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Despite risks and warnings, CNS polypharmacy is prevalent among patients with dementia
, new research suggests.
Investigators found that 14% of these individuals were receiving CNS-active polypharmacy, defined as combinations of multiple psychotropic and opioid medications taken for more than 30 days.
“For most patients, the risks of these medications, particularly in combination, are almost certainly greater than the potential benefits,” said Donovan Maust, MD, associate director of the geriatric psychiatry program, University of Michigan, Ann Arbor.
The study was published online March 9 in JAMA.
Serious risks
Memory impairment is the cardinal feature of dementia, but behavioral and psychological symptoms, which can include apathy, delusions, and agitation, are common during all stages of illness and cause significant caregiver distress, the researchers noted.
They noted that there is a dearth of high-quality evidence to support prescribing these medications in this patient population, yet “clinicians regularly prescribe psychotropic medications to community-dwelling persons with dementia in rates that far exceed use in the general older adult population.”
The Beers Criteria, from the American Geriatrics Society, advise against the practice of CNS polypharmacy because of the significant increase in risk for falls as well as impaired cognition, cardiac conduction abnormalities, respiratory suppression, and death when polypharmacy involves opioids.
They note that previous studies from Europe of polypharmacy for patients with dementia have not included antiepileptic medications or opioids, so the true extent of CNS-active polypharmacy may be “significantly” underestimated.
To determine the prevalence of polypharmacy with CNS-active medications among community-dwelling older adults with dementia, the researchers analyzed data on prescription fills for nearly 1.2 million community-dwelling Medicare patients with dementia.
The primary outcome was the prevalence of CNS-active polypharmacy in 2018. They defined CNS-active polypharmacy as exposure to three or more medications for more than 30 consecutive days from the following drug classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, nonbenzodiazepines, benzodiazepine receptor agonist hypnotics, and opioids.
They found that roughly one in seven (13.9%) patients met criteria for CNS-active polypharmacy. Of those receiving a CNS-active polypharmacy regimen, 57.8% had been doing so for longer than 180 days, and 6.8% had been doing so for a year. Nearly 30% of patients were exposed to five or more medications, and 5.2% were exposed to five or more medication classes.
Conservative approach warranted
Nearly all (92%) patients taking three or more CNS-active medications were taking an antidepressant, “consistent with their place as the psychotropic class most commonly prescribed both to older adults overall and those with dementia,” the investigators noted.
There is minimal high-quality evidence to support the efficacy of antidepressants for the treatment of depression for patients with dementia, they pointed out.
Nearly half (47%) of patients who were taking three or more CNS-active medications received at least one antipsychotic, most often quetiapine. Antipsychotics are not approved for people with dementia but are often prescribed off label for agitation, anxiety, and sleep problems, the researchers noted.
Nearly two thirds (62%) of patients with dementia who were taking three or more CNS drugs were taking an antiepileptic (most commonly, gabapentin); 41%, benzodiazepines; 32%, opioids; and 6%, Z-drugs.
The most common polypharmacy class combination included at least one antidepressant, one antiepileptic, and one antipsychotic. These accounted for 12.9% of polypharmacy days.
Despite limited high-quality evidence of efficacy, the prescribing of psychotropic medications and opioids is “pervasive” for adults with dementia in the United States, the investigators noted.
“Especially given that older adults with dementia might not be able to convey side effects they are experiencing, I think clinicians should be more conservative in how they are prescribing these medications and skeptical about the potential for benefit,” said Dr. Maust.
Regarding study limitations, the researchers noted that prescription medication claims may have led to an overestimation of the exposure to polypharmacy, insofar as the prescriptions may have been filled but not taken or were taken only on an as-needed basis.
In addition, the investigators were unable to determine the appropriateness of the particular combinations used or to examine the specific harms associated with CNS-active polypharmacy.
A major clinical challenge
Weighing in on the results, Howard Fillit, MD, founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the study is important because polypharmacy is one of the “geriatric giants, and the question is, what do you do about it?”
Dr. Fillit said it is important to conduct a careful medication review for all older patients, “making sure that the use of each drug is appropriate. The most important thing is to define what is the appropriate utilization of these kinds of drugs. That goes for both overutilization or misuse of these drugs and underutilization, where people are undertreated for symptoms that can’t be managed by behavioral management, for example,” Dr. Fillit said.
Dr. Fillit also said the finding that about 14% of dementia patients were receiving three or more of these drugs “may not be an outrageous number, because these patients, especially as they get into moderate and severe stages of disease, can be incredibly difficult to manage.
“Very often, dementia patients have depression, and up to 90% will have agitation and even psychosis during the course of dementia. And many of these patients need these types of drugs,” said Dr. Fillit.
Echoing the authors, Dr. Fillit said a key limitation of the study is not knowing whether the prescribing was appropriate or not.
The study was supported by a grant from the National Institute on Aging. Dr. Maust and Dr. Fillit have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
Investigators found that 14% of these individuals were receiving CNS-active polypharmacy, defined as combinations of multiple psychotropic and opioid medications taken for more than 30 days.
“For most patients, the risks of these medications, particularly in combination, are almost certainly greater than the potential benefits,” said Donovan Maust, MD, associate director of the geriatric psychiatry program, University of Michigan, Ann Arbor.
The study was published online March 9 in JAMA.
Serious risks
Memory impairment is the cardinal feature of dementia, but behavioral and psychological symptoms, which can include apathy, delusions, and agitation, are common during all stages of illness and cause significant caregiver distress, the researchers noted.
They noted that there is a dearth of high-quality evidence to support prescribing these medications in this patient population, yet “clinicians regularly prescribe psychotropic medications to community-dwelling persons with dementia in rates that far exceed use in the general older adult population.”
The Beers Criteria, from the American Geriatrics Society, advise against the practice of CNS polypharmacy because of the significant increase in risk for falls as well as impaired cognition, cardiac conduction abnormalities, respiratory suppression, and death when polypharmacy involves opioids.
They note that previous studies from Europe of polypharmacy for patients with dementia have not included antiepileptic medications or opioids, so the true extent of CNS-active polypharmacy may be “significantly” underestimated.
To determine the prevalence of polypharmacy with CNS-active medications among community-dwelling older adults with dementia, the researchers analyzed data on prescription fills for nearly 1.2 million community-dwelling Medicare patients with dementia.
The primary outcome was the prevalence of CNS-active polypharmacy in 2018. They defined CNS-active polypharmacy as exposure to three or more medications for more than 30 consecutive days from the following drug classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, nonbenzodiazepines, benzodiazepine receptor agonist hypnotics, and opioids.
They found that roughly one in seven (13.9%) patients met criteria for CNS-active polypharmacy. Of those receiving a CNS-active polypharmacy regimen, 57.8% had been doing so for longer than 180 days, and 6.8% had been doing so for a year. Nearly 30% of patients were exposed to five or more medications, and 5.2% were exposed to five or more medication classes.
Conservative approach warranted
Nearly all (92%) patients taking three or more CNS-active medications were taking an antidepressant, “consistent with their place as the psychotropic class most commonly prescribed both to older adults overall and those with dementia,” the investigators noted.
There is minimal high-quality evidence to support the efficacy of antidepressants for the treatment of depression for patients with dementia, they pointed out.
Nearly half (47%) of patients who were taking three or more CNS-active medications received at least one antipsychotic, most often quetiapine. Antipsychotics are not approved for people with dementia but are often prescribed off label for agitation, anxiety, and sleep problems, the researchers noted.
Nearly two thirds (62%) of patients with dementia who were taking three or more CNS drugs were taking an antiepileptic (most commonly, gabapentin); 41%, benzodiazepines; 32%, opioids; and 6%, Z-drugs.
The most common polypharmacy class combination included at least one antidepressant, one antiepileptic, and one antipsychotic. These accounted for 12.9% of polypharmacy days.
Despite limited high-quality evidence of efficacy, the prescribing of psychotropic medications and opioids is “pervasive” for adults with dementia in the United States, the investigators noted.
“Especially given that older adults with dementia might not be able to convey side effects they are experiencing, I think clinicians should be more conservative in how they are prescribing these medications and skeptical about the potential for benefit,” said Dr. Maust.
Regarding study limitations, the researchers noted that prescription medication claims may have led to an overestimation of the exposure to polypharmacy, insofar as the prescriptions may have been filled but not taken or were taken only on an as-needed basis.
In addition, the investigators were unable to determine the appropriateness of the particular combinations used or to examine the specific harms associated with CNS-active polypharmacy.
A major clinical challenge
Weighing in on the results, Howard Fillit, MD, founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the study is important because polypharmacy is one of the “geriatric giants, and the question is, what do you do about it?”
Dr. Fillit said it is important to conduct a careful medication review for all older patients, “making sure that the use of each drug is appropriate. The most important thing is to define what is the appropriate utilization of these kinds of drugs. That goes for both overutilization or misuse of these drugs and underutilization, where people are undertreated for symptoms that can’t be managed by behavioral management, for example,” Dr. Fillit said.
Dr. Fillit also said the finding that about 14% of dementia patients were receiving three or more of these drugs “may not be an outrageous number, because these patients, especially as they get into moderate and severe stages of disease, can be incredibly difficult to manage.
“Very often, dementia patients have depression, and up to 90% will have agitation and even psychosis during the course of dementia. And many of these patients need these types of drugs,” said Dr. Fillit.
Echoing the authors, Dr. Fillit said a key limitation of the study is not knowing whether the prescribing was appropriate or not.
The study was supported by a grant from the National Institute on Aging. Dr. Maust and Dr. Fillit have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
Investigators found that 14% of these individuals were receiving CNS-active polypharmacy, defined as combinations of multiple psychotropic and opioid medications taken for more than 30 days.
“For most patients, the risks of these medications, particularly in combination, are almost certainly greater than the potential benefits,” said Donovan Maust, MD, associate director of the geriatric psychiatry program, University of Michigan, Ann Arbor.
The study was published online March 9 in JAMA.
Serious risks
Memory impairment is the cardinal feature of dementia, but behavioral and psychological symptoms, which can include apathy, delusions, and agitation, are common during all stages of illness and cause significant caregiver distress, the researchers noted.
They noted that there is a dearth of high-quality evidence to support prescribing these medications in this patient population, yet “clinicians regularly prescribe psychotropic medications to community-dwelling persons with dementia in rates that far exceed use in the general older adult population.”
The Beers Criteria, from the American Geriatrics Society, advise against the practice of CNS polypharmacy because of the significant increase in risk for falls as well as impaired cognition, cardiac conduction abnormalities, respiratory suppression, and death when polypharmacy involves opioids.
They note that previous studies from Europe of polypharmacy for patients with dementia have not included antiepileptic medications or opioids, so the true extent of CNS-active polypharmacy may be “significantly” underestimated.
To determine the prevalence of polypharmacy with CNS-active medications among community-dwelling older adults with dementia, the researchers analyzed data on prescription fills for nearly 1.2 million community-dwelling Medicare patients with dementia.
The primary outcome was the prevalence of CNS-active polypharmacy in 2018. They defined CNS-active polypharmacy as exposure to three or more medications for more than 30 consecutive days from the following drug classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, nonbenzodiazepines, benzodiazepine receptor agonist hypnotics, and opioids.
They found that roughly one in seven (13.9%) patients met criteria for CNS-active polypharmacy. Of those receiving a CNS-active polypharmacy regimen, 57.8% had been doing so for longer than 180 days, and 6.8% had been doing so for a year. Nearly 30% of patients were exposed to five or more medications, and 5.2% were exposed to five or more medication classes.
Conservative approach warranted
Nearly all (92%) patients taking three or more CNS-active medications were taking an antidepressant, “consistent with their place as the psychotropic class most commonly prescribed both to older adults overall and those with dementia,” the investigators noted.
There is minimal high-quality evidence to support the efficacy of antidepressants for the treatment of depression for patients with dementia, they pointed out.
Nearly half (47%) of patients who were taking three or more CNS-active medications received at least one antipsychotic, most often quetiapine. Antipsychotics are not approved for people with dementia but are often prescribed off label for agitation, anxiety, and sleep problems, the researchers noted.
Nearly two thirds (62%) of patients with dementia who were taking three or more CNS drugs were taking an antiepileptic (most commonly, gabapentin); 41%, benzodiazepines; 32%, opioids; and 6%, Z-drugs.
The most common polypharmacy class combination included at least one antidepressant, one antiepileptic, and one antipsychotic. These accounted for 12.9% of polypharmacy days.
Despite limited high-quality evidence of efficacy, the prescribing of psychotropic medications and opioids is “pervasive” for adults with dementia in the United States, the investigators noted.
“Especially given that older adults with dementia might not be able to convey side effects they are experiencing, I think clinicians should be more conservative in how they are prescribing these medications and skeptical about the potential for benefit,” said Dr. Maust.
Regarding study limitations, the researchers noted that prescription medication claims may have led to an overestimation of the exposure to polypharmacy, insofar as the prescriptions may have been filled but not taken or were taken only on an as-needed basis.
In addition, the investigators were unable to determine the appropriateness of the particular combinations used or to examine the specific harms associated with CNS-active polypharmacy.
A major clinical challenge
Weighing in on the results, Howard Fillit, MD, founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the study is important because polypharmacy is one of the “geriatric giants, and the question is, what do you do about it?”
Dr. Fillit said it is important to conduct a careful medication review for all older patients, “making sure that the use of each drug is appropriate. The most important thing is to define what is the appropriate utilization of these kinds of drugs. That goes for both overutilization or misuse of these drugs and underutilization, where people are undertreated for symptoms that can’t be managed by behavioral management, for example,” Dr. Fillit said.
Dr. Fillit also said the finding that about 14% of dementia patients were receiving three or more of these drugs “may not be an outrageous number, because these patients, especially as they get into moderate and severe stages of disease, can be incredibly difficult to manage.
“Very often, dementia patients have depression, and up to 90% will have agitation and even psychosis during the course of dementia. And many of these patients need these types of drugs,” said Dr. Fillit.
Echoing the authors, Dr. Fillit said a key limitation of the study is not knowing whether the prescribing was appropriate or not.
The study was supported by a grant from the National Institute on Aging. Dr. Maust and Dr. Fillit have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA
Telerheumatology will thrive post pandemic
Telemedicine has had a profound effect upon the practice of rheumatology during the COVID-19 pandemic and will continue to do so afterward, speakers predicted at the 2021 Rheumatology Winter Clinical Symposium.
“Telemedicine will change the way we do business. It already has,” observed Eric M. Ruderman, MD, professor of medicine (rheumatology) at Northwestern University in Chicago.
“All of a sudden in March of last year we all turned on a dime and went 100% remote, and we made it work. And it has worked well. It’s not the same as seeing people in person, but I’m pretty sure that going forward probably somewhere in the range of 30% of our visits are going to be telemedicine. It’s an incredible way to deal with people who are stable and are driving in from an hour-and-a-half away to get their prescription refilled,” he said.
Conditions well suited for video patient visits are those where the physical exam isn’t informative or necessary, such as polymyalgia rheumatica, axial spondyloarthritis with axial disease only, childhood periodic fever syndromes, and even many cases of rheumatoid arthritis, in Dr. Ruderman’s view.
“People who are stable – maybe not in remission, but we’ve decided they’re at that their target – a lot of those visits can be done remotely. It’s way more efficient. Everybody loves it: We like it, the patients like it. But we have to get to where we can do it better. The technology is clumsy right now,” he said.
“We do need better and smarter platforms,” agreed Alvin F. Wells, MD, PhD, a telerheumatology pioneer who has been involved in digital/video communication with his patients for nearly 6 years. “But the biggest issue is connectivity. Not all of our patients can get on the Internet.”
The telerheumatology paradigm he has used during the pandemic and will continue to use afterward is to see every new patient in the office, then do the follow-up visits virtually.
“They don’t need to come back into the office in 4 weeks. I’ve done my physical exam, ordered the x-rays and lab work. At the virtual 4-week follow-up we go over everything and I tell them if they need to come in for training in giving their injections,” explained Dr. Wells, a rheumatologist in Franklin, Wisc.
“The telemedicine visit doesn’t take the place of an in-person visit, but it allows you to stratify, to say who needs to be seen sooner rather than later,” he added.
While he anticipates that physician-patient virtual visits will continue to be an important part of clinical practice post pandemic, he predicted the major growth areas for telerheumatology once COVID-19 is squashed will be in clinician-to-clinician interactions and remote patient monitoring using smart devices.
Dr. Wells hasn’t gone into the hospital once since the pandemic began. Initially, that was because he didn’t want to deal with the personal protective equipment shortage or expose himself to the virus. Now, it’s because it’s just a more efficient use of his time to conduct virtual – and billable – 15-minute e-consults with clinicians in the hospital.
“I’ve had a lot of appropriate consults with the hospitalists,” he said. He can walk a hospitalist through a real-time physical exam at a gout patient’s bedside and order the right laboratory tests.
“I don’t need to go into the hospital. The interventional radiologist can tap an ankle or toe as well as I can,” the rheumatologist said.
Dermatologist George Martin, MD, rose from the audience to say that while he recognizes that pandemic telemedicine has been a good fit for rheumatologists, it’s been a very different story in dermatology.
“I realize telemedicine works really well when you don’t have to lay your hands on a patient, or when you’re just doing a stable follow-up and talking about test results. But we in dermatology have found as a group that telemedicine is pretty worthless. When patients are trying to send you a video stream of what their melanoma looks like, or maybe it’s a benign seborrheic keratosis, you’re going to hang their life on that? Dermatology is a very hands-on, visual thing, and unless the camera work becomes better telemedicine is worthless, with the exception of a laboratory follow-up or a stable visit where a physical exam is not required,” declared Dr. Martin, who is in private practice in Maui.
Dr. Wells reported serving as a consultant to MiCare Path, a remote health and monitoring company.
Telemedicine has had a profound effect upon the practice of rheumatology during the COVID-19 pandemic and will continue to do so afterward, speakers predicted at the 2021 Rheumatology Winter Clinical Symposium.
“Telemedicine will change the way we do business. It already has,” observed Eric M. Ruderman, MD, professor of medicine (rheumatology) at Northwestern University in Chicago.
“All of a sudden in March of last year we all turned on a dime and went 100% remote, and we made it work. And it has worked well. It’s not the same as seeing people in person, but I’m pretty sure that going forward probably somewhere in the range of 30% of our visits are going to be telemedicine. It’s an incredible way to deal with people who are stable and are driving in from an hour-and-a-half away to get their prescription refilled,” he said.
Conditions well suited for video patient visits are those where the physical exam isn’t informative or necessary, such as polymyalgia rheumatica, axial spondyloarthritis with axial disease only, childhood periodic fever syndromes, and even many cases of rheumatoid arthritis, in Dr. Ruderman’s view.
“People who are stable – maybe not in remission, but we’ve decided they’re at that their target – a lot of those visits can be done remotely. It’s way more efficient. Everybody loves it: We like it, the patients like it. But we have to get to where we can do it better. The technology is clumsy right now,” he said.
“We do need better and smarter platforms,” agreed Alvin F. Wells, MD, PhD, a telerheumatology pioneer who has been involved in digital/video communication with his patients for nearly 6 years. “But the biggest issue is connectivity. Not all of our patients can get on the Internet.”
The telerheumatology paradigm he has used during the pandemic and will continue to use afterward is to see every new patient in the office, then do the follow-up visits virtually.
“They don’t need to come back into the office in 4 weeks. I’ve done my physical exam, ordered the x-rays and lab work. At the virtual 4-week follow-up we go over everything and I tell them if they need to come in for training in giving their injections,” explained Dr. Wells, a rheumatologist in Franklin, Wisc.
“The telemedicine visit doesn’t take the place of an in-person visit, but it allows you to stratify, to say who needs to be seen sooner rather than later,” he added.
While he anticipates that physician-patient virtual visits will continue to be an important part of clinical practice post pandemic, he predicted the major growth areas for telerheumatology once COVID-19 is squashed will be in clinician-to-clinician interactions and remote patient monitoring using smart devices.
Dr. Wells hasn’t gone into the hospital once since the pandemic began. Initially, that was because he didn’t want to deal with the personal protective equipment shortage or expose himself to the virus. Now, it’s because it’s just a more efficient use of his time to conduct virtual – and billable – 15-minute e-consults with clinicians in the hospital.
“I’ve had a lot of appropriate consults with the hospitalists,” he said. He can walk a hospitalist through a real-time physical exam at a gout patient’s bedside and order the right laboratory tests.
“I don’t need to go into the hospital. The interventional radiologist can tap an ankle or toe as well as I can,” the rheumatologist said.
Dermatologist George Martin, MD, rose from the audience to say that while he recognizes that pandemic telemedicine has been a good fit for rheumatologists, it’s been a very different story in dermatology.
“I realize telemedicine works really well when you don’t have to lay your hands on a patient, or when you’re just doing a stable follow-up and talking about test results. But we in dermatology have found as a group that telemedicine is pretty worthless. When patients are trying to send you a video stream of what their melanoma looks like, or maybe it’s a benign seborrheic keratosis, you’re going to hang their life on that? Dermatology is a very hands-on, visual thing, and unless the camera work becomes better telemedicine is worthless, with the exception of a laboratory follow-up or a stable visit where a physical exam is not required,” declared Dr. Martin, who is in private practice in Maui.
Dr. Wells reported serving as a consultant to MiCare Path, a remote health and monitoring company.
Telemedicine has had a profound effect upon the practice of rheumatology during the COVID-19 pandemic and will continue to do so afterward, speakers predicted at the 2021 Rheumatology Winter Clinical Symposium.
“Telemedicine will change the way we do business. It already has,” observed Eric M. Ruderman, MD, professor of medicine (rheumatology) at Northwestern University in Chicago.
“All of a sudden in March of last year we all turned on a dime and went 100% remote, and we made it work. And it has worked well. It’s not the same as seeing people in person, but I’m pretty sure that going forward probably somewhere in the range of 30% of our visits are going to be telemedicine. It’s an incredible way to deal with people who are stable and are driving in from an hour-and-a-half away to get their prescription refilled,” he said.
Conditions well suited for video patient visits are those where the physical exam isn’t informative or necessary, such as polymyalgia rheumatica, axial spondyloarthritis with axial disease only, childhood periodic fever syndromes, and even many cases of rheumatoid arthritis, in Dr. Ruderman’s view.
“People who are stable – maybe not in remission, but we’ve decided they’re at that their target – a lot of those visits can be done remotely. It’s way more efficient. Everybody loves it: We like it, the patients like it. But we have to get to where we can do it better. The technology is clumsy right now,” he said.
“We do need better and smarter platforms,” agreed Alvin F. Wells, MD, PhD, a telerheumatology pioneer who has been involved in digital/video communication with his patients for nearly 6 years. “But the biggest issue is connectivity. Not all of our patients can get on the Internet.”
The telerheumatology paradigm he has used during the pandemic and will continue to use afterward is to see every new patient in the office, then do the follow-up visits virtually.
“They don’t need to come back into the office in 4 weeks. I’ve done my physical exam, ordered the x-rays and lab work. At the virtual 4-week follow-up we go over everything and I tell them if they need to come in for training in giving their injections,” explained Dr. Wells, a rheumatologist in Franklin, Wisc.
“The telemedicine visit doesn’t take the place of an in-person visit, but it allows you to stratify, to say who needs to be seen sooner rather than later,” he added.
While he anticipates that physician-patient virtual visits will continue to be an important part of clinical practice post pandemic, he predicted the major growth areas for telerheumatology once COVID-19 is squashed will be in clinician-to-clinician interactions and remote patient monitoring using smart devices.
Dr. Wells hasn’t gone into the hospital once since the pandemic began. Initially, that was because he didn’t want to deal with the personal protective equipment shortage or expose himself to the virus. Now, it’s because it’s just a more efficient use of his time to conduct virtual – and billable – 15-minute e-consults with clinicians in the hospital.
“I’ve had a lot of appropriate consults with the hospitalists,” he said. He can walk a hospitalist through a real-time physical exam at a gout patient’s bedside and order the right laboratory tests.
“I don’t need to go into the hospital. The interventional radiologist can tap an ankle or toe as well as I can,” the rheumatologist said.
Dermatologist George Martin, MD, rose from the audience to say that while he recognizes that pandemic telemedicine has been a good fit for rheumatologists, it’s been a very different story in dermatology.
“I realize telemedicine works really well when you don’t have to lay your hands on a patient, or when you’re just doing a stable follow-up and talking about test results. But we in dermatology have found as a group that telemedicine is pretty worthless. When patients are trying to send you a video stream of what their melanoma looks like, or maybe it’s a benign seborrheic keratosis, you’re going to hang their life on that? Dermatology is a very hands-on, visual thing, and unless the camera work becomes better telemedicine is worthless, with the exception of a laboratory follow-up or a stable visit where a physical exam is not required,” declared Dr. Martin, who is in private practice in Maui.
Dr. Wells reported serving as a consultant to MiCare Path, a remote health and monitoring company.
FROM RWCS 2021
The siesta solution
Are you a napper? Unless you’re retired that may sound like a ridiculous question. When could you possibly fit in the time to doze off for even 20 minutes? I suspect there may be one or two of you who, although you are still working, have found a way to schedule a nap into your schedules. The rest of us must wait until we no longer have clinical responsibilities.
In my experience, you regular nappers seem to be the lucky few who have discovered the art of nodding off after lunch and waking up refreshed and ready to take on a full afternoon of patients. We in the unlucky majority may have tried taking a nap but run the risk of its flowing into a deep slumber the length of which we can’t control. Or, more likely, we find that we wake feeling groggy and disoriented and, even worse, the daytime nod off has messed up our nighttime schedule.
Well, it turns out the ability to take daytime naps and reap their cardiometabolic benefits is not just luck but has a significant genetic component. Investigators at Massachusetts General Hospital in Boston have recently published a study in which they report finding more than a score of gene regions that determine a person’s propensity to take daytime naps.. The researchers have also unearthed preliminary evidence supporting a link between daytime napping and cardiometabolic health. My mother began napping when my sister and I were infants and never gave it up. Unfortunately, I seem to have ended up on the wrong side of the genomic shuffle.
Although this new research is interesting, I don’t think the investigators have enough information to answer one of the questions that every pediatrician fields multiple times each week. “When should my toddler grow out of his afternoon nap?” Although it looks like we may be getting closer to a gene-based answer, I have always couched my reply in terms of behavior modification and the fostering of habit-forming associations.
As a child begins to transition from multiple short naps interspersed with feedings to a pattern of two distinct naps, I suggest to parents that they begin to think of the afternoon nap as a siesta. In other words, the nap is something that always comes immediately after lunch with no intervening shenanigans. No playtime, no Teletubbies videos, no quick trips to the grocery store, nothing, nada, zip.
At least for me, lunch has always been soporific. And I suspect we will learn eventually that association cuts across the entire genetic landscape to one degree or another. It makes sense to take advantage of that association and remove all other distractions. For some parents, that means creating the illusion that they too are taking a siesta: No TV, no phone calls. Imagine that the whole household has suddenly moved to Spain for the next hour or two. If you’ve ever been a tourist in rural Spain and tried to do anything, buy anything, or visit a museum between 2 and 4 p.m. you’ve got the idea.
When the child is young he or she will probably fall asleep as long as his parents have been reasonably successful at maintaining sleep hygiene practices. As the child is gaining more stamina and gives up the morning nap, the siesta will remain as a quiet time because that’s the way it’s always been in the household. The child may sleep or play quietly, or be read a sleep-inducing story because no other options will be available until some predetermined time. An hour is usually reasonable. If sleep hasn’t overtaken them, an earlier bedtime will probably be in order. The child will outgrow the napping part of the siesta when his or her sleep need is gone. But, the siesta/quiet time can remain as an option until all-day school intervenes. This scheme works if you can get parents to appropriately prioritize their child’s sleep needs. That’s not always an easy sell.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Are you a napper? Unless you’re retired that may sound like a ridiculous question. When could you possibly fit in the time to doze off for even 20 minutes? I suspect there may be one or two of you who, although you are still working, have found a way to schedule a nap into your schedules. The rest of us must wait until we no longer have clinical responsibilities.
In my experience, you regular nappers seem to be the lucky few who have discovered the art of nodding off after lunch and waking up refreshed and ready to take on a full afternoon of patients. We in the unlucky majority may have tried taking a nap but run the risk of its flowing into a deep slumber the length of which we can’t control. Or, more likely, we find that we wake feeling groggy and disoriented and, even worse, the daytime nod off has messed up our nighttime schedule.
Well, it turns out the ability to take daytime naps and reap their cardiometabolic benefits is not just luck but has a significant genetic component. Investigators at Massachusetts General Hospital in Boston have recently published a study in which they report finding more than a score of gene regions that determine a person’s propensity to take daytime naps.. The researchers have also unearthed preliminary evidence supporting a link between daytime napping and cardiometabolic health. My mother began napping when my sister and I were infants and never gave it up. Unfortunately, I seem to have ended up on the wrong side of the genomic shuffle.
Although this new research is interesting, I don’t think the investigators have enough information to answer one of the questions that every pediatrician fields multiple times each week. “When should my toddler grow out of his afternoon nap?” Although it looks like we may be getting closer to a gene-based answer, I have always couched my reply in terms of behavior modification and the fostering of habit-forming associations.
As a child begins to transition from multiple short naps interspersed with feedings to a pattern of two distinct naps, I suggest to parents that they begin to think of the afternoon nap as a siesta. In other words, the nap is something that always comes immediately after lunch with no intervening shenanigans. No playtime, no Teletubbies videos, no quick trips to the grocery store, nothing, nada, zip.
At least for me, lunch has always been soporific. And I suspect we will learn eventually that association cuts across the entire genetic landscape to one degree or another. It makes sense to take advantage of that association and remove all other distractions. For some parents, that means creating the illusion that they too are taking a siesta: No TV, no phone calls. Imagine that the whole household has suddenly moved to Spain for the next hour or two. If you’ve ever been a tourist in rural Spain and tried to do anything, buy anything, or visit a museum between 2 and 4 p.m. you’ve got the idea.
When the child is young he or she will probably fall asleep as long as his parents have been reasonably successful at maintaining sleep hygiene practices. As the child is gaining more stamina and gives up the morning nap, the siesta will remain as a quiet time because that’s the way it’s always been in the household. The child may sleep or play quietly, or be read a sleep-inducing story because no other options will be available until some predetermined time. An hour is usually reasonable. If sleep hasn’t overtaken them, an earlier bedtime will probably be in order. The child will outgrow the napping part of the siesta when his or her sleep need is gone. But, the siesta/quiet time can remain as an option until all-day school intervenes. This scheme works if you can get parents to appropriately prioritize their child’s sleep needs. That’s not always an easy sell.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Are you a napper? Unless you’re retired that may sound like a ridiculous question. When could you possibly fit in the time to doze off for even 20 minutes? I suspect there may be one or two of you who, although you are still working, have found a way to schedule a nap into your schedules. The rest of us must wait until we no longer have clinical responsibilities.
In my experience, you regular nappers seem to be the lucky few who have discovered the art of nodding off after lunch and waking up refreshed and ready to take on a full afternoon of patients. We in the unlucky majority may have tried taking a nap but run the risk of its flowing into a deep slumber the length of which we can’t control. Or, more likely, we find that we wake feeling groggy and disoriented and, even worse, the daytime nod off has messed up our nighttime schedule.
Well, it turns out the ability to take daytime naps and reap their cardiometabolic benefits is not just luck but has a significant genetic component. Investigators at Massachusetts General Hospital in Boston have recently published a study in which they report finding more than a score of gene regions that determine a person’s propensity to take daytime naps.. The researchers have also unearthed preliminary evidence supporting a link between daytime napping and cardiometabolic health. My mother began napping when my sister and I were infants and never gave it up. Unfortunately, I seem to have ended up on the wrong side of the genomic shuffle.
Although this new research is interesting, I don’t think the investigators have enough information to answer one of the questions that every pediatrician fields multiple times each week. “When should my toddler grow out of his afternoon nap?” Although it looks like we may be getting closer to a gene-based answer, I have always couched my reply in terms of behavior modification and the fostering of habit-forming associations.
As a child begins to transition from multiple short naps interspersed with feedings to a pattern of two distinct naps, I suggest to parents that they begin to think of the afternoon nap as a siesta. In other words, the nap is something that always comes immediately after lunch with no intervening shenanigans. No playtime, no Teletubbies videos, no quick trips to the grocery store, nothing, nada, zip.
At least for me, lunch has always been soporific. And I suspect we will learn eventually that association cuts across the entire genetic landscape to one degree or another. It makes sense to take advantage of that association and remove all other distractions. For some parents, that means creating the illusion that they too are taking a siesta: No TV, no phone calls. Imagine that the whole household has suddenly moved to Spain for the next hour or two. If you’ve ever been a tourist in rural Spain and tried to do anything, buy anything, or visit a museum between 2 and 4 p.m. you’ve got the idea.
When the child is young he or she will probably fall asleep as long as his parents have been reasonably successful at maintaining sleep hygiene practices. As the child is gaining more stamina and gives up the morning nap, the siesta will remain as a quiet time because that’s the way it’s always been in the household. The child may sleep or play quietly, or be read a sleep-inducing story because no other options will be available until some predetermined time. An hour is usually reasonable. If sleep hasn’t overtaken them, an earlier bedtime will probably be in order. The child will outgrow the napping part of the siesta when his or her sleep need is gone. But, the siesta/quiet time can remain as an option until all-day school intervenes. This scheme works if you can get parents to appropriately prioritize their child’s sleep needs. That’s not always an easy sell.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Decline in child COVID-19 cases picks up after 2-week slowdown
, according to data gathered by the American Academy of Pediatrics and the Children’s Hospital Association.
From Feb. 19 to March 4, the drop in new cases averaged just 5% each week, compared with 13.3% per week over the 5-week period from Jan. 15 to Feb. 18. For the week of March 5-11, a total of 52,695 COVID-19 cases were reported in children, down from 63,562 the previous week and the lowest number since late October, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
In those jurisdictions, 3.28 million children have been infected with SARS-CoV-2, representing 13.2% of all cases since the beginning of the pandemic. The cumulative rate of COVID-19 has now risen to 4,364 cases per 100,000 children nationally, with state rates ranging from 1,062 per 100,000 in Hawaii to 8,692 per 100,000 in North Dakota, the AAP and CHA said in their weekly COVID-19 report.
Hospitalization data are more limited – 24 states and New York City – but continue to show that serious illness is much less common in younger individuals: Children represent just 1.9% of all hospitalizations, and only 0.8% of the children who have been infected were hospitalized. Neither rate has changed since early February, the AAP and CHA said.
The number of deaths in children, however, rose from 253 to 266, the largest 1-week increase since early February in the 43 states (along with New York City, Puerto Rico, and Guam) that are tracking mortality data by age, the AAP and CHA reported.
Among those 46 jurisdictions, there are 10 (9 states and the District of Columbia) that have not yet reported a COVID-19–related child death, while Texas has almost twice as many deaths, 47, as the next state, Arizona, which has 24. Meanwhile, California’s total of 452,000 cases is almost 2½ times higher than the 183,000 recorded by Illinois, according to the report.
, according to data gathered by the American Academy of Pediatrics and the Children’s Hospital Association.
From Feb. 19 to March 4, the drop in new cases averaged just 5% each week, compared with 13.3% per week over the 5-week period from Jan. 15 to Feb. 18. For the week of March 5-11, a total of 52,695 COVID-19 cases were reported in children, down from 63,562 the previous week and the lowest number since late October, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
In those jurisdictions, 3.28 million children have been infected with SARS-CoV-2, representing 13.2% of all cases since the beginning of the pandemic. The cumulative rate of COVID-19 has now risen to 4,364 cases per 100,000 children nationally, with state rates ranging from 1,062 per 100,000 in Hawaii to 8,692 per 100,000 in North Dakota, the AAP and CHA said in their weekly COVID-19 report.
Hospitalization data are more limited – 24 states and New York City – but continue to show that serious illness is much less common in younger individuals: Children represent just 1.9% of all hospitalizations, and only 0.8% of the children who have been infected were hospitalized. Neither rate has changed since early February, the AAP and CHA said.
The number of deaths in children, however, rose from 253 to 266, the largest 1-week increase since early February in the 43 states (along with New York City, Puerto Rico, and Guam) that are tracking mortality data by age, the AAP and CHA reported.
Among those 46 jurisdictions, there are 10 (9 states and the District of Columbia) that have not yet reported a COVID-19–related child death, while Texas has almost twice as many deaths, 47, as the next state, Arizona, which has 24. Meanwhile, California’s total of 452,000 cases is almost 2½ times higher than the 183,000 recorded by Illinois, according to the report.
, according to data gathered by the American Academy of Pediatrics and the Children’s Hospital Association.
From Feb. 19 to March 4, the drop in new cases averaged just 5% each week, compared with 13.3% per week over the 5-week period from Jan. 15 to Feb. 18. For the week of March 5-11, a total of 52,695 COVID-19 cases were reported in children, down from 63,562 the previous week and the lowest number since late October, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
In those jurisdictions, 3.28 million children have been infected with SARS-CoV-2, representing 13.2% of all cases since the beginning of the pandemic. The cumulative rate of COVID-19 has now risen to 4,364 cases per 100,000 children nationally, with state rates ranging from 1,062 per 100,000 in Hawaii to 8,692 per 100,000 in North Dakota, the AAP and CHA said in their weekly COVID-19 report.
Hospitalization data are more limited – 24 states and New York City – but continue to show that serious illness is much less common in younger individuals: Children represent just 1.9% of all hospitalizations, and only 0.8% of the children who have been infected were hospitalized. Neither rate has changed since early February, the AAP and CHA said.
The number of deaths in children, however, rose from 253 to 266, the largest 1-week increase since early February in the 43 states (along with New York City, Puerto Rico, and Guam) that are tracking mortality data by age, the AAP and CHA reported.
Among those 46 jurisdictions, there are 10 (9 states and the District of Columbia) that have not yet reported a COVID-19–related child death, while Texas has almost twice as many deaths, 47, as the next state, Arizona, which has 24. Meanwhile, California’s total of 452,000 cases is almost 2½ times higher than the 183,000 recorded by Illinois, according to the report.
The Zoom effect on cosmetic procedures
As clinics were allowed to reopen under local government guidelines several months into the COVID-19 pandemic, many cosmetic dermatologists and aesthetic surgeons had no idea what our schedules would be like. .
While scheduled appointments, no shows, cancellations, and rebookings seem to wax and wane with surges in COVID-19 cases locally and with associated media coverage, there appear to be several reasons why demand has increased. Because people are wearing masks, they can easily hide signs of recovery or “something new” in their appearance. Patients aren’t typically around as many people and have more time to recover in private. There is also the positive effect a procedure can have on mood and self-esteem during what has been a difficult year. And people have had more time to read beauty and self-care articles, as well as advertisements for skin and hair care on social media.
The Zoom effect
One reason I did not anticipate is the Zoom effect. I don’t intend to single out Zoom – as there are other videoconferencing options available – but it seems to be the one patients bring up the most. Virtual meetings, conferences, and social events, and video calls with loved ones have become a part of daily routines for many, who are now seeing themselves on camera during these interactions as they never did before. It has created a strange new phenomenon.
Patients have literally said to me “I don’t like the way I look on Zoom” and ask about options to improve what they are seeing. They are often surprised to see that their appearance on virtual meetings, for example, does not reflect the way they feel inside, or how they think they should look. Even medical dermatology patients who have had no interest in cosmetic procedures previously have been coming in for this specific reason – both female and male patients.
Since photography is a hobby, I counsel patients that lighting and shadows play a huge role in how they appear on screen. Depending on the lighting, camera angle, and camera quality, suboptimal lighting can highlight shadows and wrinkles not normally seen in natural or optimal light. In a recent interview on KCRW, the Los Angeles NPR affiliate station, the founding director of the Virtual Human Interaction Lab (VHIL) at Stanford University highlighted work on the effect that Zoom and virtual interactions have had on people during the COVID-19 pandemic. He notes that during a normal in-person meeting or conference, attention is usually on the person speaking, but now with everyone on camera at once, people have the pressure and subsequent feelings of exhaustion (a different type of exhaustion than being there in person) of being seen at all times. To address “Zoom Fatigue,” the VHIL’s recommendations include turning off the camera periodically, or changing the settings so your image is not seen. Another option is to use background filters, including some face filters (a cat for example), which Zoom has created to ease some of the stress of these meetings.
Back to the actual in-person office visits: In my experience, all cosmetic procedures across the board, including injectables, skin resurfacing, and lasers have increased. In Dr. Talakoub’s practice, she has noted a tenfold increase in the use of deoxycholic acid (Kybella) and neck procedures attributed to the unflattering angle of the neck as people look down on their computer screens.There has also been an increase in the use of other injectables, such as Botox of the glabella to address scowling at the screen, facial fillers to address the dark shadows cast on the tear troughs, and lip fillers (noted to be 10-20 times higher) because of masks that can hide healing downtime. Similarly, increased use of Coolsculpting has been noted, as some patients have the flexibility of being able to take their Zoom meetings during the procedure, when they otherwise may not have had the time. Some patients have told me that the appointment with me is the only visit they’ve made outside of their home during the pandemic. Once the consultations or procedures are completed, patients often show gratitude and their self-esteem is increased. Some patients have said they even feel better and more productive at work, or note more positive interactions with their loved ones after the work has been done, likely because they feel better about themselves.There have been discussions about the benefits people have in being able to use Zoom and other videoconferencing platforms to gather and create, as well as see people and communicate in a way that can sometimes be more effective than a phone call. As physicians, these virtual tools have also allowed us to provide telehealth visits, a flexible, safe, and comfortable option for both the patient and practitioner. If done in a safe place, the ability to see each other without wearing a mask is also a nice treat.
The gratification and improvement in psyche that patients experience after our visits during this unprecedented, challenging time has been evident. Perhaps it’s the social interaction with their trusted physician, the outcome of the procedure itself, or a combination of both, which has a net positive effect on the physician-patient relationship.
While cosmetic procedures are appropriately deemed elective by hospital facilities and practitioners and should be of lower importance with regard to use of available facilities and PPE than those related to COVID-19 and other life-threatening scenarios, the longevity of this pandemic has surprisingly highlighted the numerous ways in which cosmetic visits can help patients, and the importance of being able to be there for patients – in a safe manner for all involved.
Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.
As clinics were allowed to reopen under local government guidelines several months into the COVID-19 pandemic, many cosmetic dermatologists and aesthetic surgeons had no idea what our schedules would be like. .
While scheduled appointments, no shows, cancellations, and rebookings seem to wax and wane with surges in COVID-19 cases locally and with associated media coverage, there appear to be several reasons why demand has increased. Because people are wearing masks, they can easily hide signs of recovery or “something new” in their appearance. Patients aren’t typically around as many people and have more time to recover in private. There is also the positive effect a procedure can have on mood and self-esteem during what has been a difficult year. And people have had more time to read beauty and self-care articles, as well as advertisements for skin and hair care on social media.
The Zoom effect
One reason I did not anticipate is the Zoom effect. I don’t intend to single out Zoom – as there are other videoconferencing options available – but it seems to be the one patients bring up the most. Virtual meetings, conferences, and social events, and video calls with loved ones have become a part of daily routines for many, who are now seeing themselves on camera during these interactions as they never did before. It has created a strange new phenomenon.
Patients have literally said to me “I don’t like the way I look on Zoom” and ask about options to improve what they are seeing. They are often surprised to see that their appearance on virtual meetings, for example, does not reflect the way they feel inside, or how they think they should look. Even medical dermatology patients who have had no interest in cosmetic procedures previously have been coming in for this specific reason – both female and male patients.
Since photography is a hobby, I counsel patients that lighting and shadows play a huge role in how they appear on screen. Depending on the lighting, camera angle, and camera quality, suboptimal lighting can highlight shadows and wrinkles not normally seen in natural or optimal light. In a recent interview on KCRW, the Los Angeles NPR affiliate station, the founding director of the Virtual Human Interaction Lab (VHIL) at Stanford University highlighted work on the effect that Zoom and virtual interactions have had on people during the COVID-19 pandemic. He notes that during a normal in-person meeting or conference, attention is usually on the person speaking, but now with everyone on camera at once, people have the pressure and subsequent feelings of exhaustion (a different type of exhaustion than being there in person) of being seen at all times. To address “Zoom Fatigue,” the VHIL’s recommendations include turning off the camera periodically, or changing the settings so your image is not seen. Another option is to use background filters, including some face filters (a cat for example), which Zoom has created to ease some of the stress of these meetings.
Back to the actual in-person office visits: In my experience, all cosmetic procedures across the board, including injectables, skin resurfacing, and lasers have increased. In Dr. Talakoub’s practice, she has noted a tenfold increase in the use of deoxycholic acid (Kybella) and neck procedures attributed to the unflattering angle of the neck as people look down on their computer screens.There has also been an increase in the use of other injectables, such as Botox of the glabella to address scowling at the screen, facial fillers to address the dark shadows cast on the tear troughs, and lip fillers (noted to be 10-20 times higher) because of masks that can hide healing downtime. Similarly, increased use of Coolsculpting has been noted, as some patients have the flexibility of being able to take their Zoom meetings during the procedure, when they otherwise may not have had the time. Some patients have told me that the appointment with me is the only visit they’ve made outside of their home during the pandemic. Once the consultations or procedures are completed, patients often show gratitude and their self-esteem is increased. Some patients have said they even feel better and more productive at work, or note more positive interactions with their loved ones after the work has been done, likely because they feel better about themselves.There have been discussions about the benefits people have in being able to use Zoom and other videoconferencing platforms to gather and create, as well as see people and communicate in a way that can sometimes be more effective than a phone call. As physicians, these virtual tools have also allowed us to provide telehealth visits, a flexible, safe, and comfortable option for both the patient and practitioner. If done in a safe place, the ability to see each other without wearing a mask is also a nice treat.
The gratification and improvement in psyche that patients experience after our visits during this unprecedented, challenging time has been evident. Perhaps it’s the social interaction with their trusted physician, the outcome of the procedure itself, or a combination of both, which has a net positive effect on the physician-patient relationship.
While cosmetic procedures are appropriately deemed elective by hospital facilities and practitioners and should be of lower importance with regard to use of available facilities and PPE than those related to COVID-19 and other life-threatening scenarios, the longevity of this pandemic has surprisingly highlighted the numerous ways in which cosmetic visits can help patients, and the importance of being able to be there for patients – in a safe manner for all involved.
Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.
As clinics were allowed to reopen under local government guidelines several months into the COVID-19 pandemic, many cosmetic dermatologists and aesthetic surgeons had no idea what our schedules would be like. .
While scheduled appointments, no shows, cancellations, and rebookings seem to wax and wane with surges in COVID-19 cases locally and with associated media coverage, there appear to be several reasons why demand has increased. Because people are wearing masks, they can easily hide signs of recovery or “something new” in their appearance. Patients aren’t typically around as many people and have more time to recover in private. There is also the positive effect a procedure can have on mood and self-esteem during what has been a difficult year. And people have had more time to read beauty and self-care articles, as well as advertisements for skin and hair care on social media.
The Zoom effect
One reason I did not anticipate is the Zoom effect. I don’t intend to single out Zoom – as there are other videoconferencing options available – but it seems to be the one patients bring up the most. Virtual meetings, conferences, and social events, and video calls with loved ones have become a part of daily routines for many, who are now seeing themselves on camera during these interactions as they never did before. It has created a strange new phenomenon.
Patients have literally said to me “I don’t like the way I look on Zoom” and ask about options to improve what they are seeing. They are often surprised to see that their appearance on virtual meetings, for example, does not reflect the way they feel inside, or how they think they should look. Even medical dermatology patients who have had no interest in cosmetic procedures previously have been coming in for this specific reason – both female and male patients.
Since photography is a hobby, I counsel patients that lighting and shadows play a huge role in how they appear on screen. Depending on the lighting, camera angle, and camera quality, suboptimal lighting can highlight shadows and wrinkles not normally seen in natural or optimal light. In a recent interview on KCRW, the Los Angeles NPR affiliate station, the founding director of the Virtual Human Interaction Lab (VHIL) at Stanford University highlighted work on the effect that Zoom and virtual interactions have had on people during the COVID-19 pandemic. He notes that during a normal in-person meeting or conference, attention is usually on the person speaking, but now with everyone on camera at once, people have the pressure and subsequent feelings of exhaustion (a different type of exhaustion than being there in person) of being seen at all times. To address “Zoom Fatigue,” the VHIL’s recommendations include turning off the camera periodically, or changing the settings so your image is not seen. Another option is to use background filters, including some face filters (a cat for example), which Zoom has created to ease some of the stress of these meetings.
Back to the actual in-person office visits: In my experience, all cosmetic procedures across the board, including injectables, skin resurfacing, and lasers have increased. In Dr. Talakoub’s practice, she has noted a tenfold increase in the use of deoxycholic acid (Kybella) and neck procedures attributed to the unflattering angle of the neck as people look down on their computer screens.There has also been an increase in the use of other injectables, such as Botox of the glabella to address scowling at the screen, facial fillers to address the dark shadows cast on the tear troughs, and lip fillers (noted to be 10-20 times higher) because of masks that can hide healing downtime. Similarly, increased use of Coolsculpting has been noted, as some patients have the flexibility of being able to take their Zoom meetings during the procedure, when they otherwise may not have had the time. Some patients have told me that the appointment with me is the only visit they’ve made outside of their home during the pandemic. Once the consultations or procedures are completed, patients often show gratitude and their self-esteem is increased. Some patients have said they even feel better and more productive at work, or note more positive interactions with their loved ones after the work has been done, likely because they feel better about themselves.There have been discussions about the benefits people have in being able to use Zoom and other videoconferencing platforms to gather and create, as well as see people and communicate in a way that can sometimes be more effective than a phone call. As physicians, these virtual tools have also allowed us to provide telehealth visits, a flexible, safe, and comfortable option for both the patient and practitioner. If done in a safe place, the ability to see each other without wearing a mask is also a nice treat.
The gratification and improvement in psyche that patients experience after our visits during this unprecedented, challenging time has been evident. Perhaps it’s the social interaction with their trusted physician, the outcome of the procedure itself, or a combination of both, which has a net positive effect on the physician-patient relationship.
While cosmetic procedures are appropriately deemed elective by hospital facilities and practitioners and should be of lower importance with regard to use of available facilities and PPE than those related to COVID-19 and other life-threatening scenarios, the longevity of this pandemic has surprisingly highlighted the numerous ways in which cosmetic visits can help patients, and the importance of being able to be there for patients – in a safe manner for all involved.
Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.
Nota bene: Don’t change a note
A man I saw earlier this year called my office recently. He’d read my note, and after discussing it with his attorney, wanted me to make changes. He said that the way I’d described his symptoms would be damaging to a legal action he was involved in, and so he wanted it reworded.
Obviously, I said “no.” I’m not a fiction writer. My notes are what people tell me happened. I don’t make them up.
He wasn’t happy about this, and a few days later I got a request to send his records to another neurologist, which I gladly did.
In this business a large measure of what we do is based on the patient’s symptoms. what they report to us, and how they describe it. When I put their story into a written note, my goal is to be as accurate to what they told me as possible. I’m not here to embellish, disparage, or minimize their history.
To do so is to look bad at the very least and open yourself up to malpractice and legal charges at worst.
This isn’t to say errors can’t be modified. I’m far from perfect. Sometimes I might misunderstand something a patient tells me, or get information crossed up. When that happens there’s nothing wrong with writing an addendum, clarifying or correcting what my earlier note said – but not changing the original note.
I asked the unhappy patient to write down what he thought was incorrect, and I’d be willing to include that in his chart. He wasn’t willing to do that, and there was no way I would ever change a note. I tried to politely explain the reasons why, but he wasn’t listening.
So I lost him as a patient. After 23 years of practice, that doesn’t bother me. I learned a long time ago that I can’t please everyone, nor can I be everyone’s doctor. Saying “no” is just as important as saying “yes,” though at times more difficult.
This time, though, the answer was pretty obvious, and will be the same next time I get the same request from a patient.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
A man I saw earlier this year called my office recently. He’d read my note, and after discussing it with his attorney, wanted me to make changes. He said that the way I’d described his symptoms would be damaging to a legal action he was involved in, and so he wanted it reworded.
Obviously, I said “no.” I’m not a fiction writer. My notes are what people tell me happened. I don’t make them up.
He wasn’t happy about this, and a few days later I got a request to send his records to another neurologist, which I gladly did.
In this business a large measure of what we do is based on the patient’s symptoms. what they report to us, and how they describe it. When I put their story into a written note, my goal is to be as accurate to what they told me as possible. I’m not here to embellish, disparage, or minimize their history.
To do so is to look bad at the very least and open yourself up to malpractice and legal charges at worst.
This isn’t to say errors can’t be modified. I’m far from perfect. Sometimes I might misunderstand something a patient tells me, or get information crossed up. When that happens there’s nothing wrong with writing an addendum, clarifying or correcting what my earlier note said – but not changing the original note.
I asked the unhappy patient to write down what he thought was incorrect, and I’d be willing to include that in his chart. He wasn’t willing to do that, and there was no way I would ever change a note. I tried to politely explain the reasons why, but he wasn’t listening.
So I lost him as a patient. After 23 years of practice, that doesn’t bother me. I learned a long time ago that I can’t please everyone, nor can I be everyone’s doctor. Saying “no” is just as important as saying “yes,” though at times more difficult.
This time, though, the answer was pretty obvious, and will be the same next time I get the same request from a patient.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
A man I saw earlier this year called my office recently. He’d read my note, and after discussing it with his attorney, wanted me to make changes. He said that the way I’d described his symptoms would be damaging to a legal action he was involved in, and so he wanted it reworded.
Obviously, I said “no.” I’m not a fiction writer. My notes are what people tell me happened. I don’t make them up.
He wasn’t happy about this, and a few days later I got a request to send his records to another neurologist, which I gladly did.
In this business a large measure of what we do is based on the patient’s symptoms. what they report to us, and how they describe it. When I put their story into a written note, my goal is to be as accurate to what they told me as possible. I’m not here to embellish, disparage, or minimize their history.
To do so is to look bad at the very least and open yourself up to malpractice and legal charges at worst.
This isn’t to say errors can’t be modified. I’m far from perfect. Sometimes I might misunderstand something a patient tells me, or get information crossed up. When that happens there’s nothing wrong with writing an addendum, clarifying or correcting what my earlier note said – but not changing the original note.
I asked the unhappy patient to write down what he thought was incorrect, and I’d be willing to include that in his chart. He wasn’t willing to do that, and there was no way I would ever change a note. I tried to politely explain the reasons why, but he wasn’t listening.
So I lost him as a patient. After 23 years of practice, that doesn’t bother me. I learned a long time ago that I can’t please everyone, nor can I be everyone’s doctor. Saying “no” is just as important as saying “yes,” though at times more difficult.
This time, though, the answer was pretty obvious, and will be the same next time I get the same request from a patient.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Blood cancer patients, survivors hesitate over COVID-19 vaccine
Nearly one in three patients with blood cancer, and survivors, say they are unlikely to get a COVID-19 vaccine or unsure about getting it if one were available. The findings come from a nationwide survey by The Leukemia & Lymphoma Society, which collected 6,517 responses.
“These findings are worrisome, to say the least,” Gwen Nichols, MD, chief medical officer of the society, said in a statement.
“We know cancer patients – and blood cancer patients in particular – are susceptible to the worst effects of the virus [and] all of us in the medical community need to help cancer patients understand the importance of getting vaccinated,” she added.
The survey – the largest ever done in which cancer patients and survivors were asked about their attitudes toward COVID-19 vaccines – was published online March 8 by The Leukemia & Lymphoma Society.
Survey sample
The survey asked patients with blood cancer, and survivors, about their attitudes regarding COVID-19 and COVID-19 vaccines.
“The main outcome [was] vaccine attitudes,” noted the authors, headed by Rena Conti, PhD, dean’s research scholar, Boston University.
Respondents were asked: “How likely are you to choose to get the vaccine?” Participants could indicate they were very unlikely, unlikely, neither likely nor unlikely, likely, or very likely to get vaccinated.
“We found that 17% of respondents indicate[d] that they [were] unlikely or very unlikely to take a vaccine,” Dr. Conti and colleagues observed.
Among the 17% – deemed to be “vaccine hesitant” – slightly over half (54%) stated they had concerns about the side effects associated with COVID-19 vaccination and believed neither of the two newly approved vaccines had been or would ever be tested properly.
The survey authors noted that there is no reason to believe COVID-19 vaccines are any less safe in patients with blood cancers, but concerns have been expressed that patients with some forms of blood cancer or those undergoing certain treatments may not achieve the same immune response to the vaccine as would noncancer controls.
Importantly, the survey was conducted Dec. 1-21, 2020, and responses differed depending on whether respondents answered the survey before or after the Pfizer-BioNTech and Moderna vaccines had been given emergency use authorization by the Food and Drug Administration starting Dec. 10, 2020.
There was a slight increase in positive responses after the vaccines were granted regulatory approval. (One-third of those who responded to the survey after the approval were 3.7% more likely to indicate they would get vaccinated). “This suggests that hesitancy may be influenced by emerging information dissemination, government action, and vaccine availability, transforming the hypothetical opportunity of vaccination to a real one,” the survey authors speculated.
Survey respondents who were vaccine hesitant were also over 14% more likely to indicate that they didn’t think they would require hospitalization should they contract COVID-19. But clinical data have suggested that approximately half of patients with a hematological malignancy who required hospitalization for COVID-19 die from the infection, the authors noted.
“Vaccine hesitant respondents [were] also significantly less likely to engage in protective health behaviors,” the survey authors pointed out. For example, they were almost 4% less likely to have worn a face mask and 1.6% less likely to have taken other protective measures to guard against COVID-19 infection.
Need for clear messaging
To counter vaccine hesitancy, the authors suggest there is a need for clear, consistent messaging targeting patients with cancer that emphasize the risks of COVID-19 and underscore vaccine benefits.
Dr. Conti pointed out that patients with blood cancer are, in fact, being given preferential access to vaccines in many communities, although this clearly doesn’t mean patients are willing to get vaccinated, as she also noted.
“We need both adequate supply and strong demand to keep this vulnerable population safe,” Dr. Conti emphasized.
The Leukemia & Lymphoma Society plans to repeat the survey in the near future to assess patients’ and survivors’ access to vaccines as well as their willingness to get vaccinated.
The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nearly one in three patients with blood cancer, and survivors, say they are unlikely to get a COVID-19 vaccine or unsure about getting it if one were available. The findings come from a nationwide survey by The Leukemia & Lymphoma Society, which collected 6,517 responses.
“These findings are worrisome, to say the least,” Gwen Nichols, MD, chief medical officer of the society, said in a statement.
“We know cancer patients – and blood cancer patients in particular – are susceptible to the worst effects of the virus [and] all of us in the medical community need to help cancer patients understand the importance of getting vaccinated,” she added.
The survey – the largest ever done in which cancer patients and survivors were asked about their attitudes toward COVID-19 vaccines – was published online March 8 by The Leukemia & Lymphoma Society.
Survey sample
The survey asked patients with blood cancer, and survivors, about their attitudes regarding COVID-19 and COVID-19 vaccines.
“The main outcome [was] vaccine attitudes,” noted the authors, headed by Rena Conti, PhD, dean’s research scholar, Boston University.
Respondents were asked: “How likely are you to choose to get the vaccine?” Participants could indicate they were very unlikely, unlikely, neither likely nor unlikely, likely, or very likely to get vaccinated.
“We found that 17% of respondents indicate[d] that they [were] unlikely or very unlikely to take a vaccine,” Dr. Conti and colleagues observed.
Among the 17% – deemed to be “vaccine hesitant” – slightly over half (54%) stated they had concerns about the side effects associated with COVID-19 vaccination and believed neither of the two newly approved vaccines had been or would ever be tested properly.
The survey authors noted that there is no reason to believe COVID-19 vaccines are any less safe in patients with blood cancers, but concerns have been expressed that patients with some forms of blood cancer or those undergoing certain treatments may not achieve the same immune response to the vaccine as would noncancer controls.
Importantly, the survey was conducted Dec. 1-21, 2020, and responses differed depending on whether respondents answered the survey before or after the Pfizer-BioNTech and Moderna vaccines had been given emergency use authorization by the Food and Drug Administration starting Dec. 10, 2020.
There was a slight increase in positive responses after the vaccines were granted regulatory approval. (One-third of those who responded to the survey after the approval were 3.7% more likely to indicate they would get vaccinated). “This suggests that hesitancy may be influenced by emerging information dissemination, government action, and vaccine availability, transforming the hypothetical opportunity of vaccination to a real one,” the survey authors speculated.
Survey respondents who were vaccine hesitant were also over 14% more likely to indicate that they didn’t think they would require hospitalization should they contract COVID-19. But clinical data have suggested that approximately half of patients with a hematological malignancy who required hospitalization for COVID-19 die from the infection, the authors noted.
“Vaccine hesitant respondents [were] also significantly less likely to engage in protective health behaviors,” the survey authors pointed out. For example, they were almost 4% less likely to have worn a face mask and 1.6% less likely to have taken other protective measures to guard against COVID-19 infection.
Need for clear messaging
To counter vaccine hesitancy, the authors suggest there is a need for clear, consistent messaging targeting patients with cancer that emphasize the risks of COVID-19 and underscore vaccine benefits.
Dr. Conti pointed out that patients with blood cancer are, in fact, being given preferential access to vaccines in many communities, although this clearly doesn’t mean patients are willing to get vaccinated, as she also noted.
“We need both adequate supply and strong demand to keep this vulnerable population safe,” Dr. Conti emphasized.
The Leukemia & Lymphoma Society plans to repeat the survey in the near future to assess patients’ and survivors’ access to vaccines as well as their willingness to get vaccinated.
The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nearly one in three patients with blood cancer, and survivors, say they are unlikely to get a COVID-19 vaccine or unsure about getting it if one were available. The findings come from a nationwide survey by The Leukemia & Lymphoma Society, which collected 6,517 responses.
“These findings are worrisome, to say the least,” Gwen Nichols, MD, chief medical officer of the society, said in a statement.
“We know cancer patients – and blood cancer patients in particular – are susceptible to the worst effects of the virus [and] all of us in the medical community need to help cancer patients understand the importance of getting vaccinated,” she added.
The survey – the largest ever done in which cancer patients and survivors were asked about their attitudes toward COVID-19 vaccines – was published online March 8 by The Leukemia & Lymphoma Society.
Survey sample
The survey asked patients with blood cancer, and survivors, about their attitudes regarding COVID-19 and COVID-19 vaccines.
“The main outcome [was] vaccine attitudes,” noted the authors, headed by Rena Conti, PhD, dean’s research scholar, Boston University.
Respondents were asked: “How likely are you to choose to get the vaccine?” Participants could indicate they were very unlikely, unlikely, neither likely nor unlikely, likely, or very likely to get vaccinated.
“We found that 17% of respondents indicate[d] that they [were] unlikely or very unlikely to take a vaccine,” Dr. Conti and colleagues observed.
Among the 17% – deemed to be “vaccine hesitant” – slightly over half (54%) stated they had concerns about the side effects associated with COVID-19 vaccination and believed neither of the two newly approved vaccines had been or would ever be tested properly.
The survey authors noted that there is no reason to believe COVID-19 vaccines are any less safe in patients with blood cancers, but concerns have been expressed that patients with some forms of blood cancer or those undergoing certain treatments may not achieve the same immune response to the vaccine as would noncancer controls.
Importantly, the survey was conducted Dec. 1-21, 2020, and responses differed depending on whether respondents answered the survey before or after the Pfizer-BioNTech and Moderna vaccines had been given emergency use authorization by the Food and Drug Administration starting Dec. 10, 2020.
There was a slight increase in positive responses after the vaccines were granted regulatory approval. (One-third of those who responded to the survey after the approval were 3.7% more likely to indicate they would get vaccinated). “This suggests that hesitancy may be influenced by emerging information dissemination, government action, and vaccine availability, transforming the hypothetical opportunity of vaccination to a real one,” the survey authors speculated.
Survey respondents who were vaccine hesitant were also over 14% more likely to indicate that they didn’t think they would require hospitalization should they contract COVID-19. But clinical data have suggested that approximately half of patients with a hematological malignancy who required hospitalization for COVID-19 die from the infection, the authors noted.
“Vaccine hesitant respondents [were] also significantly less likely to engage in protective health behaviors,” the survey authors pointed out. For example, they were almost 4% less likely to have worn a face mask and 1.6% less likely to have taken other protective measures to guard against COVID-19 infection.
Need for clear messaging
To counter vaccine hesitancy, the authors suggest there is a need for clear, consistent messaging targeting patients with cancer that emphasize the risks of COVID-19 and underscore vaccine benefits.
Dr. Conti pointed out that patients with blood cancer are, in fact, being given preferential access to vaccines in many communities, although this clearly doesn’t mean patients are willing to get vaccinated, as she also noted.
“We need both adequate supply and strong demand to keep this vulnerable population safe,” Dr. Conti emphasized.
The Leukemia & Lymphoma Society plans to repeat the survey in the near future to assess patients’ and survivors’ access to vaccines as well as their willingness to get vaccinated.
The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Novel Alzheimer’s drug slows cognitive decline in phase 2 trial
Results from the TRAILBLAZER-ALZ trial were presented at the 2021 International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) and were simultaneously published online March 13 in the New England Journal of Medicine.
As previously reported by Medscape Medical News, topline results showed that donanemab slowed cognitive decline by 32% on the Integrated AD Rating Scale (iADRS) from baseline to 76 weeks relative to placebo.
The newly released detailed findings showed that “the use of donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed,” the investigators, with first author Mark A. Mintun, MD, an employee of Eli Lilly, reported.
Results revealed improvement in scores on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) and the 13-item cognitive subscale of the AD Assessment Scale (ADAS-Cog13), but the differences between the two treatment groups were not significant. In addition, score changes on the AD Cooperative Study–Instrumental Activities of Daily Inventory (ADCS-iADL) and the Mini-Mental State Examination (MMSE) were not “substantial.”
However, the donanemab group did show an 85-centiloid greater reduction in amyloid plaque level at 76 weeks, as shown on PET, compared with the placebo group.
Proof of concept?
The humanized antibody donanemab, which was previously known as LY3002813, targets a modified form of deposited amyloid-beta (A-beta) peptide called N3pG.
The randomized, placebo-controlled, double-blind TRAILBLAZER-ALZ trial, which was described as a “phase 2 proof of concept trial” in the AD/PD program, was conducted at 56 sites in the United States and Canada and included 257 patients between the ages of 60 and 85 years (52% were women). PET confirmed tau and amyloid deposition in all participants.
The active treatment group (n = 131) was randomly assigned to receive donanemab 700 mg for three doses; after that, treatment was bumped up to 1,400 mg. Both the donanemab and placebo groups (n = 126) received treatment intravenously every 4 weeks for up to 72 weeks.
Participants also underwent F-florbetapir and F-flortaucipir PET scans at various timepoints and completed a slew of cognitive tests.
The study’s primary outcome measure was change between baseline and 76 weeks post treatment on composite score for cognition, as measured by the iADRS. The iADRS combines the ADAS-Cog13 and the ADCS-iADL.
This measure ranges from 0 to 144, with lower scores associated with greater cognitive impairment. Both treatment groups had an iADRS score of 106 at baseline.
More research needed
Results showed that the score change from baseline on the iADRS was –6.86 for the active treatment group vs –10.06 for the placebo group (group difference, 3.2; 95% confidence interval [CI], 0.12-6.27; P = .04). Although significant, “the trial was powered to show a 6-point difference,” which was not met, the investigators note.
Differences in score changes from baseline to 76 weeks for the treatment vs. placebo groups on the following secondary outcome measures were:
- CDR-SB: –0.36 (95% CI, –0.83 to –0.12).
- ADAS-Cog13: –1.86 (95% CI, –3.63 to –0.09).
- ADCS-iADL: 1.21 (95% CI, –0.77 to 3.2).
- MMSE: 0.64 (95% CI, –0.4 to 1.67).
The CDR-SB was designated as the first secondary outcome, and because it did not show a significant between-group difference, “the hierarchy failed and no definite conclusions can be drawn from data regarding the differences between groups in the change in the ADAS-Cog13,” the investigators wrote.
In addition, the differences in scores on the latter two secondary outcomes were not “substantial,” they reported.
However, at 76 weeks, the donanemab group showed a reduction of 84.13 centiloids in amyloid plaque level vs. an increase of 0.93 centiloids in the placebo group (between-group difference, 85.06 centiloids). At 24 weeks, the active-treatment group had a 67.83-centiloids greater reduction vs. the placebo group.
In addition, 40%, 59.8%, and 67.8% of the donanemab group achieved “amyloid-negative status” at 24, 52, and 76 weeks, respectively. Amyloid-negative status was defined as an amyloid plaque level of less than 24.1 centiloids.
Total incidence of death or serious adverse events did not differ significantly between the groups. However, the donanemab group had significantly more reports of ARIA-E compared with the placebo group (26.7% vs. 0.8%).
Overall, the researchers noted that more trials of longer duration with larger patient numbers are warranted “to further determine the efficacy and safety of donanemab” in AD.
Positive signal?
In a statement, Maria Carrillo, PhD, chief science officer for the Alzheimer’s Association, said the organization “is encouraged by this promising data.
“It is the first phase 2 Alzheimer’s trial to show positive results on a primary outcome measure related to memory and thinking,” Dr. Carrillo said. However, “more work needs to be done on this experimental drug therapy.”
Dr. Carrillo noted that because the trial was moderately sized and only 180 participants completed the study, “we look forward to the results of a second, larger phase 2 trial of this drug.”
Still, she added, there were several “novel and innovative aspects” in the way the study was conducted noting that it showcases the evolution of AD research.
“I’m hopeful for the future,” Dr. Carrillo said.
Also commenting on the results, Howard Fillit, MD, neuroscientist and founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the study showed “the pharmacology works” and that the drug did what it was supposed to do in terms of removing A-beta plaque.
“It also gave us a signal in a relatively small phase 2 study that there might be a modest cognitive benefit,” said Dr. Fillit, who was not involved with the research.
He noted that although the rate of decline slowing was statistically significant it remains to be seen whether this is clinically meaningful, particularly in light of the fact that the secondary outcome results were mixed.
“Basically, it was a positive study that probably needs to be followed by another, much larger study to get us to really see the benefit,” Dr. Fillit said.
Dr. Mintun is an employee of Eli Lilly, which funded the study. Dr. Carrillo and Dr. Fillit have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from the TRAILBLAZER-ALZ trial were presented at the 2021 International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) and were simultaneously published online March 13 in the New England Journal of Medicine.
As previously reported by Medscape Medical News, topline results showed that donanemab slowed cognitive decline by 32% on the Integrated AD Rating Scale (iADRS) from baseline to 76 weeks relative to placebo.
The newly released detailed findings showed that “the use of donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed,” the investigators, with first author Mark A. Mintun, MD, an employee of Eli Lilly, reported.
Results revealed improvement in scores on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) and the 13-item cognitive subscale of the AD Assessment Scale (ADAS-Cog13), but the differences between the two treatment groups were not significant. In addition, score changes on the AD Cooperative Study–Instrumental Activities of Daily Inventory (ADCS-iADL) and the Mini-Mental State Examination (MMSE) were not “substantial.”
However, the donanemab group did show an 85-centiloid greater reduction in amyloid plaque level at 76 weeks, as shown on PET, compared with the placebo group.
Proof of concept?
The humanized antibody donanemab, which was previously known as LY3002813, targets a modified form of deposited amyloid-beta (A-beta) peptide called N3pG.
The randomized, placebo-controlled, double-blind TRAILBLAZER-ALZ trial, which was described as a “phase 2 proof of concept trial” in the AD/PD program, was conducted at 56 sites in the United States and Canada and included 257 patients between the ages of 60 and 85 years (52% were women). PET confirmed tau and amyloid deposition in all participants.
The active treatment group (n = 131) was randomly assigned to receive donanemab 700 mg for three doses; after that, treatment was bumped up to 1,400 mg. Both the donanemab and placebo groups (n = 126) received treatment intravenously every 4 weeks for up to 72 weeks.
Participants also underwent F-florbetapir and F-flortaucipir PET scans at various timepoints and completed a slew of cognitive tests.
The study’s primary outcome measure was change between baseline and 76 weeks post treatment on composite score for cognition, as measured by the iADRS. The iADRS combines the ADAS-Cog13 and the ADCS-iADL.
This measure ranges from 0 to 144, with lower scores associated with greater cognitive impairment. Both treatment groups had an iADRS score of 106 at baseline.
More research needed
Results showed that the score change from baseline on the iADRS was –6.86 for the active treatment group vs –10.06 for the placebo group (group difference, 3.2; 95% confidence interval [CI], 0.12-6.27; P = .04). Although significant, “the trial was powered to show a 6-point difference,” which was not met, the investigators note.
Differences in score changes from baseline to 76 weeks for the treatment vs. placebo groups on the following secondary outcome measures were:
- CDR-SB: –0.36 (95% CI, –0.83 to –0.12).
- ADAS-Cog13: –1.86 (95% CI, –3.63 to –0.09).
- ADCS-iADL: 1.21 (95% CI, –0.77 to 3.2).
- MMSE: 0.64 (95% CI, –0.4 to 1.67).
The CDR-SB was designated as the first secondary outcome, and because it did not show a significant between-group difference, “the hierarchy failed and no definite conclusions can be drawn from data regarding the differences between groups in the change in the ADAS-Cog13,” the investigators wrote.
In addition, the differences in scores on the latter two secondary outcomes were not “substantial,” they reported.
However, at 76 weeks, the donanemab group showed a reduction of 84.13 centiloids in amyloid plaque level vs. an increase of 0.93 centiloids in the placebo group (between-group difference, 85.06 centiloids). At 24 weeks, the active-treatment group had a 67.83-centiloids greater reduction vs. the placebo group.
In addition, 40%, 59.8%, and 67.8% of the donanemab group achieved “amyloid-negative status” at 24, 52, and 76 weeks, respectively. Amyloid-negative status was defined as an amyloid plaque level of less than 24.1 centiloids.
Total incidence of death or serious adverse events did not differ significantly between the groups. However, the donanemab group had significantly more reports of ARIA-E compared with the placebo group (26.7% vs. 0.8%).
Overall, the researchers noted that more trials of longer duration with larger patient numbers are warranted “to further determine the efficacy and safety of donanemab” in AD.
Positive signal?
In a statement, Maria Carrillo, PhD, chief science officer for the Alzheimer’s Association, said the organization “is encouraged by this promising data.
“It is the first phase 2 Alzheimer’s trial to show positive results on a primary outcome measure related to memory and thinking,” Dr. Carrillo said. However, “more work needs to be done on this experimental drug therapy.”
Dr. Carrillo noted that because the trial was moderately sized and only 180 participants completed the study, “we look forward to the results of a second, larger phase 2 trial of this drug.”
Still, she added, there were several “novel and innovative aspects” in the way the study was conducted noting that it showcases the evolution of AD research.
“I’m hopeful for the future,” Dr. Carrillo said.
Also commenting on the results, Howard Fillit, MD, neuroscientist and founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the study showed “the pharmacology works” and that the drug did what it was supposed to do in terms of removing A-beta plaque.
“It also gave us a signal in a relatively small phase 2 study that there might be a modest cognitive benefit,” said Dr. Fillit, who was not involved with the research.
He noted that although the rate of decline slowing was statistically significant it remains to be seen whether this is clinically meaningful, particularly in light of the fact that the secondary outcome results were mixed.
“Basically, it was a positive study that probably needs to be followed by another, much larger study to get us to really see the benefit,” Dr. Fillit said.
Dr. Mintun is an employee of Eli Lilly, which funded the study. Dr. Carrillo and Dr. Fillit have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from the TRAILBLAZER-ALZ trial were presented at the 2021 International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) and were simultaneously published online March 13 in the New England Journal of Medicine.
As previously reported by Medscape Medical News, topline results showed that donanemab slowed cognitive decline by 32% on the Integrated AD Rating Scale (iADRS) from baseline to 76 weeks relative to placebo.
The newly released detailed findings showed that “the use of donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed,” the investigators, with first author Mark A. Mintun, MD, an employee of Eli Lilly, reported.
Results revealed improvement in scores on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) and the 13-item cognitive subscale of the AD Assessment Scale (ADAS-Cog13), but the differences between the two treatment groups were not significant. In addition, score changes on the AD Cooperative Study–Instrumental Activities of Daily Inventory (ADCS-iADL) and the Mini-Mental State Examination (MMSE) were not “substantial.”
However, the donanemab group did show an 85-centiloid greater reduction in amyloid plaque level at 76 weeks, as shown on PET, compared with the placebo group.
Proof of concept?
The humanized antibody donanemab, which was previously known as LY3002813, targets a modified form of deposited amyloid-beta (A-beta) peptide called N3pG.
The randomized, placebo-controlled, double-blind TRAILBLAZER-ALZ trial, which was described as a “phase 2 proof of concept trial” in the AD/PD program, was conducted at 56 sites in the United States and Canada and included 257 patients between the ages of 60 and 85 years (52% were women). PET confirmed tau and amyloid deposition in all participants.
The active treatment group (n = 131) was randomly assigned to receive donanemab 700 mg for three doses; after that, treatment was bumped up to 1,400 mg. Both the donanemab and placebo groups (n = 126) received treatment intravenously every 4 weeks for up to 72 weeks.
Participants also underwent F-florbetapir and F-flortaucipir PET scans at various timepoints and completed a slew of cognitive tests.
The study’s primary outcome measure was change between baseline and 76 weeks post treatment on composite score for cognition, as measured by the iADRS. The iADRS combines the ADAS-Cog13 and the ADCS-iADL.
This measure ranges from 0 to 144, with lower scores associated with greater cognitive impairment. Both treatment groups had an iADRS score of 106 at baseline.
More research needed
Results showed that the score change from baseline on the iADRS was –6.86 for the active treatment group vs –10.06 for the placebo group (group difference, 3.2; 95% confidence interval [CI], 0.12-6.27; P = .04). Although significant, “the trial was powered to show a 6-point difference,” which was not met, the investigators note.
Differences in score changes from baseline to 76 weeks for the treatment vs. placebo groups on the following secondary outcome measures were:
- CDR-SB: –0.36 (95% CI, –0.83 to –0.12).
- ADAS-Cog13: –1.86 (95% CI, –3.63 to –0.09).
- ADCS-iADL: 1.21 (95% CI, –0.77 to 3.2).
- MMSE: 0.64 (95% CI, –0.4 to 1.67).
The CDR-SB was designated as the first secondary outcome, and because it did not show a significant between-group difference, “the hierarchy failed and no definite conclusions can be drawn from data regarding the differences between groups in the change in the ADAS-Cog13,” the investigators wrote.
In addition, the differences in scores on the latter two secondary outcomes were not “substantial,” they reported.
However, at 76 weeks, the donanemab group showed a reduction of 84.13 centiloids in amyloid plaque level vs. an increase of 0.93 centiloids in the placebo group (between-group difference, 85.06 centiloids). At 24 weeks, the active-treatment group had a 67.83-centiloids greater reduction vs. the placebo group.
In addition, 40%, 59.8%, and 67.8% of the donanemab group achieved “amyloid-negative status” at 24, 52, and 76 weeks, respectively. Amyloid-negative status was defined as an amyloid plaque level of less than 24.1 centiloids.
Total incidence of death or serious adverse events did not differ significantly between the groups. However, the donanemab group had significantly more reports of ARIA-E compared with the placebo group (26.7% vs. 0.8%).
Overall, the researchers noted that more trials of longer duration with larger patient numbers are warranted “to further determine the efficacy and safety of donanemab” in AD.
Positive signal?
In a statement, Maria Carrillo, PhD, chief science officer for the Alzheimer’s Association, said the organization “is encouraged by this promising data.
“It is the first phase 2 Alzheimer’s trial to show positive results on a primary outcome measure related to memory and thinking,” Dr. Carrillo said. However, “more work needs to be done on this experimental drug therapy.”
Dr. Carrillo noted that because the trial was moderately sized and only 180 participants completed the study, “we look forward to the results of a second, larger phase 2 trial of this drug.”
Still, she added, there were several “novel and innovative aspects” in the way the study was conducted noting that it showcases the evolution of AD research.
“I’m hopeful for the future,” Dr. Carrillo said.
Also commenting on the results, Howard Fillit, MD, neuroscientist and founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the study showed “the pharmacology works” and that the drug did what it was supposed to do in terms of removing A-beta plaque.
“It also gave us a signal in a relatively small phase 2 study that there might be a modest cognitive benefit,” said Dr. Fillit, who was not involved with the research.
He noted that although the rate of decline slowing was statistically significant it remains to be seen whether this is clinically meaningful, particularly in light of the fact that the secondary outcome results were mixed.
“Basically, it was a positive study that probably needs to be followed by another, much larger study to get us to really see the benefit,” Dr. Fillit said.
Dr. Mintun is an employee of Eli Lilly, which funded the study. Dr. Carrillo and Dr. Fillit have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
‘Major update’ of BP guidance for kidney disease; treat to 120 mm Hg
The new 2021 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with chronic kidney disease (CKD) who are not receiving dialysis advises treating to a target systolic blood pressure of less than 120 mm Hg, provided measurements are “standardized” and that blood pressure is “measured properly.”
This blood pressure target – largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) – represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of less than or equal to 130/80 mm Hg for patients with albuminuria or less than or equal to 140/90 mm Hg for patients without albuminuria.
The new goal is also lower than the less than 130/80 mm Hg target in the 2017 American College of Cardiology/American Heart Association guideline.
In a study of the public health implications of the guideline, Kathryn Foti, PhD, and colleagues determined that 70% of U.S. adults with CKD would now be eligible for treatment to lower blood pressure, as opposed to 50% under the previous KDIGO guideline and 56% under the ACC/AHA guideline.
“This is a major update of an influential set of guidelines for chronic kidney disease patients” at a time when blood pressure control is worsening in the United States, Dr. Foti, a postdoctoral researcher in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in a statement from her institution.
The 2021 KDIGO blood pressure guideline and executive summary and the public health implications study are published online in Kidney International.
First, ‘take blood pressure well’
The cochair of the new KDIGO guidelines, Alfred K. Cheung, MD, from the University of Utah, Salt Lake City, said in an interview that the guideline has “two important points.”
First, “take that blood pressure well,” he said. “That has a lot to do with patient preparation rather than any fancy instrument,” he emphasized.
Second, the guideline proposes a systolic blood pressure target of less than 120 mm Hg for most people with CKD not receiving dialysis, except for children and kidney transplant recipients. This target is “contingent on ‘standardized’ blood pressure measurement.”
The document provides a checklist for obtaining a standardized blood pressure measurement, adapted from the 2017 ACC/AHA blood pressure guidelines. It starts with the patient relaxed and sitting on a chair for more than 5 minutes.
In contrast to this measurement, a “routine” or “casual” office blood pressure measurement could be off by plus or minus 10 mm Hg, Dr. Cheung noted.
In a typical scenario, he continued, a patient cannot find a place to park, rushes into the clinic, and has his or her blood pressure checked right away, which would provide a “totally unreliable” reading. Adding a “fudge factor” (correction factor) would not provide an accurate reading.
Clinicians “would not settle for a potassium measurement that is 5.0 mmol/L plus or minus a few decimal points” to guide treatment, he pointed out.
Second, target 120, properly measured
“The very first chapter of the guidelines is devoted to blood pressure measurement, because we recognize if we’re going to do 120 [mm Hg] – the emphasis is on 120 measured properly – so we try to drive that point home,” Tara I. Chang, MD, guideline second author and a coauthor of the public health implications study, pointed out in an interview.
“There are a lot of other things that we base clinical decisions on where we really require some degree of precision, and blood pressure is important enough that to us it’s kind of in the same boat,” said Dr. Chang, from Stanford (Calif.) University.
“In SPRINT, people were randomized to less than less than 120 vs. less than 140 (they weren’t randomized to <130),” she noted.
“The recommendation should be widely adopted in clinical practice,” the guideline authors write, “since accurate measurements will ensure that proper guidance is being applied to the management of BP, as it is to the management of other risk factors.”
Still need individual treatment
Nevertheless, patients still need individualized treatment, the document stresses. “Not every patient with CKD will be appropriate to target to less than 120,” Dr. Chang said. However, “we want people to at least consider less than 120,” she added, to avoid therapeutic inertia.
“If you take the blood pressure in a standardized manner – such as in the ACCORD trial and in the SPRINT trial – even patients over 75 years old, or people over 80 years old, they have very little side effects,” Dr. Cheung noted.
“In the overall cohort,” he continued, “they do not have a significant increase in serious adverse events, do not have adverse events of postural hypotension, syncope, bradycardia, injurious falls – so people are worried about it, but it’s not borne out by the data.
“That said, I have two cautions,” Dr. Cheung noted. “One. If you drop somebody’s blood pressure rapidly over a week, you may be more likely to get in trouble. If you drop the blood pressure gradually over several weeks, several months, you’re much less likely to get into trouble.”
“Two. If the patient is old, you know the patient has carotid stenosis and already has postural dizziness, you may not want to try on that patient – but just because the patient is old is not the reason not to target 120.”
ACE inhibitors and ARBs beneficial in albuminuria, underused
“How do you get to less than 120? The short answer is, use whatever medications you need to – there is no necessarily right cocktail,” Dr. Chang said.
“We’ve known that angiotensin-converting enzyme (ACE) inhibitors and ARBs [angiotensin II receptor blockers] are beneficial in patients with CKD and in particular those with heavier albuminuria,” she continued. “We’ve known this for over 20 years.”
Yet, the study identified underutilization – “a persistent gap, just like blood pressure control and awareness,” she noted. “We’re just not making much headway.
“We are not recommending ACE inhibitors or ARBs for all the patients,” Dr. Cheung clarified. “If you are diabetic and have heavy proteinuria, that’s when the use of ACE inhibitors and ARBs are most indicated.”
Public health implications
SPRINT showed that treating to a systolic blood pressure of less than 120 mm Hg vs. less than 140 mm Hg reduced the risk for cardiovascular disease by 25% and all-cause mortality by 27% for participants with and those without CKD, Dr. Foti and colleagues stress.
They aimed to estimate how the new guideline would affect (1) the number of U.S. patients with CKD who would be eligible for blood pressure lowering treatment, and (2) the proportion of those with albuminuria who would be eligible for an ACE inhibitor or an ARB.
The researchers analyzed data from 1,699 adults with CKD (estimated glomerular filtration rate, 15-59 mL/min/1.73 m2 or a urinary albumin-to-creatinine ratio of ≥30 mg/g) who participated in the 2015-2018 National Health and Nutrition Examination Survey.
Both the 2021 and 2012 KDIGO guidelines recommend that patients with albuminuria and blood pressure higher than the target value who are not kidney transplant recipients should be treated with an ACE inhibitor or an ARB.
On the basis of the new target, 78% of patients with CKD and albuminuria were eligible for ACE inhibitor/ARB treatment by the 2021 KDIGO guideline, compared with 71% by the 2012 KDIGO guideline. However, only 39% were taking one of these drugs.
These findings show that “with the new guideline and with the lower blood pressure target, you potentially have an even larger pool of people who have blood pressure that’s not under control, and a potential larger group of people who may benefit from ACE inhibitors and ARBs,” Dr. Chang said.
“Our paper is not the only one to show that we haven’t made a whole lot of progress,” she said, “and now that the bar has been lowered, there [have] to be some renewed efforts on controlling blood pressure, because we know that blood pressure control is such an important risk factor for cardiovascular outcomes.”
Dr. Foti is supported by an NIH/National Heart, Lung, and Blood Institute grant. Dr. Cheung has received consultancy fees from Amgen, Bard, Boehringer Ingelheim, Calliditas, Tricida, and UpToDate, and grant/research support from the National Institutes of Health for SPRINT (monies paid to institution). Dr. Chang has received consultancy fees from Bayer, Gilead, Janssen Research and Development, Novo Nordisk, Tricida, and Vascular Dynamics; grant/research support from AstraZeneca and Satellite Healthcare (monies paid to institution), the NIH, and the American Heart Association; is on advisory boards for AstraZeneca and Fresenius Medical Care Renal Therapies Group; and has received workshop honoraria from Fresenius. Disclosures of relevant financial relationships of the other authors are listed in the original articles.
A version of this article first appeared on Medscape.com.
The new 2021 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with chronic kidney disease (CKD) who are not receiving dialysis advises treating to a target systolic blood pressure of less than 120 mm Hg, provided measurements are “standardized” and that blood pressure is “measured properly.”
This blood pressure target – largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) – represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of less than or equal to 130/80 mm Hg for patients with albuminuria or less than or equal to 140/90 mm Hg for patients without albuminuria.
The new goal is also lower than the less than 130/80 mm Hg target in the 2017 American College of Cardiology/American Heart Association guideline.
In a study of the public health implications of the guideline, Kathryn Foti, PhD, and colleagues determined that 70% of U.S. adults with CKD would now be eligible for treatment to lower blood pressure, as opposed to 50% under the previous KDIGO guideline and 56% under the ACC/AHA guideline.
“This is a major update of an influential set of guidelines for chronic kidney disease patients” at a time when blood pressure control is worsening in the United States, Dr. Foti, a postdoctoral researcher in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in a statement from her institution.
The 2021 KDIGO blood pressure guideline and executive summary and the public health implications study are published online in Kidney International.
First, ‘take blood pressure well’
The cochair of the new KDIGO guidelines, Alfred K. Cheung, MD, from the University of Utah, Salt Lake City, said in an interview that the guideline has “two important points.”
First, “take that blood pressure well,” he said. “That has a lot to do with patient preparation rather than any fancy instrument,” he emphasized.
Second, the guideline proposes a systolic blood pressure target of less than 120 mm Hg for most people with CKD not receiving dialysis, except for children and kidney transplant recipients. This target is “contingent on ‘standardized’ blood pressure measurement.”
The document provides a checklist for obtaining a standardized blood pressure measurement, adapted from the 2017 ACC/AHA blood pressure guidelines. It starts with the patient relaxed and sitting on a chair for more than 5 minutes.
In contrast to this measurement, a “routine” or “casual” office blood pressure measurement could be off by plus or minus 10 mm Hg, Dr. Cheung noted.
In a typical scenario, he continued, a patient cannot find a place to park, rushes into the clinic, and has his or her blood pressure checked right away, which would provide a “totally unreliable” reading. Adding a “fudge factor” (correction factor) would not provide an accurate reading.
Clinicians “would not settle for a potassium measurement that is 5.0 mmol/L plus or minus a few decimal points” to guide treatment, he pointed out.
Second, target 120, properly measured
“The very first chapter of the guidelines is devoted to blood pressure measurement, because we recognize if we’re going to do 120 [mm Hg] – the emphasis is on 120 measured properly – so we try to drive that point home,” Tara I. Chang, MD, guideline second author and a coauthor of the public health implications study, pointed out in an interview.
“There are a lot of other things that we base clinical decisions on where we really require some degree of precision, and blood pressure is important enough that to us it’s kind of in the same boat,” said Dr. Chang, from Stanford (Calif.) University.
“In SPRINT, people were randomized to less than less than 120 vs. less than 140 (they weren’t randomized to <130),” she noted.
“The recommendation should be widely adopted in clinical practice,” the guideline authors write, “since accurate measurements will ensure that proper guidance is being applied to the management of BP, as it is to the management of other risk factors.”
Still need individual treatment
Nevertheless, patients still need individualized treatment, the document stresses. “Not every patient with CKD will be appropriate to target to less than 120,” Dr. Chang said. However, “we want people to at least consider less than 120,” she added, to avoid therapeutic inertia.
“If you take the blood pressure in a standardized manner – such as in the ACCORD trial and in the SPRINT trial – even patients over 75 years old, or people over 80 years old, they have very little side effects,” Dr. Cheung noted.
“In the overall cohort,” he continued, “they do not have a significant increase in serious adverse events, do not have adverse events of postural hypotension, syncope, bradycardia, injurious falls – so people are worried about it, but it’s not borne out by the data.
“That said, I have two cautions,” Dr. Cheung noted. “One. If you drop somebody’s blood pressure rapidly over a week, you may be more likely to get in trouble. If you drop the blood pressure gradually over several weeks, several months, you’re much less likely to get into trouble.”
“Two. If the patient is old, you know the patient has carotid stenosis and already has postural dizziness, you may not want to try on that patient – but just because the patient is old is not the reason not to target 120.”
ACE inhibitors and ARBs beneficial in albuminuria, underused
“How do you get to less than 120? The short answer is, use whatever medications you need to – there is no necessarily right cocktail,” Dr. Chang said.
“We’ve known that angiotensin-converting enzyme (ACE) inhibitors and ARBs [angiotensin II receptor blockers] are beneficial in patients with CKD and in particular those with heavier albuminuria,” she continued. “We’ve known this for over 20 years.”
Yet, the study identified underutilization – “a persistent gap, just like blood pressure control and awareness,” she noted. “We’re just not making much headway.
“We are not recommending ACE inhibitors or ARBs for all the patients,” Dr. Cheung clarified. “If you are diabetic and have heavy proteinuria, that’s when the use of ACE inhibitors and ARBs are most indicated.”
Public health implications
SPRINT showed that treating to a systolic blood pressure of less than 120 mm Hg vs. less than 140 mm Hg reduced the risk for cardiovascular disease by 25% and all-cause mortality by 27% for participants with and those without CKD, Dr. Foti and colleagues stress.
They aimed to estimate how the new guideline would affect (1) the number of U.S. patients with CKD who would be eligible for blood pressure lowering treatment, and (2) the proportion of those with albuminuria who would be eligible for an ACE inhibitor or an ARB.
The researchers analyzed data from 1,699 adults with CKD (estimated glomerular filtration rate, 15-59 mL/min/1.73 m2 or a urinary albumin-to-creatinine ratio of ≥30 mg/g) who participated in the 2015-2018 National Health and Nutrition Examination Survey.
Both the 2021 and 2012 KDIGO guidelines recommend that patients with albuminuria and blood pressure higher than the target value who are not kidney transplant recipients should be treated with an ACE inhibitor or an ARB.
On the basis of the new target, 78% of patients with CKD and albuminuria were eligible for ACE inhibitor/ARB treatment by the 2021 KDIGO guideline, compared with 71% by the 2012 KDIGO guideline. However, only 39% were taking one of these drugs.
These findings show that “with the new guideline and with the lower blood pressure target, you potentially have an even larger pool of people who have blood pressure that’s not under control, and a potential larger group of people who may benefit from ACE inhibitors and ARBs,” Dr. Chang said.
“Our paper is not the only one to show that we haven’t made a whole lot of progress,” she said, “and now that the bar has been lowered, there [have] to be some renewed efforts on controlling blood pressure, because we know that blood pressure control is such an important risk factor for cardiovascular outcomes.”
Dr. Foti is supported by an NIH/National Heart, Lung, and Blood Institute grant. Dr. Cheung has received consultancy fees from Amgen, Bard, Boehringer Ingelheim, Calliditas, Tricida, and UpToDate, and grant/research support from the National Institutes of Health for SPRINT (monies paid to institution). Dr. Chang has received consultancy fees from Bayer, Gilead, Janssen Research and Development, Novo Nordisk, Tricida, and Vascular Dynamics; grant/research support from AstraZeneca and Satellite Healthcare (monies paid to institution), the NIH, and the American Heart Association; is on advisory boards for AstraZeneca and Fresenius Medical Care Renal Therapies Group; and has received workshop honoraria from Fresenius. Disclosures of relevant financial relationships of the other authors are listed in the original articles.
A version of this article first appeared on Medscape.com.
The new 2021 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with chronic kidney disease (CKD) who are not receiving dialysis advises treating to a target systolic blood pressure of less than 120 mm Hg, provided measurements are “standardized” and that blood pressure is “measured properly.”
This blood pressure target – largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) – represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of less than or equal to 130/80 mm Hg for patients with albuminuria or less than or equal to 140/90 mm Hg for patients without albuminuria.
The new goal is also lower than the less than 130/80 mm Hg target in the 2017 American College of Cardiology/American Heart Association guideline.
In a study of the public health implications of the guideline, Kathryn Foti, PhD, and colleagues determined that 70% of U.S. adults with CKD would now be eligible for treatment to lower blood pressure, as opposed to 50% under the previous KDIGO guideline and 56% under the ACC/AHA guideline.
“This is a major update of an influential set of guidelines for chronic kidney disease patients” at a time when blood pressure control is worsening in the United States, Dr. Foti, a postdoctoral researcher in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in a statement from her institution.
The 2021 KDIGO blood pressure guideline and executive summary and the public health implications study are published online in Kidney International.
First, ‘take blood pressure well’
The cochair of the new KDIGO guidelines, Alfred K. Cheung, MD, from the University of Utah, Salt Lake City, said in an interview that the guideline has “two important points.”
First, “take that blood pressure well,” he said. “That has a lot to do with patient preparation rather than any fancy instrument,” he emphasized.
Second, the guideline proposes a systolic blood pressure target of less than 120 mm Hg for most people with CKD not receiving dialysis, except for children and kidney transplant recipients. This target is “contingent on ‘standardized’ blood pressure measurement.”
The document provides a checklist for obtaining a standardized blood pressure measurement, adapted from the 2017 ACC/AHA blood pressure guidelines. It starts with the patient relaxed and sitting on a chair for more than 5 minutes.
In contrast to this measurement, a “routine” or “casual” office blood pressure measurement could be off by plus or minus 10 mm Hg, Dr. Cheung noted.
In a typical scenario, he continued, a patient cannot find a place to park, rushes into the clinic, and has his or her blood pressure checked right away, which would provide a “totally unreliable” reading. Adding a “fudge factor” (correction factor) would not provide an accurate reading.
Clinicians “would not settle for a potassium measurement that is 5.0 mmol/L plus or minus a few decimal points” to guide treatment, he pointed out.
Second, target 120, properly measured
“The very first chapter of the guidelines is devoted to blood pressure measurement, because we recognize if we’re going to do 120 [mm Hg] – the emphasis is on 120 measured properly – so we try to drive that point home,” Tara I. Chang, MD, guideline second author and a coauthor of the public health implications study, pointed out in an interview.
“There are a lot of other things that we base clinical decisions on where we really require some degree of precision, and blood pressure is important enough that to us it’s kind of in the same boat,” said Dr. Chang, from Stanford (Calif.) University.
“In SPRINT, people were randomized to less than less than 120 vs. less than 140 (they weren’t randomized to <130),” she noted.
“The recommendation should be widely adopted in clinical practice,” the guideline authors write, “since accurate measurements will ensure that proper guidance is being applied to the management of BP, as it is to the management of other risk factors.”
Still need individual treatment
Nevertheless, patients still need individualized treatment, the document stresses. “Not every patient with CKD will be appropriate to target to less than 120,” Dr. Chang said. However, “we want people to at least consider less than 120,” she added, to avoid therapeutic inertia.
“If you take the blood pressure in a standardized manner – such as in the ACCORD trial and in the SPRINT trial – even patients over 75 years old, or people over 80 years old, they have very little side effects,” Dr. Cheung noted.
“In the overall cohort,” he continued, “they do not have a significant increase in serious adverse events, do not have adverse events of postural hypotension, syncope, bradycardia, injurious falls – so people are worried about it, but it’s not borne out by the data.
“That said, I have two cautions,” Dr. Cheung noted. “One. If you drop somebody’s blood pressure rapidly over a week, you may be more likely to get in trouble. If you drop the blood pressure gradually over several weeks, several months, you’re much less likely to get into trouble.”
“Two. If the patient is old, you know the patient has carotid stenosis and already has postural dizziness, you may not want to try on that patient – but just because the patient is old is not the reason not to target 120.”
ACE inhibitors and ARBs beneficial in albuminuria, underused
“How do you get to less than 120? The short answer is, use whatever medications you need to – there is no necessarily right cocktail,” Dr. Chang said.
“We’ve known that angiotensin-converting enzyme (ACE) inhibitors and ARBs [angiotensin II receptor blockers] are beneficial in patients with CKD and in particular those with heavier albuminuria,” she continued. “We’ve known this for over 20 years.”
Yet, the study identified underutilization – “a persistent gap, just like blood pressure control and awareness,” she noted. “We’re just not making much headway.
“We are not recommending ACE inhibitors or ARBs for all the patients,” Dr. Cheung clarified. “If you are diabetic and have heavy proteinuria, that’s when the use of ACE inhibitors and ARBs are most indicated.”
Public health implications
SPRINT showed that treating to a systolic blood pressure of less than 120 mm Hg vs. less than 140 mm Hg reduced the risk for cardiovascular disease by 25% and all-cause mortality by 27% for participants with and those without CKD, Dr. Foti and colleagues stress.
They aimed to estimate how the new guideline would affect (1) the number of U.S. patients with CKD who would be eligible for blood pressure lowering treatment, and (2) the proportion of those with albuminuria who would be eligible for an ACE inhibitor or an ARB.
The researchers analyzed data from 1,699 adults with CKD (estimated glomerular filtration rate, 15-59 mL/min/1.73 m2 or a urinary albumin-to-creatinine ratio of ≥30 mg/g) who participated in the 2015-2018 National Health and Nutrition Examination Survey.
Both the 2021 and 2012 KDIGO guidelines recommend that patients with albuminuria and blood pressure higher than the target value who are not kidney transplant recipients should be treated with an ACE inhibitor or an ARB.
On the basis of the new target, 78% of patients with CKD and albuminuria were eligible for ACE inhibitor/ARB treatment by the 2021 KDIGO guideline, compared with 71% by the 2012 KDIGO guideline. However, only 39% were taking one of these drugs.
These findings show that “with the new guideline and with the lower blood pressure target, you potentially have an even larger pool of people who have blood pressure that’s not under control, and a potential larger group of people who may benefit from ACE inhibitors and ARBs,” Dr. Chang said.
“Our paper is not the only one to show that we haven’t made a whole lot of progress,” she said, “and now that the bar has been lowered, there [have] to be some renewed efforts on controlling blood pressure, because we know that blood pressure control is such an important risk factor for cardiovascular outcomes.”
Dr. Foti is supported by an NIH/National Heart, Lung, and Blood Institute grant. Dr. Cheung has received consultancy fees from Amgen, Bard, Boehringer Ingelheim, Calliditas, Tricida, and UpToDate, and grant/research support from the National Institutes of Health for SPRINT (monies paid to institution). Dr. Chang has received consultancy fees from Bayer, Gilead, Janssen Research and Development, Novo Nordisk, Tricida, and Vascular Dynamics; grant/research support from AstraZeneca and Satellite Healthcare (monies paid to institution), the NIH, and the American Heart Association; is on advisory boards for AstraZeneca and Fresenius Medical Care Renal Therapies Group; and has received workshop honoraria from Fresenius. Disclosures of relevant financial relationships of the other authors are listed in the original articles.
A version of this article first appeared on Medscape.com.
CDC’s new gonorrhea treatment recs: What’s changed, and when to retest
REFERENCES
- CDC. Expedited partner therapy. Accessed March 15, 2021. www.cdc.gov/std/ept/default.htm
- St. Cyr S, Barbee L, Workowski KA, et al. Update to CDC's treatment guidelines for gonococcal infection, 2020. MMWR Morbid Mortal Wkly Rep. 2020;69:1911-1916. Accessed March 15, 2021. https://www.cdc.gov/mmwr/volumes/69/wr/mm6950a6.htm
- CDC. Gonococcal infections. Accessed March 15, 2021. www.cdc.gov/std/tg2015/gonorrhea.htm
REFERENCES
- CDC. Expedited partner therapy. Accessed March 15, 2021. www.cdc.gov/std/ept/default.htm
- St. Cyr S, Barbee L, Workowski KA, et al. Update to CDC's treatment guidelines for gonococcal infection, 2020. MMWR Morbid Mortal Wkly Rep. 2020;69:1911-1916. Accessed March 15, 2021. https://www.cdc.gov/mmwr/volumes/69/wr/mm6950a6.htm
- CDC. Gonococcal infections. Accessed March 15, 2021. www.cdc.gov/std/tg2015/gonorrhea.htm
REFERENCES
- CDC. Expedited partner therapy. Accessed March 15, 2021. www.cdc.gov/std/ept/default.htm
- St. Cyr S, Barbee L, Workowski KA, et al. Update to CDC's treatment guidelines for gonococcal infection, 2020. MMWR Morbid Mortal Wkly Rep. 2020;69:1911-1916. Accessed March 15, 2021. https://www.cdc.gov/mmwr/volumes/69/wr/mm6950a6.htm
- CDC. Gonococcal infections. Accessed March 15, 2021. www.cdc.gov/std/tg2015/gonorrhea.htm
