hopefully bring more groundbreaking developments. Better biomarkers to facilitate faster, easier diagnosis. More drugs that go beyond amyloid proteins for their therapeutic targets. Treatments for later-stage disease. Drugs that prevent dementia altogether.
Ultimately, these new antiamyloid beta drugs are an exciting indication that we will eventually have a toolkit of Alzheimer’s drugs to choose from. For now, we’ve taken a solid step forward and there is ample reason to be hopeful for the future.
Dr. Croll is assistant professor of neurology at Temple University, Philadelphia. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
With the Food and Drug Administration’s full stamp of approval in hand, Leqembi (lecanemab) is poised to catapult us into a new era of treatment for Alzheimer’s disease. And now that the donanemab trial data are out, there’s another antiamyloid drug waiting in the wings.
To finally have true disease-modifying therapies for Alzheimer’s disease is a massive step forward for a field that’s been plagued with disappointment. But these drugs come with serious concerns and unknowns. They will require complex decision-making, putting doctors, patients, and their families in a medical quandary.
Striking the right balance between cautious optimism and realistic expectations will be a formidable challenge.
Managing patient and family expectations
These drugs are no magic bullet. They slow down the dementia’s progression, buying patients more time (on the order of months) before they begin to experience significant worsening. We’ll need a lot more information from research and clinical experience before we can understand how meaningful that treatment effect is. Right now, it is unclear whether eligible patients and their families will even perceive tangible differences.
In the CLARITY-AD trial, participants on lecanemab experienced a 27% slowing in the rate of cognitive decline over 18 months. Donanemab was shown to slow decline in memory and cognition by about 35% over the same time frame in the TRAILBLAZER-ALZ 2 trial. That translates to more time for patients and their families to enjoy independence, maintain normal life, and stave off the most distressing parts of the disease.
But what happens after 18 months of treatment – will the treatment effect magnify or dissipate? How much time are we really buying in the long run? Counseling patients and their families is made all the more difficult when the answers to important questions like these remain to be seen.
Only a sliver of Alzheimer’s patients are current candidates
The fact is that most patients living with Alzheimer’s disease will not qualify for treatment with these drugs. Lecanemab is approved for people with early-stage disease, meaning their dementia is mild or they have mild cognitive impairment, which is a precursor to full-blown Alzheimer’s disease. Of the 6 million people in the United States living with Alzheimer’s, about 1.5 million are estimated to fall into that category. We can expect to see a similar qualifier for donanemab if it receives FDA approval, especially because that trial suggested a more pronounced treatment effect for patients in the earliest stages of the disease.
Even if a patient hits the sweet spot where they have just enough cognitive impairment, but not too much, they aren’t technically therapeutic candidates until prerequisite testing confirms amyloid protein accumulation in the brain via PET scan or cerebrospinal fluid analysis.
Even then, the FDA’s boxed warning for lecanemab recommends that patients undergo genetic testing for the apo E4 mutation to identify those at a particularly high risk for severe adverse effects including brain bleeding and swelling. This recommendation is not unreasonable considering that 15% of the Alzheimer’s population has two copies of the apo E4 mutation and fall into that high-risk group.
Significant risks
Antiamyloid drugs are well-known to cause serious side effects. In the lecanemab trial, 13% of participants receiving Leqembi experienced brain swelling (vs. 2% of participants receiving placebo) and 17% of participants had brain bleeding (vs. 9% of participants on placebo). In the donanemab trial, brain bleeding occurred in 31.4% of participants on the drug (vs. 13.6% on placebo) and swelling occurred in 24% (vs. 2.1% receiving placebo). Thankfully, in both trials, most of these adverse events did not produce significant symptoms, but in rare cases these events caused severe or catastrophic neurologic injury, including death.
How can we best guide patients and their families to weigh the uncertain benefits against potentially serious risks? We can start by considering the patient characteristics most likely to portend increased risk for serious side effects: apo E4 mutations, blood thinner use, and the presence of microhemorrhages on brain imaging. But after that, we’re left with a lot of uncertainty in terms of which patients are most likely to see meaningful clinical improvements from the drug and unknown factors that may increase the risks of treatment.
A costly therapy
Medicare plans to cover 80% of lecanemab’s steep cost of $26,500 per year. Still, that will leave many patients with a hefty copay, potentially over $6,000 per year. But that only scratches the surface. Consider the frequent medical visits, repeated brain scans, laboratory tests, and infusion center appointments. It’s been estimated that all-in, the treatment will actually cost about $90,000 per year.
Yes, Medicare will reimburse a large portion of that cost, but it adds up to an estimated $2 billion per year for about 85,000 patients. This will probably spur increases to Medicare premiums, among other economic consequences for the health care system.
We’ll probably have to wait for an FDA approval decision before we know where donanemab will be priced.
Logistical challenges could be a rate-limiting step
Ask anyone who’s tried to see a neurologist recently, and they’ll tell you that the wait for a new patient appointment is months long. The shortage of neurologists in the United States is already a crisis, and there are even fewer cognitive neurologists. How long will patients be forced to wait for their diagnosis?
Many geriatricians will get comfortable prescribing these drugs, but will our already overburdened primary care providers have the bandwidth to do the same? It’s a tall order.
A new world of Alzheimer’s treatments also means that the infrastructure of our health care systems will need to be ramped up. Lecanemab infusions are administered every 2 weeks and donanemab every 4 weeks. Infusion centers will need to accommodate a lot more patients. And those patients will need frequent brain scans, so neuroimaging centers will need to increase their capacity to perform many more brain MRI and PET scans.
Antiamyloid drugs: An exciting first step
The bottom line is that these drugs aren’t the Alzheimer’s holy grail: An accessible treatment that could stop the disease in its tracks or reverse cognitive impairment. They are, however, a very promising breakthrough.
Yes, there are a ton of kinks to work out here, but this is an exciting start. Alzheimer’s research is entering a renaissance era that will hopefully bring more groundbreaking developments. Better biomarkers to facilitate faster, easier diagnosis. More drugs that go beyond amyloid proteins for their therapeutic targets. Treatments for later-stage disease. Drugs that prevent dementia altogether.
Ultimately, these new antiamyloid beta drugs are an exciting indication that we will eventually have a toolkit of Alzheimer’s drugs to choose from. For now, we’ve taken a solid step forward and there is ample reason to be hopeful for the future.
Dr. Croll is assistant professor of neurology at Temple University, Philadelphia. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
With the Food and Drug Administration’s full stamp of approval in hand, Leqembi (lecanemab) is poised to catapult us into a new era of treatment for Alzheimer’s disease. And now that the donanemab trial data are out, there’s another antiamyloid drug waiting in the wings.
To finally have true disease-modifying therapies for Alzheimer’s disease is a massive step forward for a field that’s been plagued with disappointment. But these drugs come with serious concerns and unknowns. They will require complex decision-making, putting doctors, patients, and their families in a medical quandary.
Striking the right balance between cautious optimism and realistic expectations will be a formidable challenge.
Managing patient and family expectations
These drugs are no magic bullet. They slow down the dementia’s progression, buying patients more time (on the order of months) before they begin to experience significant worsening. We’ll need a lot more information from research and clinical experience before we can understand how meaningful that treatment effect is. Right now, it is unclear whether eligible patients and their families will even perceive tangible differences.
In the CLARITY-AD trial, participants on lecanemab experienced a 27% slowing in the rate of cognitive decline over 18 months. Donanemab was shown to slow decline in memory and cognition by about 35% over the same time frame in the TRAILBLAZER-ALZ 2 trial. That translates to more time for patients and their families to enjoy independence, maintain normal life, and stave off the most distressing parts of the disease.
But what happens after 18 months of treatment – will the treatment effect magnify or dissipate? How much time are we really buying in the long run? Counseling patients and their families is made all the more difficult when the answers to important questions like these remain to be seen.
Only a sliver of Alzheimer’s patients are current candidates
The fact is that most patients living with Alzheimer’s disease will not qualify for treatment with these drugs. Lecanemab is approved for people with early-stage disease, meaning their dementia is mild or they have mild cognitive impairment, which is a precursor to full-blown Alzheimer’s disease. Of the 6 million people in the United States living with Alzheimer’s, about 1.5 million are estimated to fall into that category. We can expect to see a similar qualifier for donanemab if it receives FDA approval, especially because that trial suggested a more pronounced treatment effect for patients in the earliest stages of the disease.
Even if a patient hits the sweet spot where they have just enough cognitive impairment, but not too much, they aren’t technically therapeutic candidates until prerequisite testing confirms amyloid protein accumulation in the brain via PET scan or cerebrospinal fluid analysis.
Even then, the FDA’s boxed warning for lecanemab recommends that patients undergo genetic testing for the apo E4 mutation to identify those at a particularly high risk for severe adverse effects including brain bleeding and swelling. This recommendation is not unreasonable considering that 15% of the Alzheimer’s population has two copies of the apo E4 mutation and fall into that high-risk group.
Significant risks
Antiamyloid drugs are well-known to cause serious side effects. In the lecanemab trial, 13% of participants receiving Leqembi experienced brain swelling (vs. 2% of participants receiving placebo) and 17% of participants had brain bleeding (vs. 9% of participants on placebo). In the donanemab trial, brain bleeding occurred in 31.4% of participants on the drug (vs. 13.6% on placebo) and swelling occurred in 24% (vs. 2.1% receiving placebo). Thankfully, in both trials, most of these adverse events did not produce significant symptoms, but in rare cases these events caused severe or catastrophic neurologic injury, including death.
How can we best guide patients and their families to weigh the uncertain benefits against potentially serious risks? We can start by considering the patient characteristics most likely to portend increased risk for serious side effects: apo E4 mutations, blood thinner use, and the presence of microhemorrhages on brain imaging. But after that, we’re left with a lot of uncertainty in terms of which patients are most likely to see meaningful clinical improvements from the drug and unknown factors that may increase the risks of treatment.
A costly therapy
Medicare plans to cover 80% of lecanemab’s steep cost of $26,500 per year. Still, that will leave many patients with a hefty copay, potentially over $6,000 per year. But that only scratches the surface. Consider the frequent medical visits, repeated brain scans, laboratory tests, and infusion center appointments. It’s been estimated that all-in, the treatment will actually cost about $90,000 per year.
Yes, Medicare will reimburse a large portion of that cost, but it adds up to an estimated $2 billion per year for about 85,000 patients. This will probably spur increases to Medicare premiums, among other economic consequences for the health care system.
We’ll probably have to wait for an FDA approval decision before we know where donanemab will be priced.
Logistical challenges could be a rate-limiting step
Ask anyone who’s tried to see a neurologist recently, and they’ll tell you that the wait for a new patient appointment is months long. The shortage of neurologists in the United States is already a crisis, and there are even fewer cognitive neurologists. How long will patients be forced to wait for their diagnosis?
Many geriatricians will get comfortable prescribing these drugs, but will our already overburdened primary care providers have the bandwidth to do the same? It’s a tall order.
A new world of Alzheimer’s treatments also means that the infrastructure of our health care systems will need to be ramped up. Lecanemab infusions are administered every 2 weeks and donanemab every 4 weeks. Infusion centers will need to accommodate a lot more patients. And those patients will need frequent brain scans, so neuroimaging centers will need to increase their capacity to perform many more brain MRI and PET scans.
Antiamyloid drugs: An exciting first step
The bottom line is that these drugs aren’t the Alzheimer’s holy grail: An accessible treatment that could stop the disease in its tracks or reverse cognitive impairment. They are, however, a very promising breakthrough.
Yes, there are a ton of kinks to work out here, but this is an exciting start. Alzheimer’s research is entering a renaissance era that will hopefully bring more groundbreaking developments. Better biomarkers to facilitate faster, easier diagnosis. More drugs that go beyond amyloid proteins for their therapeutic targets. Treatments for later-stage disease. Drugs that prevent dementia altogether.
Ultimately, these new antiamyloid beta drugs are an exciting indication that we will eventually have a toolkit of Alzheimer’s drugs to choose from. For now, we’ve taken a solid step forward and there is ample reason to be hopeful for the future.
Dr. Croll is assistant professor of neurology at Temple University, Philadelphia. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
No cognitive benefit from meditation, learning a language?
The findings are similar to results from another study published last year but are contrary to previous findings showing cognitive benefits for practicing meditation and learning a new language later in life.
“Based on existing literature, which has provided support for the efficacy of meditation and foreign language training in promoting cognition among older adults, perhaps the most surprising outcome of our study was the lack of evidence indicating cognitive benefits after 18 months of either intervention,” lead author Harriet Demnitz-King, MSc, a doctoral candidate at University College London, said in an interview. The findings were published online in JAMA Network Open.
Contradictory findings
For the study, 135 French-speaking, cognitively healthy people were randomized to English-language training, meditation, or a control group. All participants were aged 65 years or older, had been retired for at least 1 year, and had completed at least 7 years of education.
The meditation and English-language training interventions were both 18 months long and included a 2-hour weekly group session, daily home practice of at least 20 minutes, and 1-day intensive 5-hour practice.
Researchers found no significant changes in global cognition, episodic memory, executive function, or attention with either intervention, compared with the control group or to each other.
The findings contradict the researchers’ earlier work that found mindfulness meditation boosted cognitive function in older adults with subjective cognitive decline.
“We are still trying to reconcile these findings,” senior author Natalie Marchant, PhD, associate professor in the division of psychiatry at University College London, said. “It may be that mindfulness meditation may not improve cognition beyond normally functioning levels but may help to preserve cognition in the face of cognitive decline.”
This study was the longest randomized controlled trial in older adults to investigate the effects of non-native language learning on cognition, Dr. Marchant said.
“It may be that language-learning may buffer against age-related cognitive decline but does not boost cognition in high-functioning individuals,” Dr. Marchant said. “While language learning may not improve cognition, we do not want to discard the other possibility without first examining it.”
Dr. Marchant plans to follow participants for years to come to study that very question.
More to learn
The results harken to those of a study last year with a similar participant group and similar results. In that work, mindfulness meditation and exercise also failed to boost cognition in healthy adults. But that may not be the whole story, according to Eric Lenze, MD, professor and chair of psychiatry at Washington University School of Medicine, St. Louis.
Dr. Lenze was a lead author on that earlier research, known as the MEDEX trial, but was not involved with this study. He commented on the new findings for this news organization.
“People may read these results, and ours that were published in JAMA in December, as suggesting that lifestyle and cognitive interventions don’t work in older adults, but that’s not what this shows, in my opinion,” Dr. Lenze said. “It shows that we don’t understand the science of the aging brain as much as we would like to.”
Participants in most of these studies were mostly White, highly educated, and in good cognitive health, all characteristics that could have skewed these findings, he added.
“It may be that interventions to improve cognitive function in older adults would be more likely to help people who have more room to benefit,” Dr. Lenze said. “If you’re already highly educated, healthy, and cognitively normal, why should we expect that you could do even better than that?”
The Age-Well study was funded by European Union in Horizon 2020 program and Inserm, Région Normandie, Fondation d’entreprise MMA des Entrepreneurs du Futur. Dr. Marchant reports grants from Alzheimer’s Society and the U.K. Medical Research Council. Dr. Lenze reports funding from Takeda pharmaceuticals and has been a consultant for Pritikin Intensive Cardiac Rehabilitation.
A version of this article first appeared on Medscape.com.
The findings are similar to results from another study published last year but are contrary to previous findings showing cognitive benefits for practicing meditation and learning a new language later in life.
“Based on existing literature, which has provided support for the efficacy of meditation and foreign language training in promoting cognition among older adults, perhaps the most surprising outcome of our study was the lack of evidence indicating cognitive benefits after 18 months of either intervention,” lead author Harriet Demnitz-King, MSc, a doctoral candidate at University College London, said in an interview. The findings were published online in JAMA Network Open.
Contradictory findings
For the study, 135 French-speaking, cognitively healthy people were randomized to English-language training, meditation, or a control group. All participants were aged 65 years or older, had been retired for at least 1 year, and had completed at least 7 years of education.
The meditation and English-language training interventions were both 18 months long and included a 2-hour weekly group session, daily home practice of at least 20 minutes, and 1-day intensive 5-hour practice.
Researchers found no significant changes in global cognition, episodic memory, executive function, or attention with either intervention, compared with the control group or to each other.
The findings contradict the researchers’ earlier work that found mindfulness meditation boosted cognitive function in older adults with subjective cognitive decline.
“We are still trying to reconcile these findings,” senior author Natalie Marchant, PhD, associate professor in the division of psychiatry at University College London, said. “It may be that mindfulness meditation may not improve cognition beyond normally functioning levels but may help to preserve cognition in the face of cognitive decline.”
This study was the longest randomized controlled trial in older adults to investigate the effects of non-native language learning on cognition, Dr. Marchant said.
“It may be that language-learning may buffer against age-related cognitive decline but does not boost cognition in high-functioning individuals,” Dr. Marchant said. “While language learning may not improve cognition, we do not want to discard the other possibility without first examining it.”
Dr. Marchant plans to follow participants for years to come to study that very question.
More to learn
The results harken to those of a study last year with a similar participant group and similar results. In that work, mindfulness meditation and exercise also failed to boost cognition in healthy adults. But that may not be the whole story, according to Eric Lenze, MD, professor and chair of psychiatry at Washington University School of Medicine, St. Louis.
Dr. Lenze was a lead author on that earlier research, known as the MEDEX trial, but was not involved with this study. He commented on the new findings for this news organization.
“People may read these results, and ours that were published in JAMA in December, as suggesting that lifestyle and cognitive interventions don’t work in older adults, but that’s not what this shows, in my opinion,” Dr. Lenze said. “It shows that we don’t understand the science of the aging brain as much as we would like to.”
Participants in most of these studies were mostly White, highly educated, and in good cognitive health, all characteristics that could have skewed these findings, he added.
“It may be that interventions to improve cognitive function in older adults would be more likely to help people who have more room to benefit,” Dr. Lenze said. “If you’re already highly educated, healthy, and cognitively normal, why should we expect that you could do even better than that?”
The Age-Well study was funded by European Union in Horizon 2020 program and Inserm, Région Normandie, Fondation d’entreprise MMA des Entrepreneurs du Futur. Dr. Marchant reports grants from Alzheimer’s Society and the U.K. Medical Research Council. Dr. Lenze reports funding from Takeda pharmaceuticals and has been a consultant for Pritikin Intensive Cardiac Rehabilitation.
A version of this article first appeared on Medscape.com.
The findings are similar to results from another study published last year but are contrary to previous findings showing cognitive benefits for practicing meditation and learning a new language later in life.
“Based on existing literature, which has provided support for the efficacy of meditation and foreign language training in promoting cognition among older adults, perhaps the most surprising outcome of our study was the lack of evidence indicating cognitive benefits after 18 months of either intervention,” lead author Harriet Demnitz-King, MSc, a doctoral candidate at University College London, said in an interview. The findings were published online in JAMA Network Open.
Contradictory findings
For the study, 135 French-speaking, cognitively healthy people were randomized to English-language training, meditation, or a control group. All participants were aged 65 years or older, had been retired for at least 1 year, and had completed at least 7 years of education.
The meditation and English-language training interventions were both 18 months long and included a 2-hour weekly group session, daily home practice of at least 20 minutes, and 1-day intensive 5-hour practice.
Researchers found no significant changes in global cognition, episodic memory, executive function, or attention with either intervention, compared with the control group or to each other.
The findings contradict the researchers’ earlier work that found mindfulness meditation boosted cognitive function in older adults with subjective cognitive decline.
“We are still trying to reconcile these findings,” senior author Natalie Marchant, PhD, associate professor in the division of psychiatry at University College London, said. “It may be that mindfulness meditation may not improve cognition beyond normally functioning levels but may help to preserve cognition in the face of cognitive decline.”
This study was the longest randomized controlled trial in older adults to investigate the effects of non-native language learning on cognition, Dr. Marchant said.
“It may be that language-learning may buffer against age-related cognitive decline but does not boost cognition in high-functioning individuals,” Dr. Marchant said. “While language learning may not improve cognition, we do not want to discard the other possibility without first examining it.”
Dr. Marchant plans to follow participants for years to come to study that very question.
More to learn
The results harken to those of a study last year with a similar participant group and similar results. In that work, mindfulness meditation and exercise also failed to boost cognition in healthy adults. But that may not be the whole story, according to Eric Lenze, MD, professor and chair of psychiatry at Washington University School of Medicine, St. Louis.
Dr. Lenze was a lead author on that earlier research, known as the MEDEX trial, but was not involved with this study. He commented on the new findings for this news organization.
“People may read these results, and ours that were published in JAMA in December, as suggesting that lifestyle and cognitive interventions don’t work in older adults, but that’s not what this shows, in my opinion,” Dr. Lenze said. “It shows that we don’t understand the science of the aging brain as much as we would like to.”
Participants in most of these studies were mostly White, highly educated, and in good cognitive health, all characteristics that could have skewed these findings, he added.
“It may be that interventions to improve cognitive function in older adults would be more likely to help people who have more room to benefit,” Dr. Lenze said. “If you’re already highly educated, healthy, and cognitively normal, why should we expect that you could do even better than that?”
The Age-Well study was funded by European Union in Horizon 2020 program and Inserm, Région Normandie, Fondation d’entreprise MMA des Entrepreneurs du Futur. Dr. Marchant reports grants from Alzheimer’s Society and the U.K. Medical Research Council. Dr. Lenze reports funding from Takeda pharmaceuticals and has been a consultant for Pritikin Intensive Cardiac Rehabilitation.
A version of this article first appeared on Medscape.com.
FROM JAMA Network Open
CDC offers guidance on RSV vaccines for adults
Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.
Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.
Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.
Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
Two new vaccines
In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.
On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.
The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.
Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.
The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.
Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.
“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.
Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
At higher risk
Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.
Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.
People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.
The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.
As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.
However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.
For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.
RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
A version of this article first appeared on Medscape.com.
Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.
Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.
Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.
Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
Two new vaccines
In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.
On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.
The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.
Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.
The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.
Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.
“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.
Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
At higher risk
Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.
Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.
People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.
The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.
As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.
However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.
For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.
RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
A version of this article first appeared on Medscape.com.
Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.
Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.
Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.
Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
Two new vaccines
In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.
On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.
The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.
Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.
The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.
Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.
“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.
Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
At higher risk
Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.
Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.
People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.
The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.
As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.
However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.
For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.
RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
A version of this article first appeared on Medscape.com.
FROM THE MMWR
Consistent primary care beforehand may reduce mortality after emergency surgery
Primary care utilization within a year of emergency general surgery was significantly associated with lower mortality up to 180 days later for older adults, based on data from more than 100,000 individuals.
Although previous research has shown the benefits of routine health and preventive care visits for surgery patients, many individuals in the United States live in areas with a shortage of primary care providers, wrote Sanford E. Roberts, MD, of the University of Pennsylvania, Philadelphia, and colleagues. The effect of primary care use on adverse outcomes after emergency general surgery, including mortality, remains unknown, they said.
In a study published in JAMA Surgery the researchers reviewed data from 102,384 Medicare patients aged 66 years and older who underwent emergency general surgery (EGS) between July 1, 2015, and June 30, 2018. Participants were classified into five EGS categories: colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, and upper gastrointestinal. The mean age of the participants was 73.8 years; 8.4% were Black, 91.6% were White.
The primary outcome was mortality in hospital and at 30, 60, 90, and 180 days. In the year before hospitalization for EGS, 88,340 patients (86.3%) had visited a primary care physician.
After adjusting for multiple risk factors, the overall risk of in-hospital mortality was 19% lower for patients who had a history of primary care visits than for those without prior-year exposure to primary care (odds ratio, 0.81).
Mortality at 30 days was 27% lower overall in patients with primary care exposure, compared with those without primary care exposure (OR, 0.73). This trend continued at 60 days (OR, 0.75), 90 days (OR, 0.74), and 180 days (OR, 0.75); mortality rates at each time period were similar for Black and White patients with primary care exposure, both groups had reduced mortality, compared with those without primary care exposure.
However, when analyzed by race, in-hospital mortality was not significantly different for Black patients with and without primary care exposure (OR, 1.09), but in-hospital mortality was 21% less in White patients with primary care exposure (OR, 0.79). Interactions between race and primary care exposure related to mortality were not significantly different at any of the follow-up time points of 30, 60, 90, and 180 days.
“These findings suggest that primary care may be exerting a protective effect on postoperative morbidity and mortality,” the researchers wrote in their discussion. “This protective effect could be mediated through several different paths, such as identifying and managing a patient’s comorbidities, medically optimizing patients preoperatively, earlier detection of the primary EGS condition leading to early referral to treatment, and encouraging better lifestyle decisions,” they said.
The findings were limited by several factors including the retrospective design and inability to extract clinical data from a claims database, the researchers noted. Other limitations included potential confounding of unmeasured factors such as the other beneficial health behaviors often associated with seeking primary care.
Patients who avoid primary care may be more likely to delay presentation to the emergency department, which might promote poorer postoperative outcomes, the researchers said. Consequently, surgeons should consider primary care exposure in preoperative assessment, and perform a more comprehensive presurgical assessment as needed, the researchers said.
More studies are needed to examine trends in racial groups, but the results of the current study suggest that primary care provides similar benefits for Black and White individuals, and therefore could help reduce health disparities, they concluded.
Primary care benefits elude many patients
The current study shows a “rather dramatic” association between utilization of primary care within a year before surgery and patient mortality after surgery, wrote Caroline E. Reinke, MD, and David C. Slawson, MD, both of Atrium Health, Charlotte, N.C., in an accompanying editorial. The authors reiterated that possible reasons for the positive effect of primary care on postsurgical mortality included identification and management of comorbidities that could complicate surgery, as well as earlier detection of disease.
However, the editorialists noted that the benefits of primary care exposure depend on patient access to primary care, and on patient adherence to recommendations from their primary care provider. They identified barriers to potential effective interventions with primary care providers including time, money, and transportation.
An unanswered question is “whether the PCP visit itself is the causative factor associated with decreased mortality or if seeing a PCP on an annual basis is a marker of the patient possessing some other ‘magic sauce’ that improves outcomes,” they wrote.
Further, individuals in areas of primary care shortage also are more likely to lack the socioeconomic resources to benefit from primary care, the editorialists said. “Future evaluations of the interaction between PCP visits and social determinants of health may shed light on how to achieve the greatest impact,” they concluded.
Study supports value of consistent primary care
The increasingly aging population across the United States may undergo surgical procedures on an emergent basis and the current study provides data on the benefits of established and effective primary care for these individuals, said Noel Deep, MD, in an interview.
“Having data from this study supports the current position of many physicians and health care organizations and medical professional organizations that older individuals in particular, and adults in general, who have regular routine primary care visits tend to lead healthier lives and have better prognosis and quality of life,” said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The study findings reinforce what most physicians in primary care, himself included, have been advising adult patients, especially older adults about maintaining regular follow-up visits with their physicians for health screening and management of chronic medical conditions, Dr. Deep said in an interview.
However, barriers to the routine use of primary care to improve postsurgical outcomes include health illiteracy, being overwhelmed by a sudden change in health or emergent surgery, and lack of access to primary care physician, as well as issues such as transportation, financial difficulties, and physical limitations, Dr. Deep added.
“Patients who avoid routine health care visits with primary care may be lacking health insurance or financial resources, have time constraints or family responsibilities, or may be unaware of the benefits of routine health care,” he noted.
As for additional research, “I would like to see studies that can document the impact of having primary care physicians comanage these hospitalized patients in the perioperative period with continued follow-up in the postoperative/convalescent period,” said Dr. Deep.
The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Roberts disclosed grants from the National Institute on Aging and from NIH during the conduct of the study. The editorial author had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.
Primary care utilization within a year of emergency general surgery was significantly associated with lower mortality up to 180 days later for older adults, based on data from more than 100,000 individuals.
Although previous research has shown the benefits of routine health and preventive care visits for surgery patients, many individuals in the United States live in areas with a shortage of primary care providers, wrote Sanford E. Roberts, MD, of the University of Pennsylvania, Philadelphia, and colleagues. The effect of primary care use on adverse outcomes after emergency general surgery, including mortality, remains unknown, they said.
In a study published in JAMA Surgery the researchers reviewed data from 102,384 Medicare patients aged 66 years and older who underwent emergency general surgery (EGS) between July 1, 2015, and June 30, 2018. Participants were classified into five EGS categories: colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, and upper gastrointestinal. The mean age of the participants was 73.8 years; 8.4% were Black, 91.6% were White.
The primary outcome was mortality in hospital and at 30, 60, 90, and 180 days. In the year before hospitalization for EGS, 88,340 patients (86.3%) had visited a primary care physician.
After adjusting for multiple risk factors, the overall risk of in-hospital mortality was 19% lower for patients who had a history of primary care visits than for those without prior-year exposure to primary care (odds ratio, 0.81).
Mortality at 30 days was 27% lower overall in patients with primary care exposure, compared with those without primary care exposure (OR, 0.73). This trend continued at 60 days (OR, 0.75), 90 days (OR, 0.74), and 180 days (OR, 0.75); mortality rates at each time period were similar for Black and White patients with primary care exposure, both groups had reduced mortality, compared with those without primary care exposure.
However, when analyzed by race, in-hospital mortality was not significantly different for Black patients with and without primary care exposure (OR, 1.09), but in-hospital mortality was 21% less in White patients with primary care exposure (OR, 0.79). Interactions between race and primary care exposure related to mortality were not significantly different at any of the follow-up time points of 30, 60, 90, and 180 days.
“These findings suggest that primary care may be exerting a protective effect on postoperative morbidity and mortality,” the researchers wrote in their discussion. “This protective effect could be mediated through several different paths, such as identifying and managing a patient’s comorbidities, medically optimizing patients preoperatively, earlier detection of the primary EGS condition leading to early referral to treatment, and encouraging better lifestyle decisions,” they said.
The findings were limited by several factors including the retrospective design and inability to extract clinical data from a claims database, the researchers noted. Other limitations included potential confounding of unmeasured factors such as the other beneficial health behaviors often associated with seeking primary care.
Patients who avoid primary care may be more likely to delay presentation to the emergency department, which might promote poorer postoperative outcomes, the researchers said. Consequently, surgeons should consider primary care exposure in preoperative assessment, and perform a more comprehensive presurgical assessment as needed, the researchers said.
More studies are needed to examine trends in racial groups, but the results of the current study suggest that primary care provides similar benefits for Black and White individuals, and therefore could help reduce health disparities, they concluded.
Primary care benefits elude many patients
The current study shows a “rather dramatic” association between utilization of primary care within a year before surgery and patient mortality after surgery, wrote Caroline E. Reinke, MD, and David C. Slawson, MD, both of Atrium Health, Charlotte, N.C., in an accompanying editorial. The authors reiterated that possible reasons for the positive effect of primary care on postsurgical mortality included identification and management of comorbidities that could complicate surgery, as well as earlier detection of disease.
However, the editorialists noted that the benefits of primary care exposure depend on patient access to primary care, and on patient adherence to recommendations from their primary care provider. They identified barriers to potential effective interventions with primary care providers including time, money, and transportation.
An unanswered question is “whether the PCP visit itself is the causative factor associated with decreased mortality or if seeing a PCP on an annual basis is a marker of the patient possessing some other ‘magic sauce’ that improves outcomes,” they wrote.
Further, individuals in areas of primary care shortage also are more likely to lack the socioeconomic resources to benefit from primary care, the editorialists said. “Future evaluations of the interaction between PCP visits and social determinants of health may shed light on how to achieve the greatest impact,” they concluded.
Study supports value of consistent primary care
The increasingly aging population across the United States may undergo surgical procedures on an emergent basis and the current study provides data on the benefits of established and effective primary care for these individuals, said Noel Deep, MD, in an interview.
“Having data from this study supports the current position of many physicians and health care organizations and medical professional organizations that older individuals in particular, and adults in general, who have regular routine primary care visits tend to lead healthier lives and have better prognosis and quality of life,” said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The study findings reinforce what most physicians in primary care, himself included, have been advising adult patients, especially older adults about maintaining regular follow-up visits with their physicians for health screening and management of chronic medical conditions, Dr. Deep said in an interview.
However, barriers to the routine use of primary care to improve postsurgical outcomes include health illiteracy, being overwhelmed by a sudden change in health or emergent surgery, and lack of access to primary care physician, as well as issues such as transportation, financial difficulties, and physical limitations, Dr. Deep added.
“Patients who avoid routine health care visits with primary care may be lacking health insurance or financial resources, have time constraints or family responsibilities, or may be unaware of the benefits of routine health care,” he noted.
As for additional research, “I would like to see studies that can document the impact of having primary care physicians comanage these hospitalized patients in the perioperative period with continued follow-up in the postoperative/convalescent period,” said Dr. Deep.
The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Roberts disclosed grants from the National Institute on Aging and from NIH during the conduct of the study. The editorial author had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.
Primary care utilization within a year of emergency general surgery was significantly associated with lower mortality up to 180 days later for older adults, based on data from more than 100,000 individuals.
Although previous research has shown the benefits of routine health and preventive care visits for surgery patients, many individuals in the United States live in areas with a shortage of primary care providers, wrote Sanford E. Roberts, MD, of the University of Pennsylvania, Philadelphia, and colleagues. The effect of primary care use on adverse outcomes after emergency general surgery, including mortality, remains unknown, they said.
In a study published in JAMA Surgery the researchers reviewed data from 102,384 Medicare patients aged 66 years and older who underwent emergency general surgery (EGS) between July 1, 2015, and June 30, 2018. Participants were classified into five EGS categories: colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, and upper gastrointestinal. The mean age of the participants was 73.8 years; 8.4% were Black, 91.6% were White.
The primary outcome was mortality in hospital and at 30, 60, 90, and 180 days. In the year before hospitalization for EGS, 88,340 patients (86.3%) had visited a primary care physician.
After adjusting for multiple risk factors, the overall risk of in-hospital mortality was 19% lower for patients who had a history of primary care visits than for those without prior-year exposure to primary care (odds ratio, 0.81).
Mortality at 30 days was 27% lower overall in patients with primary care exposure, compared with those without primary care exposure (OR, 0.73). This trend continued at 60 days (OR, 0.75), 90 days (OR, 0.74), and 180 days (OR, 0.75); mortality rates at each time period were similar for Black and White patients with primary care exposure, both groups had reduced mortality, compared with those without primary care exposure.
However, when analyzed by race, in-hospital mortality was not significantly different for Black patients with and without primary care exposure (OR, 1.09), but in-hospital mortality was 21% less in White patients with primary care exposure (OR, 0.79). Interactions between race and primary care exposure related to mortality were not significantly different at any of the follow-up time points of 30, 60, 90, and 180 days.
“These findings suggest that primary care may be exerting a protective effect on postoperative morbidity and mortality,” the researchers wrote in their discussion. “This protective effect could be mediated through several different paths, such as identifying and managing a patient’s comorbidities, medically optimizing patients preoperatively, earlier detection of the primary EGS condition leading to early referral to treatment, and encouraging better lifestyle decisions,” they said.
The findings were limited by several factors including the retrospective design and inability to extract clinical data from a claims database, the researchers noted. Other limitations included potential confounding of unmeasured factors such as the other beneficial health behaviors often associated with seeking primary care.
Patients who avoid primary care may be more likely to delay presentation to the emergency department, which might promote poorer postoperative outcomes, the researchers said. Consequently, surgeons should consider primary care exposure in preoperative assessment, and perform a more comprehensive presurgical assessment as needed, the researchers said.
More studies are needed to examine trends in racial groups, but the results of the current study suggest that primary care provides similar benefits for Black and White individuals, and therefore could help reduce health disparities, they concluded.
Primary care benefits elude many patients
The current study shows a “rather dramatic” association between utilization of primary care within a year before surgery and patient mortality after surgery, wrote Caroline E. Reinke, MD, and David C. Slawson, MD, both of Atrium Health, Charlotte, N.C., in an accompanying editorial. The authors reiterated that possible reasons for the positive effect of primary care on postsurgical mortality included identification and management of comorbidities that could complicate surgery, as well as earlier detection of disease.
However, the editorialists noted that the benefits of primary care exposure depend on patient access to primary care, and on patient adherence to recommendations from their primary care provider. They identified barriers to potential effective interventions with primary care providers including time, money, and transportation.
An unanswered question is “whether the PCP visit itself is the causative factor associated with decreased mortality or if seeing a PCP on an annual basis is a marker of the patient possessing some other ‘magic sauce’ that improves outcomes,” they wrote.
Further, individuals in areas of primary care shortage also are more likely to lack the socioeconomic resources to benefit from primary care, the editorialists said. “Future evaluations of the interaction between PCP visits and social determinants of health may shed light on how to achieve the greatest impact,” they concluded.
Study supports value of consistent primary care
The increasingly aging population across the United States may undergo surgical procedures on an emergent basis and the current study provides data on the benefits of established and effective primary care for these individuals, said Noel Deep, MD, in an interview.
“Having data from this study supports the current position of many physicians and health care organizations and medical professional organizations that older individuals in particular, and adults in general, who have regular routine primary care visits tend to lead healthier lives and have better prognosis and quality of life,” said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The study findings reinforce what most physicians in primary care, himself included, have been advising adult patients, especially older adults about maintaining regular follow-up visits with their physicians for health screening and management of chronic medical conditions, Dr. Deep said in an interview.
However, barriers to the routine use of primary care to improve postsurgical outcomes include health illiteracy, being overwhelmed by a sudden change in health or emergent surgery, and lack of access to primary care physician, as well as issues such as transportation, financial difficulties, and physical limitations, Dr. Deep added.
“Patients who avoid routine health care visits with primary care may be lacking health insurance or financial resources, have time constraints or family responsibilities, or may be unaware of the benefits of routine health care,” he noted.
As for additional research, “I would like to see studies that can document the impact of having primary care physicians comanage these hospitalized patients in the perioperative period with continued follow-up in the postoperative/convalescent period,” said Dr. Deep.
The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Roberts disclosed grants from the National Institute on Aging and from NIH during the conduct of the study. The editorial author had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.
FROM JAMA SURGERY
Oral tau inhibitor continues to show promise in Alzheimer’s
in the LUCIDITY phase 3 trial.
Blood concentrations of neurofilament light chain (NfL) showed a 93% reduction in change over 12 months in participants receiving HMTM at the target dose of 16 mg/day relative to the control group, which correlated significantly with a tau biomarker (p-tau 181) in blood and changes in cognitive test scores.
“This is the first tau aggregation inhibitor to reach the phase 3 stage of development and to produce results like this,” Claude Wischik, PhD, executive chairman of TauRx Therapeutics, which is developing the drug, noted in an interview.
“NfL is one of the best studied biomarkers in the business because it goes off the rails in a range of neurodegenerative disorders. In AD, it correlates with disease severity, and it tracks ongoing damage to neurons,” Dr. Wischik explained.
Oral HMTM was designed to reduce tau pathology in AD, and the noted changes in NfL concentration by HMTM indicate a “direct impact on disease pathology,” Dr. Wischik said.
The findings, from a prespecified blood biomarker analysis of the LUCIDITY phase 3 trial, were presented at the annual Alzheimer’s Association International Conference.
Support for tau inhibitor
Topline results from the LUCIDITY trial showed improvement in cognition over 18 months in participants with mild cognitive impairment (MCI) caused by AD who were treated with a 16-mg/day dose of HMTM.
However, in an odd twist, participants in the control group who received a low dose of methylthioninium chloride (MTC) also showed cognitive improvement.
As a result, HMTM 16 mg/day failed to reach its two primary endpoints – change from baseline on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL23) – relative to the MTC control group.
That’s likely because treatment with MTC, which is a variant of HMTM, unexpectedly achieved blood levels of active drug above the threshold needed to produce a clinical effect.
For the prespecified biomarker analysis reported at AAIC 2023, baseline and 12-month NfL plasma levels were available in 161 of 185 participants receiving HMTM 16 mg/day, 38 of 48 receiving HMTM 8 mg/day and 136 of 185 receiving MTC 8 mg/week.
Blood concentrations of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day relative to the control group (P = .0278), Dr. Wischik reported.
In addition, the p-tau 181 increase over 12 months “reduced to zero” with HMTM 16 mg/day and there was significant correlation between change in NfL and p-tau 181 concentration, he noted.
NfL reductions were significantly correlated with change in ADAS-Cog11 (P = .0038) and whole brain volume (P = .0359) over 24 months.
‘Exciting’ biomarker data
Commenting on the new data in an interview, Christopher Weber, PhD, director of global science initiatives at the Alzheimer’s Association, said the phase 3 LUCIDITY results “suggest that HMTM could be a potential therapeutic for slowing down neurodegenerative processes in Alzheimer’s disease.”
“Plasma NfL is an interesting biomarker which is used more and more in clinical trials because it’s noninvasive, accessible, and can assist in diagnosing and monitoring the disease in the early stages. Elevated NfL levels suggest that neurons are being affected in the brain, which could indicate the presence or progression of Alzheimer’s disease,” Dr. Weber said in an interview.
He said the biomarker data from the LUCIDITY study are “exciting.”
“However, due to the relatively small sample size, we look forward to seeing additional research on HMTM in larger, and even more diverse cohorts to better understand the performance of this treatment and the role of NfL in Alzheimer’s disease,” Dr. Weber said.
Also providing outside perspective, Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, noted that currently “there is a lot of effort in trying to address the abnormal tau that occurs in Alzheimer’s disease.”
The biomarker data from LUCIDITY show that HMTM “seems to markedly decrease the amount of NfL in plasma and there is some correlation with cognitive scores. The obvious unknown is whether these changes in plasma NfL will predict clinical benefit,” Dr. Fillit said in an interview.
“This is an oral drug that has a good safety profile, and the mechanism of action makes sense, but we need to see the clinical data,” Dr. Fillit said.
Final 2-year data from the LUCIDITY trial are expected to be released later in 2023.
In the United Kingdom, TauRx has entered an accelerated approval process for the drug, and the company said it plans to seek regulatory approval in the United States and Canada in 2023.
The study was funded by TauRx Therapeutics. Dr. Wischik is an employee of the University of Aberdeen (Scotland), and TauRx Therapeutics. Dr. Weber and Dr. Fillit reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in the LUCIDITY phase 3 trial.
Blood concentrations of neurofilament light chain (NfL) showed a 93% reduction in change over 12 months in participants receiving HMTM at the target dose of 16 mg/day relative to the control group, which correlated significantly with a tau biomarker (p-tau 181) in blood and changes in cognitive test scores.
“This is the first tau aggregation inhibitor to reach the phase 3 stage of development and to produce results like this,” Claude Wischik, PhD, executive chairman of TauRx Therapeutics, which is developing the drug, noted in an interview.
“NfL is one of the best studied biomarkers in the business because it goes off the rails in a range of neurodegenerative disorders. In AD, it correlates with disease severity, and it tracks ongoing damage to neurons,” Dr. Wischik explained.
Oral HMTM was designed to reduce tau pathology in AD, and the noted changes in NfL concentration by HMTM indicate a “direct impact on disease pathology,” Dr. Wischik said.
The findings, from a prespecified blood biomarker analysis of the LUCIDITY phase 3 trial, were presented at the annual Alzheimer’s Association International Conference.
Support for tau inhibitor
Topline results from the LUCIDITY trial showed improvement in cognition over 18 months in participants with mild cognitive impairment (MCI) caused by AD who were treated with a 16-mg/day dose of HMTM.
However, in an odd twist, participants in the control group who received a low dose of methylthioninium chloride (MTC) also showed cognitive improvement.
As a result, HMTM 16 mg/day failed to reach its two primary endpoints – change from baseline on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL23) – relative to the MTC control group.
That’s likely because treatment with MTC, which is a variant of HMTM, unexpectedly achieved blood levels of active drug above the threshold needed to produce a clinical effect.
For the prespecified biomarker analysis reported at AAIC 2023, baseline and 12-month NfL plasma levels were available in 161 of 185 participants receiving HMTM 16 mg/day, 38 of 48 receiving HMTM 8 mg/day and 136 of 185 receiving MTC 8 mg/week.
Blood concentrations of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day relative to the control group (P = .0278), Dr. Wischik reported.
In addition, the p-tau 181 increase over 12 months “reduced to zero” with HMTM 16 mg/day and there was significant correlation between change in NfL and p-tau 181 concentration, he noted.
NfL reductions were significantly correlated with change in ADAS-Cog11 (P = .0038) and whole brain volume (P = .0359) over 24 months.
‘Exciting’ biomarker data
Commenting on the new data in an interview, Christopher Weber, PhD, director of global science initiatives at the Alzheimer’s Association, said the phase 3 LUCIDITY results “suggest that HMTM could be a potential therapeutic for slowing down neurodegenerative processes in Alzheimer’s disease.”
“Plasma NfL is an interesting biomarker which is used more and more in clinical trials because it’s noninvasive, accessible, and can assist in diagnosing and monitoring the disease in the early stages. Elevated NfL levels suggest that neurons are being affected in the brain, which could indicate the presence or progression of Alzheimer’s disease,” Dr. Weber said in an interview.
He said the biomarker data from the LUCIDITY study are “exciting.”
“However, due to the relatively small sample size, we look forward to seeing additional research on HMTM in larger, and even more diverse cohorts to better understand the performance of this treatment and the role of NfL in Alzheimer’s disease,” Dr. Weber said.
Also providing outside perspective, Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, noted that currently “there is a lot of effort in trying to address the abnormal tau that occurs in Alzheimer’s disease.”
The biomarker data from LUCIDITY show that HMTM “seems to markedly decrease the amount of NfL in plasma and there is some correlation with cognitive scores. The obvious unknown is whether these changes in plasma NfL will predict clinical benefit,” Dr. Fillit said in an interview.
“This is an oral drug that has a good safety profile, and the mechanism of action makes sense, but we need to see the clinical data,” Dr. Fillit said.
Final 2-year data from the LUCIDITY trial are expected to be released later in 2023.
In the United Kingdom, TauRx has entered an accelerated approval process for the drug, and the company said it plans to seek regulatory approval in the United States and Canada in 2023.
The study was funded by TauRx Therapeutics. Dr. Wischik is an employee of the University of Aberdeen (Scotland), and TauRx Therapeutics. Dr. Weber and Dr. Fillit reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in the LUCIDITY phase 3 trial.
Blood concentrations of neurofilament light chain (NfL) showed a 93% reduction in change over 12 months in participants receiving HMTM at the target dose of 16 mg/day relative to the control group, which correlated significantly with a tau biomarker (p-tau 181) in blood and changes in cognitive test scores.
“This is the first tau aggregation inhibitor to reach the phase 3 stage of development and to produce results like this,” Claude Wischik, PhD, executive chairman of TauRx Therapeutics, which is developing the drug, noted in an interview.
“NfL is one of the best studied biomarkers in the business because it goes off the rails in a range of neurodegenerative disorders. In AD, it correlates with disease severity, and it tracks ongoing damage to neurons,” Dr. Wischik explained.
Oral HMTM was designed to reduce tau pathology in AD, and the noted changes in NfL concentration by HMTM indicate a “direct impact on disease pathology,” Dr. Wischik said.
The findings, from a prespecified blood biomarker analysis of the LUCIDITY phase 3 trial, were presented at the annual Alzheimer’s Association International Conference.
Support for tau inhibitor
Topline results from the LUCIDITY trial showed improvement in cognition over 18 months in participants with mild cognitive impairment (MCI) caused by AD who were treated with a 16-mg/day dose of HMTM.
However, in an odd twist, participants in the control group who received a low dose of methylthioninium chloride (MTC) also showed cognitive improvement.
As a result, HMTM 16 mg/day failed to reach its two primary endpoints – change from baseline on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL23) – relative to the MTC control group.
That’s likely because treatment with MTC, which is a variant of HMTM, unexpectedly achieved blood levels of active drug above the threshold needed to produce a clinical effect.
For the prespecified biomarker analysis reported at AAIC 2023, baseline and 12-month NfL plasma levels were available in 161 of 185 participants receiving HMTM 16 mg/day, 38 of 48 receiving HMTM 8 mg/day and 136 of 185 receiving MTC 8 mg/week.
Blood concentrations of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day relative to the control group (P = .0278), Dr. Wischik reported.
In addition, the p-tau 181 increase over 12 months “reduced to zero” with HMTM 16 mg/day and there was significant correlation between change in NfL and p-tau 181 concentration, he noted.
NfL reductions were significantly correlated with change in ADAS-Cog11 (P = .0038) and whole brain volume (P = .0359) over 24 months.
‘Exciting’ biomarker data
Commenting on the new data in an interview, Christopher Weber, PhD, director of global science initiatives at the Alzheimer’s Association, said the phase 3 LUCIDITY results “suggest that HMTM could be a potential therapeutic for slowing down neurodegenerative processes in Alzheimer’s disease.”
“Plasma NfL is an interesting biomarker which is used more and more in clinical trials because it’s noninvasive, accessible, and can assist in diagnosing and monitoring the disease in the early stages. Elevated NfL levels suggest that neurons are being affected in the brain, which could indicate the presence or progression of Alzheimer’s disease,” Dr. Weber said in an interview.
He said the biomarker data from the LUCIDITY study are “exciting.”
“However, due to the relatively small sample size, we look forward to seeing additional research on HMTM in larger, and even more diverse cohorts to better understand the performance of this treatment and the role of NfL in Alzheimer’s disease,” Dr. Weber said.
Also providing outside perspective, Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, noted that currently “there is a lot of effort in trying to address the abnormal tau that occurs in Alzheimer’s disease.”
The biomarker data from LUCIDITY show that HMTM “seems to markedly decrease the amount of NfL in plasma and there is some correlation with cognitive scores. The obvious unknown is whether these changes in plasma NfL will predict clinical benefit,” Dr. Fillit said in an interview.
“This is an oral drug that has a good safety profile, and the mechanism of action makes sense, but we need to see the clinical data,” Dr. Fillit said.
Final 2-year data from the LUCIDITY trial are expected to be released later in 2023.
In the United Kingdom, TauRx has entered an accelerated approval process for the drug, and the company said it plans to seek regulatory approval in the United States and Canada in 2023.
The study was funded by TauRx Therapeutics. Dr. Wischik is an employee of the University of Aberdeen (Scotland), and TauRx Therapeutics. Dr. Weber and Dr. Fillit reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AAIC 2023