Up to half of patients with type 2 diabetes report poor adherence to their non-insulin medications. In this ReCAP, Dr Anne Peters, director of the University of Southern California Clinical Diabetes Programs in Los Angeles, California, offers clinicians suggestions on how to get their patients to "buy in" to these treatments, many of which do not make them feel any better. Research shows that quality of life, short- and long-term clinical outcomes, and side effects are important factors in treatment adherence. Dr Peters explains that adherence may be improved if patients understand why they need to take a medication, how it might make them feel, what to do about it, and how taking it will fit into their daily pattern. She also points out that access and affordability of the medication regimen are additional factors for which patients may need support to increase treatment adherence.

--

Anne L. Peters, MD, Professor, Department of Clinical Medicine, Clinical Scholar, Keck School of Medicine of the University of Southern California; Director, USC Clinical Diabetes Programs, University of Southern California Westside Center for Diabetes, Los Angeles, California

Anne L. Peters, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or a trustee for: Blue Circle Health; Vertex; Abbott Diabetes Care Received research grant from: Abbott Diabetes Care; Insulet Stock options from: Teladoc; Omada Health

Up to half of patients with type 2 diabetes report poor adherence to their non-insulin medications. In this ReCAP, Dr Anne Peters, director of the University of Southern California Clinical Diabetes Programs in Los Angeles, California, offers clinicians suggestions on how to get their patients to "buy in" to these treatments, many of which do not make them feel any better. Research shows that quality of life, short- and long-term clinical outcomes, and side effects are important factors in treatment adherence. Dr Peters explains that adherence may be improved if patients understand why they need to take a medication, how it might make them feel, what to do about it, and how taking it will fit into their daily pattern. She also points out that access and affordability of the medication regimen are additional factors for which patients may need support to increase treatment adherence.

--

Anne L. Peters, MD, Professor, Department of Clinical Medicine, Clinical Scholar, Keck School of Medicine of the University of Southern California; Director, USC Clinical Diabetes Programs, University of Southern California Westside Center for Diabetes, Los Angeles, California

Anne L. Peters, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or a trustee for: Blue Circle Health; Vertex; Abbott Diabetes Care Received research grant from: Abbott Diabetes Care; Insulet Stock options from: Teladoc; Omada Health

Up to half of patients with type 2 diabetes report poor adherence to their non-insulin medications. In this ReCAP, Dr Anne Peters, director of the University of Southern California Clinical Diabetes Programs in Los Angeles, California, offers clinicians suggestions on how to get their patients to "buy in" to these treatments, many of which do not make them feel any better. Research shows that quality of life, short- and long-term clinical outcomes, and side effects are important factors in treatment adherence. Dr Peters explains that adherence may be improved if patients understand why they need to take a medication, how it might make them feel, what to do about it, and how taking it will fit into their daily pattern. She also points out that access and affordability of the medication regimen are additional factors for which patients may need support to increase treatment adherence.

--

Anne L. Peters, MD, Professor, Department of Clinical Medicine, Clinical Scholar, Keck School of Medicine of the University of Southern California; Director, USC Clinical Diabetes Programs, University of Southern California Westside Center for Diabetes, Los Angeles, California

Anne L. Peters, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or a trustee for: Blue Circle Health; Vertex; Abbott Diabetes Care Received research grant from: Abbott Diabetes Care; Insulet Stock options from: Teladoc; Omada Health

Endocrine therapy (ET) has long been the therapeutic mainstay for first-line treatment of HR+/HER2- breast cancer. Yet, approximately one third of patients exhibit primary or acquired ET resistance, and some patients progress within 2 years after adjuvant ET. Resistance to endocrine therapy is a major challenge for a significant number of patients who go on to develop metastatic breast cancer.

Dr Jennifer Litton from The University of Texas MD Anderson Cancer Center in Houston, Texas, reports on current treatment recommendations and supporting research on the use of endocrine therapy and CDK4/6 inhibitors in both the metastatic and, more recently, the high-risk, early HR+/HER2- breast cancer settings.

Dr Litton also reviews key drivers of endocrine resistance, including somatic mutations such as ESR1. She emphasizes the need for next-generation testing in patients with metastatic HR+/HER2- disease to look for evidence of resistance, which may have implications for the next line of therapy.

--

Professor, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas

Jennifer K. Litton, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: The University of Texas MD Anderson Cancer Center

Serve(d) as a speaker or a member of a speakers bureau for: Clinical Care Options; Med Learning Group; Medpage; Medscape; PRIME; Physicians Education Resource; UpToDate

Endocrine therapy (ET) has long been the therapeutic mainstay for first-line treatment of HR+/HER2- breast cancer. Yet, approximately one third of patients exhibit primary or acquired ET resistance, and some patients progress within 2 years after adjuvant ET. Resistance to endocrine therapy is a major challenge for a significant number of patients who go on to develop metastatic breast cancer.

Dr Jennifer Litton from The University of Texas MD Anderson Cancer Center in Houston, Texas, reports on current treatment recommendations and supporting research on the use of endocrine therapy and CDK4/6 inhibitors in both the metastatic and, more recently, the high-risk, early HR+/HER2- breast cancer settings.

Dr Litton also reviews key drivers of endocrine resistance, including somatic mutations such as ESR1. She emphasizes the need for next-generation testing in patients with metastatic HR+/HER2- disease to look for evidence of resistance, which may have implications for the next line of therapy.

--

Professor, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas

Jennifer K. Litton, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: The University of Texas MD Anderson Cancer Center

Serve(d) as a speaker or a member of a speakers bureau for: Clinical Care Options; Med Learning Group; Medpage; Medscape; PRIME; Physicians Education Resource; UpToDate

Endocrine therapy (ET) has long been the therapeutic mainstay for first-line treatment of HR+/HER2- breast cancer. Yet, approximately one third of patients exhibit primary or acquired ET resistance, and some patients progress within 2 years after adjuvant ET. Resistance to endocrine therapy is a major challenge for a significant number of patients who go on to develop metastatic breast cancer.

Dr Jennifer Litton from The University of Texas MD Anderson Cancer Center in Houston, Texas, reports on current treatment recommendations and supporting research on the use of endocrine therapy and CDK4/6 inhibitors in both the metastatic and, more recently, the high-risk, early HR+/HER2- breast cancer settings.

Dr Litton also reviews key drivers of endocrine resistance, including somatic mutations such as ESR1. She emphasizes the need for next-generation testing in patients with metastatic HR+/HER2- disease to look for evidence of resistance, which may have implications for the next line of therapy.

--

Professor, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas

Jennifer K. Litton, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: The University of Texas MD Anderson Cancer Center

Serve(d) as a speaker or a member of a speakers bureau for: Clinical Care Options; Med Learning Group; Medpage; Medscape; PRIME; Physicians Education Resource; UpToDate

Joint hypermobility syndrome, popularly known as being double-jointed, may be a common but underrecognized disorder in adults that is difficult to diagnose and often mistaken for fibromyalgia or other conditions.

So said Matthew B. Carroll, MD, a board-certified rheumatologist with Singing River Health System, Ocean Springs, Miss., during a presentation about hypermobility at the annual meeting of the American College of Physicians.

According to Dr. Carroll, the concept of a hypermobility spectrum disorder (HSD) associated with double-jointedness is relatively new and not part of the conventional nomenclature.

“One of the frustrations about HSD is that there really aren’t any good theories,” as to why some with hypermobility suffer from the syndrome while others do not, Dr. Carroll said.

Hypermobility is defined as having joints that are looser than normal. Examples of this include hyperextending the forearm at the elbow or pressing the thumb against the surface of the forearm.

Approximately 20% of the adult population has hypermobility, which affects women more than men and is more common in younger people. In children ages 3-19 years, 32% of girls and 18% of boys are hypermobile.

But the condition is not a diagnosis, “it’s a descriptor of a finding that you notice on a physical exam,” Dr. Carroll said.
 

When flexibility is a problem

Although hypermobility often is benign and rarely progresses to more serious health issues, HSD can cause symptoms such as recurrent dislocations, joint pain, and other degenerative changes. Recent evidence suggests that abnormal bleeding may also accompany hypermobility.

A 2013 survey in the United Kingdom found that about 3% of respondents reported pain as a consequence of their hypermobility. Dr. Carroll hypothesized that up to a quarter of those diagnosed with hypermobility have some associated pain.

“We kind of think of hypermobility as either being benign, or you kind of have it as a kid and grow out of it,” Dr. Carroll said. “But the reality is a lot of our patients keep that into adulthood and can have problems as a consequence.”

Because some of the symptoms of HSD, such as abdominal pain and fatigue, mimic other whole-body pain conditions, specifically fibromyalgia, Dr. Carroll said it likely is widely undiagnosed.

“I think a lot of these patients were diagnosed with fibromyalgia,” Dr. Carroll said. “It’s incumbent upon us to be able to start teasing some of those nuances out, or at least have rheumatology help you and other specialists figure out where you can go with these patients and their health.”
 

Causes of HSD

HSD can be both genetic and environmental in nature; sports injuries, spontaneous dislocations, and a fear of injury leading to a sedentary lifestyle should also be considered. The condition can overlap with Ehlers-Danlos syndromes, a rare group of inherited conditions that affect connectivity tissue.

Treating patients with HSD requires a multidisciplinary approach, including primary care, rheumatologists, geneticists, and orthopedists. If primary care physicians suspect their patient has hypermobility, they should explore this possibility before moving on to another diagnosis. Whether an adult has or had joint mobility can be determined through a series of simple questions:

• Can you bend your thumb to touch your forearm?
• As a child, did you amuse your friends by contorting your body into strange shapes?
• Do you consider yourself double-jointed?

“It gets really kind of muddy and really difficult to tease out, but I think it’s something that takes time in an iterative process to figure out,” Dr. Carroll said.

Treatment options for HSD are limited. No disease-directed pharmacologic agents exist, and interventions in general lack rigorous studies to support their use. Dr. Carroll recommends anti-inflammatory drugs and physical therapy as first-line approaches. He also stressed that lifestyle interventions – particularly exercise and weight loss – are essential. The role of surgery at this time is unclear and only used in highly selected cases. An appointment with a geneticist could also be necessary to explore family history and look for Ehlers‐Danlos syndromes. 

“You’re going to need several different specialists to try to really help our patients get back up and running,” he said.

Dr. Carroll reported no relevant financial relationships.

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

Joint hypermobility syndrome, popularly known as being double-jointed, may be a common but underrecognized disorder in adults that is difficult to diagnose and often mistaken for fibromyalgia or other conditions.

So said Matthew B. Carroll, MD, a board-certified rheumatologist with Singing River Health System, Ocean Springs, Miss., during a presentation about hypermobility at the annual meeting of the American College of Physicians.

According to Dr. Carroll, the concept of a hypermobility spectrum disorder (HSD) associated with double-jointedness is relatively new and not part of the conventional nomenclature.

“One of the frustrations about HSD is that there really aren’t any good theories,” as to why some with hypermobility suffer from the syndrome while others do not, Dr. Carroll said.

Hypermobility is defined as having joints that are looser than normal. Examples of this include hyperextending the forearm at the elbow or pressing the thumb against the surface of the forearm.

Approximately 20% of the adult population has hypermobility, which affects women more than men and is more common in younger people. In children ages 3-19 years, 32% of girls and 18% of boys are hypermobile.

But the condition is not a diagnosis, “it’s a descriptor of a finding that you notice on a physical exam,” Dr. Carroll said.
 

When flexibility is a problem

Although hypermobility often is benign and rarely progresses to more serious health issues, HSD can cause symptoms such as recurrent dislocations, joint pain, and other degenerative changes. Recent evidence suggests that abnormal bleeding may also accompany hypermobility.

A 2013 survey in the United Kingdom found that about 3% of respondents reported pain as a consequence of their hypermobility. Dr. Carroll hypothesized that up to a quarter of those diagnosed with hypermobility have some associated pain.

“We kind of think of hypermobility as either being benign, or you kind of have it as a kid and grow out of it,” Dr. Carroll said. “But the reality is a lot of our patients keep that into adulthood and can have problems as a consequence.”

Because some of the symptoms of HSD, such as abdominal pain and fatigue, mimic other whole-body pain conditions, specifically fibromyalgia, Dr. Carroll said it likely is widely undiagnosed.

“I think a lot of these patients were diagnosed with fibromyalgia,” Dr. Carroll said. “It’s incumbent upon us to be able to start teasing some of those nuances out, or at least have rheumatology help you and other specialists figure out where you can go with these patients and their health.”
 

Causes of HSD

HSD can be both genetic and environmental in nature; sports injuries, spontaneous dislocations, and a fear of injury leading to a sedentary lifestyle should also be considered. The condition can overlap with Ehlers-Danlos syndromes, a rare group of inherited conditions that affect connectivity tissue.

Treating patients with HSD requires a multidisciplinary approach, including primary care, rheumatologists, geneticists, and orthopedists. If primary care physicians suspect their patient has hypermobility, they should explore this possibility before moving on to another diagnosis. Whether an adult has or had joint mobility can be determined through a series of simple questions:

• Can you bend your thumb to touch your forearm?
• As a child, did you amuse your friends by contorting your body into strange shapes?
• Do you consider yourself double-jointed?

“It gets really kind of muddy and really difficult to tease out, but I think it’s something that takes time in an iterative process to figure out,” Dr. Carroll said.

Treatment options for HSD are limited. No disease-directed pharmacologic agents exist, and interventions in general lack rigorous studies to support their use. Dr. Carroll recommends anti-inflammatory drugs and physical therapy as first-line approaches. He also stressed that lifestyle interventions – particularly exercise and weight loss – are essential. The role of surgery at this time is unclear and only used in highly selected cases. An appointment with a geneticist could also be necessary to explore family history and look for Ehlers‐Danlos syndromes. 

“You’re going to need several different specialists to try to really help our patients get back up and running,” he said.

Dr. Carroll reported no relevant financial relationships.

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

Joint hypermobility syndrome, popularly known as being double-jointed, may be a common but underrecognized disorder in adults that is difficult to diagnose and often mistaken for fibromyalgia or other conditions.

So said Matthew B. Carroll, MD, a board-certified rheumatologist with Singing River Health System, Ocean Springs, Miss., during a presentation about hypermobility at the annual meeting of the American College of Physicians.

According to Dr. Carroll, the concept of a hypermobility spectrum disorder (HSD) associated with double-jointedness is relatively new and not part of the conventional nomenclature.

“One of the frustrations about HSD is that there really aren’t any good theories,” as to why some with hypermobility suffer from the syndrome while others do not, Dr. Carroll said.

Hypermobility is defined as having joints that are looser than normal. Examples of this include hyperextending the forearm at the elbow or pressing the thumb against the surface of the forearm.

Approximately 20% of the adult population has hypermobility, which affects women more than men and is more common in younger people. In children ages 3-19 years, 32% of girls and 18% of boys are hypermobile.

But the condition is not a diagnosis, “it’s a descriptor of a finding that you notice on a physical exam,” Dr. Carroll said.
 

When flexibility is a problem

Although hypermobility often is benign and rarely progresses to more serious health issues, HSD can cause symptoms such as recurrent dislocations, joint pain, and other degenerative changes. Recent evidence suggests that abnormal bleeding may also accompany hypermobility.

A 2013 survey in the United Kingdom found that about 3% of respondents reported pain as a consequence of their hypermobility. Dr. Carroll hypothesized that up to a quarter of those diagnosed with hypermobility have some associated pain.

“We kind of think of hypermobility as either being benign, or you kind of have it as a kid and grow out of it,” Dr. Carroll said. “But the reality is a lot of our patients keep that into adulthood and can have problems as a consequence.”

Because some of the symptoms of HSD, such as abdominal pain and fatigue, mimic other whole-body pain conditions, specifically fibromyalgia, Dr. Carroll said it likely is widely undiagnosed.

“I think a lot of these patients were diagnosed with fibromyalgia,” Dr. Carroll said. “It’s incumbent upon us to be able to start teasing some of those nuances out, or at least have rheumatology help you and other specialists figure out where you can go with these patients and their health.”
 

Causes of HSD

HSD can be both genetic and environmental in nature; sports injuries, spontaneous dislocations, and a fear of injury leading to a sedentary lifestyle should also be considered. The condition can overlap with Ehlers-Danlos syndromes, a rare group of inherited conditions that affect connectivity tissue.

Treating patients with HSD requires a multidisciplinary approach, including primary care, rheumatologists, geneticists, and orthopedists. If primary care physicians suspect their patient has hypermobility, they should explore this possibility before moving on to another diagnosis. Whether an adult has or had joint mobility can be determined through a series of simple questions:

• Can you bend your thumb to touch your forearm?
• As a child, did you amuse your friends by contorting your body into strange shapes?
• Do you consider yourself double-jointed?

“It gets really kind of muddy and really difficult to tease out, but I think it’s something that takes time in an iterative process to figure out,” Dr. Carroll said.

Treatment options for HSD are limited. No disease-directed pharmacologic agents exist, and interventions in general lack rigorous studies to support their use. Dr. Carroll recommends anti-inflammatory drugs and physical therapy as first-line approaches. He also stressed that lifestyle interventions – particularly exercise and weight loss – are essential. The role of surgery at this time is unclear and only used in highly selected cases. An appointment with a geneticist could also be necessary to explore family history and look for Ehlers‐Danlos syndromes. 

“You’re going to need several different specialists to try to really help our patients get back up and running,” he said.

Dr. Carroll reported no relevant financial relationships.

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

BOSTON – The investigational drug donanemab yielded greater amyloid clearance and amyloid plaque reduction than aducanumab in early, symptomatic Alzheimer’s disease, according to the results of a head-to-head study.

Nearly 40% of patients treated with donanemab had amyloid clearance at 6 months compared with less than 2% of those who received aducanumab, which was approved in 2021 amid a great deal of controversy.

Titration for donanemab progressed more quickly, with participants receiving a maximum dose twice as early as those on aducanumab, without any increase in rates of amyloid-related imaging abnormalities (ARIA) – the most common side effect of amyloid drugs.

Early results from the randomized phase 3 TRAILBLAZER-ALZ 4 trial of donanemab come just 3 months after the Food and Drug Administration denied manufacturer Eli Lilly’s request for accelerated approval for the drug.

“This study shows that the drug with the quicker titration scheme, donanemab, produced more amyloid lowering and did it without having more ARIA,” said lead investigator Stephen P. Salloway, MD, director of the Memory and Aging Program at Butler Hospital in Providence, R.I., and a professor of neurology at Brown University.

The findings were presented at the 2023 annual meeting of the American Academy of Neurology.
 

Multicenter, head-to-head trial

Donanemab received breakthrough therapy designation in 2021. The drug works similarly to aducanumab and lecanemab, which was approved earlier this year. All three bind to different parts of the amyloid molecule and stimulate an immune response to help clear amyloid plaques, although they each have a distinctive binding component.

TRAILBLAZER-ALZ 4 was conducted at 31 sites across the United States, enrolling 140 patients aged 50-85 years with early and symptomatic Alzheimer’s disease. Study participants received donanemab or aducanumab at escalating doses for 18 months.

Donanemab was titrated more quickly, with participants receiving 700 mg via IV infusion once a month for 3 months before reaching the maximum dose of 1,400 mg in the fourth month of the study.

Aducanumab titration was slower, beginning at 1 mg/kg via IV monthly for 2 months, then 3 mg/kg for another 2 months, and 6 mg/kg for 2 more months before reaching the maximum dose of 10 mg/kg in the seventh month.

After 6 months of treatment, PET scan analysis revealed that 37.9% of donanemab-treated patients achieved amyloid clearance compared with just 1.6% of those who received aducanumab (P < .001).

Among patients with intermediate tau levels (n = 27 for donanemab and n = 28 for aducanumab), 38.5% of those who received donanemab achieved amyloid clearance compared with 3.8% of patients in the aducanumab group (P = .008).

Amyloid levels were 65.2% lower in donanemab patients, while levels in those receiving aducanumab were reduced by 17.0% (P < .001). Among those with intermediate tau, amyloid levels decreased with donanemab by 63.9% and 25.4% with aducanumab (P ≤ .001).

Investigators also noted a greater reduction in plasma ptau217 with donanemab.

Adverse events were similar between groups, with 62.0% of the donanemab group and 66.7% of aducanumab-treated participants reporting an adverse event.

There were no serious adverse events due to ARIA with donanemab, but one participant in the aducanumab group had a serious adverse event linked to ARIA.

“Even though the amyloid lowering was greater with donanemab, the rate of ARIA was similar, which suggests that the speed and depth of amyloid removal is not driving ARIA,” Dr. Salloway said.

There are three other Trailblazer trials of donanemab. Unlike in similar trials, participants in all three of these studies who received the trial drug could discontinue treatment once criteria for amyloid clearance were met.

That’s precisely what happened with Trailblazer 2, the study on which Lilly based its request for accelerated approval. Ironically, that trial design also contributed to the FDA’s decision to reject that request.

The FDA required data from at least 100 patients who had received donanemab for a minimum of 1 year. While the trial included more than 100 patients, many patients discontinued treatment early after achieving the targeted amount of amyloid clearance.

“They had success, and they got punished for it, in my opinion,” Dr. Salloway said.

Final data from Trailblazer 2 is due in the next month, and if results are positive, Lilly is expected to file for full approval.
 

Questions remain

“This is an interesting study that suggests donanemab may remove amyloid faster in more people than aducanumab,” said Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, who commented on the findings.

Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, also commented on the findings. He noted that faster amyloid clearance “means less time for requiring sometimes burdensome and expensive infusions.”

Both Dr. Snyder and Dr. Fillit noted that longer-term results are needed, along with studies of whether amyloid clearance offers a protective benefit against Alzheimer’s dementia. More results from Trailblazer 4 will be reported after 12 months and again at 18 months.

“There are obviously still a lot of questions about these drugs and whether reducing amyloid plaque will actually preserve cognitive function or at least slow decline,” Dr. Fillit said.

It will also be important to understand the timing of treatment, including when anti-amyloid therapies should be administered and for how long.

“It will be important to understand how these results translate to patient care and treatment plans, should this drug receive FDA approval,” Dr. Snyder said. “Patients should have the opportunity to make a decision, alongside their physician, on a treatment path that is right for them.”

The study was funded by Eli Lilly. Dr. Salloway has been a consultant for Biogen, EISAI, Lilly, Genentech, Novo Nordisk, Prothena, and others. Dr. Snyder and Dr. Fillit have disclosed no relevant financial relationships.
 

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

BOSTON – The investigational drug donanemab yielded greater amyloid clearance and amyloid plaque reduction than aducanumab in early, symptomatic Alzheimer’s disease, according to the results of a head-to-head study.

Nearly 40% of patients treated with donanemab had amyloid clearance at 6 months compared with less than 2% of those who received aducanumab, which was approved in 2021 amid a great deal of controversy.

Titration for donanemab progressed more quickly, with participants receiving a maximum dose twice as early as those on aducanumab, without any increase in rates of amyloid-related imaging abnormalities (ARIA) – the most common side effect of amyloid drugs.

Early results from the randomized phase 3 TRAILBLAZER-ALZ 4 trial of donanemab come just 3 months after the Food and Drug Administration denied manufacturer Eli Lilly’s request for accelerated approval for the drug.

“This study shows that the drug with the quicker titration scheme, donanemab, produced more amyloid lowering and did it without having more ARIA,” said lead investigator Stephen P. Salloway, MD, director of the Memory and Aging Program at Butler Hospital in Providence, R.I., and a professor of neurology at Brown University.

The findings were presented at the 2023 annual meeting of the American Academy of Neurology.
 

Multicenter, head-to-head trial

Donanemab received breakthrough therapy designation in 2021. The drug works similarly to aducanumab and lecanemab, which was approved earlier this year. All three bind to different parts of the amyloid molecule and stimulate an immune response to help clear amyloid plaques, although they each have a distinctive binding component.

TRAILBLAZER-ALZ 4 was conducted at 31 sites across the United States, enrolling 140 patients aged 50-85 years with early and symptomatic Alzheimer’s disease. Study participants received donanemab or aducanumab at escalating doses for 18 months.

Donanemab was titrated more quickly, with participants receiving 700 mg via IV infusion once a month for 3 months before reaching the maximum dose of 1,400 mg in the fourth month of the study.

Aducanumab titration was slower, beginning at 1 mg/kg via IV monthly for 2 months, then 3 mg/kg for another 2 months, and 6 mg/kg for 2 more months before reaching the maximum dose of 10 mg/kg in the seventh month.

After 6 months of treatment, PET scan analysis revealed that 37.9% of donanemab-treated patients achieved amyloid clearance compared with just 1.6% of those who received aducanumab (P < .001).

Among patients with intermediate tau levels (n = 27 for donanemab and n = 28 for aducanumab), 38.5% of those who received donanemab achieved amyloid clearance compared with 3.8% of patients in the aducanumab group (P = .008).

Amyloid levels were 65.2% lower in donanemab patients, while levels in those receiving aducanumab were reduced by 17.0% (P < .001). Among those with intermediate tau, amyloid levels decreased with donanemab by 63.9% and 25.4% with aducanumab (P ≤ .001).

Investigators also noted a greater reduction in plasma ptau217 with donanemab.

Adverse events were similar between groups, with 62.0% of the donanemab group and 66.7% of aducanumab-treated participants reporting an adverse event.

There were no serious adverse events due to ARIA with donanemab, but one participant in the aducanumab group had a serious adverse event linked to ARIA.

“Even though the amyloid lowering was greater with donanemab, the rate of ARIA was similar, which suggests that the speed and depth of amyloid removal is not driving ARIA,” Dr. Salloway said.

There are three other Trailblazer trials of donanemab. Unlike in similar trials, participants in all three of these studies who received the trial drug could discontinue treatment once criteria for amyloid clearance were met.

That’s precisely what happened with Trailblazer 2, the study on which Lilly based its request for accelerated approval. Ironically, that trial design also contributed to the FDA’s decision to reject that request.

The FDA required data from at least 100 patients who had received donanemab for a minimum of 1 year. While the trial included more than 100 patients, many patients discontinued treatment early after achieving the targeted amount of amyloid clearance.

“They had success, and they got punished for it, in my opinion,” Dr. Salloway said.

Final data from Trailblazer 2 is due in the next month, and if results are positive, Lilly is expected to file for full approval.
 

Questions remain

“This is an interesting study that suggests donanemab may remove amyloid faster in more people than aducanumab,” said Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, who commented on the findings.

Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, also commented on the findings. He noted that faster amyloid clearance “means less time for requiring sometimes burdensome and expensive infusions.”

Both Dr. Snyder and Dr. Fillit noted that longer-term results are needed, along with studies of whether amyloid clearance offers a protective benefit against Alzheimer’s dementia. More results from Trailblazer 4 will be reported after 12 months and again at 18 months.

“There are obviously still a lot of questions about these drugs and whether reducing amyloid plaque will actually preserve cognitive function or at least slow decline,” Dr. Fillit said.

It will also be important to understand the timing of treatment, including when anti-amyloid therapies should be administered and for how long.

“It will be important to understand how these results translate to patient care and treatment plans, should this drug receive FDA approval,” Dr. Snyder said. “Patients should have the opportunity to make a decision, alongside their physician, on a treatment path that is right for them.”

The study was funded by Eli Lilly. Dr. Salloway has been a consultant for Biogen, EISAI, Lilly, Genentech, Novo Nordisk, Prothena, and others. Dr. Snyder and Dr. Fillit have disclosed no relevant financial relationships.
 

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

BOSTON – The investigational drug donanemab yielded greater amyloid clearance and amyloid plaque reduction than aducanumab in early, symptomatic Alzheimer’s disease, according to the results of a head-to-head study.

Nearly 40% of patients treated with donanemab had amyloid clearance at 6 months compared with less than 2% of those who received aducanumab, which was approved in 2021 amid a great deal of controversy.

Titration for donanemab progressed more quickly, with participants receiving a maximum dose twice as early as those on aducanumab, without any increase in rates of amyloid-related imaging abnormalities (ARIA) – the most common side effect of amyloid drugs.

Early results from the randomized phase 3 TRAILBLAZER-ALZ 4 trial of donanemab come just 3 months after the Food and Drug Administration denied manufacturer Eli Lilly’s request for accelerated approval for the drug.

“This study shows that the drug with the quicker titration scheme, donanemab, produced more amyloid lowering and did it without having more ARIA,” said lead investigator Stephen P. Salloway, MD, director of the Memory and Aging Program at Butler Hospital in Providence, R.I., and a professor of neurology at Brown University.

The findings were presented at the 2023 annual meeting of the American Academy of Neurology.
 

Multicenter, head-to-head trial

Donanemab received breakthrough therapy designation in 2021. The drug works similarly to aducanumab and lecanemab, which was approved earlier this year. All three bind to different parts of the amyloid molecule and stimulate an immune response to help clear amyloid plaques, although they each have a distinctive binding component.

TRAILBLAZER-ALZ 4 was conducted at 31 sites across the United States, enrolling 140 patients aged 50-85 years with early and symptomatic Alzheimer’s disease. Study participants received donanemab or aducanumab at escalating doses for 18 months.

Donanemab was titrated more quickly, with participants receiving 700 mg via IV infusion once a month for 3 months before reaching the maximum dose of 1,400 mg in the fourth month of the study.

Aducanumab titration was slower, beginning at 1 mg/kg via IV monthly for 2 months, then 3 mg/kg for another 2 months, and 6 mg/kg for 2 more months before reaching the maximum dose of 10 mg/kg in the seventh month.

After 6 months of treatment, PET scan analysis revealed that 37.9% of donanemab-treated patients achieved amyloid clearance compared with just 1.6% of those who received aducanumab (P < .001).

Among patients with intermediate tau levels (n = 27 for donanemab and n = 28 for aducanumab), 38.5% of those who received donanemab achieved amyloid clearance compared with 3.8% of patients in the aducanumab group (P = .008).

Amyloid levels were 65.2% lower in donanemab patients, while levels in those receiving aducanumab were reduced by 17.0% (P < .001). Among those with intermediate tau, amyloid levels decreased with donanemab by 63.9% and 25.4% with aducanumab (P ≤ .001).

Investigators also noted a greater reduction in plasma ptau217 with donanemab.

Adverse events were similar between groups, with 62.0% of the donanemab group and 66.7% of aducanumab-treated participants reporting an adverse event.

There were no serious adverse events due to ARIA with donanemab, but one participant in the aducanumab group had a serious adverse event linked to ARIA.

“Even though the amyloid lowering was greater with donanemab, the rate of ARIA was similar, which suggests that the speed and depth of amyloid removal is not driving ARIA,” Dr. Salloway said.

There are three other Trailblazer trials of donanemab. Unlike in similar trials, participants in all three of these studies who received the trial drug could discontinue treatment once criteria for amyloid clearance were met.

That’s precisely what happened with Trailblazer 2, the study on which Lilly based its request for accelerated approval. Ironically, that trial design also contributed to the FDA’s decision to reject that request.

The FDA required data from at least 100 patients who had received donanemab for a minimum of 1 year. While the trial included more than 100 patients, many patients discontinued treatment early after achieving the targeted amount of amyloid clearance.

“They had success, and they got punished for it, in my opinion,” Dr. Salloway said.

Final data from Trailblazer 2 is due in the next month, and if results are positive, Lilly is expected to file for full approval.
 

Questions remain

“This is an interesting study that suggests donanemab may remove amyloid faster in more people than aducanumab,” said Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, who commented on the findings.

Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, also commented on the findings. He noted that faster amyloid clearance “means less time for requiring sometimes burdensome and expensive infusions.”

Both Dr. Snyder and Dr. Fillit noted that longer-term results are needed, along with studies of whether amyloid clearance offers a protective benefit against Alzheimer’s dementia. More results from Trailblazer 4 will be reported after 12 months and again at 18 months.

“There are obviously still a lot of questions about these drugs and whether reducing amyloid plaque will actually preserve cognitive function or at least slow decline,” Dr. Fillit said.

It will also be important to understand the timing of treatment, including when anti-amyloid therapies should be administered and for how long.

“It will be important to understand how these results translate to patient care and treatment plans, should this drug receive FDA approval,” Dr. Snyder said. “Patients should have the opportunity to make a decision, alongside their physician, on a treatment path that is right for them.”

The study was funded by Eli Lilly. Dr. Salloway has been a consultant for Biogen, EISAI, Lilly, Genentech, Novo Nordisk, Prothena, and others. Dr. Snyder and Dr. Fillit have disclosed no relevant financial relationships.
 

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

In this supplement to Family Medicine, Charles P Vega, MD, and Pamela R Kushner, MD, discuss failure of the PROMINENT trial and implications for use of fibrates to reduce cardiovascular risk.

Read More 

In this supplement to Family Medicine, Charles P Vega, MD, and Pamela R Kushner, MD, discuss failure of the PROMINENT trial and implications for use of fibrates to reduce cardiovascular risk.

Read More 

In this supplement to Family Medicine, Charles P Vega, MD, and Pamela R Kushner, MD, discuss failure of the PROMINENT trial and implications for use of fibrates to reduce cardiovascular risk.

Read More 

WASHINGTON – A novel program for parents of highly dependent adult children reduces parental burden and anxiety in their offspring, a new pilot study shows.

Known as failure to launch (FTL) syndrome, the criteria for this condition include the absence of a neurodevelopmental, mental, or intellectual condition, difficulty adapting to the challenges of adulthood, and living with or at the expense of parents.

Results suggest that the program benefits families dealing with FTL, said study investigator Uri Berger, PhD, postdoctoral associate, Yale Child Study Center Anxiety and Mood Disorders Program, New Haven, Conn.

“If you encounter parents who are say 50-60 years old who have a child with FTL, you can tell them there’s something they can do; there’s work they can do even if their child is refusing to go to therapy,” he said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Anxious, isolated

Estimates suggest that there are 3.3 million physically able adults with FTL and that the disorder may be on the rise. These individuals often present with mental health symptoms including anxiety, depression, and suicidality, and tend to be socially isolated.

The investigators noted that intervening is often challenging because individuals with the syndrome are frequently noncompliant with therapy, and currently there is no standard of care.

“The longer you’re isolated, the harder it is getting out of your cocoon, and when these adult children get to the point where they seek help, they’re less likely to comply,” he said. However, he noted, this is not because they are lazy; it’s that they’re “very, very anxious.”

Parents and other family members are also negatively affected. Dr. Berger noted that 15% of parents of a child with FTL equate their caregiver burden with having a family member with a chronic physical illness. “It’s huge; parents go through hell and it’s very hard on them. Many believe it is their fault and they feel a lot of shame.”

Supportive Parenting for Anxious Childhood Emotions (SPACE) is a manualized, parent-based program for childhood anxiety and obsessive-compulsive disorder. It has been tested in clinical trials and found to be noninferior to cognitive behavioral therapy for childhood anxiety.

The research adapted it to treat FTL. SPACE-FTL focuses on reducing parents’ family accommodation (FA), a descriptor for a child’s excessive dependence on their parents to help them avoid anxiety-provoking situations.

The study examined the feasibility, acceptability, and treatment satisfaction and its effect on adult child psychopathology symptoms, parents’ FA, and the paternal burden of caring for adult children.

The study included parents (mean age, 59.46 years; 85% female) of 40 adult children with FTL (mean age, 23.51 years; 20% female) from across the United States.

Parents were randomized to a 13-week wait-list or the SPACE-FTL program, which involves 13-20 therapy sessions, depending on the need. The average number of sessions in the study was 15. The program has five key components:

• Providing information emphasizing FTL as not a character flaw but a problem with anxiety.
• Helping parents identify how they accommodate their child’s behavior, and facilitating an environment that encourages independence.
• Getting parents to show acceptance and confidence in their child who’s trying to overcome anxiety when, for example, they seek employment, instead of being overprotective and demanding.
• Focusing on change nonconfrontationally.
• Involving other family, community members, and professionals who can support the parent, child, or both.

The recruitment, treatment sessions, and assessments were all done online. Most participants rated the intervention as highly satisfactory on the Client Satisfaction Questionnaire (CSQ-8; mean score, 27.7 out of a maximum of 32). About 60% of the offspring no longer met full criteria for FTL (P < .001; Cohen’s D = 1.76).

All children of the wait-listed parents still met criteria for FTL.

FTL symptoms decreased significantly in the offspring of the intervention group, as seen in both in the Adult Entitled Dependence Scale (AED; P < .05; Cohen’s D = 0.84); and the Adaptive Behaviors Scale (ABS; P < .05; Cohen’s D = 0.70).

There was no change in anxiety as assessed by the Adult Behavior Checklist (ABCL). But Dr. Berger noted that child anxiety is difficult to assess through parental report.

“This population is self-isolating and parents sometimes don’t know what’s going on,” and ABCL measures may not be “as sensitive as we would have liked them to be,” Dr. Berger said.

Parental burden was significantly decreased as measured by the Zarit Burden Interview (ZBI; P < .05; Cohen’s D = 0.70). In addition, family accommodation decreased significantly as determined by the Family Accommodation Scale–Anxiety (FASA; P < .05; Cohen’s D = 0.70).
 

Innovative work

In a comment, Jonathan E. Alpert, MD, PhD, chair, department of psychiatry and behavioral sciences, and professor of psychiatry, neuroscience, and pediatrics, Albert Einstein College of Medicine, New York, described the program as “innovative.”

He noted that the SPACE-FTL approach provides parents with education and skills to reduce behaviors that reinforce their child’s avoidance of independent activities. Such behaviors “may inadvertently contribute to the adult child remaining stuck,” he said.

“Through its involvement of parents and use of a structured approach, SPACE-FTL is a very interesting step toward more evidence-based therapies.”

However, he noted that the number of study participants is still “very low” and further work is needed to better characterize this condition and develop effective therapies.

He noted that parents of adult children with FTL should not be judged or blamed. “They have been living with a worrisome problem for years and are simply doing their best to cope as any of us would do.”

In addition, he noted that some adult children aren’t capable of launching because of a serious mental illness or substance use disorder that needs treatment.

It’s unclear just how many adult children have FTL, as the condition lacks formal, agreed-upon clinical and research criteria and a reliable evidence base for treatment, Dr. Alpert said.

“Whatever the actual numbers of FTL, my anecdotal clinical experience suggests that it is a very common problem which is understudied.”

He added that the definitions of FTL should include cultural context. In some groups, it’s quite normal for adults in their 20s, 30s, or even older to live with their parents, Dr. Alpert said.

Dr. Berger and Dr. Albert report no relevant financial relationships.

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

WASHINGTON – A novel program for parents of highly dependent adult children reduces parental burden and anxiety in their offspring, a new pilot study shows.

Known as failure to launch (FTL) syndrome, the criteria for this condition include the absence of a neurodevelopmental, mental, or intellectual condition, difficulty adapting to the challenges of adulthood, and living with or at the expense of parents.

Results suggest that the program benefits families dealing with FTL, said study investigator Uri Berger, PhD, postdoctoral associate, Yale Child Study Center Anxiety and Mood Disorders Program, New Haven, Conn.

“If you encounter parents who are say 50-60 years old who have a child with FTL, you can tell them there’s something they can do; there’s work they can do even if their child is refusing to go to therapy,” he said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Anxious, isolated

Estimates suggest that there are 3.3 million physically able adults with FTL and that the disorder may be on the rise. These individuals often present with mental health symptoms including anxiety, depression, and suicidality, and tend to be socially isolated.

The investigators noted that intervening is often challenging because individuals with the syndrome are frequently noncompliant with therapy, and currently there is no standard of care.

“The longer you’re isolated, the harder it is getting out of your cocoon, and when these adult children get to the point where they seek help, they’re less likely to comply,” he said. However, he noted, this is not because they are lazy; it’s that they’re “very, very anxious.”

Parents and other family members are also negatively affected. Dr. Berger noted that 15% of parents of a child with FTL equate their caregiver burden with having a family member with a chronic physical illness. “It’s huge; parents go through hell and it’s very hard on them. Many believe it is their fault and they feel a lot of shame.”

Supportive Parenting for Anxious Childhood Emotions (SPACE) is a manualized, parent-based program for childhood anxiety and obsessive-compulsive disorder. It has been tested in clinical trials and found to be noninferior to cognitive behavioral therapy for childhood anxiety.

The research adapted it to treat FTL. SPACE-FTL focuses on reducing parents’ family accommodation (FA), a descriptor for a child’s excessive dependence on their parents to help them avoid anxiety-provoking situations.

The study examined the feasibility, acceptability, and treatment satisfaction and its effect on adult child psychopathology symptoms, parents’ FA, and the paternal burden of caring for adult children.

The study included parents (mean age, 59.46 years; 85% female) of 40 adult children with FTL (mean age, 23.51 years; 20% female) from across the United States.

Parents were randomized to a 13-week wait-list or the SPACE-FTL program, which involves 13-20 therapy sessions, depending on the need. The average number of sessions in the study was 15. The program has five key components:

• Providing information emphasizing FTL as not a character flaw but a problem with anxiety.
• Helping parents identify how they accommodate their child’s behavior, and facilitating an environment that encourages independence.
• Getting parents to show acceptance and confidence in their child who’s trying to overcome anxiety when, for example, they seek employment, instead of being overprotective and demanding.
• Focusing on change nonconfrontationally.
• Involving other family, community members, and professionals who can support the parent, child, or both.

The recruitment, treatment sessions, and assessments were all done online. Most participants rated the intervention as highly satisfactory on the Client Satisfaction Questionnaire (CSQ-8; mean score, 27.7 out of a maximum of 32). About 60% of the offspring no longer met full criteria for FTL (P < .001; Cohen’s D = 1.76).

All children of the wait-listed parents still met criteria for FTL.

FTL symptoms decreased significantly in the offspring of the intervention group, as seen in both in the Adult Entitled Dependence Scale (AED; P < .05; Cohen’s D = 0.84); and the Adaptive Behaviors Scale (ABS; P < .05; Cohen’s D = 0.70).

There was no change in anxiety as assessed by the Adult Behavior Checklist (ABCL). But Dr. Berger noted that child anxiety is difficult to assess through parental report.

“This population is self-isolating and parents sometimes don’t know what’s going on,” and ABCL measures may not be “as sensitive as we would have liked them to be,” Dr. Berger said.

Parental burden was significantly decreased as measured by the Zarit Burden Interview (ZBI; P < .05; Cohen’s D = 0.70). In addition, family accommodation decreased significantly as determined by the Family Accommodation Scale–Anxiety (FASA; P < .05; Cohen’s D = 0.70).
 

Innovative work

In a comment, Jonathan E. Alpert, MD, PhD, chair, department of psychiatry and behavioral sciences, and professor of psychiatry, neuroscience, and pediatrics, Albert Einstein College of Medicine, New York, described the program as “innovative.”

He noted that the SPACE-FTL approach provides parents with education and skills to reduce behaviors that reinforce their child’s avoidance of independent activities. Such behaviors “may inadvertently contribute to the adult child remaining stuck,” he said.

“Through its involvement of parents and use of a structured approach, SPACE-FTL is a very interesting step toward more evidence-based therapies.”

However, he noted that the number of study participants is still “very low” and further work is needed to better characterize this condition and develop effective therapies.

He noted that parents of adult children with FTL should not be judged or blamed. “They have been living with a worrisome problem for years and are simply doing their best to cope as any of us would do.”

In addition, he noted that some adult children aren’t capable of launching because of a serious mental illness or substance use disorder that needs treatment.

It’s unclear just how many adult children have FTL, as the condition lacks formal, agreed-upon clinical and research criteria and a reliable evidence base for treatment, Dr. Alpert said.

“Whatever the actual numbers of FTL, my anecdotal clinical experience suggests that it is a very common problem which is understudied.”

He added that the definitions of FTL should include cultural context. In some groups, it’s quite normal for adults in their 20s, 30s, or even older to live with their parents, Dr. Alpert said.

Dr. Berger and Dr. Albert report no relevant financial relationships.

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

WASHINGTON – A novel program for parents of highly dependent adult children reduces parental burden and anxiety in their offspring, a new pilot study shows.

Known as failure to launch (FTL) syndrome, the criteria for this condition include the absence of a neurodevelopmental, mental, or intellectual condition, difficulty adapting to the challenges of adulthood, and living with or at the expense of parents.

Results suggest that the program benefits families dealing with FTL, said study investigator Uri Berger, PhD, postdoctoral associate, Yale Child Study Center Anxiety and Mood Disorders Program, New Haven, Conn.

“If you encounter parents who are say 50-60 years old who have a child with FTL, you can tell them there’s something they can do; there’s work they can do even if their child is refusing to go to therapy,” he said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Anxious, isolated

Estimates suggest that there are 3.3 million physically able adults with FTL and that the disorder may be on the rise. These individuals often present with mental health symptoms including anxiety, depression, and suicidality, and tend to be socially isolated.

The investigators noted that intervening is often challenging because individuals with the syndrome are frequently noncompliant with therapy, and currently there is no standard of care.

“The longer you’re isolated, the harder it is getting out of your cocoon, and when these adult children get to the point where they seek help, they’re less likely to comply,” he said. However, he noted, this is not because they are lazy; it’s that they’re “very, very anxious.”

Parents and other family members are also negatively affected. Dr. Berger noted that 15% of parents of a child with FTL equate their caregiver burden with having a family member with a chronic physical illness. “It’s huge; parents go through hell and it’s very hard on them. Many believe it is their fault and they feel a lot of shame.”

Supportive Parenting for Anxious Childhood Emotions (SPACE) is a manualized, parent-based program for childhood anxiety and obsessive-compulsive disorder. It has been tested in clinical trials and found to be noninferior to cognitive behavioral therapy for childhood anxiety.

The research adapted it to treat FTL. SPACE-FTL focuses on reducing parents’ family accommodation (FA), a descriptor for a child’s excessive dependence on their parents to help them avoid anxiety-provoking situations.

The study examined the feasibility, acceptability, and treatment satisfaction and its effect on adult child psychopathology symptoms, parents’ FA, and the paternal burden of caring for adult children.

The study included parents (mean age, 59.46 years; 85% female) of 40 adult children with FTL (mean age, 23.51 years; 20% female) from across the United States.

Parents were randomized to a 13-week wait-list or the SPACE-FTL program, which involves 13-20 therapy sessions, depending on the need. The average number of sessions in the study was 15. The program has five key components:

• Providing information emphasizing FTL as not a character flaw but a problem with anxiety.
• Helping parents identify how they accommodate their child’s behavior, and facilitating an environment that encourages independence.
• Getting parents to show acceptance and confidence in their child who’s trying to overcome anxiety when, for example, they seek employment, instead of being overprotective and demanding.
• Focusing on change nonconfrontationally.
• Involving other family, community members, and professionals who can support the parent, child, or both.

The recruitment, treatment sessions, and assessments were all done online. Most participants rated the intervention as highly satisfactory on the Client Satisfaction Questionnaire (CSQ-8; mean score, 27.7 out of a maximum of 32). About 60% of the offspring no longer met full criteria for FTL (P < .001; Cohen’s D = 1.76).

All children of the wait-listed parents still met criteria for FTL.

FTL symptoms decreased significantly in the offspring of the intervention group, as seen in both in the Adult Entitled Dependence Scale (AED; P < .05; Cohen’s D = 0.84); and the Adaptive Behaviors Scale (ABS; P < .05; Cohen’s D = 0.70).

There was no change in anxiety as assessed by the Adult Behavior Checklist (ABCL). But Dr. Berger noted that child anxiety is difficult to assess through parental report.

“This population is self-isolating and parents sometimes don’t know what’s going on,” and ABCL measures may not be “as sensitive as we would have liked them to be,” Dr. Berger said.

Parental burden was significantly decreased as measured by the Zarit Burden Interview (ZBI; P < .05; Cohen’s D = 0.70). In addition, family accommodation decreased significantly as determined by the Family Accommodation Scale–Anxiety (FASA; P < .05; Cohen’s D = 0.70).
 

Innovative work

In a comment, Jonathan E. Alpert, MD, PhD, chair, department of psychiatry and behavioral sciences, and professor of psychiatry, neuroscience, and pediatrics, Albert Einstein College of Medicine, New York, described the program as “innovative.”

He noted that the SPACE-FTL approach provides parents with education and skills to reduce behaviors that reinforce their child’s avoidance of independent activities. Such behaviors “may inadvertently contribute to the adult child remaining stuck,” he said.

“Through its involvement of parents and use of a structured approach, SPACE-FTL is a very interesting step toward more evidence-based therapies.”

However, he noted that the number of study participants is still “very low” and further work is needed to better characterize this condition and develop effective therapies.

He noted that parents of adult children with FTL should not be judged or blamed. “They have been living with a worrisome problem for years and are simply doing their best to cope as any of us would do.”

In addition, he noted that some adult children aren’t capable of launching because of a serious mental illness or substance use disorder that needs treatment.

It’s unclear just how many adult children have FTL, as the condition lacks formal, agreed-upon clinical and research criteria and a reliable evidence base for treatment, Dr. Alpert said.

“Whatever the actual numbers of FTL, my anecdotal clinical experience suggests that it is a very common problem which is understudied.”

He added that the definitions of FTL should include cultural context. In some groups, it’s quite normal for adults in their 20s, 30s, or even older to live with their parents, Dr. Alpert said.

Dr. Berger and Dr. Albert report no relevant financial relationships.

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

A cohort study by Minami and colleagues assessed the association between surgery type (lumpectomy vs mastectomy) and change in frailty status in older patients with early-stage breast cancer (BC) undergoing locoregional therapy. The study included 31,084 women, age ≥ 65 years, with ductal carcinoma in situ (n = 9962) or stage I hormone receptor–positive (HR+) and ERBB2+ (human epidermal growth factor receptor 2 positive [HER2+]) BC (n = 21,122), of which 22.6% and 77.4% of patients underwent mastectomy and lumpectomy, respectively. The study showed that older patients who underwent mastectomy vs lumpectomy were more likely to experience worse frailty (adjusted odds ratio 1.31; 95% CI 1.23-1.39). Additionally, women who were robust vs having moderate to severe frailty at baseline, ≥ 75 years vs 65-69 years, or African American/Black vs non-Hispanic White, had significantly higher odds of decline. Given that prior data have shown comparable survival between lumpectomy and mastectomy, careful and thoughtful treatment considerations are needed before deciding to intensify surgical management in this population, even in women who do not appear frail at baseline.

Low-dose tamoxifen continues to prevent BC recurrence in breast noninvasive neoplasia

Low-dose tamoxifen is a treatment option for women with noninvasive BC, especially if the patient was not able to tolerate the standard dose of 20 mg daily. The phase 3 TAM-01 trial included 500 women with intraepithelial neoplasia of the breast who were randomly assigned to receive low-dose tamoxifen (5 mg once daily) or placebo. The 10-year follow-up analysis by Lazzeroni and colleagues showed that treatment with low-dose tamoxifen for 3 years continued to prevent a BC recurrence for at least 7 years after treatment cessation. After a median follow-up of 9.7 years, fewer cases of both invasive and in situ BC (hazard ratio 0.58; log-rank P = .03) and contralateral BC (hazard ratio 0.36; P = .025) were reported in the tamoxifen vs placebo group. These results are meaningful, especially in a setting of an optimal safety profile, where patients on low-dose tamoxifen were experiencing similar menopausal symptoms to placebo, and serious adverse events, such as deep vein thrombosis and pulmonary embolism, were not increased during low-dose tamoxifen therapy. This is different from the threefold increased risk reported with standard dosing.

Worse survival in BRCA1/2 germline mutation carriers receiving ET in HR+/HER2− BC

Inconsistent data have been reported on the prognostic impact of BRCA1/2 mutation in HR+ BC. A retrospective study by Frenel and colleagues included 13,776 patients with metastatic BC (MBC) from the Epidemiological Strategy and Medical Economics (ESME) MBC database, of which 676 and 170 patients were germline BRCA wild-type (gBRCAwt) and germline BRCA mutation (gBRCAm) carriers, respectively. They looked at outcomes and first-line endocrine treatment efficacy in patients with HR+/HER2- MBC, treated in a pre–cyclin-dependent kinase (CDK) 4/6 inhibitors era. The results showed that gBRCAm carriers had shorter overall survival (OS; adjusted hazard ratio [aHR] 1.26; P = .024) and progression-free survival (PFS; aHR 1.21; P = .017) compared with gBRCAwt carriers. Furthermore, among those treated with front-line endocrine therapy, gBRCAm patients had lower adjusted OS (aHR [95% CI] 1.54 [1.03-2.32]) and PFS (aHR [95% CI] 1.58 [1.17-2.12]) compared with gBRCAwt patients. Outcomes were similar for gBRCAm patients who received first-line chemotherapy compared with the gBRCAwt group (OS: aHR [95% CI] 1.12 [0.88-1.41]; first-line PFS: aHR [95% CI] 1.09 [0.90-1.31]). A previous retrospective study by Lambertini and colleagues, focusing on young patients with gBRCAm, also showed a tendency for a worse distant recurrence-free interval (aHR 1.39; 95% CI  0.94-2.05) in patients with HR+ BC. Additional studies are needed, especially in the setting of an evolving treatment landscape that includes CDK4/6 inhibitors and poly-ADP ribose polymerase (PARP) inhibitors.

A cohort study by Minami and colleagues assessed the association between surgery type (lumpectomy vs mastectomy) and change in frailty status in older patients with early-stage breast cancer (BC) undergoing locoregional therapy. The study included 31,084 women, age ≥ 65 years, with ductal carcinoma in situ (n = 9962) or stage I hormone receptor–positive (HR+) and ERBB2+ (human epidermal growth factor receptor 2 positive [HER2+]) BC (n = 21,122), of which 22.6% and 77.4% of patients underwent mastectomy and lumpectomy, respectively. The study showed that older patients who underwent mastectomy vs lumpectomy were more likely to experience worse frailty (adjusted odds ratio 1.31; 95% CI 1.23-1.39). Additionally, women who were robust vs having moderate to severe frailty at baseline, ≥ 75 years vs 65-69 years, or African American/Black vs non-Hispanic White, had significantly higher odds of decline. Given that prior data have shown comparable survival between lumpectomy and mastectomy, careful and thoughtful treatment considerations are needed before deciding to intensify surgical management in this population, even in women who do not appear frail at baseline.

Low-dose tamoxifen continues to prevent BC recurrence in breast noninvasive neoplasia

Low-dose tamoxifen is a treatment option for women with noninvasive BC, especially if the patient was not able to tolerate the standard dose of 20 mg daily. The phase 3 TAM-01 trial included 500 women with intraepithelial neoplasia of the breast who were randomly assigned to receive low-dose tamoxifen (5 mg once daily) or placebo. The 10-year follow-up analysis by Lazzeroni and colleagues showed that treatment with low-dose tamoxifen for 3 years continued to prevent a BC recurrence for at least 7 years after treatment cessation. After a median follow-up of 9.7 years, fewer cases of both invasive and in situ BC (hazard ratio 0.58; log-rank P = .03) and contralateral BC (hazard ratio 0.36; P = .025) were reported in the tamoxifen vs placebo group. These results are meaningful, especially in a setting of an optimal safety profile, where patients on low-dose tamoxifen were experiencing similar menopausal symptoms to placebo, and serious adverse events, such as deep vein thrombosis and pulmonary embolism, were not increased during low-dose tamoxifen therapy. This is different from the threefold increased risk reported with standard dosing.

Worse survival in BRCA1/2 germline mutation carriers receiving ET in HR+/HER2− BC

Inconsistent data have been reported on the prognostic impact of BRCA1/2 mutation in HR+ BC. A retrospective study by Frenel and colleagues included 13,776 patients with metastatic BC (MBC) from the Epidemiological Strategy and Medical Economics (ESME) MBC database, of which 676 and 170 patients were germline BRCA wild-type (gBRCAwt) and germline BRCA mutation (gBRCAm) carriers, respectively. They looked at outcomes and first-line endocrine treatment efficacy in patients with HR+/HER2- MBC, treated in a pre–cyclin-dependent kinase (CDK) 4/6 inhibitors era. The results showed that gBRCAm carriers had shorter overall survival (OS; adjusted hazard ratio [aHR] 1.26; P = .024) and progression-free survival (PFS; aHR 1.21; P = .017) compared with gBRCAwt carriers. Furthermore, among those treated with front-line endocrine therapy, gBRCAm patients had lower adjusted OS (aHR [95% CI] 1.54 [1.03-2.32]) and PFS (aHR [95% CI] 1.58 [1.17-2.12]) compared with gBRCAwt patients. Outcomes were similar for gBRCAm patients who received first-line chemotherapy compared with the gBRCAwt group (OS: aHR [95% CI] 1.12 [0.88-1.41]; first-line PFS: aHR [95% CI] 1.09 [0.90-1.31]). A previous retrospective study by Lambertini and colleagues, focusing on young patients with gBRCAm, also showed a tendency for a worse distant recurrence-free interval (aHR 1.39; 95% CI  0.94-2.05) in patients with HR+ BC. Additional studies are needed, especially in the setting of an evolving treatment landscape that includes CDK4/6 inhibitors and poly-ADP ribose polymerase (PARP) inhibitors.

A cohort study by Minami and colleagues assessed the association between surgery type (lumpectomy vs mastectomy) and change in frailty status in older patients with early-stage breast cancer (BC) undergoing locoregional therapy. The study included 31,084 women, age ≥ 65 years, with ductal carcinoma in situ (n = 9962) or stage I hormone receptor–positive (HR+) and ERBB2+ (human epidermal growth factor receptor 2 positive [HER2+]) BC (n = 21,122), of which 22.6% and 77.4% of patients underwent mastectomy and lumpectomy, respectively. The study showed that older patients who underwent mastectomy vs lumpectomy were more likely to experience worse frailty (adjusted odds ratio 1.31; 95% CI 1.23-1.39). Additionally, women who were robust vs having moderate to severe frailty at baseline, ≥ 75 years vs 65-69 years, or African American/Black vs non-Hispanic White, had significantly higher odds of decline. Given that prior data have shown comparable survival between lumpectomy and mastectomy, careful and thoughtful treatment considerations are needed before deciding to intensify surgical management in this population, even in women who do not appear frail at baseline.

Low-dose tamoxifen continues to prevent BC recurrence in breast noninvasive neoplasia

Low-dose tamoxifen is a treatment option for women with noninvasive BC, especially if the patient was not able to tolerate the standard dose of 20 mg daily. The phase 3 TAM-01 trial included 500 women with intraepithelial neoplasia of the breast who were randomly assigned to receive low-dose tamoxifen (5 mg once daily) or placebo. The 10-year follow-up analysis by Lazzeroni and colleagues showed that treatment with low-dose tamoxifen for 3 years continued to prevent a BC recurrence for at least 7 years after treatment cessation. After a median follow-up of 9.7 years, fewer cases of both invasive and in situ BC (hazard ratio 0.58; log-rank P = .03) and contralateral BC (hazard ratio 0.36; P = .025) were reported in the tamoxifen vs placebo group. These results are meaningful, especially in a setting of an optimal safety profile, where patients on low-dose tamoxifen were experiencing similar menopausal symptoms to placebo, and serious adverse events, such as deep vein thrombosis and pulmonary embolism, were not increased during low-dose tamoxifen therapy. This is different from the threefold increased risk reported with standard dosing.

Worse survival in BRCA1/2 germline mutation carriers receiving ET in HR+/HER2− BC

Inconsistent data have been reported on the prognostic impact of BRCA1/2 mutation in HR+ BC. A retrospective study by Frenel and colleagues included 13,776 patients with metastatic BC (MBC) from the Epidemiological Strategy and Medical Economics (ESME) MBC database, of which 676 and 170 patients were germline BRCA wild-type (gBRCAwt) and germline BRCA mutation (gBRCAm) carriers, respectively. They looked at outcomes and first-line endocrine treatment efficacy in patients with HR+/HER2- MBC, treated in a pre–cyclin-dependent kinase (CDK) 4/6 inhibitors era. The results showed that gBRCAm carriers had shorter overall survival (OS; adjusted hazard ratio [aHR] 1.26; P = .024) and progression-free survival (PFS; aHR 1.21; P = .017) compared with gBRCAwt carriers. Furthermore, among those treated with front-line endocrine therapy, gBRCAm patients had lower adjusted OS (aHR [95% CI] 1.54 [1.03-2.32]) and PFS (aHR [95% CI] 1.58 [1.17-2.12]) compared with gBRCAwt patients. Outcomes were similar for gBRCAm patients who received first-line chemotherapy compared with the gBRCAwt group (OS: aHR [95% CI] 1.12 [0.88-1.41]; first-line PFS: aHR [95% CI] 1.09 [0.90-1.31]). A previous retrospective study by Lambertini and colleagues, focusing on young patients with gBRCAm, also showed a tendency for a worse distant recurrence-free interval (aHR 1.39; 95% CI  0.94-2.05) in patients with HR+ BC. Additional studies are needed, especially in the setting of an evolving treatment landscape that includes CDK4/6 inhibitors and poly-ADP ribose polymerase (PARP) inhibitors.

SAN DIEGO – Emerging biomarkers and treatments offer more options to diagnose and manage Alzheimer’s disease (AD) and related dementias, but high costs and potentially serious complications mean using them with caution, said a presenter at the annual meeting of the American College of Physicians.

Dementia prevalence is increasing as the proportion of the U.S. population older than 65 rises, said Zaldy Tan, MD, professor of neurology at Cedars-Sinai Medical Center, Los Angeles. AD deaths more than doubled between 2000 and 2018, he noted, while deaths from HIV infection, stroke, and heart disease decreased.

Most people in the United States who have AD are White, but studies suggest that, compared with Whites, the risk of AD is two times higher in Blacks and 1.5 times higher in Hispanics . “These data suggest that both genes and social determinants of health are at play,” Dr. Tan said.
 

Diagnosis of Alzheimer’s disease

The different types of dementia make it challenging for primary care physicians to identify the cause of cognitive impairment. “Even though AD is the most common type, clinicians should keep in mind that another type of dementia may be the cause of cognitive impairment,” Dr. Tan cautioned. Other dementia diagnoses include vascular, Lewy body, and frontotemporal.

Diagnostic criteria for AD include evidence of significant cognitive decline in at least one cognitive domain that interferes with independence in everyday activities, as well as the absence of another mental disorder or delirium that would explain the cognitive deficits.

“We see many patients with depressive symptoms and mild cognitive impairment, and it is not always easy to tell which of them have dementia because of the overlap in the symptoms of depression and AD,” said internist Roderick Kim, MD, of Grand Rapids, Mich., who attended the session.

It can be challenging to convince patients to undergo the appropriate diagnostic workup, Dr. Kim said. “This can delay treatment, so it is important to explain to patients that cognitive decline can progress quickly and that there are treatment options to slow it down.”
 

Why do we need biomarkers for Alzheimer’s disease?

AD is characterized by a long preclinical phase with no specific symptoms other than the typical signs and symptoms of aging, Dr. Tan said. That means cognitive impairment progresses rapidly after diagnosis in most patients with AD.

“In most cases, an accurate history, physical and neurologic examinations, basic labs, and neuroimaging are sufficient for memory loss evaluation. However, as more disease-modifying therapies come to market, biomarkers will rise in importance in primary care,” he said.

This long asymptomatic phase of AD creates the need for diagnostic biomarkers for an earlier diagnosis, he said. Amyloid-beta and tau deposits in PET images and the levels of amyloid-beta seeds, phosphorylated tau, and neurofilament light chain in the cerebrospinal fluid can be used as diagnostic biomarkers in patients with suspected AD. Emerging blood biomarkers for earlier detection include the levels of amyloid-beta_1–42, phosphorylated tau, and neurofilament light chain.

With biomarkers and other new tools for the diagnosis of dementia in primary care, Dr. Tan said: “The greatest challenge is cost, as blood-based biomarkers are not currently covered by insurance and still rather costly. In addition, blood-based biomarkers will need to receive [Food and Drug Administration] approval in order to have more widespread availability.”


 

New and emerging therapies for Alzheimer’s disease

There are two classes of FDA-approved medications to manage cognitive symptoms of dementia: acetylcholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists. The selections may be trial and error for each patient, Dr. Tan said.

“The approved medications can exert subtle benefits that are clinically observable. Thus, barring any contraindications or intolerance, most patients with AD would benefit from a trial of one or both of these medication classes,” said Dr. Tan. He added that it is equally important to wean off and discontinue these medications if there is intolerance or lack of a subjective or objective beneficial response.

Other medications are available for some of the most common behavioral problems associated with dementia, such as agitation, depression, and disorientation. Dr. Tan advised not to prescribe behavioral medications until nonpharmacologic interventions prove to be ineffective or impractical. Behavioral medications have many side effects, some of which are potentially serious, he said, so the risk-benefit ratio should be considered.

In his own practice, when nonpharmacologic strategies do not improve the behavioral symptoms of dementia, Dr. Tan said that, “in cases where a person is at risk of harm to themselves or others, a discussion with the patient and their caregivers about the pros and cons of medications to treat the behavior need to be had. Careful monitoring of the response and dose escalation or deprescribing when appropriate is important to keep in mind.”

Disease-modifying agents have recently provided new hope for AD treatment. Aducanumab and lecanemab, both monoclonal antibodies that target amyloids, are the first two drugs that received accelerated FDA approval for AD.

Although these monoclonal antibodies can help clear deposited amyloid plaques and show some benefit in slowing cognitive impairment in clinical trials, the real-world benefits were unclear enough for Medicare to limit coverage to people enrolled in approved studies to gather more data. Additionally, these agents can cause potentially amyloid-related imaging abnormalities, which may indicate edema, effusion, or microhemorrhage. Therefore, clinicians need to have a clear conversation of risks and benefits with patients and caregivers about these treatments.
 

Looking ahead

When asked about the most promising emerging technologies or techniques related to dementia diagnosis and management, Dr. Tan noted that multiple technology companies and start-ups are looking for new ways to detect dementia earlier or keep persons with dementia safe at home. Some devices deliver brain waves, computerized brain games or tests, automated pill dispensers, and fall monitors.

“Some of these are potentially helpful, but not every person with dementia will benefit. In addition, most of these technologies are out-of-pocket expenses for the patients and their families. It is important to know what is out there but also be cautious about outrageous claims,” he added.

Dr. Tan reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.

SAN DIEGO – Emerging biomarkers and treatments offer more options to diagnose and manage Alzheimer’s disease (AD) and related dementias, but high costs and potentially serious complications mean using them with caution, said a presenter at the annual meeting of the American College of Physicians.

Dementia prevalence is increasing as the proportion of the U.S. population older than 65 rises, said Zaldy Tan, MD, professor of neurology at Cedars-Sinai Medical Center, Los Angeles. AD deaths more than doubled between 2000 and 2018, he noted, while deaths from HIV infection, stroke, and heart disease decreased.

Most people in the United States who have AD are White, but studies suggest that, compared with Whites, the risk of AD is two times higher in Blacks and 1.5 times higher in Hispanics . “These data suggest that both genes and social determinants of health are at play,” Dr. Tan said.
 

Diagnosis of Alzheimer’s disease

The different types of dementia make it challenging for primary care physicians to identify the cause of cognitive impairment. “Even though AD is the most common type, clinicians should keep in mind that another type of dementia may be the cause of cognitive impairment,” Dr. Tan cautioned. Other dementia diagnoses include vascular, Lewy body, and frontotemporal.

Diagnostic criteria for AD include evidence of significant cognitive decline in at least one cognitive domain that interferes with independence in everyday activities, as well as the absence of another mental disorder or delirium that would explain the cognitive deficits.

“We see many patients with depressive symptoms and mild cognitive impairment, and it is not always easy to tell which of them have dementia because of the overlap in the symptoms of depression and AD,” said internist Roderick Kim, MD, of Grand Rapids, Mich., who attended the session.

It can be challenging to convince patients to undergo the appropriate diagnostic workup, Dr. Kim said. “This can delay treatment, so it is important to explain to patients that cognitive decline can progress quickly and that there are treatment options to slow it down.”
 

Why do we need biomarkers for Alzheimer’s disease?

AD is characterized by a long preclinical phase with no specific symptoms other than the typical signs and symptoms of aging, Dr. Tan said. That means cognitive impairment progresses rapidly after diagnosis in most patients with AD.

“In most cases, an accurate history, physical and neurologic examinations, basic labs, and neuroimaging are sufficient for memory loss evaluation. However, as more disease-modifying therapies come to market, biomarkers will rise in importance in primary care,” he said.

This long asymptomatic phase of AD creates the need for diagnostic biomarkers for an earlier diagnosis, he said. Amyloid-beta and tau deposits in PET images and the levels of amyloid-beta seeds, phosphorylated tau, and neurofilament light chain in the cerebrospinal fluid can be used as diagnostic biomarkers in patients with suspected AD. Emerging blood biomarkers for earlier detection include the levels of amyloid-beta_1–42, phosphorylated tau, and neurofilament light chain.

With biomarkers and other new tools for the diagnosis of dementia in primary care, Dr. Tan said: “The greatest challenge is cost, as blood-based biomarkers are not currently covered by insurance and still rather costly. In addition, blood-based biomarkers will need to receive [Food and Drug Administration] approval in order to have more widespread availability.”


 

New and emerging therapies for Alzheimer’s disease

There are two classes of FDA-approved medications to manage cognitive symptoms of dementia: acetylcholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists. The selections may be trial and error for each patient, Dr. Tan said.

“The approved medications can exert subtle benefits that are clinically observable. Thus, barring any contraindications or intolerance, most patients with AD would benefit from a trial of one or both of these medication classes,” said Dr. Tan. He added that it is equally important to wean off and discontinue these medications if there is intolerance or lack of a subjective or objective beneficial response.

Other medications are available for some of the most common behavioral problems associated with dementia, such as agitation, depression, and disorientation. Dr. Tan advised not to prescribe behavioral medications until nonpharmacologic interventions prove to be ineffective or impractical. Behavioral medications have many side effects, some of which are potentially serious, he said, so the risk-benefit ratio should be considered.

In his own practice, when nonpharmacologic strategies do not improve the behavioral symptoms of dementia, Dr. Tan said that, “in cases where a person is at risk of harm to themselves or others, a discussion with the patient and their caregivers about the pros and cons of medications to treat the behavior need to be had. Careful monitoring of the response and dose escalation or deprescribing when appropriate is important to keep in mind.”

Disease-modifying agents have recently provided new hope for AD treatment. Aducanumab and lecanemab, both monoclonal antibodies that target amyloids, are the first two drugs that received accelerated FDA approval for AD.

Although these monoclonal antibodies can help clear deposited amyloid plaques and show some benefit in slowing cognitive impairment in clinical trials, the real-world benefits were unclear enough for Medicare to limit coverage to people enrolled in approved studies to gather more data. Additionally, these agents can cause potentially amyloid-related imaging abnormalities, which may indicate edema, effusion, or microhemorrhage. Therefore, clinicians need to have a clear conversation of risks and benefits with patients and caregivers about these treatments.
 

Looking ahead

When asked about the most promising emerging technologies or techniques related to dementia diagnosis and management, Dr. Tan noted that multiple technology companies and start-ups are looking for new ways to detect dementia earlier or keep persons with dementia safe at home. Some devices deliver brain waves, computerized brain games or tests, automated pill dispensers, and fall monitors.

“Some of these are potentially helpful, but not every person with dementia will benefit. In addition, most of these technologies are out-of-pocket expenses for the patients and their families. It is important to know what is out there but also be cautious about outrageous claims,” he added.

Dr. Tan reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.

SAN DIEGO – Emerging biomarkers and treatments offer more options to diagnose and manage Alzheimer’s disease (AD) and related dementias, but high costs and potentially serious complications mean using them with caution, said a presenter at the annual meeting of the American College of Physicians.

Dementia prevalence is increasing as the proportion of the U.S. population older than 65 rises, said Zaldy Tan, MD, professor of neurology at Cedars-Sinai Medical Center, Los Angeles. AD deaths more than doubled between 2000 and 2018, he noted, while deaths from HIV infection, stroke, and heart disease decreased.

Most people in the United States who have AD are White, but studies suggest that, compared with Whites, the risk of AD is two times higher in Blacks and 1.5 times higher in Hispanics . “These data suggest that both genes and social determinants of health are at play,” Dr. Tan said.
 

Diagnosis of Alzheimer’s disease

The different types of dementia make it challenging for primary care physicians to identify the cause of cognitive impairment. “Even though AD is the most common type, clinicians should keep in mind that another type of dementia may be the cause of cognitive impairment,” Dr. Tan cautioned. Other dementia diagnoses include vascular, Lewy body, and frontotemporal.

Diagnostic criteria for AD include evidence of significant cognitive decline in at least one cognitive domain that interferes with independence in everyday activities, as well as the absence of another mental disorder or delirium that would explain the cognitive deficits.

“We see many patients with depressive symptoms and mild cognitive impairment, and it is not always easy to tell which of them have dementia because of the overlap in the symptoms of depression and AD,” said internist Roderick Kim, MD, of Grand Rapids, Mich., who attended the session.

It can be challenging to convince patients to undergo the appropriate diagnostic workup, Dr. Kim said. “This can delay treatment, so it is important to explain to patients that cognitive decline can progress quickly and that there are treatment options to slow it down.”
 

Why do we need biomarkers for Alzheimer’s disease?

AD is characterized by a long preclinical phase with no specific symptoms other than the typical signs and symptoms of aging, Dr. Tan said. That means cognitive impairment progresses rapidly after diagnosis in most patients with AD.

“In most cases, an accurate history, physical and neurologic examinations, basic labs, and neuroimaging are sufficient for memory loss evaluation. However, as more disease-modifying therapies come to market, biomarkers will rise in importance in primary care,” he said.

This long asymptomatic phase of AD creates the need for diagnostic biomarkers for an earlier diagnosis, he said. Amyloid-beta and tau deposits in PET images and the levels of amyloid-beta seeds, phosphorylated tau, and neurofilament light chain in the cerebrospinal fluid can be used as diagnostic biomarkers in patients with suspected AD. Emerging blood biomarkers for earlier detection include the levels of amyloid-beta_1–42, phosphorylated tau, and neurofilament light chain.

With biomarkers and other new tools for the diagnosis of dementia in primary care, Dr. Tan said: “The greatest challenge is cost, as blood-based biomarkers are not currently covered by insurance and still rather costly. In addition, blood-based biomarkers will need to receive [Food and Drug Administration] approval in order to have more widespread availability.”


 

New and emerging therapies for Alzheimer’s disease

There are two classes of FDA-approved medications to manage cognitive symptoms of dementia: acetylcholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists. The selections may be trial and error for each patient, Dr. Tan said.

“The approved medications can exert subtle benefits that are clinically observable. Thus, barring any contraindications or intolerance, most patients with AD would benefit from a trial of one or both of these medication classes,” said Dr. Tan. He added that it is equally important to wean off and discontinue these medications if there is intolerance or lack of a subjective or objective beneficial response.

Other medications are available for some of the most common behavioral problems associated with dementia, such as agitation, depression, and disorientation. Dr. Tan advised not to prescribe behavioral medications until nonpharmacologic interventions prove to be ineffective or impractical. Behavioral medications have many side effects, some of which are potentially serious, he said, so the risk-benefit ratio should be considered.

In his own practice, when nonpharmacologic strategies do not improve the behavioral symptoms of dementia, Dr. Tan said that, “in cases where a person is at risk of harm to themselves or others, a discussion with the patient and their caregivers about the pros and cons of medications to treat the behavior need to be had. Careful monitoring of the response and dose escalation or deprescribing when appropriate is important to keep in mind.”

Disease-modifying agents have recently provided new hope for AD treatment. Aducanumab and lecanemab, both monoclonal antibodies that target amyloids, are the first two drugs that received accelerated FDA approval for AD.

Although these monoclonal antibodies can help clear deposited amyloid plaques and show some benefit in slowing cognitive impairment in clinical trials, the real-world benefits were unclear enough for Medicare to limit coverage to people enrolled in approved studies to gather more data. Additionally, these agents can cause potentially amyloid-related imaging abnormalities, which may indicate edema, effusion, or microhemorrhage. Therefore, clinicians need to have a clear conversation of risks and benefits with patients and caregivers about these treatments.
 

Looking ahead

When asked about the most promising emerging technologies or techniques related to dementia diagnosis and management, Dr. Tan noted that multiple technology companies and start-ups are looking for new ways to detect dementia earlier or keep persons with dementia safe at home. Some devices deliver brain waves, computerized brain games or tests, automated pill dispensers, and fall monitors.

“Some of these are potentially helpful, but not every person with dementia will benefit. In addition, most of these technologies are out-of-pocket expenses for the patients and their families. It is important to know what is out there but also be cautious about outrageous claims,” he added.

Dr. Tan reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.

A liquid biopsy assay that tests for only six circulating tumor DNA (ctDNA) methylation markers has shown high accuracy in identifying the risk for relapse among patients with colorectal cancer (CRC).

Patients who were ctDNA methylation positive 1 month after surgery were 17.5 times more likely to relapse, compared with ctDNA-negative patients. And following adjuvant chemotherapy, ctDNA-positive patients had a significantly shorter recurrence-free survival than their ctDNA-negative peers.

Overall, “we found that ctDNA methylation was the most significant prognostic factor for recurrence-free survival among all clinicopathologic risk factors on multivariable analysis,” the authors, led by Shaobo Mo, MD, Fudan University Shanghai (China) Cancer Center, reported in research published in JAMA Oncology.

Van Morris, MD, an oncologist with University of Texas MD Anderson Cancer Center, Houston, who was not involved in the research, noted that other commercially available ctDNA assays have achieved similar findings, but this assay involves the least number of biomarkers.

More notably, the broader message emerging from this research is that “ctDNA is a powerful tool in oncology that is here to stay,” said Dr. Morris.

Dr. Morris added a note of caution, however: Despite the study providing further support for this technology in CRC, “we do not have definitive predictive utility for routinely guiding adjuvant chemotherapy decisions with the use of this [or other] ctDNA assays.”
 

Recurrence common, predictors important

CRC has a relatively high recurrence rate even after curative-intent therapies, with a 5-year survival rate as low as 60%. Adjuvant chemotherapy in patients with stage III CRC generally lowers the risk of recurrence by about 10%-20%; however, the benefits of adjuvant chemotherapy among patients with stage II CRC remain unclear.

Strategies to identify patients most likely to relapse after adjuvant therapy largely focus on CRC stage and clinical risk factors, though postoperative ctDNA testing has emerged as a tool to help identify patients at risk for recurrence. Often, however, this approach involves ultradeep next-generation sequencing, which limits the strategy’s ease of implementation and cost effectiveness.

As an alternative, the authors used a plasma ctDNA methylation test, ColonAiQ, which identifies the presence of six genomic biomarkers hypermethylated in CRC. This test avoids the complex process of primary tumor profiling among individual patients.

In the multicenter, prospective longitudinal cohort study, conducted from December 2019 to February 2022, Dr. Mo and colleagues evaluated 1,228 blood samples from 299 patients with stage I-III CRC. Samples were collected before and after surgery, during and after adjuvant chemotherapy, and every 3 months for up to 2 years.

Of 296 patients with preoperative samples available, as many as 232 (78.4%) tested positive for at least one of the 6 ctDNA methylation markers. The detection rates were 65.1% for stage I CRC, 82.7% for stage II disease, and 81.5% for stage III disease.

At postoperative month 1, ctDNA methylation–positive patients were 17.5 times more likely to relapse, compared with ctDNA-negative patients (hazard ratio, 17.5; P < .001).

When integrating carcinoembryonic antigen testing alongside ctDNA testing, patients with positive test results had significantly worse prognoses, compared with those who had negative results (HR, 19.0; P < .001).

The association of ctDNA methylation positivity at postoperative month 1 and CRC recurrence was consistent across varying durations and intensities of adjuvant chemotherapy. The researchers found that ctDNA methylation analysis detected CRC recurrence a median of 3.3 months earlier than radiologically confirmed recurrence.

Patients who were ctDNA positive also had significantly shorter periods of recurrence-free survival following adjuvant chemotherapy, compared with ctDNA-negative patients (HR, 13.8; P < .001). That effect was enhanced when positive ctDNA status was maintained longitudinally, compared with those who were persistently ctDNA negative (HR, 68.8; P < .001).

More specifically, 140 patients exhibited sustained ctDNA-positive status over time; 6 of 7 ctDNA-positive patients experienced recurrence within 12 months, whereas 129 of 133 ctDNA-negative patients (97%) remained relapse free. And being ctDNA negative before surgery indicated patients’ relapse risk, with 95.3% of patients who were ctDNA negative presurgery remaining relapse free.

Dr. Mo and colleagues concluded that the simplicity of the assay work flow and convenience of taking blood samples make this approach practical and cost effective in the clinical setting.

In an editorial published alongside the study, Juan Ruiz-Bañobre, MD, PhD, and Ajay Goel, PhD, noted that the field is evolving rapidly but “there is substantial value in prospectively validating the clinical importance of ColonAiQ in randomized clinical trials.”

“If successful, this liquid biopsy assay could represent a simple and cost-effective means for a more accessible and facile decentralized implementation in routine clinical practice,” said Dr. Ruiz-Bañobre, of the University of Santiago de Compostela, A Coruña, Spain, and Dr. Goel, from City of Hope Comprehensive Cancer Center in Duarte, Calif.

Several of the study coauthors are employees of Singlera Genomics, which makes the ColonAiQ test. Dr. Ruiz-Bañobre reported grants from the Spanish Cooperative Group for the Treatment of Digestive Tumors and support from Institute of Health Carlos III. Dr. Morris is the principal investigator on the NRG GI005 trial of the Guardant Reveal liquid biopsy, sponsored by Guardant Health in collaboration with funding support from the National Cancer Institute.

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

A liquid biopsy assay that tests for only six circulating tumor DNA (ctDNA) methylation markers has shown high accuracy in identifying the risk for relapse among patients with colorectal cancer (CRC).

Patients who were ctDNA methylation positive 1 month after surgery were 17.5 times more likely to relapse, compared with ctDNA-negative patients. And following adjuvant chemotherapy, ctDNA-positive patients had a significantly shorter recurrence-free survival than their ctDNA-negative peers.

Overall, “we found that ctDNA methylation was the most significant prognostic factor for recurrence-free survival among all clinicopathologic risk factors on multivariable analysis,” the authors, led by Shaobo Mo, MD, Fudan University Shanghai (China) Cancer Center, reported in research published in JAMA Oncology.

Van Morris, MD, an oncologist with University of Texas MD Anderson Cancer Center, Houston, who was not involved in the research, noted that other commercially available ctDNA assays have achieved similar findings, but this assay involves the least number of biomarkers.

More notably, the broader message emerging from this research is that “ctDNA is a powerful tool in oncology that is here to stay,” said Dr. Morris.

Dr. Morris added a note of caution, however: Despite the study providing further support for this technology in CRC, “we do not have definitive predictive utility for routinely guiding adjuvant chemotherapy decisions with the use of this [or other] ctDNA assays.”
 

Recurrence common, predictors important

CRC has a relatively high recurrence rate even after curative-intent therapies, with a 5-year survival rate as low as 60%. Adjuvant chemotherapy in patients with stage III CRC generally lowers the risk of recurrence by about 10%-20%; however, the benefits of adjuvant chemotherapy among patients with stage II CRC remain unclear.

Strategies to identify patients most likely to relapse after adjuvant therapy largely focus on CRC stage and clinical risk factors, though postoperative ctDNA testing has emerged as a tool to help identify patients at risk for recurrence. Often, however, this approach involves ultradeep next-generation sequencing, which limits the strategy’s ease of implementation and cost effectiveness.

As an alternative, the authors used a plasma ctDNA methylation test, ColonAiQ, which identifies the presence of six genomic biomarkers hypermethylated in CRC. This test avoids the complex process of primary tumor profiling among individual patients.

In the multicenter, prospective longitudinal cohort study, conducted from December 2019 to February 2022, Dr. Mo and colleagues evaluated 1,228 blood samples from 299 patients with stage I-III CRC. Samples were collected before and after surgery, during and after adjuvant chemotherapy, and every 3 months for up to 2 years.

Of 296 patients with preoperative samples available, as many as 232 (78.4%) tested positive for at least one of the 6 ctDNA methylation markers. The detection rates were 65.1% for stage I CRC, 82.7% for stage II disease, and 81.5% for stage III disease.

At postoperative month 1, ctDNA methylation–positive patients were 17.5 times more likely to relapse, compared with ctDNA-negative patients (hazard ratio, 17.5; P < .001).

When integrating carcinoembryonic antigen testing alongside ctDNA testing, patients with positive test results had significantly worse prognoses, compared with those who had negative results (HR, 19.0; P < .001).

The association of ctDNA methylation positivity at postoperative month 1 and CRC recurrence was consistent across varying durations and intensities of adjuvant chemotherapy. The researchers found that ctDNA methylation analysis detected CRC recurrence a median of 3.3 months earlier than radiologically confirmed recurrence.

Patients who were ctDNA positive also had significantly shorter periods of recurrence-free survival following adjuvant chemotherapy, compared with ctDNA-negative patients (HR, 13.8; P < .001). That effect was enhanced when positive ctDNA status was maintained longitudinally, compared with those who were persistently ctDNA negative (HR, 68.8; P < .001).

More specifically, 140 patients exhibited sustained ctDNA-positive status over time; 6 of 7 ctDNA-positive patients experienced recurrence within 12 months, whereas 129 of 133 ctDNA-negative patients (97%) remained relapse free. And being ctDNA negative before surgery indicated patients’ relapse risk, with 95.3% of patients who were ctDNA negative presurgery remaining relapse free.

Dr. Mo and colleagues concluded that the simplicity of the assay work flow and convenience of taking blood samples make this approach practical and cost effective in the clinical setting.

In an editorial published alongside the study, Juan Ruiz-Bañobre, MD, PhD, and Ajay Goel, PhD, noted that the field is evolving rapidly but “there is substantial value in prospectively validating the clinical importance of ColonAiQ in randomized clinical trials.”

“If successful, this liquid biopsy assay could represent a simple and cost-effective means for a more accessible and facile decentralized implementation in routine clinical practice,” said Dr. Ruiz-Bañobre, of the University of Santiago de Compostela, A Coruña, Spain, and Dr. Goel, from City of Hope Comprehensive Cancer Center in Duarte, Calif.

Several of the study coauthors are employees of Singlera Genomics, which makes the ColonAiQ test. Dr. Ruiz-Bañobre reported grants from the Spanish Cooperative Group for the Treatment of Digestive Tumors and support from Institute of Health Carlos III. Dr. Morris is the principal investigator on the NRG GI005 trial of the Guardant Reveal liquid biopsy, sponsored by Guardant Health in collaboration with funding support from the National Cancer Institute.

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

A liquid biopsy assay that tests for only six circulating tumor DNA (ctDNA) methylation markers has shown high accuracy in identifying the risk for relapse among patients with colorectal cancer (CRC).

Patients who were ctDNA methylation positive 1 month after surgery were 17.5 times more likely to relapse, compared with ctDNA-negative patients. And following adjuvant chemotherapy, ctDNA-positive patients had a significantly shorter recurrence-free survival than their ctDNA-negative peers.

Overall, “we found that ctDNA methylation was the most significant prognostic factor for recurrence-free survival among all clinicopathologic risk factors on multivariable analysis,” the authors, led by Shaobo Mo, MD, Fudan University Shanghai (China) Cancer Center, reported in research published in JAMA Oncology.

Van Morris, MD, an oncologist with University of Texas MD Anderson Cancer Center, Houston, who was not involved in the research, noted that other commercially available ctDNA assays have achieved similar findings, but this assay involves the least number of biomarkers.

More notably, the broader message emerging from this research is that “ctDNA is a powerful tool in oncology that is here to stay,” said Dr. Morris.

Dr. Morris added a note of caution, however: Despite the study providing further support for this technology in CRC, “we do not have definitive predictive utility for routinely guiding adjuvant chemotherapy decisions with the use of this [or other] ctDNA assays.”
 

Recurrence common, predictors important

CRC has a relatively high recurrence rate even after curative-intent therapies, with a 5-year survival rate as low as 60%. Adjuvant chemotherapy in patients with stage III CRC generally lowers the risk of recurrence by about 10%-20%; however, the benefits of adjuvant chemotherapy among patients with stage II CRC remain unclear.

Strategies to identify patients most likely to relapse after adjuvant therapy largely focus on CRC stage and clinical risk factors, though postoperative ctDNA testing has emerged as a tool to help identify patients at risk for recurrence. Often, however, this approach involves ultradeep next-generation sequencing, which limits the strategy’s ease of implementation and cost effectiveness.

As an alternative, the authors used a plasma ctDNA methylation test, ColonAiQ, which identifies the presence of six genomic biomarkers hypermethylated in CRC. This test avoids the complex process of primary tumor profiling among individual patients.

In the multicenter, prospective longitudinal cohort study, conducted from December 2019 to February 2022, Dr. Mo and colleagues evaluated 1,228 blood samples from 299 patients with stage I-III CRC. Samples were collected before and after surgery, during and after adjuvant chemotherapy, and every 3 months for up to 2 years.

Of 296 patients with preoperative samples available, as many as 232 (78.4%) tested positive for at least one of the 6 ctDNA methylation markers. The detection rates were 65.1% for stage I CRC, 82.7% for stage II disease, and 81.5% for stage III disease.

At postoperative month 1, ctDNA methylation–positive patients were 17.5 times more likely to relapse, compared with ctDNA-negative patients (hazard ratio, 17.5; P < .001).

When integrating carcinoembryonic antigen testing alongside ctDNA testing, patients with positive test results had significantly worse prognoses, compared with those who had negative results (HR, 19.0; P < .001).

The association of ctDNA methylation positivity at postoperative month 1 and CRC recurrence was consistent across varying durations and intensities of adjuvant chemotherapy. The researchers found that ctDNA methylation analysis detected CRC recurrence a median of 3.3 months earlier than radiologically confirmed recurrence.

Patients who were ctDNA positive also had significantly shorter periods of recurrence-free survival following adjuvant chemotherapy, compared with ctDNA-negative patients (HR, 13.8; P < .001). That effect was enhanced when positive ctDNA status was maintained longitudinally, compared with those who were persistently ctDNA negative (HR, 68.8; P < .001).

More specifically, 140 patients exhibited sustained ctDNA-positive status over time; 6 of 7 ctDNA-positive patients experienced recurrence within 12 months, whereas 129 of 133 ctDNA-negative patients (97%) remained relapse free. And being ctDNA negative before surgery indicated patients’ relapse risk, with 95.3% of patients who were ctDNA negative presurgery remaining relapse free.

Dr. Mo and colleagues concluded that the simplicity of the assay work flow and convenience of taking blood samples make this approach practical and cost effective in the clinical setting.

In an editorial published alongside the study, Juan Ruiz-Bañobre, MD, PhD, and Ajay Goel, PhD, noted that the field is evolving rapidly but “there is substantial value in prospectively validating the clinical importance of ColonAiQ in randomized clinical trials.”

“If successful, this liquid biopsy assay could represent a simple and cost-effective means for a more accessible and facile decentralized implementation in routine clinical practice,” said Dr. Ruiz-Bañobre, of the University of Santiago de Compostela, A Coruña, Spain, and Dr. Goel, from City of Hope Comprehensive Cancer Center in Duarte, Calif.

Several of the study coauthors are employees of Singlera Genomics, which makes the ColonAiQ test. Dr. Ruiz-Bañobre reported grants from the Spanish Cooperative Group for the Treatment of Digestive Tumors and support from Institute of Health Carlos III. Dr. Morris is the principal investigator on the NRG GI005 trial of the Guardant Reveal liquid biopsy, sponsored by Guardant Health in collaboration with funding support from the National Cancer Institute.

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

A new report details a comprehensive strategy to prevent preeclampsia, which affects about 250,000 pregnant women a year in the United States and 10 million worldwide.

Preeclampsia is a leading cause of maternal mortality and premature births. The report, published in the American Journal of Obstetrics and Gynecology, developed by a working group of clinicians, researchers, patients, advocates, and payers, recommends daily low-dose aspirin, surveillance, behavioral strategies, patient and provider education, long-term follow-up, and addressing social determinants of health.

Titled “Care plan for individuals at risk for preeclampsia: Shared approach to education, strategies for prevention, surveillance and follow up,” the report includes recommendations for providers and for patients at moderate to high risk of preeclampsia.

Top recommendations for providers include performing a risk assessment, including social determinants of health, medication recommendations (including daily aspirin and antihypertensive therapy), and behavioral recommendations (including specific information about diet, exercise, and sleep.)

The recommendations for patients include asking providers about aspirin use, checking blood pressure at home, and reporting any readings greater than 140/90. For those with BPs measuring 140/90 mm Hg or higher, the plan recommends antihypertensive therapy. The recommendations include making changes to diet, exercise, and sleep in consultation with providers.
 

Home blood pressure checks controversial

James Roberts, MD, a maternal-fetal medicine researcher at the Magee-Women’s Research Institute at University of Pittsburgh Medical Center and lead author on the paper, told this publication the home blood pressure checks may be the most controversial item in the report as not all insurers cover the at-home equipment.

University of Pittsburgh Medical Center

In this report, the authors write that the working group “strongly advocates that payers of health care services cover the modest expense of home blood pressure determination including equipment and training.”

Dr. Roberts is the founding principal investigator of the Global Pregnancy Collaboration (CoLab), a consortium of 40 centers and one of the groups leading the creation of this report.

He said that while most of the recommendations are already recommended in guidelines, the report puts the preeclampsia plan into easy-to-read steps and downloadable checklists and compiles the evidence all in one place.

Dr. Roberts said the working group hopes this report will be adapted into guidelines developed by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, and made part of electronic health records.

So far, the authors say, a comprehensive, integrated preeclampsia care plan has not been widely adopted.
 

Fewer than half of patients at risk receive aspirin

The coauthors note that “today, most pregnant individuals at increased risk do not receive even one of the interventions to prevent preeclampsia. For example, less than half of high-risk patients receive low-dose aspirin.”

A big part of this plan, Dr. Roberts said, calls for further educating both providers and patients.

Vesna Garovic, MD, PhD, a preeclampsia specialist at the Mayo Clinic in Rochester, Minn., who was not part of the working group, said, “This is the first comprehensive plan that provides a safe, cost-effective approach to reduce the risk of preeclampsia in individuals at moderate to high risk for this condition who qualify to receive aspirin for prevention.”

Dr. Garovic said the plan is novel in several ways, including the multispecialty input that also includes patients and advocates. Also, she says, it can be easily included in electronic health records and routine care of patients.

“The recommendations that were made, other than self-monitoring of blood pressure, are already standard of care. It will be important to understand as to which extent this comprehensive program, compared to the standard approach, would reduce further the risk of preeclampsia,” Dr. Garovic said. “A prospective, adequately powered comparative study would not only address this question, but will investigate compliance of providers and pregnant women with this shared approach, as well as patient satisfaction.”

The authors note the approach presented is for care in developed countries and that low- and middle-income countries would need to tailor the plan. The Care Plan is also meant only for prevention and is not meant to guide care for women who have developed preeclampsia.

Funding was provided to The Precia Group and the Global Pregnancy Collaboration to assemble this care plan by Mirvie, which is developing a biochemical predictor for preeclampsia. Precia and CoLab used a portion of these funds to support the time of some of the authors. Mirvie had no part in selecting authors or in the content of the manuscript.

Several authors received an honorarium for participation in the Working Group that developed the Care Plan. Two coauthors are site principal investigators overseeing sample collection on a Mirvie project. The remaining authors and Dr. Garovic report no conflicts of interest.

A new report details a comprehensive strategy to prevent preeclampsia, which affects about 250,000 pregnant women a year in the United States and 10 million worldwide.

Preeclampsia is a leading cause of maternal mortality and premature births. The report, published in the American Journal of Obstetrics and Gynecology, developed by a working group of clinicians, researchers, patients, advocates, and payers, recommends daily low-dose aspirin, surveillance, behavioral strategies, patient and provider education, long-term follow-up, and addressing social determinants of health.

Titled “Care plan for individuals at risk for preeclampsia: Shared approach to education, strategies for prevention, surveillance and follow up,” the report includes recommendations for providers and for patients at moderate to high risk of preeclampsia.

Top recommendations for providers include performing a risk assessment, including social determinants of health, medication recommendations (including daily aspirin and antihypertensive therapy), and behavioral recommendations (including specific information about diet, exercise, and sleep.)

The recommendations for patients include asking providers about aspirin use, checking blood pressure at home, and reporting any readings greater than 140/90. For those with BPs measuring 140/90 mm Hg or higher, the plan recommends antihypertensive therapy. The recommendations include making changes to diet, exercise, and sleep in consultation with providers.
 

Home blood pressure checks controversial

James Roberts, MD, a maternal-fetal medicine researcher at the Magee-Women’s Research Institute at University of Pittsburgh Medical Center and lead author on the paper, told this publication the home blood pressure checks may be the most controversial item in the report as not all insurers cover the at-home equipment.

University of Pittsburgh Medical Center

In this report, the authors write that the working group “strongly advocates that payers of health care services cover the modest expense of home blood pressure determination including equipment and training.”

Dr. Roberts is the founding principal investigator of the Global Pregnancy Collaboration (CoLab), a consortium of 40 centers and one of the groups leading the creation of this report.

He said that while most of the recommendations are already recommended in guidelines, the report puts the preeclampsia plan into easy-to-read steps and downloadable checklists and compiles the evidence all in one place.

Dr. Roberts said the working group hopes this report will be adapted into guidelines developed by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, and made part of electronic health records.

So far, the authors say, a comprehensive, integrated preeclampsia care plan has not been widely adopted.
 

Fewer than half of patients at risk receive aspirin

The coauthors note that “today, most pregnant individuals at increased risk do not receive even one of the interventions to prevent preeclampsia. For example, less than half of high-risk patients receive low-dose aspirin.”

A big part of this plan, Dr. Roberts said, calls for further educating both providers and patients.

Vesna Garovic, MD, PhD, a preeclampsia specialist at the Mayo Clinic in Rochester, Minn., who was not part of the working group, said, “This is the first comprehensive plan that provides a safe, cost-effective approach to reduce the risk of preeclampsia in individuals at moderate to high risk for this condition who qualify to receive aspirin for prevention.”

Dr. Garovic said the plan is novel in several ways, including the multispecialty input that also includes patients and advocates. Also, she says, it can be easily included in electronic health records and routine care of patients.

“The recommendations that were made, other than self-monitoring of blood pressure, are already standard of care. It will be important to understand as to which extent this comprehensive program, compared to the standard approach, would reduce further the risk of preeclampsia,” Dr. Garovic said. “A prospective, adequately powered comparative study would not only address this question, but will investigate compliance of providers and pregnant women with this shared approach, as well as patient satisfaction.”

The authors note the approach presented is for care in developed countries and that low- and middle-income countries would need to tailor the plan. The Care Plan is also meant only for prevention and is not meant to guide care for women who have developed preeclampsia.

Funding was provided to The Precia Group and the Global Pregnancy Collaboration to assemble this care plan by Mirvie, which is developing a biochemical predictor for preeclampsia. Precia and CoLab used a portion of these funds to support the time of some of the authors. Mirvie had no part in selecting authors or in the content of the manuscript.

Several authors received an honorarium for participation in the Working Group that developed the Care Plan. Two coauthors are site principal investigators overseeing sample collection on a Mirvie project. The remaining authors and Dr. Garovic report no conflicts of interest.

A new report details a comprehensive strategy to prevent preeclampsia, which affects about 250,000 pregnant women a year in the United States and 10 million worldwide.

Preeclampsia is a leading cause of maternal mortality and premature births. The report, published in the American Journal of Obstetrics and Gynecology, developed by a working group of clinicians, researchers, patients, advocates, and payers, recommends daily low-dose aspirin, surveillance, behavioral strategies, patient and provider education, long-term follow-up, and addressing social determinants of health.

Titled “Care plan for individuals at risk for preeclampsia: Shared approach to education, strategies for prevention, surveillance and follow up,” the report includes recommendations for providers and for patients at moderate to high risk of preeclampsia.

Top recommendations for providers include performing a risk assessment, including social determinants of health, medication recommendations (including daily aspirin and antihypertensive therapy), and behavioral recommendations (including specific information about diet, exercise, and sleep.)

The recommendations for patients include asking providers about aspirin use, checking blood pressure at home, and reporting any readings greater than 140/90. For those with BPs measuring 140/90 mm Hg or higher, the plan recommends antihypertensive therapy. The recommendations include making changes to diet, exercise, and sleep in consultation with providers.
 

Home blood pressure checks controversial

James Roberts, MD, a maternal-fetal medicine researcher at the Magee-Women’s Research Institute at University of Pittsburgh Medical Center and lead author on the paper, told this publication the home blood pressure checks may be the most controversial item in the report as not all insurers cover the at-home equipment.

University of Pittsburgh Medical Center

In this report, the authors write that the working group “strongly advocates that payers of health care services cover the modest expense of home blood pressure determination including equipment and training.”

Dr. Roberts is the founding principal investigator of the Global Pregnancy Collaboration (CoLab), a consortium of 40 centers and one of the groups leading the creation of this report.

He said that while most of the recommendations are already recommended in guidelines, the report puts the preeclampsia plan into easy-to-read steps and downloadable checklists and compiles the evidence all in one place.

Dr. Roberts said the working group hopes this report will be adapted into guidelines developed by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, and made part of electronic health records.

So far, the authors say, a comprehensive, integrated preeclampsia care plan has not been widely adopted.
 

Fewer than half of patients at risk receive aspirin

The coauthors note that “today, most pregnant individuals at increased risk do not receive even one of the interventions to prevent preeclampsia. For example, less than half of high-risk patients receive low-dose aspirin.”

A big part of this plan, Dr. Roberts said, calls for further educating both providers and patients.

Vesna Garovic, MD, PhD, a preeclampsia specialist at the Mayo Clinic in Rochester, Minn., who was not part of the working group, said, “This is the first comprehensive plan that provides a safe, cost-effective approach to reduce the risk of preeclampsia in individuals at moderate to high risk for this condition who qualify to receive aspirin for prevention.”

Dr. Garovic said the plan is novel in several ways, including the multispecialty input that also includes patients and advocates. Also, she says, it can be easily included in electronic health records and routine care of patients.

“The recommendations that were made, other than self-monitoring of blood pressure, are already standard of care. It will be important to understand as to which extent this comprehensive program, compared to the standard approach, would reduce further the risk of preeclampsia,” Dr. Garovic said. “A prospective, adequately powered comparative study would not only address this question, but will investigate compliance of providers and pregnant women with this shared approach, as well as patient satisfaction.”

The authors note the approach presented is for care in developed countries and that low- and middle-income countries would need to tailor the plan. The Care Plan is also meant only for prevention and is not meant to guide care for women who have developed preeclampsia.

Funding was provided to The Precia Group and the Global Pregnancy Collaboration to assemble this care plan by Mirvie, which is developing a biochemical predictor for preeclampsia. Precia and CoLab used a portion of these funds to support the time of some of the authors. Mirvie had no part in selecting authors or in the content of the manuscript.

Several authors received an honorarium for participation in the Working Group that developed the Care Plan. Two coauthors are site principal investigators overseeing sample collection on a Mirvie project. The remaining authors and Dr. Garovic report no conflicts of interest.