Latest News

A new light therapy device could be a game-changer for millions at risk of vision loss. The Food and Drug Administration (FDA) has approved a first-of-its-kind treatment for dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 55.

Developed by LumiThera, the device showed promising results in a clinical trial, marking it as the first effective therapy for AMD. Approved under the FDA’s “De Novo” process, the treatment offers hope where no similar options existed.

The LumiThera study, done at 10 retinal centers in the United States, assessed the safety and effectiveness of the system on the eyes of 100 people over a 24-month period. The data collected during the trial was then analyzed over a 13-month period. 

The trial found that LumiThera’s Valeda Light Delivery System significantly reduced the risk of vision loss and the start of geographic atrophy in dry AMD. More than 58% of the people studied reported improvements in their sight after the therapy. 

Geographic atrophy is a treacherous hallmark of late-stage dry AMD, in which cells in the center of the eye’s retina — called the macula — die, which can cause severe vision loss in advanced forms of the disease.

LumiThera’s system is the first treatment authorized by the FDA for vision loss from dry AMD. AMD is a leading cause of irreversible blindness or vision loss in people over 60. Around 20 million people in the United States have AMD, with dry AMD accounting for 90% of diagnosed cases. It’s considered “dry” because it doesn’t involve the growth of abnormal blood vessels, the way the “wet” form of AMD does.

The percentage of people with dry AMD who lose their vision depends on how severe the disease is and whether it becomes the wet form, which is more severe than the dry form. The wet form is marked by blood vessels leaking into the macula and the loss of central vision. Around 10%-15% of dry AMD cases become the wet form. 

During a presentation in 2024 at a meeting of the American Society of Retina Specialists, Eleonora Lad, MD, PhD, vice chair of ophthalmology clinical research at Duke University Medical Center, said the treatment — known as “photobiomodulation” (PBM) — is the first to deliver “meaningful effects” in dry AMD.

But how does PBM work, and what specifically improved in the eyes of the people in the study to help combat the disease?

 

Specific Wavelengths of Light Improve Cellular Function

Until now, taking nutritional supplements (vitamin C, vitamin E, lutein, zeaxanthin, zinc, and copper) was among the most common ways of treating dry AMD. The efficacy with this combo of nutritional supplements was established by the Age-Related Eye Disease Study 2 (AREDS2). The supplements help lower the risk of advanced dry AMD and wet AMD. 

There are also recently approved eye injections for dry AMD, such as the drugs Syfovre and Izervay, to treat later stages of the disease. But while both Syfovre and Izervay can slow the progression of geographic atrophy by about 14%-20%, patients receiving either drug have a higher risk of getting wet AMD, and the treatments are invasive. The drugs must be injected directly into the middle of the eye around once per month. 

PBM works by delivering specific wavelengths of light to the retina that help cells in retinal tissue, increasing energy production by mitochondria in eye cells, decreasing inflammation, and increasing nutrients and oxygen for cells. This improves cell survival in dry AMD and could slow the disease or stop it from reaching later stages.

Several eye disorders may be partly caused by oxidative stress and impaired mitochondrial function. The wavelength of light used in PBM stimulates an enzyme in eye cells that is key to healthy cellular function and vision. 

Research has shown that PBM prevents oxidative stress, which damages retinal pigment epithelial cells and could lead to AMD.

 

More Study Is Needed

PBM has been around for decades and has been promoted as a treatment for dementia, smoking cessation, spinal cord injury, and wound healing, along with AMD. 

“Google photobiomodulation or light therapy, and you’ll find it’s supposed to fix everything ... people try to sell it for everything, and that’s because they own the equipment, and they’re looking to recoup their costs,” said Jason M. Miller, MD, PhD, a retinal disease specialist at the Kellogg Eye Center at the University of Michigan School of Medicine, Ann Arbor.

He said more rigorous and larger trials are need before PBM therapy should gain wider FDA approval.

The FDA’s De Novo approval process is for medical devices that have designs that are unlike others already on the market. To get full approval from the FDA, a new drug or device must be assessed in a clinical trial that involves more people than the 100 or so that LumiThera used in its trial. For example, phase 3 trials for drugs usually involve 1,000-3,000 people.

Syfovre’s phase 3 clinical trials involved 1,258 patients. 

Research has shown that perceptions of visual acuity could also color the study results in a way that distorts the actual effectiveness of treatment, the way the placebo effect works. Some people in studies may simply think their vision is improving because they know they’re getting treatment. 

In a 2022 study, researchers showed that people in a trial who were given a placebo with the expectation the treatment would work reported a more favorable response to treatment than those who received a “nocebo” they were told wouldn’t work. 

The sensitivity of response to the placebo/nocebo treatments were shown to rely on the expectations caused by the experiment, and the study’s findings provided evidence that “both ocular accommodation and stereoacuity can be influenced by manipulating expectations and belief about the efficacy of an inert treatment.”

“The placebo effect in medicine is just rampant. It accounts for, in some trials, 30%-40% of an effect. ... I would have a hard time buying this device right now. I don’t want to say it’s ineffective, I just want more data,” said Miller.

A version of this article appeared on WebMD.com.

A new light therapy device could be a game-changer for millions at risk of vision loss. The Food and Drug Administration (FDA) has approved a first-of-its-kind treatment for dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 55.

Developed by LumiThera, the device showed promising results in a clinical trial, marking it as the first effective therapy for AMD. Approved under the FDA’s “De Novo” process, the treatment offers hope where no similar options existed.

The LumiThera study, done at 10 retinal centers in the United States, assessed the safety and effectiveness of the system on the eyes of 100 people over a 24-month period. The data collected during the trial was then analyzed over a 13-month period. 

The trial found that LumiThera’s Valeda Light Delivery System significantly reduced the risk of vision loss and the start of geographic atrophy in dry AMD. More than 58% of the people studied reported improvements in their sight after the therapy. 

Geographic atrophy is a treacherous hallmark of late-stage dry AMD, in which cells in the center of the eye’s retina — called the macula — die, which can cause severe vision loss in advanced forms of the disease.

LumiThera’s system is the first treatment authorized by the FDA for vision loss from dry AMD. AMD is a leading cause of irreversible blindness or vision loss in people over 60. Around 20 million people in the United States have AMD, with dry AMD accounting for 90% of diagnosed cases. It’s considered “dry” because it doesn’t involve the growth of abnormal blood vessels, the way the “wet” form of AMD does.

The percentage of people with dry AMD who lose their vision depends on how severe the disease is and whether it becomes the wet form, which is more severe than the dry form. The wet form is marked by blood vessels leaking into the macula and the loss of central vision. Around 10%-15% of dry AMD cases become the wet form. 

During a presentation in 2024 at a meeting of the American Society of Retina Specialists, Eleonora Lad, MD, PhD, vice chair of ophthalmology clinical research at Duke University Medical Center, said the treatment — known as “photobiomodulation” (PBM) — is the first to deliver “meaningful effects” in dry AMD.

But how does PBM work, and what specifically improved in the eyes of the people in the study to help combat the disease?

 

Specific Wavelengths of Light Improve Cellular Function

Until now, taking nutritional supplements (vitamin C, vitamin E, lutein, zeaxanthin, zinc, and copper) was among the most common ways of treating dry AMD. The efficacy with this combo of nutritional supplements was established by the Age-Related Eye Disease Study 2 (AREDS2). The supplements help lower the risk of advanced dry AMD and wet AMD. 

There are also recently approved eye injections for dry AMD, such as the drugs Syfovre and Izervay, to treat later stages of the disease. But while both Syfovre and Izervay can slow the progression of geographic atrophy by about 14%-20%, patients receiving either drug have a higher risk of getting wet AMD, and the treatments are invasive. The drugs must be injected directly into the middle of the eye around once per month. 

PBM works by delivering specific wavelengths of light to the retina that help cells in retinal tissue, increasing energy production by mitochondria in eye cells, decreasing inflammation, and increasing nutrients and oxygen for cells. This improves cell survival in dry AMD and could slow the disease or stop it from reaching later stages.

Several eye disorders may be partly caused by oxidative stress and impaired mitochondrial function. The wavelength of light used in PBM stimulates an enzyme in eye cells that is key to healthy cellular function and vision. 

Research has shown that PBM prevents oxidative stress, which damages retinal pigment epithelial cells and could lead to AMD.

 

More Study Is Needed

PBM has been around for decades and has been promoted as a treatment for dementia, smoking cessation, spinal cord injury, and wound healing, along with AMD. 

“Google photobiomodulation or light therapy, and you’ll find it’s supposed to fix everything ... people try to sell it for everything, and that’s because they own the equipment, and they’re looking to recoup their costs,” said Jason M. Miller, MD, PhD, a retinal disease specialist at the Kellogg Eye Center at the University of Michigan School of Medicine, Ann Arbor.

He said more rigorous and larger trials are need before PBM therapy should gain wider FDA approval.

The FDA’s De Novo approval process is for medical devices that have designs that are unlike others already on the market. To get full approval from the FDA, a new drug or device must be assessed in a clinical trial that involves more people than the 100 or so that LumiThera used in its trial. For example, phase 3 trials for drugs usually involve 1,000-3,000 people.

Syfovre’s phase 3 clinical trials involved 1,258 patients. 

Research has shown that perceptions of visual acuity could also color the study results in a way that distorts the actual effectiveness of treatment, the way the placebo effect works. Some people in studies may simply think their vision is improving because they know they’re getting treatment. 

In a 2022 study, researchers showed that people in a trial who were given a placebo with the expectation the treatment would work reported a more favorable response to treatment than those who received a “nocebo” they were told wouldn’t work. 

The sensitivity of response to the placebo/nocebo treatments were shown to rely on the expectations caused by the experiment, and the study’s findings provided evidence that “both ocular accommodation and stereoacuity can be influenced by manipulating expectations and belief about the efficacy of an inert treatment.”

“The placebo effect in medicine is just rampant. It accounts for, in some trials, 30%-40% of an effect. ... I would have a hard time buying this device right now. I don’t want to say it’s ineffective, I just want more data,” said Miller.

A version of this article appeared on WebMD.com.

A new light therapy device could be a game-changer for millions at risk of vision loss. The Food and Drug Administration (FDA) has approved a first-of-its-kind treatment for dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 55.

Developed by LumiThera, the device showed promising results in a clinical trial, marking it as the first effective therapy for AMD. Approved under the FDA’s “De Novo” process, the treatment offers hope where no similar options existed.

The LumiThera study, done at 10 retinal centers in the United States, assessed the safety and effectiveness of the system on the eyes of 100 people over a 24-month period. The data collected during the trial was then analyzed over a 13-month period. 

The trial found that LumiThera’s Valeda Light Delivery System significantly reduced the risk of vision loss and the start of geographic atrophy in dry AMD. More than 58% of the people studied reported improvements in their sight after the therapy. 

Geographic atrophy is a treacherous hallmark of late-stage dry AMD, in which cells in the center of the eye’s retina — called the macula — die, which can cause severe vision loss in advanced forms of the disease.

LumiThera’s system is the first treatment authorized by the FDA for vision loss from dry AMD. AMD is a leading cause of irreversible blindness or vision loss in people over 60. Around 20 million people in the United States have AMD, with dry AMD accounting for 90% of diagnosed cases. It’s considered “dry” because it doesn’t involve the growth of abnormal blood vessels, the way the “wet” form of AMD does.

The percentage of people with dry AMD who lose their vision depends on how severe the disease is and whether it becomes the wet form, which is more severe than the dry form. The wet form is marked by blood vessels leaking into the macula and the loss of central vision. Around 10%-15% of dry AMD cases become the wet form. 

During a presentation in 2024 at a meeting of the American Society of Retina Specialists, Eleonora Lad, MD, PhD, vice chair of ophthalmology clinical research at Duke University Medical Center, said the treatment — known as “photobiomodulation” (PBM) — is the first to deliver “meaningful effects” in dry AMD.

But how does PBM work, and what specifically improved in the eyes of the people in the study to help combat the disease?

 

Specific Wavelengths of Light Improve Cellular Function

Until now, taking nutritional supplements (vitamin C, vitamin E, lutein, zeaxanthin, zinc, and copper) was among the most common ways of treating dry AMD. The efficacy with this combo of nutritional supplements was established by the Age-Related Eye Disease Study 2 (AREDS2). The supplements help lower the risk of advanced dry AMD and wet AMD. 

There are also recently approved eye injections for dry AMD, such as the drugs Syfovre and Izervay, to treat later stages of the disease. But while both Syfovre and Izervay can slow the progression of geographic atrophy by about 14%-20%, patients receiving either drug have a higher risk of getting wet AMD, and the treatments are invasive. The drugs must be injected directly into the middle of the eye around once per month. 

PBM works by delivering specific wavelengths of light to the retina that help cells in retinal tissue, increasing energy production by mitochondria in eye cells, decreasing inflammation, and increasing nutrients and oxygen for cells. This improves cell survival in dry AMD and could slow the disease or stop it from reaching later stages.

Several eye disorders may be partly caused by oxidative stress and impaired mitochondrial function. The wavelength of light used in PBM stimulates an enzyme in eye cells that is key to healthy cellular function and vision. 

Research has shown that PBM prevents oxidative stress, which damages retinal pigment epithelial cells and could lead to AMD.

 

More Study Is Needed

PBM has been around for decades and has been promoted as a treatment for dementia, smoking cessation, spinal cord injury, and wound healing, along with AMD. 

“Google photobiomodulation or light therapy, and you’ll find it’s supposed to fix everything ... people try to sell it for everything, and that’s because they own the equipment, and they’re looking to recoup their costs,” said Jason M. Miller, MD, PhD, a retinal disease specialist at the Kellogg Eye Center at the University of Michigan School of Medicine, Ann Arbor.

He said more rigorous and larger trials are need before PBM therapy should gain wider FDA approval.

The FDA’s De Novo approval process is for medical devices that have designs that are unlike others already on the market. To get full approval from the FDA, a new drug or device must be assessed in a clinical trial that involves more people than the 100 or so that LumiThera used in its trial. For example, phase 3 trials for drugs usually involve 1,000-3,000 people.

Syfovre’s phase 3 clinical trials involved 1,258 patients. 

Research has shown that perceptions of visual acuity could also color the study results in a way that distorts the actual effectiveness of treatment, the way the placebo effect works. Some people in studies may simply think their vision is improving because they know they’re getting treatment. 

In a 2022 study, researchers showed that people in a trial who were given a placebo with the expectation the treatment would work reported a more favorable response to treatment than those who received a “nocebo” they were told wouldn’t work. 

The sensitivity of response to the placebo/nocebo treatments were shown to rely on the expectations caused by the experiment, and the study’s findings provided evidence that “both ocular accommodation and stereoacuity can be influenced by manipulating expectations and belief about the efficacy of an inert treatment.”

“The placebo effect in medicine is just rampant. It accounts for, in some trials, 30%-40% of an effect. ... I would have a hard time buying this device right now. I don’t want to say it’s ineffective, I just want more data,” said Miller.

A version of this article appeared on WebMD.com.

In 2024, the Guttmacher Institute reported that eight states enacted or proposed limits on contraceptive access. Currently, more than 19 million women aged 13-44 years in the United States live in “contraceptive deserts” or places that lack access to a full range of birth control methods. About 1.2 million of those women live in counties that don’t have a single health center that has complete birth control services.

Providing contraceptive care in primary care settings has long been deemed a best practice by the Centers for Disease Control and Prevention (CDC). But the percentage of primary care physicians (PCPs) prescribing contraception or offering contraceptive procedures is strikingly low.

 

Only Half of Family Physicians (FPs) Prescribe Contraceptives

Research by Candice Chen, MD, MPH, and colleagues found that while 73.1% of obstetrician-gynecologists (OB/GYNs) and 72.6% of nurse-midwives prescribed the pill, patch, or vaginal ring; only 51% of FPs, 32.4% of pediatricians, and 19.8% of internal medicine physicians did so. And while 92.8% of OB/GYNs provided intrauterine device (IUD) services, only 16.4% of FPs, 2.6% of internists, and 0.6% of pediatricians did so.

One reason primary care is positioned so well to fill contraception gaps is found in the sheer numbers of PCPs. Chen and colleagues found that while the percentage of FPs prescribing contraception was much smaller (51.4%) than the percentage of OB/GYN prescribers (72.6%), the numbers translate to 72,725 FPs prescribing contraceptives, which is nearly double the number of OB/GYNs prescribing them (36,887).

Access to contraception services took a big hit with the COVID-19 pandemic as did access to healthcare in general. And the 2022 Supreme Court ruling that struck down Roe V. Wade has shaken up the landscape for reproductive services with potential consequences for contraceptive access.

 

Why Aren’t More PCPs Offering Contraceptive Services?

Reasons for the relatively low numbers of PCPs prescribing contraceptives include lack of training in residency, health systems’ financial choices, insurance barriers, and expectation by some physicians and many patients that birth control belongs in the OB/GYN sector. Access, patient awareness that PCPs can provide the care, expectations, and options vary by states and regions.

Angeline Ti, MD, an FP who teaches in a residency program at Wellstar Douglasville Medical Center in Douglasville, Georgia, told this news organization that the awareness issue might be the easiest change for PCPs as many patients aren’t aware you can get contraceptive services in primary care.

 

Things PCPs ‘Could Do Tomorrow’

Those physicians who want to add those services might want to start with universal screening, Ti said — having conversations with patients about contraceptive needs and letting them know they don’t have to get those prescriptions from an OB/GYN. The conversations could center on laying out the options and counseling on risks and benefits of various options and providing referrals, if that is the best option. “There are definitely things that you could do tomorrow,” she said.

PCPs should be familiar with the CDC’s Contraceptive Guidance for Health Care Providers and the federal Office of Population Affairs’ Quality Family Planning Recommendations for providers, which offer practice-level information, Ti said.

PCPs should not feel they need to be able to provide same-day contraceptive care to get started. Having nurses and medical assistants and practice managers on board who are passionate about adding the services can also help bring about change with a team approach, she said.

Even when the provider is enthusiastic about providing the care and is trained to do so, however, insurance barriers may exist, Ti acknowledged. For example, at her clinic a common IUD insertion requires prior authorization.

 

Including Other Providers

Julia Strasser, DrPH, MPH, a member of the core faculty at the Fitzhugh Mullan Institute for Health Workforce Equity in Washington, DC, told this news organization that including other clinicians could help expand contraceptive services in primary care. Her research showed that the proportion of the contraception workforce that is made up of advanced practice clinicians and nurse practitioners is increasing, whereas the proportion that includes physicians is either static or declining.

A paper by her team found that although OB/GYNs and nurse-midwives were more likely to prescribe the pill, patch, or ring, the largest numbers of contraception prescribers were FPs (72,725) and advanced practice nurses (70,115).

“We also know that pharmacists can safely prescribe contraception, and some states have authorized this practice, but uptake is low and policies vary by state,” she said. “Some health systems have pharmacists embedded in their practice — for example in federally qualified health centers and others.”

It’s important, she said, not to frame the gaps in contraceptive care as a failure on the part of individual clinicians but rather as: “How can we change some of the system-level factors that have gotten us to this point?”

Yalda Jabbarpour, MD, an FP and director of the Robert Graham Center of the American Academy of Family Physicians, said sometimes it’s the health center’s cost analysis that stands in the way. She gave an example from her own health system.

“The health system doesn’t want to pay for us to have the IUDs stored in our offices and provide that procedure because they feel it’s more cost effective if the OB/GYNs do it.” IUD insertions take more appointment time than the standard appointment, which also goes into the cost analysis. “Even though you’re trained to do it, you can’t necessarily do it when you get to the real world,” Jabbarpour said.

She said the thinking is that while OB/GYNs focus on women, FPs cover all ages and family members, so having the equipment and the storage space is best left to the OB/GYNs. She said that thinking may be short sighted.

“We have good data that the highest number of office visits in the United States actually happen in the family physician’s office,” she said. Not providing the services injects a barrier into the system as women are being referred for a simple procedure to a physician they’ve never seen. “That’s not very patient centered,” Jabbarpour noted.

In systems that refer contraceptive procedures to OB/GYNs, doctors also can’t practice skills they learned in residency and then may not feel comfortable performing the procedures when they enter a health system that offers the procedures in primary care.

 

Number of FPs Prescribing Long-Acting Contraception Growing

Jabbarpour said there has been some improvement in that area in terms of long-acting reversible contraception.

She pointed to a study of recertifying FPs that found that the percent of FPs who offer either IUDs or implants increased from 23.9% in 2018 to 30% in 2022. The share of FPs providing implant insertion increased from 12.9% to 20.8%; those providing IUDs also increased from 22.9% to 25.5% from 2018 to 2022.

FPs also have the advantage of being more widely distributed in rural and remote areas than OB/GYNs, she noted. “They are in almost every county in the United States.”

Jabbarpour said the education must start with health system leaders. If they deem it important to offer these services in primary care, then residency programs will see that their residents must be appropriately trained to provide it.

“Right now, it’s not an expectation of many of the employers that primary care physicians should do this,” she said.

Ti said that expectation should change. The value proposition for all PCPs and health systems, she said, is this: “Most of contraceptive care is well within the scope of primary care providers. This is care that we can do, and it’s care that we should be doing. So why aren’t we doing it?”

Ti, Strasser, and Jabbarpour reported no relevant financial disclosures.

A version of this article appeared on Medscape.com.

In 2024, the Guttmacher Institute reported that eight states enacted or proposed limits on contraceptive access. Currently, more than 19 million women aged 13-44 years in the United States live in “contraceptive deserts” or places that lack access to a full range of birth control methods. About 1.2 million of those women live in counties that don’t have a single health center that has complete birth control services.

Providing contraceptive care in primary care settings has long been deemed a best practice by the Centers for Disease Control and Prevention (CDC). But the percentage of primary care physicians (PCPs) prescribing contraception or offering contraceptive procedures is strikingly low.

 

Only Half of Family Physicians (FPs) Prescribe Contraceptives

Research by Candice Chen, MD, MPH, and colleagues found that while 73.1% of obstetrician-gynecologists (OB/GYNs) and 72.6% of nurse-midwives prescribed the pill, patch, or vaginal ring; only 51% of FPs, 32.4% of pediatricians, and 19.8% of internal medicine physicians did so. And while 92.8% of OB/GYNs provided intrauterine device (IUD) services, only 16.4% of FPs, 2.6% of internists, and 0.6% of pediatricians did so.

One reason primary care is positioned so well to fill contraception gaps is found in the sheer numbers of PCPs. Chen and colleagues found that while the percentage of FPs prescribing contraception was much smaller (51.4%) than the percentage of OB/GYN prescribers (72.6%), the numbers translate to 72,725 FPs prescribing contraceptives, which is nearly double the number of OB/GYNs prescribing them (36,887).

Access to contraception services took a big hit with the COVID-19 pandemic as did access to healthcare in general. And the 2022 Supreme Court ruling that struck down Roe V. Wade has shaken up the landscape for reproductive services with potential consequences for contraceptive access.

 

Why Aren’t More PCPs Offering Contraceptive Services?

Reasons for the relatively low numbers of PCPs prescribing contraceptives include lack of training in residency, health systems’ financial choices, insurance barriers, and expectation by some physicians and many patients that birth control belongs in the OB/GYN sector. Access, patient awareness that PCPs can provide the care, expectations, and options vary by states and regions.

Angeline Ti, MD, an FP who teaches in a residency program at Wellstar Douglasville Medical Center in Douglasville, Georgia, told this news organization that the awareness issue might be the easiest change for PCPs as many patients aren’t aware you can get contraceptive services in primary care.

 

Things PCPs ‘Could Do Tomorrow’

Those physicians who want to add those services might want to start with universal screening, Ti said — having conversations with patients about contraceptive needs and letting them know they don’t have to get those prescriptions from an OB/GYN. The conversations could center on laying out the options and counseling on risks and benefits of various options and providing referrals, if that is the best option. “There are definitely things that you could do tomorrow,” she said.

PCPs should be familiar with the CDC’s Contraceptive Guidance for Health Care Providers and the federal Office of Population Affairs’ Quality Family Planning Recommendations for providers, which offer practice-level information, Ti said.

PCPs should not feel they need to be able to provide same-day contraceptive care to get started. Having nurses and medical assistants and practice managers on board who are passionate about adding the services can also help bring about change with a team approach, she said.

Even when the provider is enthusiastic about providing the care and is trained to do so, however, insurance barriers may exist, Ti acknowledged. For example, at her clinic a common IUD insertion requires prior authorization.

 

Including Other Providers

Julia Strasser, DrPH, MPH, a member of the core faculty at the Fitzhugh Mullan Institute for Health Workforce Equity in Washington, DC, told this news organization that including other clinicians could help expand contraceptive services in primary care. Her research showed that the proportion of the contraception workforce that is made up of advanced practice clinicians and nurse practitioners is increasing, whereas the proportion that includes physicians is either static or declining.

A paper by her team found that although OB/GYNs and nurse-midwives were more likely to prescribe the pill, patch, or ring, the largest numbers of contraception prescribers were FPs (72,725) and advanced practice nurses (70,115).

“We also know that pharmacists can safely prescribe contraception, and some states have authorized this practice, but uptake is low and policies vary by state,” she said. “Some health systems have pharmacists embedded in their practice — for example in federally qualified health centers and others.”

It’s important, she said, not to frame the gaps in contraceptive care as a failure on the part of individual clinicians but rather as: “How can we change some of the system-level factors that have gotten us to this point?”

Yalda Jabbarpour, MD, an FP and director of the Robert Graham Center of the American Academy of Family Physicians, said sometimes it’s the health center’s cost analysis that stands in the way. She gave an example from her own health system.

“The health system doesn’t want to pay for us to have the IUDs stored in our offices and provide that procedure because they feel it’s more cost effective if the OB/GYNs do it.” IUD insertions take more appointment time than the standard appointment, which also goes into the cost analysis. “Even though you’re trained to do it, you can’t necessarily do it when you get to the real world,” Jabbarpour said.

She said the thinking is that while OB/GYNs focus on women, FPs cover all ages and family members, so having the equipment and the storage space is best left to the OB/GYNs. She said that thinking may be short sighted.

“We have good data that the highest number of office visits in the United States actually happen in the family physician’s office,” she said. Not providing the services injects a barrier into the system as women are being referred for a simple procedure to a physician they’ve never seen. “That’s not very patient centered,” Jabbarpour noted.

In systems that refer contraceptive procedures to OB/GYNs, doctors also can’t practice skills they learned in residency and then may not feel comfortable performing the procedures when they enter a health system that offers the procedures in primary care.

 

Number of FPs Prescribing Long-Acting Contraception Growing

Jabbarpour said there has been some improvement in that area in terms of long-acting reversible contraception.

She pointed to a study of recertifying FPs that found that the percent of FPs who offer either IUDs or implants increased from 23.9% in 2018 to 30% in 2022. The share of FPs providing implant insertion increased from 12.9% to 20.8%; those providing IUDs also increased from 22.9% to 25.5% from 2018 to 2022.

FPs also have the advantage of being more widely distributed in rural and remote areas than OB/GYNs, she noted. “They are in almost every county in the United States.”

Jabbarpour said the education must start with health system leaders. If they deem it important to offer these services in primary care, then residency programs will see that their residents must be appropriately trained to provide it.

“Right now, it’s not an expectation of many of the employers that primary care physicians should do this,” she said.

Ti said that expectation should change. The value proposition for all PCPs and health systems, she said, is this: “Most of contraceptive care is well within the scope of primary care providers. This is care that we can do, and it’s care that we should be doing. So why aren’t we doing it?”

Ti, Strasser, and Jabbarpour reported no relevant financial disclosures.

A version of this article appeared on Medscape.com.

In 2024, the Guttmacher Institute reported that eight states enacted or proposed limits on contraceptive access. Currently, more than 19 million women aged 13-44 years in the United States live in “contraceptive deserts” or places that lack access to a full range of birth control methods. About 1.2 million of those women live in counties that don’t have a single health center that has complete birth control services.

Providing contraceptive care in primary care settings has long been deemed a best practice by the Centers for Disease Control and Prevention (CDC). But the percentage of primary care physicians (PCPs) prescribing contraception or offering contraceptive procedures is strikingly low.

 

Only Half of Family Physicians (FPs) Prescribe Contraceptives

Research by Candice Chen, MD, MPH, and colleagues found that while 73.1% of obstetrician-gynecologists (OB/GYNs) and 72.6% of nurse-midwives prescribed the pill, patch, or vaginal ring; only 51% of FPs, 32.4% of pediatricians, and 19.8% of internal medicine physicians did so. And while 92.8% of OB/GYNs provided intrauterine device (IUD) services, only 16.4% of FPs, 2.6% of internists, and 0.6% of pediatricians did so.

One reason primary care is positioned so well to fill contraception gaps is found in the sheer numbers of PCPs. Chen and colleagues found that while the percentage of FPs prescribing contraception was much smaller (51.4%) than the percentage of OB/GYN prescribers (72.6%), the numbers translate to 72,725 FPs prescribing contraceptives, which is nearly double the number of OB/GYNs prescribing them (36,887).

Access to contraception services took a big hit with the COVID-19 pandemic as did access to healthcare in general. And the 2022 Supreme Court ruling that struck down Roe V. Wade has shaken up the landscape for reproductive services with potential consequences for contraceptive access.

 

Why Aren’t More PCPs Offering Contraceptive Services?

Reasons for the relatively low numbers of PCPs prescribing contraceptives include lack of training in residency, health systems’ financial choices, insurance barriers, and expectation by some physicians and many patients that birth control belongs in the OB/GYN sector. Access, patient awareness that PCPs can provide the care, expectations, and options vary by states and regions.

Angeline Ti, MD, an FP who teaches in a residency program at Wellstar Douglasville Medical Center in Douglasville, Georgia, told this news organization that the awareness issue might be the easiest change for PCPs as many patients aren’t aware you can get contraceptive services in primary care.

 

Things PCPs ‘Could Do Tomorrow’

Those physicians who want to add those services might want to start with universal screening, Ti said — having conversations with patients about contraceptive needs and letting them know they don’t have to get those prescriptions from an OB/GYN. The conversations could center on laying out the options and counseling on risks and benefits of various options and providing referrals, if that is the best option. “There are definitely things that you could do tomorrow,” she said.

PCPs should be familiar with the CDC’s Contraceptive Guidance for Health Care Providers and the federal Office of Population Affairs’ Quality Family Planning Recommendations for providers, which offer practice-level information, Ti said.

PCPs should not feel they need to be able to provide same-day contraceptive care to get started. Having nurses and medical assistants and practice managers on board who are passionate about adding the services can also help bring about change with a team approach, she said.

Even when the provider is enthusiastic about providing the care and is trained to do so, however, insurance barriers may exist, Ti acknowledged. For example, at her clinic a common IUD insertion requires prior authorization.

 

Including Other Providers

Julia Strasser, DrPH, MPH, a member of the core faculty at the Fitzhugh Mullan Institute for Health Workforce Equity in Washington, DC, told this news organization that including other clinicians could help expand contraceptive services in primary care. Her research showed that the proportion of the contraception workforce that is made up of advanced practice clinicians and nurse practitioners is increasing, whereas the proportion that includes physicians is either static or declining.

A paper by her team found that although OB/GYNs and nurse-midwives were more likely to prescribe the pill, patch, or ring, the largest numbers of contraception prescribers were FPs (72,725) and advanced practice nurses (70,115).

“We also know that pharmacists can safely prescribe contraception, and some states have authorized this practice, but uptake is low and policies vary by state,” she said. “Some health systems have pharmacists embedded in their practice — for example in federally qualified health centers and others.”

It’s important, she said, not to frame the gaps in contraceptive care as a failure on the part of individual clinicians but rather as: “How can we change some of the system-level factors that have gotten us to this point?”

Yalda Jabbarpour, MD, an FP and director of the Robert Graham Center of the American Academy of Family Physicians, said sometimes it’s the health center’s cost analysis that stands in the way. She gave an example from her own health system.

“The health system doesn’t want to pay for us to have the IUDs stored in our offices and provide that procedure because they feel it’s more cost effective if the OB/GYNs do it.” IUD insertions take more appointment time than the standard appointment, which also goes into the cost analysis. “Even though you’re trained to do it, you can’t necessarily do it when you get to the real world,” Jabbarpour said.

She said the thinking is that while OB/GYNs focus on women, FPs cover all ages and family members, so having the equipment and the storage space is best left to the OB/GYNs. She said that thinking may be short sighted.

“We have good data that the highest number of office visits in the United States actually happen in the family physician’s office,” she said. Not providing the services injects a barrier into the system as women are being referred for a simple procedure to a physician they’ve never seen. “That’s not very patient centered,” Jabbarpour noted.

In systems that refer contraceptive procedures to OB/GYNs, doctors also can’t practice skills they learned in residency and then may not feel comfortable performing the procedures when they enter a health system that offers the procedures in primary care.

 

Number of FPs Prescribing Long-Acting Contraception Growing

Jabbarpour said there has been some improvement in that area in terms of long-acting reversible contraception.

She pointed to a study of recertifying FPs that found that the percent of FPs who offer either IUDs or implants increased from 23.9% in 2018 to 30% in 2022. The share of FPs providing implant insertion increased from 12.9% to 20.8%; those providing IUDs also increased from 22.9% to 25.5% from 2018 to 2022.

FPs also have the advantage of being more widely distributed in rural and remote areas than OB/GYNs, she noted. “They are in almost every county in the United States.”

Jabbarpour said the education must start with health system leaders. If they deem it important to offer these services in primary care, then residency programs will see that their residents must be appropriately trained to provide it.

“Right now, it’s not an expectation of many of the employers that primary care physicians should do this,” she said.

Ti said that expectation should change. The value proposition for all PCPs and health systems, she said, is this: “Most of contraceptive care is well within the scope of primary care providers. This is care that we can do, and it’s care that we should be doing. So why aren’t we doing it?”

Ti, Strasser, and Jabbarpour reported no relevant financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

An artificial intelligence–ECG risk estimation model designed to predict incident hypertension (AIRE-HTN) identifies cases and stratifies the risk for adverse outcomes in addition to traditional markers.

METHODOLOGY:

• Researchers conducted a development and external validation prognostic cohort study in a secondary care setting to identify individuals at risk for incident hypertension.
• They developed AIRE-HTN, which was trained on a derivation cohort from the Beth Israel Deaconess Medical Center in Boston, involving 1,163,401 ECGs from 189,539 patients (mean age, 57.7 years; 52.1% women; 64.5% White individuals).
• External validation was conducted on 65,610 ECGs from a UK-based volunteer cohort, drawn from an equal number of patients (mean age, 65.4 years; 51.5% women; 96.3% White individuals).
• Incident hypertension was evaluated in 19,423 individuals without hypertension from the medical center cohort and in 35,806 individuals without hypertension from the UK cohort.

TAKEAWAY:

• AIRE-HTN predicted incident hypertension with a C-index of 0.70 (95% CI, 0.69-0.71) in both the cohorts. Those in the quartile with the highest AIRE-HTN scores had a fourfold increased risk for incident hypertension (P < .001).
• The model’s predictive accuracy was maintained in individuals without left ventricular hypertrophy and those with normal ECGs and baseline blood pressure, indicating its robustness.
• The model was significantly additive to traditional clinical markers, with a continuous net reclassification index of 0.44 for the medical center cohort and 0.32 for the UK cohort.
• AIRE-HTN was an independent predictor of cardiovascular death (hazard ratio per 1-SD increase in score [HR], 2.24), heart failure (HR, 2.60), myocardial infarction (HR, 3.13), ischemic stroke (HR, 1.23), and chronic kidney disease (HR, 1.89) in outpatients from the medical center cohort (all P < .001), with largely consistent findings in the UK cohort.

IN PRACTICE:

“Results of exploratory and phenotypic analyses suggest the biological plausibility of these findings. Enhanced predictability could influence surveillance programs and primordial prevention,” the authors wrote.

SOURCE:

The study was led by Arunashis Sau, PhD, and Joseph Barker, MRes, National Heart and Lung Institute, Imperial College London, England. It was published online on January 2, 2025, in JAMA Cardiology.

LIMITATIONS:

In one cohort, hypertension was defined using International Classification of Diseases codes, which may lack granularity and not align with contemporary guidelines. The findings were not validated against ambulatory monitoring standards. The performance of the model in different populations and clinical settings remains to be explored.

DISCLOSURES:

The authors acknowledged receiving support from Imperial’s British Heart Foundation Centre for Excellence Award and disclosed receiving support from the British Heart Foundation, the National Institute for Health Research Imperial College Biomedical Research Centre, the EJP RD Research Mobility Fellowship, the Medical Research Council, and the Sir Jules Thorn Charitable Trust. Some authors reported receiving grants, personal fees, advisory fees, or laboratory work fees outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An artificial intelligence–ECG risk estimation model designed to predict incident hypertension (AIRE-HTN) identifies cases and stratifies the risk for adverse outcomes in addition to traditional markers.

METHODOLOGY:

• Researchers conducted a development and external validation prognostic cohort study in a secondary care setting to identify individuals at risk for incident hypertension.
• They developed AIRE-HTN, which was trained on a derivation cohort from the Beth Israel Deaconess Medical Center in Boston, involving 1,163,401 ECGs from 189,539 patients (mean age, 57.7 years; 52.1% women; 64.5% White individuals).
• External validation was conducted on 65,610 ECGs from a UK-based volunteer cohort, drawn from an equal number of patients (mean age, 65.4 years; 51.5% women; 96.3% White individuals).
• Incident hypertension was evaluated in 19,423 individuals without hypertension from the medical center cohort and in 35,806 individuals without hypertension from the UK cohort.

TAKEAWAY:

• AIRE-HTN predicted incident hypertension with a C-index of 0.70 (95% CI, 0.69-0.71) in both the cohorts. Those in the quartile with the highest AIRE-HTN scores had a fourfold increased risk for incident hypertension (P < .001).
• The model’s predictive accuracy was maintained in individuals without left ventricular hypertrophy and those with normal ECGs and baseline blood pressure, indicating its robustness.
• The model was significantly additive to traditional clinical markers, with a continuous net reclassification index of 0.44 for the medical center cohort and 0.32 for the UK cohort.
• AIRE-HTN was an independent predictor of cardiovascular death (hazard ratio per 1-SD increase in score [HR], 2.24), heart failure (HR, 2.60), myocardial infarction (HR, 3.13), ischemic stroke (HR, 1.23), and chronic kidney disease (HR, 1.89) in outpatients from the medical center cohort (all P < .001), with largely consistent findings in the UK cohort.

IN PRACTICE:

“Results of exploratory and phenotypic analyses suggest the biological plausibility of these findings. Enhanced predictability could influence surveillance programs and primordial prevention,” the authors wrote.

SOURCE:

The study was led by Arunashis Sau, PhD, and Joseph Barker, MRes, National Heart and Lung Institute, Imperial College London, England. It was published online on January 2, 2025, in JAMA Cardiology.

LIMITATIONS:

In one cohort, hypertension was defined using International Classification of Diseases codes, which may lack granularity and not align with contemporary guidelines. The findings were not validated against ambulatory monitoring standards. The performance of the model in different populations and clinical settings remains to be explored.

DISCLOSURES:

The authors acknowledged receiving support from Imperial’s British Heart Foundation Centre for Excellence Award and disclosed receiving support from the British Heart Foundation, the National Institute for Health Research Imperial College Biomedical Research Centre, the EJP RD Research Mobility Fellowship, the Medical Research Council, and the Sir Jules Thorn Charitable Trust. Some authors reported receiving grants, personal fees, advisory fees, or laboratory work fees outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An artificial intelligence–ECG risk estimation model designed to predict incident hypertension (AIRE-HTN) identifies cases and stratifies the risk for adverse outcomes in addition to traditional markers.

METHODOLOGY:

• Researchers conducted a development and external validation prognostic cohort study in a secondary care setting to identify individuals at risk for incident hypertension.
• They developed AIRE-HTN, which was trained on a derivation cohort from the Beth Israel Deaconess Medical Center in Boston, involving 1,163,401 ECGs from 189,539 patients (mean age, 57.7 years; 52.1% women; 64.5% White individuals).
• External validation was conducted on 65,610 ECGs from a UK-based volunteer cohort, drawn from an equal number of patients (mean age, 65.4 years; 51.5% women; 96.3% White individuals).
• Incident hypertension was evaluated in 19,423 individuals without hypertension from the medical center cohort and in 35,806 individuals without hypertension from the UK cohort.

TAKEAWAY:

• AIRE-HTN predicted incident hypertension with a C-index of 0.70 (95% CI, 0.69-0.71) in both the cohorts. Those in the quartile with the highest AIRE-HTN scores had a fourfold increased risk for incident hypertension (P < .001).
• The model’s predictive accuracy was maintained in individuals without left ventricular hypertrophy and those with normal ECGs and baseline blood pressure, indicating its robustness.
• The model was significantly additive to traditional clinical markers, with a continuous net reclassification index of 0.44 for the medical center cohort and 0.32 for the UK cohort.
• AIRE-HTN was an independent predictor of cardiovascular death (hazard ratio per 1-SD increase in score [HR], 2.24), heart failure (HR, 2.60), myocardial infarction (HR, 3.13), ischemic stroke (HR, 1.23), and chronic kidney disease (HR, 1.89) in outpatients from the medical center cohort (all P < .001), with largely consistent findings in the UK cohort.

IN PRACTICE:

“Results of exploratory and phenotypic analyses suggest the biological plausibility of these findings. Enhanced predictability could influence surveillance programs and primordial prevention,” the authors wrote.

SOURCE:

The study was led by Arunashis Sau, PhD, and Joseph Barker, MRes, National Heart and Lung Institute, Imperial College London, England. It was published online on January 2, 2025, in JAMA Cardiology.

LIMITATIONS:

In one cohort, hypertension was defined using International Classification of Diseases codes, which may lack granularity and not align with contemporary guidelines. The findings were not validated against ambulatory monitoring standards. The performance of the model in different populations and clinical settings remains to be explored.

DISCLOSURES:

The authors acknowledged receiving support from Imperial’s British Heart Foundation Centre for Excellence Award and disclosed receiving support from the British Heart Foundation, the National Institute for Health Research Imperial College Biomedical Research Centre, the EJP RD Research Mobility Fellowship, the Medical Research Council, and the Sir Jules Thorn Charitable Trust. Some authors reported receiving grants, personal fees, advisory fees, or laboratory work fees outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The cardiovascular benefits observed with intensive blood pressure (BP) control in patients with hypertension and elevated cardiovascular risk from the Systolic Blood Pressure Intervention Trial (SPRINT) can be largely replicated in real-world settings among patients with chronic kidney disease (CKD), highlighting the advantages of adopting intensive BP targets.
 

METHODOLOGY:

• The SPRINT showed that an intensive systolic BP goal < 120 mm Hg reduced mortality, cardiovascular events, and mild cognitive impairment in patients with hypertension and elevated cardiovascular risk, including in patients with CKD.
• Researchers conducted a comparative effectiveness study to determine if the beneficial and adverse effects of intensive vs standard BP control observed in SPRINT were replicable in patients with CKD and hypertension in clinical practice.
• They identified 85,938 patients (mean age, 75.7 years; 95.0% men) and 13,983 patients (mean age, 77.4 years; 38.4% men) from the Veterans Health Administration (VHA) and Kaiser Permanente of Southern California (KPSC) databases, respectively.
• The treatment effect was estimated by combining baseline covariate, treatment, and outcome data of participants from the SPRINT with covariate data from the VHA and KPSC databases.
• The primary outcomes included major cardiovascular events, all-cause death, cognitive impairment, CKD progression, and adverse events at 4 years.

TAKEAWAY:

• Compared with SPRINT participants, those in the VHA and KPSC databases were older, had less prevalent cardiovascular disease, higher albuminuria, and used more statins.
• The benefits of intensive vs standard BP control on major cardiovascular events, all-cause mortality, and certain adverse events (hypotension, syncope, bradycardia, acute kidney injury, and electrolyte abnormality) were transferable from the trial to the VHA and KPSC populations.
• The treatment effect of intensive BP management on CKD progression was transportable to the KPSC population but not to the VHA population. However, the trial’s impact on cognitive outcomes, such as dementia, was not transportable to either the VHA or KPSC populations.
• On the absolute scale, intensive vs standard BP treatment showed greater cardiovascular benefits and fewer safety concerns in the VHA and KPSC populations than in the SPRINT.

IN PRACTICE:

“This example highlights the potential for transportability methods to provide insights that can bridge evidence gaps and inform the application of novel therapies to patients with CKD who are treated in everyday practice,” the authors wrote.
 

SOURCE:

This study was led by Manjula Kurella Tamura, MD, MPH, Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, California. It was published online on January 7, 2025, in JAMA Network Open.
 

LIMITATIONS:

Transportability analyses could not account for characteristics that were not well-documented in electronic health records, such as limited life expectancy. The study was conducted before the widespread use of sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and nonsteroidal mineralocorticoid receptor antagonists, making it unclear whether intensive BP treatment would result in similar benefits with current pharmacotherapy regimens. Eligibility for this study was based on BP measurements in routine practice, which tend to be more variable than those collected in research settings.
 

DISCLOSURES:

This study was supported by grants from the National Institutes of Health. Some authors disclosed serving as a consultant and receiving grants, personal fees, and consulting fees from pharmaceutical companies and other sources.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The cardiovascular benefits observed with intensive blood pressure (BP) control in patients with hypertension and elevated cardiovascular risk from the Systolic Blood Pressure Intervention Trial (SPRINT) can be largely replicated in real-world settings among patients with chronic kidney disease (CKD), highlighting the advantages of adopting intensive BP targets.
 

METHODOLOGY:

• The SPRINT showed that an intensive systolic BP goal < 120 mm Hg reduced mortality, cardiovascular events, and mild cognitive impairment in patients with hypertension and elevated cardiovascular risk, including in patients with CKD.
• Researchers conducted a comparative effectiveness study to determine if the beneficial and adverse effects of intensive vs standard BP control observed in SPRINT were replicable in patients with CKD and hypertension in clinical practice.
• They identified 85,938 patients (mean age, 75.7 years; 95.0% men) and 13,983 patients (mean age, 77.4 years; 38.4% men) from the Veterans Health Administration (VHA) and Kaiser Permanente of Southern California (KPSC) databases, respectively.
• The treatment effect was estimated by combining baseline covariate, treatment, and outcome data of participants from the SPRINT with covariate data from the VHA and KPSC databases.
• The primary outcomes included major cardiovascular events, all-cause death, cognitive impairment, CKD progression, and adverse events at 4 years.

TAKEAWAY:

• Compared with SPRINT participants, those in the VHA and KPSC databases were older, had less prevalent cardiovascular disease, higher albuminuria, and used more statins.
• The benefits of intensive vs standard BP control on major cardiovascular events, all-cause mortality, and certain adverse events (hypotension, syncope, bradycardia, acute kidney injury, and electrolyte abnormality) were transferable from the trial to the VHA and KPSC populations.
• The treatment effect of intensive BP management on CKD progression was transportable to the KPSC population but not to the VHA population. However, the trial’s impact on cognitive outcomes, such as dementia, was not transportable to either the VHA or KPSC populations.
• On the absolute scale, intensive vs standard BP treatment showed greater cardiovascular benefits and fewer safety concerns in the VHA and KPSC populations than in the SPRINT.

IN PRACTICE:

“This example highlights the potential for transportability methods to provide insights that can bridge evidence gaps and inform the application of novel therapies to patients with CKD who are treated in everyday practice,” the authors wrote.
 

SOURCE:

This study was led by Manjula Kurella Tamura, MD, MPH, Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, California. It was published online on January 7, 2025, in JAMA Network Open.
 

LIMITATIONS:

Transportability analyses could not account for characteristics that were not well-documented in electronic health records, such as limited life expectancy. The study was conducted before the widespread use of sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and nonsteroidal mineralocorticoid receptor antagonists, making it unclear whether intensive BP treatment would result in similar benefits with current pharmacotherapy regimens. Eligibility for this study was based on BP measurements in routine practice, which tend to be more variable than those collected in research settings.
 

DISCLOSURES:

This study was supported by grants from the National Institutes of Health. Some authors disclosed serving as a consultant and receiving grants, personal fees, and consulting fees from pharmaceutical companies and other sources.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The cardiovascular benefits observed with intensive blood pressure (BP) control in patients with hypertension and elevated cardiovascular risk from the Systolic Blood Pressure Intervention Trial (SPRINT) can be largely replicated in real-world settings among patients with chronic kidney disease (CKD), highlighting the advantages of adopting intensive BP targets.
 

METHODOLOGY:

• The SPRINT showed that an intensive systolic BP goal < 120 mm Hg reduced mortality, cardiovascular events, and mild cognitive impairment in patients with hypertension and elevated cardiovascular risk, including in patients with CKD.
• Researchers conducted a comparative effectiveness study to determine if the beneficial and adverse effects of intensive vs standard BP control observed in SPRINT were replicable in patients with CKD and hypertension in clinical practice.
• They identified 85,938 patients (mean age, 75.7 years; 95.0% men) and 13,983 patients (mean age, 77.4 years; 38.4% men) from the Veterans Health Administration (VHA) and Kaiser Permanente of Southern California (KPSC) databases, respectively.
• The treatment effect was estimated by combining baseline covariate, treatment, and outcome data of participants from the SPRINT with covariate data from the VHA and KPSC databases.
• The primary outcomes included major cardiovascular events, all-cause death, cognitive impairment, CKD progression, and adverse events at 4 years.

TAKEAWAY:

• Compared with SPRINT participants, those in the VHA and KPSC databases were older, had less prevalent cardiovascular disease, higher albuminuria, and used more statins.
• The benefits of intensive vs standard BP control on major cardiovascular events, all-cause mortality, and certain adverse events (hypotension, syncope, bradycardia, acute kidney injury, and electrolyte abnormality) were transferable from the trial to the VHA and KPSC populations.
• The treatment effect of intensive BP management on CKD progression was transportable to the KPSC population but not to the VHA population. However, the trial’s impact on cognitive outcomes, such as dementia, was not transportable to either the VHA or KPSC populations.
• On the absolute scale, intensive vs standard BP treatment showed greater cardiovascular benefits and fewer safety concerns in the VHA and KPSC populations than in the SPRINT.

IN PRACTICE:

“This example highlights the potential for transportability methods to provide insights that can bridge evidence gaps and inform the application of novel therapies to patients with CKD who are treated in everyday practice,” the authors wrote.
 

SOURCE:

This study was led by Manjula Kurella Tamura, MD, MPH, Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, California. It was published online on January 7, 2025, in JAMA Network Open.
 

LIMITATIONS:

Transportability analyses could not account for characteristics that were not well-documented in electronic health records, such as limited life expectancy. The study was conducted before the widespread use of sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and nonsteroidal mineralocorticoid receptor antagonists, making it unclear whether intensive BP treatment would result in similar benefits with current pharmacotherapy regimens. Eligibility for this study was based on BP measurements in routine practice, which tend to be more variable than those collected in research settings.
 

DISCLOSURES:

This study was supported by grants from the National Institutes of Health. Some authors disclosed serving as a consultant and receiving grants, personal fees, and consulting fees from pharmaceutical companies and other sources.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Patients with rectal cancer managed by watch and wait and subsequent local regrowth have a higher risk for distant metastases than those undergoing immediate surgery. The new study highlights the importance of timely surgical intervention to improve distant metastases–free survival rates.

METHODOLOGY:

• Organ preservation has become an attractive alternative to surgery for patients with rectal cancer who achieve a clinical complete response after neoadjuvant therapy, with the risk for local regrowth after initial clinical complete response being around 25%-30%.
• The new study aimed to compare the risk for distant metastases between patients with local regrowth after watch and wait and patients with near-complete pathologic response managed by total mesorectal excision.
• A total of 508 patients with local regrowth were included from the International Watch & Wait Database, and 893 patients with near-complete pathologic response were included from the Spanish Rectal Cancer Project.
• The primary endpoint was distant metastases–free survival at 3 years from the decision to watch and wait or total mesorectal excision, and the secondary endpoints included possible risk factors associated with distant metastases.

TAKEAWAY:

• Patients with local regrowth had a significantly higher rate of distant metastases (rate, 22.8% vs 10.2%; P ≤.001) than those with near-complete pathologic response managed by total mesorectal excision.
• Distant metastases–free survival at 3 years was significantly worse for patients with local regrowth (rate, 75% vs 87%; P < .001).
• Independent risk factors for distant metastases included local regrowth (vs total mesorectal excision at reassessment; P = .001), ypT3-4 status (P = .016), and ypN+ status (P = .001) at the time of surgery.
• Patients with local regrowth had worse distant metastases–free survival across all pathologic stages than those managed by total mesorectal excision.

IN PRACTICE:

“Patients with local regrowth appear to have a higher risk for subsequent distant metastases development than patients with near-complete pathologic response managed by total mesorectal excision at restaging irrespective of final pathology,” the authors wrote.

SOURCE:

This study was led by Laura M. Fernandez, MD, of the Champalimaud Foundation in Lisbon, Portugal. It was published online in Journal of Clinical Oncology.

LIMITATIONS:

This study’s limitations included the heterogeneity in defining clinical complete response and the decision to watch and wait across different institutions. The majority of patients did not receive total neoadjuvant therapy regimens, which may have affected the generalizability of the findings. The study had a considerable amount of follow-up losses, which could have introduced bias.

DISCLOSURES:

This study was supported by the European Society of Surgical Oncology, the Champalimaud Foundation, the Bas Mulder Award, the Alpe d’HuZes Foundation, the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. Fernandez disclosed receiving grants from Johnson & Johnson. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Patients with rectal cancer managed by watch and wait and subsequent local regrowth have a higher risk for distant metastases than those undergoing immediate surgery. The new study highlights the importance of timely surgical intervention to improve distant metastases–free survival rates.

METHODOLOGY:

• Organ preservation has become an attractive alternative to surgery for patients with rectal cancer who achieve a clinical complete response after neoadjuvant therapy, with the risk for local regrowth after initial clinical complete response being around 25%-30%.
• The new study aimed to compare the risk for distant metastases between patients with local regrowth after watch and wait and patients with near-complete pathologic response managed by total mesorectal excision.
• A total of 508 patients with local regrowth were included from the International Watch & Wait Database, and 893 patients with near-complete pathologic response were included from the Spanish Rectal Cancer Project.
• The primary endpoint was distant metastases–free survival at 3 years from the decision to watch and wait or total mesorectal excision, and the secondary endpoints included possible risk factors associated with distant metastases.

TAKEAWAY:

• Patients with local regrowth had a significantly higher rate of distant metastases (rate, 22.8% vs 10.2%; P ≤.001) than those with near-complete pathologic response managed by total mesorectal excision.
• Distant metastases–free survival at 3 years was significantly worse for patients with local regrowth (rate, 75% vs 87%; P < .001).
• Independent risk factors for distant metastases included local regrowth (vs total mesorectal excision at reassessment; P = .001), ypT3-4 status (P = .016), and ypN+ status (P = .001) at the time of surgery.
• Patients with local regrowth had worse distant metastases–free survival across all pathologic stages than those managed by total mesorectal excision.

IN PRACTICE:

“Patients with local regrowth appear to have a higher risk for subsequent distant metastases development than patients with near-complete pathologic response managed by total mesorectal excision at restaging irrespective of final pathology,” the authors wrote.

SOURCE:

This study was led by Laura M. Fernandez, MD, of the Champalimaud Foundation in Lisbon, Portugal. It was published online in Journal of Clinical Oncology.

LIMITATIONS:

This study’s limitations included the heterogeneity in defining clinical complete response and the decision to watch and wait across different institutions. The majority of patients did not receive total neoadjuvant therapy regimens, which may have affected the generalizability of the findings. The study had a considerable amount of follow-up losses, which could have introduced bias.

DISCLOSURES:

This study was supported by the European Society of Surgical Oncology, the Champalimaud Foundation, the Bas Mulder Award, the Alpe d’HuZes Foundation, the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. Fernandez disclosed receiving grants from Johnson & Johnson. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Patients with rectal cancer managed by watch and wait and subsequent local regrowth have a higher risk for distant metastases than those undergoing immediate surgery. The new study highlights the importance of timely surgical intervention to improve distant metastases–free survival rates.

METHODOLOGY:

• Organ preservation has become an attractive alternative to surgery for patients with rectal cancer who achieve a clinical complete response after neoadjuvant therapy, with the risk for local regrowth after initial clinical complete response being around 25%-30%.
• The new study aimed to compare the risk for distant metastases between patients with local regrowth after watch and wait and patients with near-complete pathologic response managed by total mesorectal excision.
• A total of 508 patients with local regrowth were included from the International Watch & Wait Database, and 893 patients with near-complete pathologic response were included from the Spanish Rectal Cancer Project.
• The primary endpoint was distant metastases–free survival at 3 years from the decision to watch and wait or total mesorectal excision, and the secondary endpoints included possible risk factors associated with distant metastases.

TAKEAWAY:

• Patients with local regrowth had a significantly higher rate of distant metastases (rate, 22.8% vs 10.2%; P ≤.001) than those with near-complete pathologic response managed by total mesorectal excision.
• Distant metastases–free survival at 3 years was significantly worse for patients with local regrowth (rate, 75% vs 87%; P < .001).
• Independent risk factors for distant metastases included local regrowth (vs total mesorectal excision at reassessment; P = .001), ypT3-4 status (P = .016), and ypN+ status (P = .001) at the time of surgery.
• Patients with local regrowth had worse distant metastases–free survival across all pathologic stages than those managed by total mesorectal excision.

IN PRACTICE:

“Patients with local regrowth appear to have a higher risk for subsequent distant metastases development than patients with near-complete pathologic response managed by total mesorectal excision at restaging irrespective of final pathology,” the authors wrote.

SOURCE:

This study was led by Laura M. Fernandez, MD, of the Champalimaud Foundation in Lisbon, Portugal. It was published online in Journal of Clinical Oncology.

LIMITATIONS:

This study’s limitations included the heterogeneity in defining clinical complete response and the decision to watch and wait across different institutions. The majority of patients did not receive total neoadjuvant therapy regimens, which may have affected the generalizability of the findings. The study had a considerable amount of follow-up losses, which could have introduced bias.

DISCLOSURES:

This study was supported by the European Society of Surgical Oncology, the Champalimaud Foundation, the Bas Mulder Award, the Alpe d’HuZes Foundation, the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. Fernandez disclosed receiving grants from Johnson & Johnson. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Among 57,086 older adults, new gabapentin users demonstrated lower fall-related healthcare visits than duloxetine users, with a weighted cumulative incidence of 84.44 vs 158.21 per 1000 person-years at 180 days. Incident gabapentin use showed a 48% lower hazard of falls at 6-month follow-up, with no increase in severe fall-related events.
 

METHODOLOGY:

• Researchers conducted a new user, active comparator cohort study using IBM MarketScan Research Databases from January 2014 to December 2021.
• Analysis included 57,086 adults aged 65 years or older with postherpetic neuralgia, diabetic neuropathy, or fibromyalgia, excluding those with depression, anxiety, seizures, or cancer in the prior 365 days.
• The primary outcome measured the hazard of experiencing any fall-related visit in the 6 months after initiating gabapentin or duloxetine until treatment discontinuation.
• Secondary outcomes examined severe fall-related events, including falls with hip fractures or emergency department visits/hospitalizations associated with falls.

TAKEAWAY:

• The analytic cohort included 52,152 gabapentin users and 4934 duloxetine users, with a median follow-up duration of 30 days (interquartile range, 30-90 days).
• Weighted cumulative incidence of fall-related visits per 1000 person-years at 30, 90, and 180 days was 103.60, 90.44, and 84.44 for gabapentin users vs 203.43, 177.73, and 158.21 for duloxetine users.
• At 6-month follow-up, incident gabapentin users demonstrated lower hazard of falls (hazard ratio, 0.52; 95% CI, 0.43-0.64), with no difference in hazards of severe falls.
• Results remained consistent across sensitivity and subgroup analyses.

IN PRACTICE:

“One bioplausible explanation for our results is that gabapentin is a highly titratable medication and many in our cohort started on low doses. Alternatively, duloxetine is usually titrated only once or twice. Thus, although it may be that gabapentin is simply safer than duloxetine from a falls perspective, it may also be likely that we are measuring specific clinical scenarios, the peri-initiation and titration period, in which gabapentin may be less likely to cause falls than duloxetine,” the authors wrote.
 

SOURCE:

The study was led by Alexander Chaitoff, MD, MPH, Department of Internal Medicine, University of Michigan School of Medicine in Ann Arbor, and Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School in Boston. It was published online in Annals of Internal Medicine.
 

LIMITATIONS:

Despite the design aimed at limiting confounding effects, the observational nature of the study introduces potential bias. Claims data may undercount falls for which patients do not seek care, though this limitation likely affects both medication groups equally. The commercial claims database includes only Medicare supplemental insurance beneficiaries, potentially limiting generalizability. Regional variations in prescribing patterns could not be accounted for in the analysis.
 

DISCLOSURES:

No funding was provided for this study.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com. 

TOPLINE:

Among 57,086 older adults, new gabapentin users demonstrated lower fall-related healthcare visits than duloxetine users, with a weighted cumulative incidence of 84.44 vs 158.21 per 1000 person-years at 180 days. Incident gabapentin use showed a 48% lower hazard of falls at 6-month follow-up, with no increase in severe fall-related events.
 

METHODOLOGY:

• Researchers conducted a new user, active comparator cohort study using IBM MarketScan Research Databases from January 2014 to December 2021.
• Analysis included 57,086 adults aged 65 years or older with postherpetic neuralgia, diabetic neuropathy, or fibromyalgia, excluding those with depression, anxiety, seizures, or cancer in the prior 365 days.
• The primary outcome measured the hazard of experiencing any fall-related visit in the 6 months after initiating gabapentin or duloxetine until treatment discontinuation.
• Secondary outcomes examined severe fall-related events, including falls with hip fractures or emergency department visits/hospitalizations associated with falls.

TAKEAWAY:

• The analytic cohort included 52,152 gabapentin users and 4934 duloxetine users, with a median follow-up duration of 30 days (interquartile range, 30-90 days).
• Weighted cumulative incidence of fall-related visits per 1000 person-years at 30, 90, and 180 days was 103.60, 90.44, and 84.44 for gabapentin users vs 203.43, 177.73, and 158.21 for duloxetine users.
• At 6-month follow-up, incident gabapentin users demonstrated lower hazard of falls (hazard ratio, 0.52; 95% CI, 0.43-0.64), with no difference in hazards of severe falls.
• Results remained consistent across sensitivity and subgroup analyses.

IN PRACTICE:

“One bioplausible explanation for our results is that gabapentin is a highly titratable medication and many in our cohort started on low doses. Alternatively, duloxetine is usually titrated only once or twice. Thus, although it may be that gabapentin is simply safer than duloxetine from a falls perspective, it may also be likely that we are measuring specific clinical scenarios, the peri-initiation and titration period, in which gabapentin may be less likely to cause falls than duloxetine,” the authors wrote.
 

SOURCE:

The study was led by Alexander Chaitoff, MD, MPH, Department of Internal Medicine, University of Michigan School of Medicine in Ann Arbor, and Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School in Boston. It was published online in Annals of Internal Medicine.
 

LIMITATIONS:

Despite the design aimed at limiting confounding effects, the observational nature of the study introduces potential bias. Claims data may undercount falls for which patients do not seek care, though this limitation likely affects both medication groups equally. The commercial claims database includes only Medicare supplemental insurance beneficiaries, potentially limiting generalizability. Regional variations in prescribing patterns could not be accounted for in the analysis.
 

DISCLOSURES:

No funding was provided for this study.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com. 

TOPLINE:

Among 57,086 older adults, new gabapentin users demonstrated lower fall-related healthcare visits than duloxetine users, with a weighted cumulative incidence of 84.44 vs 158.21 per 1000 person-years at 180 days. Incident gabapentin use showed a 48% lower hazard of falls at 6-month follow-up, with no increase in severe fall-related events.
 

METHODOLOGY:

• Researchers conducted a new user, active comparator cohort study using IBM MarketScan Research Databases from January 2014 to December 2021.
• Analysis included 57,086 adults aged 65 years or older with postherpetic neuralgia, diabetic neuropathy, or fibromyalgia, excluding those with depression, anxiety, seizures, or cancer in the prior 365 days.
• The primary outcome measured the hazard of experiencing any fall-related visit in the 6 months after initiating gabapentin or duloxetine until treatment discontinuation.
• Secondary outcomes examined severe fall-related events, including falls with hip fractures or emergency department visits/hospitalizations associated with falls.

TAKEAWAY:

• The analytic cohort included 52,152 gabapentin users and 4934 duloxetine users, with a median follow-up duration of 30 days (interquartile range, 30-90 days).
• Weighted cumulative incidence of fall-related visits per 1000 person-years at 30, 90, and 180 days was 103.60, 90.44, and 84.44 for gabapentin users vs 203.43, 177.73, and 158.21 for duloxetine users.
• At 6-month follow-up, incident gabapentin users demonstrated lower hazard of falls (hazard ratio, 0.52; 95% CI, 0.43-0.64), with no difference in hazards of severe falls.
• Results remained consistent across sensitivity and subgroup analyses.

IN PRACTICE:

“One bioplausible explanation for our results is that gabapentin is a highly titratable medication and many in our cohort started on low doses. Alternatively, duloxetine is usually titrated only once or twice. Thus, although it may be that gabapentin is simply safer than duloxetine from a falls perspective, it may also be likely that we are measuring specific clinical scenarios, the peri-initiation and titration period, in which gabapentin may be less likely to cause falls than duloxetine,” the authors wrote.
 

SOURCE:

The study was led by Alexander Chaitoff, MD, MPH, Department of Internal Medicine, University of Michigan School of Medicine in Ann Arbor, and Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School in Boston. It was published online in Annals of Internal Medicine.
 

LIMITATIONS:

Despite the design aimed at limiting confounding effects, the observational nature of the study introduces potential bias. Claims data may undercount falls for which patients do not seek care, though this limitation likely affects both medication groups equally. The commercial claims database includes only Medicare supplemental insurance beneficiaries, potentially limiting generalizability. Regional variations in prescribing patterns could not be accounted for in the analysis.
 

DISCLOSURES:

No funding was provided for this study.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com. 

TOPLINE:

Nearly one in six adults with asthma in the United States is nonadherent to medications due to costs, with younger patients, women, and those without insurance having an increased likelihood of being nonadherent.

METHODOLOGY:

• Researchers evaluated the prevalence and determinants of cost-related nonadherence (CRN) to medications among adults with asthma in the United States between 2011 and 2022. Data were obtained from the National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics.
• They used the data from the NHIS to include a total of 30,793 adults who had asthma, representing 8.1% of the US population.
• CRN was defined through three components: Skipping medication doses, taking less medication, or delaying medication refills to save money over the past 12 months.
• CRN prevalence, factors associated with CRN, and asthma-related adverse events were analyzed.

TAKEAWAY:

• Overall, 17.8% of US adults with asthma reported CRN; 11.6% skipped medication, 12.4% took less medication, and 15.1% delayed refilling medications to save money.
• Patients aged > 60 years were the least likely to report CRN compared with those aged 18-40 years and 41-60 years; women were more likely to report CRN to medications than men (both P < .01).
• Patients who were current or former smokers or had two or more comorbidities, no health insurance coverage, or a family income below 400% of the federal poverty level had an increased likelihood of reporting CRN.
• Compared with patients without CRN, those who reported CRN had almost double the odds of experiencing asthma attacks (adjusted odds ratio [aOR], 1.95; 95% CI, 1.78-2.13) and increased emergency room visits for asthma (aOR, 1.63; 95% CI, 1.44-1.84).

IN PRACTICE:

“The present study reinforces the recommendation that patients with asthma are best controlled when they are prescribed and take medications that are strongly recommended by clinical guidelines,” the authors wrote. “For healthcare providers, it is imperative to monitor patient’s adherence to medications to prevent asthma exacerbations, especially when treating patients with financial concerns,” they further added.

SOURCE:

The study was led by Chun-Tse Hung, School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan. It was published online in Thorax.

LIMITATIONS:

The reliance on self-reported data introduced potential recall bias, and the absence of medical records may have led to misclassification of disease status. The study could not evaluate the effect of asthma severity due to limited measures in the NHIS. Some important variables reflecting economic indicators, such as the consumer price index, could not be included due to limited measures in the NHIS.

DISCLOSURES:

No disclosures or conflicts of interest statements were provided in the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Nearly one in six adults with asthma in the United States is nonadherent to medications due to costs, with younger patients, women, and those without insurance having an increased likelihood of being nonadherent.

METHODOLOGY:

• Researchers evaluated the prevalence and determinants of cost-related nonadherence (CRN) to medications among adults with asthma in the United States between 2011 and 2022. Data were obtained from the National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics.
• They used the data from the NHIS to include a total of 30,793 adults who had asthma, representing 8.1% of the US population.
• CRN was defined through three components: Skipping medication doses, taking less medication, or delaying medication refills to save money over the past 12 months.
• CRN prevalence, factors associated with CRN, and asthma-related adverse events were analyzed.

TAKEAWAY:

• Overall, 17.8% of US adults with asthma reported CRN; 11.6% skipped medication, 12.4% took less medication, and 15.1% delayed refilling medications to save money.
• Patients aged > 60 years were the least likely to report CRN compared with those aged 18-40 years and 41-60 years; women were more likely to report CRN to medications than men (both P < .01).
• Patients who were current or former smokers or had two or more comorbidities, no health insurance coverage, or a family income below 400% of the federal poverty level had an increased likelihood of reporting CRN.
• Compared with patients without CRN, those who reported CRN had almost double the odds of experiencing asthma attacks (adjusted odds ratio [aOR], 1.95; 95% CI, 1.78-2.13) and increased emergency room visits for asthma (aOR, 1.63; 95% CI, 1.44-1.84).

IN PRACTICE:

“The present study reinforces the recommendation that patients with asthma are best controlled when they are prescribed and take medications that are strongly recommended by clinical guidelines,” the authors wrote. “For healthcare providers, it is imperative to monitor patient’s adherence to medications to prevent asthma exacerbations, especially when treating patients with financial concerns,” they further added.

SOURCE:

The study was led by Chun-Tse Hung, School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan. It was published online in Thorax.

LIMITATIONS:

The reliance on self-reported data introduced potential recall bias, and the absence of medical records may have led to misclassification of disease status. The study could not evaluate the effect of asthma severity due to limited measures in the NHIS. Some important variables reflecting economic indicators, such as the consumer price index, could not be included due to limited measures in the NHIS.

DISCLOSURES:

No disclosures or conflicts of interest statements were provided in the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Nearly one in six adults with asthma in the United States is nonadherent to medications due to costs, with younger patients, women, and those without insurance having an increased likelihood of being nonadherent.

METHODOLOGY:

• Researchers evaluated the prevalence and determinants of cost-related nonadherence (CRN) to medications among adults with asthma in the United States between 2011 and 2022. Data were obtained from the National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics.
• They used the data from the NHIS to include a total of 30,793 adults who had asthma, representing 8.1% of the US population.
• CRN was defined through three components: Skipping medication doses, taking less medication, or delaying medication refills to save money over the past 12 months.
• CRN prevalence, factors associated with CRN, and asthma-related adverse events were analyzed.

TAKEAWAY:

• Overall, 17.8% of US adults with asthma reported CRN; 11.6% skipped medication, 12.4% took less medication, and 15.1% delayed refilling medications to save money.
• Patients aged > 60 years were the least likely to report CRN compared with those aged 18-40 years and 41-60 years; women were more likely to report CRN to medications than men (both P < .01).
• Patients who were current or former smokers or had two or more comorbidities, no health insurance coverage, or a family income below 400% of the federal poverty level had an increased likelihood of reporting CRN.
• Compared with patients without CRN, those who reported CRN had almost double the odds of experiencing asthma attacks (adjusted odds ratio [aOR], 1.95; 95% CI, 1.78-2.13) and increased emergency room visits for asthma (aOR, 1.63; 95% CI, 1.44-1.84).

IN PRACTICE:

“The present study reinforces the recommendation that patients with asthma are best controlled when they are prescribed and take medications that are strongly recommended by clinical guidelines,” the authors wrote. “For healthcare providers, it is imperative to monitor patient’s adherence to medications to prevent asthma exacerbations, especially when treating patients with financial concerns,” they further added.

SOURCE:

The study was led by Chun-Tse Hung, School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan. It was published online in Thorax.

LIMITATIONS:

The reliance on self-reported data introduced potential recall bias, and the absence of medical records may have led to misclassification of disease status. The study could not evaluate the effect of asthma severity due to limited measures in the NHIS. Some important variables reflecting economic indicators, such as the consumer price index, could not be included due to limited measures in the NHIS.

DISCLOSURES:

No disclosures or conflicts of interest statements were provided in the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Daily treatment with 1200 mg of choline alfoscerate for 12 months shows a modest yet significant improvement in cognitive function and physical health in older patients with type 2 diabetes (T2D) and early signs of cognitive decline. 
 

METHODOLOGY:

• Prior studies have demonstrated the efficacy of choline alfoscerate, a phospholipid metabolite naturally found in the brain, in improving cognitive function in patients with neurodegenerative conditions, but its use in patients with T2D remains unexplored.
• Researchers at a hospital in Korea enrolled patients aged over 60 years with T2D and mild cognitive impairment (assessed by Mini-Mental State Examination [MMSE] scores of 25-28), who were randomly assigned to receive either 1200 mg/d choline alfoscerate or placebo for 12 months.
• The primary efficacy endpoint was the change in the total MMSE score from baseline to month 6; secondary efficacy endpoints included changes in cognitive performance and quality of life, measured by the 36-Item Short Form Health Survey, at 6 and 12 months.

TAKEAWAY:

• Thirty-six patients (average age, 71.8 years; 25% men) with an average diabetes duration of 12.1 years were randomized to receive choline alfoscerate (n = 18) or placebo (n = 18).
• At 6 months, there was modest but nonsignificant improvement in MMSE score with choline alfoscerate vs placebo (P = .059).
• After 12 months, the choline alfoscerate group showed an increase in the MMSE score from 26.2 to 27.1, whereas the placebo group showed a slight decline from 26.6 to 25.8, which represented a significant improvement for the treatment arm (P < .001).
• Physical health scores were significantly superior in the choline alfoscerate group vs the placebo group at 6 months (P = .014), with similar observations at 12 months (P = .039).
• No serious adverse events were reported in either group.

IN PRACTICE:

“Choline alfoscerate could be considered an anticipated therapeutic option to preserve cognitive function and subsequently physical health in elderly patients with diabetes and mild cognitive impairment,” the authors wrote.
 

SOURCE:

The study was led by Minji Sohn, PhD, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea, and published online in Diabetes, Obesity and Metabolism.
 

LIMITATIONS:

The study population primarily comprised non–insulin-dependent patients with controlled glycemia and minimal comorbidities, which may have limited the applicability of the results to a broader population. The small sample size may have contributed to the lack of statistical significance in some outcomes. Moreover, the 12-month study duration may have not been sufficient to investigate the long-term effects of choline alfoscerate.
 

DISCLOSURES:

This study was funded by Daewoong Pharmaceutical through subcontracting with Seoul National University Bundang Hospital. The authors declared no competing interests.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Daily treatment with 1200 mg of choline alfoscerate for 12 months shows a modest yet significant improvement in cognitive function and physical health in older patients with type 2 diabetes (T2D) and early signs of cognitive decline. 
 

METHODOLOGY:

• Prior studies have demonstrated the efficacy of choline alfoscerate, a phospholipid metabolite naturally found in the brain, in improving cognitive function in patients with neurodegenerative conditions, but its use in patients with T2D remains unexplored.
• Researchers at a hospital in Korea enrolled patients aged over 60 years with T2D and mild cognitive impairment (assessed by Mini-Mental State Examination [MMSE] scores of 25-28), who were randomly assigned to receive either 1200 mg/d choline alfoscerate or placebo for 12 months.
• The primary efficacy endpoint was the change in the total MMSE score from baseline to month 6; secondary efficacy endpoints included changes in cognitive performance and quality of life, measured by the 36-Item Short Form Health Survey, at 6 and 12 months.

TAKEAWAY:

• Thirty-six patients (average age, 71.8 years; 25% men) with an average diabetes duration of 12.1 years were randomized to receive choline alfoscerate (n = 18) or placebo (n = 18).
• At 6 months, there was modest but nonsignificant improvement in MMSE score with choline alfoscerate vs placebo (P = .059).
• After 12 months, the choline alfoscerate group showed an increase in the MMSE score from 26.2 to 27.1, whereas the placebo group showed a slight decline from 26.6 to 25.8, which represented a significant improvement for the treatment arm (P < .001).
• Physical health scores were significantly superior in the choline alfoscerate group vs the placebo group at 6 months (P = .014), with similar observations at 12 months (P = .039).
• No serious adverse events were reported in either group.

IN PRACTICE:

“Choline alfoscerate could be considered an anticipated therapeutic option to preserve cognitive function and subsequently physical health in elderly patients with diabetes and mild cognitive impairment,” the authors wrote.
 

SOURCE:

The study was led by Minji Sohn, PhD, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea, and published online in Diabetes, Obesity and Metabolism.
 

LIMITATIONS:

The study population primarily comprised non–insulin-dependent patients with controlled glycemia and minimal comorbidities, which may have limited the applicability of the results to a broader population. The small sample size may have contributed to the lack of statistical significance in some outcomes. Moreover, the 12-month study duration may have not been sufficient to investigate the long-term effects of choline alfoscerate.
 

DISCLOSURES:

This study was funded by Daewoong Pharmaceutical through subcontracting with Seoul National University Bundang Hospital. The authors declared no competing interests.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Daily treatment with 1200 mg of choline alfoscerate for 12 months shows a modest yet significant improvement in cognitive function and physical health in older patients with type 2 diabetes (T2D) and early signs of cognitive decline. 
 

METHODOLOGY:

• Prior studies have demonstrated the efficacy of choline alfoscerate, a phospholipid metabolite naturally found in the brain, in improving cognitive function in patients with neurodegenerative conditions, but its use in patients with T2D remains unexplored.
• Researchers at a hospital in Korea enrolled patients aged over 60 years with T2D and mild cognitive impairment (assessed by Mini-Mental State Examination [MMSE] scores of 25-28), who were randomly assigned to receive either 1200 mg/d choline alfoscerate or placebo for 12 months.
• The primary efficacy endpoint was the change in the total MMSE score from baseline to month 6; secondary efficacy endpoints included changes in cognitive performance and quality of life, measured by the 36-Item Short Form Health Survey, at 6 and 12 months.

TAKEAWAY:

• Thirty-six patients (average age, 71.8 years; 25% men) with an average diabetes duration of 12.1 years were randomized to receive choline alfoscerate (n = 18) or placebo (n = 18).
• At 6 months, there was modest but nonsignificant improvement in MMSE score with choline alfoscerate vs placebo (P = .059).
• After 12 months, the choline alfoscerate group showed an increase in the MMSE score from 26.2 to 27.1, whereas the placebo group showed a slight decline from 26.6 to 25.8, which represented a significant improvement for the treatment arm (P < .001).
• Physical health scores were significantly superior in the choline alfoscerate group vs the placebo group at 6 months (P = .014), with similar observations at 12 months (P = .039).
• No serious adverse events were reported in either group.

IN PRACTICE:

“Choline alfoscerate could be considered an anticipated therapeutic option to preserve cognitive function and subsequently physical health in elderly patients with diabetes and mild cognitive impairment,” the authors wrote.
 

SOURCE:

The study was led by Minji Sohn, PhD, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea, and published online in Diabetes, Obesity and Metabolism.
 

LIMITATIONS:

The study population primarily comprised non–insulin-dependent patients with controlled glycemia and minimal comorbidities, which may have limited the applicability of the results to a broader population. The small sample size may have contributed to the lack of statistical significance in some outcomes. Moreover, the 12-month study duration may have not been sufficient to investigate the long-term effects of choline alfoscerate.
 

DISCLOSURES:

This study was funded by Daewoong Pharmaceutical through subcontracting with Seoul National University Bundang Hospital. The authors declared no competing interests.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.