Heidi Splete

Progression of chronic kidney disease (CKD) and cardiovascular disease risk in hypertensive adults was significantly slower among those who consumed more fruits and vegetables or oral sodium bicarbonate, compared with controls who received usual care.

A primary focus on pharmacologic strategies has failed to reduced hypertension-related CKD and cardiovascular disease mortality, Nimrit Goraya, MD, of Texas A&M Health Sciences Center College of Medicine, Temple, and colleagues wrote. High-acid diets (those with greater amounts of animal-sourced foods) have been associated with increased incidence and progression of CKD and with increased risk of cardiovascular disease.

Diets high in fruits and vegetables are associated with reduced CKD and cardiovascular disease but are not routinely used as part of hypertension treatment. The researchers hypothesized that dietary acid reduction could slow kidney disease progression and reduce cardiovascular disease risk.

In a study published in The American Journal of Medicine, the researchers randomized 153 adults aged 18-70 years with hypertension and CKD to fruits and vegetables, oral sodium bicarbonate (NaHCO₃), or usual care; 51 to each group. The fruit and vegetable group received 2-4 cups daily of base-producing food items including apples, apricots, oranges, peaches, pears, raisins, strawberries, carrots, cauliflower, eggplant, lettuce, potatoes, spinach, tomatoes, and zucchini. Participants were not instructed how to incorporate these foods into their diets. The sodium bicarbonate group received an average of four to five NaHCO₃ tablets daily (650 mg), divided into two doses.

The mean age of the participants was 48.8 years, 51% were female, and 47% were African American. The primary outcome was CKD progression and cardiovascular disease risk over 5 years. All participants met criteria at baseline for macroalbuminuria (a urine albumin to creatinine ratio of at least 200 mg/g) and were considered at increased risk for CKD progression.

Over the 5-year follow-up, CKD progression was significantly slower in the groups receiving fruits and vegetables and oral sodium bicarbonate, compared with usual care, based on trajectories showing a lower decline of estimated glomerular filtration rates (mean declines of 1.08 and 1.17 for fruits/vegetables and NaHCO₃, respectively, vs 19.4 for usual care, P < .001 for both).

However, systolic blood pressure and subsequent cardiovascular disease risk indicators were lower only in the fruit and vegetable group, compared with both the NaHCO₃ or usual-care groups over the long term. “Specifically, with fruits and vegetables, systolic blood pressure, plasma LDL and Lp(a) cholesterol, and body mass index decreased from baseline, consistent with better cardiovascular disease protection,” the researchers wrote. The protection against cardiovascular disease in the fruits and vegetables group occurred with lower doses of antihypertensive and statin medications and was not affected by baseline differences in medication doses.

The findings were limited by several factors, including the lack of data on compliance with the NaHCO₃ supplements, although urine net acid excretion in this group suggested increased alkali intake similar to that provided by fruits and vegetables, the researchers noted. Other limitations included the focus only on individuals with very high albuminuria.

More basic science studies are needed to explore how the potential vascular injury suggested by albuminuria affects CKD progression and cardiovascular disease, and clinical studies are needed to assess the impact of dietary acid reduction on patients with lower levels of albuminuria that the current study, the researchers said.

However, the results suggest that consuming fruits and vegetables, rather than NaHCO₃, is the preferred strategy for dietary acid reduction for patients with primary hypertension and CKD, they concluded. The findings also support routine measurement of urine albumin-to-creatinine ratios in hypertensive patients to identify CKD and assess risk for progression and subsequent cardiovascular disease.

The study was supported by the Larry and Jane Woirhaye Memorial Endowment in Renal Research at the Texas Tech University Health Sciences Center, the University Medical Center (both in Lubbock, Texas), the Endowment, Academic Operations Division of Baylor Scott & White Health, and the Episcopal Health Foundation. The researchers had no financial conflicts to disclose.

Progression of chronic kidney disease (CKD) and cardiovascular disease risk in hypertensive adults was significantly slower among those who consumed more fruits and vegetables or oral sodium bicarbonate, compared with controls who received usual care.

A primary focus on pharmacologic strategies has failed to reduced hypertension-related CKD and cardiovascular disease mortality, Nimrit Goraya, MD, of Texas A&M Health Sciences Center College of Medicine, Temple, and colleagues wrote. High-acid diets (those with greater amounts of animal-sourced foods) have been associated with increased incidence and progression of CKD and with increased risk of cardiovascular disease.

Diets high in fruits and vegetables are associated with reduced CKD and cardiovascular disease but are not routinely used as part of hypertension treatment. The researchers hypothesized that dietary acid reduction could slow kidney disease progression and reduce cardiovascular disease risk.

In a study published in The American Journal of Medicine, the researchers randomized 153 adults aged 18-70 years with hypertension and CKD to fruits and vegetables, oral sodium bicarbonate (NaHCO₃), or usual care; 51 to each group. The fruit and vegetable group received 2-4 cups daily of base-producing food items including apples, apricots, oranges, peaches, pears, raisins, strawberries, carrots, cauliflower, eggplant, lettuce, potatoes, spinach, tomatoes, and zucchini. Participants were not instructed how to incorporate these foods into their diets. The sodium bicarbonate group received an average of four to five NaHCO₃ tablets daily (650 mg), divided into two doses.

The mean age of the participants was 48.8 years, 51% were female, and 47% were African American. The primary outcome was CKD progression and cardiovascular disease risk over 5 years. All participants met criteria at baseline for macroalbuminuria (a urine albumin to creatinine ratio of at least 200 mg/g) and were considered at increased risk for CKD progression.

Over the 5-year follow-up, CKD progression was significantly slower in the groups receiving fruits and vegetables and oral sodium bicarbonate, compared with usual care, based on trajectories showing a lower decline of estimated glomerular filtration rates (mean declines of 1.08 and 1.17 for fruits/vegetables and NaHCO₃, respectively, vs 19.4 for usual care, P < .001 for both).

However, systolic blood pressure and subsequent cardiovascular disease risk indicators were lower only in the fruit and vegetable group, compared with both the NaHCO₃ or usual-care groups over the long term. “Specifically, with fruits and vegetables, systolic blood pressure, plasma LDL and Lp(a) cholesterol, and body mass index decreased from baseline, consistent with better cardiovascular disease protection,” the researchers wrote. The protection against cardiovascular disease in the fruits and vegetables group occurred with lower doses of antihypertensive and statin medications and was not affected by baseline differences in medication doses.

The findings were limited by several factors, including the lack of data on compliance with the NaHCO₃ supplements, although urine net acid excretion in this group suggested increased alkali intake similar to that provided by fruits and vegetables, the researchers noted. Other limitations included the focus only on individuals with very high albuminuria.

More basic science studies are needed to explore how the potential vascular injury suggested by albuminuria affects CKD progression and cardiovascular disease, and clinical studies are needed to assess the impact of dietary acid reduction on patients with lower levels of albuminuria that the current study, the researchers said.

However, the results suggest that consuming fruits and vegetables, rather than NaHCO₃, is the preferred strategy for dietary acid reduction for patients with primary hypertension and CKD, they concluded. The findings also support routine measurement of urine albumin-to-creatinine ratios in hypertensive patients to identify CKD and assess risk for progression and subsequent cardiovascular disease.

The study was supported by the Larry and Jane Woirhaye Memorial Endowment in Renal Research at the Texas Tech University Health Sciences Center, the University Medical Center (both in Lubbock, Texas), the Endowment, Academic Operations Division of Baylor Scott & White Health, and the Episcopal Health Foundation. The researchers had no financial conflicts to disclose.

Progression of chronic kidney disease (CKD) and cardiovascular disease risk in hypertensive adults was significantly slower among those who consumed more fruits and vegetables or oral sodium bicarbonate, compared with controls who received usual care.

A primary focus on pharmacologic strategies has failed to reduced hypertension-related CKD and cardiovascular disease mortality, Nimrit Goraya, MD, of Texas A&M Health Sciences Center College of Medicine, Temple, and colleagues wrote. High-acid diets (those with greater amounts of animal-sourced foods) have been associated with increased incidence and progression of CKD and with increased risk of cardiovascular disease.

Diets high in fruits and vegetables are associated with reduced CKD and cardiovascular disease but are not routinely used as part of hypertension treatment. The researchers hypothesized that dietary acid reduction could slow kidney disease progression and reduce cardiovascular disease risk.

In a study published in The American Journal of Medicine, the researchers randomized 153 adults aged 18-70 years with hypertension and CKD to fruits and vegetables, oral sodium bicarbonate (NaHCO₃), or usual care; 51 to each group. The fruit and vegetable group received 2-4 cups daily of base-producing food items including apples, apricots, oranges, peaches, pears, raisins, strawberries, carrots, cauliflower, eggplant, lettuce, potatoes, spinach, tomatoes, and zucchini. Participants were not instructed how to incorporate these foods into their diets. The sodium bicarbonate group received an average of four to five NaHCO₃ tablets daily (650 mg), divided into two doses.

The mean age of the participants was 48.8 years, 51% were female, and 47% were African American. The primary outcome was CKD progression and cardiovascular disease risk over 5 years. All participants met criteria at baseline for macroalbuminuria (a urine albumin to creatinine ratio of at least 200 mg/g) and were considered at increased risk for CKD progression.

Over the 5-year follow-up, CKD progression was significantly slower in the groups receiving fruits and vegetables and oral sodium bicarbonate, compared with usual care, based on trajectories showing a lower decline of estimated glomerular filtration rates (mean declines of 1.08 and 1.17 for fruits/vegetables and NaHCO₃, respectively, vs 19.4 for usual care, P < .001 for both).

However, systolic blood pressure and subsequent cardiovascular disease risk indicators were lower only in the fruit and vegetable group, compared with both the NaHCO₃ or usual-care groups over the long term. “Specifically, with fruits and vegetables, systolic blood pressure, plasma LDL and Lp(a) cholesterol, and body mass index decreased from baseline, consistent with better cardiovascular disease protection,” the researchers wrote. The protection against cardiovascular disease in the fruits and vegetables group occurred with lower doses of antihypertensive and statin medications and was not affected by baseline differences in medication doses.

The findings were limited by several factors, including the lack of data on compliance with the NaHCO₃ supplements, although urine net acid excretion in this group suggested increased alkali intake similar to that provided by fruits and vegetables, the researchers noted. Other limitations included the focus only on individuals with very high albuminuria.

More basic science studies are needed to explore how the potential vascular injury suggested by albuminuria affects CKD progression and cardiovascular disease, and clinical studies are needed to assess the impact of dietary acid reduction on patients with lower levels of albuminuria that the current study, the researchers said.

However, the results suggest that consuming fruits and vegetables, rather than NaHCO₃, is the preferred strategy for dietary acid reduction for patients with primary hypertension and CKD, they concluded. The findings also support routine measurement of urine albumin-to-creatinine ratios in hypertensive patients to identify CKD and assess risk for progression and subsequent cardiovascular disease.

The study was supported by the Larry and Jane Woirhaye Memorial Endowment in Renal Research at the Texas Tech University Health Sciences Center, the University Medical Center (both in Lubbock, Texas), the Endowment, Academic Operations Division of Baylor Scott & White Health, and the Episcopal Health Foundation. The researchers had no financial conflicts to disclose.

Adults who self-rated their health as poor in middle age were at least three times more likely to die or be hospitalized when older than those who self-rated their health as excellent, based on data from nearly 15,000 individuals.

Previous research has shown that self-rated health is an independent predictor of hospitalization or death, but the effects of individual subject-specific risks on these outcomes has not been examined, wrote Scott Z. Mu, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues.

In a study published in the Journal of General Internal Medicine, the researchers reviewed data from 14,937 members of the Atherosclerosis Risk in Communities (ARIC) cohort, a community-based prospective study of middle-aged men and women that began with their enrollment from 1987 to 1989. The primary outcome was the association between baseline self-rated health and subsequent recurrent hospitalizations and deaths over a median follow-up period of 27.7 years.

At baseline, 34% of the participants rated their health as excellent, 47% good, 16% fair, and 3% poor. After the median follow-up, 39%, 51%, 67%, and 83% of individuals who rated their health as excellent, good, fair, and poor, respectively, had died.

The researchers used a recurrent events survival model that adjusted for clinical and demographic factors and also allowed for dependency between the rates of hospitalization and hazards of death.

After controlling for demographics and medical history, a lower self-rating of health was associated with increased rates of hospitalization and death. Compared with individuals with baseline reports of excellent health, hospitalization rates were 1.22, 2.01, and 3.13 times higher for those with baseline reports of good, fair, or poor health, respectively. Similarly, compared with individuals with baseline reports of excellent health, hazards of death were 1.30, 2.15, and 3.40 for those with baseline reports of good, fair, or poor health, respectively.

Overall, individuals who reported poor health at baseline were significantly more likely than those who reported excellent health to be older (57.0 years vs 53.0 years), obese (44% vs 18%), and current smokers (39% vs 21%). Those who reported poor health at baseline also were significantly more likely than those who reported excellent health to have a history of cancer (9.5% vs 4.4%), emphysema/COPD (18% vs 2.3%), coronary heart disease (21% vs 1.6%), myocardial infarction (19% vs 1.3%), heart failure (25% vs. 1.2%), hypertension (67% vs 19%), or diabetes (39% vs 4.6%).

Potential explanations for the independent association between poor self-rated health and poor outcomes include the ability of self-rated health to capture health information not accounted for by traditional risk factors, the researchers wrote in their discussion. “Another explanation is that self-rated health reflects subconscious bodily sensations that provide a direct sense of health unavailable to external observation,” they said. Alternatively, self-rated health may reinforce beneficial behaviors in those with higher self-rated health and harmful behaviors in those with lower self-rated health, they said.

The findings were limited by several factors including the measurement of self-rated health and the validity of hospitalization as a proxy for morbidity, the researchers noted. Other limitations include the use of models instead of repeated self-rated health measures, and a lack of data on interventions to directly or indirectly improve self-rated health, the researchers noted.

However, the study shows the potential value of self-rated health in routine clinical care to predict future hospitalizations, they said. “Clinicians can use this simple and convenient measure for individual patients to provide more accurate and personalized risk assessments,” they said.

Looking ahead, the current study findings also support the need for more research into the routine assessment not only of self-rated health but also targeted interventions to improve self-rated health and its determinants, the researchers concluded. The ARIC study has been supported by the National Heart, Lung, and Blood Institute, National Institutes of Health. Dr. Mu disclosed support from the National Heart, Lung, and Blood Institute.

Adults who self-rated their health as poor in middle age were at least three times more likely to die or be hospitalized when older than those who self-rated their health as excellent, based on data from nearly 15,000 individuals.

Previous research has shown that self-rated health is an independent predictor of hospitalization or death, but the effects of individual subject-specific risks on these outcomes has not been examined, wrote Scott Z. Mu, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues.

In a study published in the Journal of General Internal Medicine, the researchers reviewed data from 14,937 members of the Atherosclerosis Risk in Communities (ARIC) cohort, a community-based prospective study of middle-aged men and women that began with their enrollment from 1987 to 1989. The primary outcome was the association between baseline self-rated health and subsequent recurrent hospitalizations and deaths over a median follow-up period of 27.7 years.

At baseline, 34% of the participants rated their health as excellent, 47% good, 16% fair, and 3% poor. After the median follow-up, 39%, 51%, 67%, and 83% of individuals who rated their health as excellent, good, fair, and poor, respectively, had died.

The researchers used a recurrent events survival model that adjusted for clinical and demographic factors and also allowed for dependency between the rates of hospitalization and hazards of death.

After controlling for demographics and medical history, a lower self-rating of health was associated with increased rates of hospitalization and death. Compared with individuals with baseline reports of excellent health, hospitalization rates were 1.22, 2.01, and 3.13 times higher for those with baseline reports of good, fair, or poor health, respectively. Similarly, compared with individuals with baseline reports of excellent health, hazards of death were 1.30, 2.15, and 3.40 for those with baseline reports of good, fair, or poor health, respectively.

Overall, individuals who reported poor health at baseline were significantly more likely than those who reported excellent health to be older (57.0 years vs 53.0 years), obese (44% vs 18%), and current smokers (39% vs 21%). Those who reported poor health at baseline also were significantly more likely than those who reported excellent health to have a history of cancer (9.5% vs 4.4%), emphysema/COPD (18% vs 2.3%), coronary heart disease (21% vs 1.6%), myocardial infarction (19% vs 1.3%), heart failure (25% vs. 1.2%), hypertension (67% vs 19%), or diabetes (39% vs 4.6%).

Potential explanations for the independent association between poor self-rated health and poor outcomes include the ability of self-rated health to capture health information not accounted for by traditional risk factors, the researchers wrote in their discussion. “Another explanation is that self-rated health reflects subconscious bodily sensations that provide a direct sense of health unavailable to external observation,” they said. Alternatively, self-rated health may reinforce beneficial behaviors in those with higher self-rated health and harmful behaviors in those with lower self-rated health, they said.

The findings were limited by several factors including the measurement of self-rated health and the validity of hospitalization as a proxy for morbidity, the researchers noted. Other limitations include the use of models instead of repeated self-rated health measures, and a lack of data on interventions to directly or indirectly improve self-rated health, the researchers noted.

However, the study shows the potential value of self-rated health in routine clinical care to predict future hospitalizations, they said. “Clinicians can use this simple and convenient measure for individual patients to provide more accurate and personalized risk assessments,” they said.

Looking ahead, the current study findings also support the need for more research into the routine assessment not only of self-rated health but also targeted interventions to improve self-rated health and its determinants, the researchers concluded. The ARIC study has been supported by the National Heart, Lung, and Blood Institute, National Institutes of Health. Dr. Mu disclosed support from the National Heart, Lung, and Blood Institute.

Adults who self-rated their health as poor in middle age were at least three times more likely to die or be hospitalized when older than those who self-rated their health as excellent, based on data from nearly 15,000 individuals.

Previous research has shown that self-rated health is an independent predictor of hospitalization or death, but the effects of individual subject-specific risks on these outcomes has not been examined, wrote Scott Z. Mu, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues.

In a study published in the Journal of General Internal Medicine, the researchers reviewed data from 14,937 members of the Atherosclerosis Risk in Communities (ARIC) cohort, a community-based prospective study of middle-aged men and women that began with their enrollment from 1987 to 1989. The primary outcome was the association between baseline self-rated health and subsequent recurrent hospitalizations and deaths over a median follow-up period of 27.7 years.

At baseline, 34% of the participants rated their health as excellent, 47% good, 16% fair, and 3% poor. After the median follow-up, 39%, 51%, 67%, and 83% of individuals who rated their health as excellent, good, fair, and poor, respectively, had died.

The researchers used a recurrent events survival model that adjusted for clinical and demographic factors and also allowed for dependency between the rates of hospitalization and hazards of death.

After controlling for demographics and medical history, a lower self-rating of health was associated with increased rates of hospitalization and death. Compared with individuals with baseline reports of excellent health, hospitalization rates were 1.22, 2.01, and 3.13 times higher for those with baseline reports of good, fair, or poor health, respectively. Similarly, compared with individuals with baseline reports of excellent health, hazards of death were 1.30, 2.15, and 3.40 for those with baseline reports of good, fair, or poor health, respectively.

Overall, individuals who reported poor health at baseline were significantly more likely than those who reported excellent health to be older (57.0 years vs 53.0 years), obese (44% vs 18%), and current smokers (39% vs 21%). Those who reported poor health at baseline also were significantly more likely than those who reported excellent health to have a history of cancer (9.5% vs 4.4%), emphysema/COPD (18% vs 2.3%), coronary heart disease (21% vs 1.6%), myocardial infarction (19% vs 1.3%), heart failure (25% vs. 1.2%), hypertension (67% vs 19%), or diabetes (39% vs 4.6%).

Potential explanations for the independent association between poor self-rated health and poor outcomes include the ability of self-rated health to capture health information not accounted for by traditional risk factors, the researchers wrote in their discussion. “Another explanation is that self-rated health reflects subconscious bodily sensations that provide a direct sense of health unavailable to external observation,” they said. Alternatively, self-rated health may reinforce beneficial behaviors in those with higher self-rated health and harmful behaviors in those with lower self-rated health, they said.

The findings were limited by several factors including the measurement of self-rated health and the validity of hospitalization as a proxy for morbidity, the researchers noted. Other limitations include the use of models instead of repeated self-rated health measures, and a lack of data on interventions to directly or indirectly improve self-rated health, the researchers noted.

However, the study shows the potential value of self-rated health in routine clinical care to predict future hospitalizations, they said. “Clinicians can use this simple and convenient measure for individual patients to provide more accurate and personalized risk assessments,” they said.

Looking ahead, the current study findings also support the need for more research into the routine assessment not only of self-rated health but also targeted interventions to improve self-rated health and its determinants, the researchers concluded. The ARIC study has been supported by the National Heart, Lung, and Blood Institute, National Institutes of Health. Dr. Mu disclosed support from the National Heart, Lung, and Blood Institute.

Rapid eye movement (REM) sleep, deep sleep, and sleep irregularity were significantly associated with increased risk for a range of chronic diseases, based on a new study of > 6000 individuals. 

“Most of what we think we know about sleep patterns in adults comes from either self-report surveys, which are widely used but have all sorts of problems with over- and under-estimating sleep duration and quality, or single-night sleep studies,” corresponding author Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. 

The single-night study yields the highest quality data but is limited by extrapolating a single night’s sleep to represent habitual sleep patterns, which is often not the case, he said. In the current study, published in Nature Medicine, “we had a unique opportunity to understand sleep using a large cohort of individuals using wearable devices that measure sleep duration, quality, and variability. The All of Us Research Program is the first to link wearables data to the electronic health record at scale and allowed us to study long-term, real-world sleep behavior,” Dr. Brittain said.

The timing of the study is important because the American Heart Association now recognizes sleep as a key component of heart health, and public awareness of the value of sleep is increasing, he added. 

The researchers reviewed objectively measured, longitudinal sleep data from 6785 adults who used commercial wearable devices (Fitbit) linked to electronic health record data in the All of Us Research Program. The median age of the participants was 50.2 years, 71% were women, and 84% self-identified as White individuals. The median period of sleep monitoring was 4.5 years.

REM sleep and deep sleep were inversely associated with the odds of incident heart rhythm and heart rate abnormalities. Each percent increase in REM sleep was associated with a reduced incidence of atrial fibrillation (odds ratio [OR], 0.86), atrial flutter (OR, 0.78), and sinoatrial node dysfunction/bradycardia (OR, 0.72). A higher percentage of deep sleep was associated with reduced odds of atrial fibrillation (OR, 0.87), major depressive disorder (OR, 0.93), and anxiety disorder (OR, 0.94). 

Increased irregular sleep was significantly associated with increased odds of incident obesity (OR, 1.49), hyperlipidemia (OR, 1.39), and hypertension (OR, 1.56), as well as major depressive disorder (OR, 1.75), anxiety disorder (OR, 1.55), and bipolar disorder (OR, 2.27). 

The researchers also identified J-shaped associations between average daily sleep duration and hypertension (P for nonlinearity = .003), as well as major depressive disorder and generalized anxiety disorder (both P < .001). 

The study was limited by several factors including the relatively young, White, and female study population. However, the results illustrate how sleep stages, duration, and regularity are associated with chronic disease development, and may inform evidence-based recommendations on healthy sleeping habits, the researchers wrote.
 

Findings Support Need for Sleep Consistency 

“The biggest surprise for me was the impact of sleep variability of health,” Dr. Brittain told this news organization. “The more your sleep duration varies, the higher your risk of numerous chronic diseases across the entire spectrum of organ systems. Sleep duration and quality were also important but that was less surprising,” he said. 

The clinical implications of the findings are that sleep duration, quality, and variability are all important, said Dr. Brittain. “To me, the easiest finding to translate into the clinic is the importance of reducing the variability of sleep duration as much as possible,” he said. For patients, that means explaining that they need to go to sleep and wake up at roughly the same time night to night, he said. 

“Commercial wearable devices are not perfect compared with research grade devices, but our study showed that they nonetheless collect clinically relevant information,” Dr. Brittain added. “For patients who own a device, I have adopted the practice of reviewing my patients’ sleep and activity data which gives objective insight into behavior that is not always accurate through routine questioning,” he said.

As for other limitations, “Our cohort was limited to individuals who already owned a Fitbit; not surprisingly, these individuals differ from a random sample of the community in important ways, both demographic and behavioral, and our findings need to be validated in a more diverse population,” said Dr. Brittain. 

Looking ahead, “we are interested in using commercial devices as a tool for sleep interventions to test the impact of improving sleep hygiene on chronic disease incidence, severity, and progression,” he said.
 

Device Data Will Evolve to Inform Patient Care

“With the increasing use of commercial wearable devices, it is crucial to identify and understand the data they can collect,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. “This study specifically analyzed sleep data from Fitbit devices among participants in the All of Us Research Program to assess sleep patterns and their association with chronic disease risk,” said Dr. Baldomero, who was not involved in the study. 

The significant relationships between sleep patterns and risk for chronic diseases were not surprising, said Dr. Baldomero. The findings of an association between shorter sleep duration and greater sleep irregularity with obesity and sleep apnea validated previous studies in large-scale population surveys, she said. Findings from the current study also reflect data from the literature on sleep duration associated with hypertension, major depressive disorder, and generalized anxiety findings, she added.

“This study reinforces the importance of adequate sleep, typically around 7 hours per night, and suggests that insufficient or poor-quality sleep may be associated with chronic diseases,” Dr. Baldomero told this news organization. “Pulmonologists should remain vigilant about sleep-related issues, and consider further investigation and referrals to sleep specialty clinics for patients suspected of having sleep disturbances,” she said.

“What remains unclear is whether abnormal sleep patterns are a cause or an effect of chronic diseases,” Dr. Baldomero noted. “Additionally, it is essential to ensure that these devices accurately capture sleep patterns and continue to validate their data against gold standard measures of sleep disturbances,” she said.

The study was based on work that was partially funded by an unrestricted gift from Google, and the study itself was supported by National Institutes of Health. Dr. Brittain disclosed received research funds unrelated to this work from United Therapeutics. Dr. Baldomero had no financial conflicts to disclose.

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

Rapid eye movement (REM) sleep, deep sleep, and sleep irregularity were significantly associated with increased risk for a range of chronic diseases, based on a new study of > 6000 individuals. 

“Most of what we think we know about sleep patterns in adults comes from either self-report surveys, which are widely used but have all sorts of problems with over- and under-estimating sleep duration and quality, or single-night sleep studies,” corresponding author Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. 

The single-night study yields the highest quality data but is limited by extrapolating a single night’s sleep to represent habitual sleep patterns, which is often not the case, he said. In the current study, published in Nature Medicine, “we had a unique opportunity to understand sleep using a large cohort of individuals using wearable devices that measure sleep duration, quality, and variability. The All of Us Research Program is the first to link wearables data to the electronic health record at scale and allowed us to study long-term, real-world sleep behavior,” Dr. Brittain said.

The timing of the study is important because the American Heart Association now recognizes sleep as a key component of heart health, and public awareness of the value of sleep is increasing, he added. 

The researchers reviewed objectively measured, longitudinal sleep data from 6785 adults who used commercial wearable devices (Fitbit) linked to electronic health record data in the All of Us Research Program. The median age of the participants was 50.2 years, 71% were women, and 84% self-identified as White individuals. The median period of sleep monitoring was 4.5 years.

REM sleep and deep sleep were inversely associated with the odds of incident heart rhythm and heart rate abnormalities. Each percent increase in REM sleep was associated with a reduced incidence of atrial fibrillation (odds ratio [OR], 0.86), atrial flutter (OR, 0.78), and sinoatrial node dysfunction/bradycardia (OR, 0.72). A higher percentage of deep sleep was associated with reduced odds of atrial fibrillation (OR, 0.87), major depressive disorder (OR, 0.93), and anxiety disorder (OR, 0.94). 

Increased irregular sleep was significantly associated with increased odds of incident obesity (OR, 1.49), hyperlipidemia (OR, 1.39), and hypertension (OR, 1.56), as well as major depressive disorder (OR, 1.75), anxiety disorder (OR, 1.55), and bipolar disorder (OR, 2.27). 

The researchers also identified J-shaped associations between average daily sleep duration and hypertension (P for nonlinearity = .003), as well as major depressive disorder and generalized anxiety disorder (both P < .001). 

The study was limited by several factors including the relatively young, White, and female study population. However, the results illustrate how sleep stages, duration, and regularity are associated with chronic disease development, and may inform evidence-based recommendations on healthy sleeping habits, the researchers wrote.
 

Findings Support Need for Sleep Consistency 

“The biggest surprise for me was the impact of sleep variability of health,” Dr. Brittain told this news organization. “The more your sleep duration varies, the higher your risk of numerous chronic diseases across the entire spectrum of organ systems. Sleep duration and quality were also important but that was less surprising,” he said. 

The clinical implications of the findings are that sleep duration, quality, and variability are all important, said Dr. Brittain. “To me, the easiest finding to translate into the clinic is the importance of reducing the variability of sleep duration as much as possible,” he said. For patients, that means explaining that they need to go to sleep and wake up at roughly the same time night to night, he said. 

“Commercial wearable devices are not perfect compared with research grade devices, but our study showed that they nonetheless collect clinically relevant information,” Dr. Brittain added. “For patients who own a device, I have adopted the practice of reviewing my patients’ sleep and activity data which gives objective insight into behavior that is not always accurate through routine questioning,” he said.

As for other limitations, “Our cohort was limited to individuals who already owned a Fitbit; not surprisingly, these individuals differ from a random sample of the community in important ways, both demographic and behavioral, and our findings need to be validated in a more diverse population,” said Dr. Brittain. 

Looking ahead, “we are interested in using commercial devices as a tool for sleep interventions to test the impact of improving sleep hygiene on chronic disease incidence, severity, and progression,” he said.
 

Device Data Will Evolve to Inform Patient Care

“With the increasing use of commercial wearable devices, it is crucial to identify and understand the data they can collect,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. “This study specifically analyzed sleep data from Fitbit devices among participants in the All of Us Research Program to assess sleep patterns and their association with chronic disease risk,” said Dr. Baldomero, who was not involved in the study. 

The significant relationships between sleep patterns and risk for chronic diseases were not surprising, said Dr. Baldomero. The findings of an association between shorter sleep duration and greater sleep irregularity with obesity and sleep apnea validated previous studies in large-scale population surveys, she said. Findings from the current study also reflect data from the literature on sleep duration associated with hypertension, major depressive disorder, and generalized anxiety findings, she added.

“This study reinforces the importance of adequate sleep, typically around 7 hours per night, and suggests that insufficient or poor-quality sleep may be associated with chronic diseases,” Dr. Baldomero told this news organization. “Pulmonologists should remain vigilant about sleep-related issues, and consider further investigation and referrals to sleep specialty clinics for patients suspected of having sleep disturbances,” she said.

“What remains unclear is whether abnormal sleep patterns are a cause or an effect of chronic diseases,” Dr. Baldomero noted. “Additionally, it is essential to ensure that these devices accurately capture sleep patterns and continue to validate their data against gold standard measures of sleep disturbances,” she said.

The study was based on work that was partially funded by an unrestricted gift from Google, and the study itself was supported by National Institutes of Health. Dr. Brittain disclosed received research funds unrelated to this work from United Therapeutics. Dr. Baldomero had no financial conflicts to disclose.

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

Rapid eye movement (REM) sleep, deep sleep, and sleep irregularity were significantly associated with increased risk for a range of chronic diseases, based on a new study of > 6000 individuals. 

“Most of what we think we know about sleep patterns in adults comes from either self-report surveys, which are widely used but have all sorts of problems with over- and under-estimating sleep duration and quality, or single-night sleep studies,” corresponding author Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. 

The single-night study yields the highest quality data but is limited by extrapolating a single night’s sleep to represent habitual sleep patterns, which is often not the case, he said. In the current study, published in Nature Medicine, “we had a unique opportunity to understand sleep using a large cohort of individuals using wearable devices that measure sleep duration, quality, and variability. The All of Us Research Program is the first to link wearables data to the electronic health record at scale and allowed us to study long-term, real-world sleep behavior,” Dr. Brittain said.

The timing of the study is important because the American Heart Association now recognizes sleep as a key component of heart health, and public awareness of the value of sleep is increasing, he added. 

The researchers reviewed objectively measured, longitudinal sleep data from 6785 adults who used commercial wearable devices (Fitbit) linked to electronic health record data in the All of Us Research Program. The median age of the participants was 50.2 years, 71% were women, and 84% self-identified as White individuals. The median period of sleep monitoring was 4.5 years.

REM sleep and deep sleep were inversely associated with the odds of incident heart rhythm and heart rate abnormalities. Each percent increase in REM sleep was associated with a reduced incidence of atrial fibrillation (odds ratio [OR], 0.86), atrial flutter (OR, 0.78), and sinoatrial node dysfunction/bradycardia (OR, 0.72). A higher percentage of deep sleep was associated with reduced odds of atrial fibrillation (OR, 0.87), major depressive disorder (OR, 0.93), and anxiety disorder (OR, 0.94). 

Increased irregular sleep was significantly associated with increased odds of incident obesity (OR, 1.49), hyperlipidemia (OR, 1.39), and hypertension (OR, 1.56), as well as major depressive disorder (OR, 1.75), anxiety disorder (OR, 1.55), and bipolar disorder (OR, 2.27). 

The researchers also identified J-shaped associations between average daily sleep duration and hypertension (P for nonlinearity = .003), as well as major depressive disorder and generalized anxiety disorder (both P < .001). 

The study was limited by several factors including the relatively young, White, and female study population. However, the results illustrate how sleep stages, duration, and regularity are associated with chronic disease development, and may inform evidence-based recommendations on healthy sleeping habits, the researchers wrote.
 

Findings Support Need for Sleep Consistency 

“The biggest surprise for me was the impact of sleep variability of health,” Dr. Brittain told this news organization. “The more your sleep duration varies, the higher your risk of numerous chronic diseases across the entire spectrum of organ systems. Sleep duration and quality were also important but that was less surprising,” he said. 

The clinical implications of the findings are that sleep duration, quality, and variability are all important, said Dr. Brittain. “To me, the easiest finding to translate into the clinic is the importance of reducing the variability of sleep duration as much as possible,” he said. For patients, that means explaining that they need to go to sleep and wake up at roughly the same time night to night, he said. 

“Commercial wearable devices are not perfect compared with research grade devices, but our study showed that they nonetheless collect clinically relevant information,” Dr. Brittain added. “For patients who own a device, I have adopted the practice of reviewing my patients’ sleep and activity data which gives objective insight into behavior that is not always accurate through routine questioning,” he said.

As for other limitations, “Our cohort was limited to individuals who already owned a Fitbit; not surprisingly, these individuals differ from a random sample of the community in important ways, both demographic and behavioral, and our findings need to be validated in a more diverse population,” said Dr. Brittain. 

Looking ahead, “we are interested in using commercial devices as a tool for sleep interventions to test the impact of improving sleep hygiene on chronic disease incidence, severity, and progression,” he said.
 

Device Data Will Evolve to Inform Patient Care

“With the increasing use of commercial wearable devices, it is crucial to identify and understand the data they can collect,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. “This study specifically analyzed sleep data from Fitbit devices among participants in the All of Us Research Program to assess sleep patterns and their association with chronic disease risk,” said Dr. Baldomero, who was not involved in the study. 

The significant relationships between sleep patterns and risk for chronic diseases were not surprising, said Dr. Baldomero. The findings of an association between shorter sleep duration and greater sleep irregularity with obesity and sleep apnea validated previous studies in large-scale population surveys, she said. Findings from the current study also reflect data from the literature on sleep duration associated with hypertension, major depressive disorder, and generalized anxiety findings, she added.

“This study reinforces the importance of adequate sleep, typically around 7 hours per night, and suggests that insufficient or poor-quality sleep may be associated with chronic diseases,” Dr. Baldomero told this news organization. “Pulmonologists should remain vigilant about sleep-related issues, and consider further investigation and referrals to sleep specialty clinics for patients suspected of having sleep disturbances,” she said.

“What remains unclear is whether abnormal sleep patterns are a cause or an effect of chronic diseases,” Dr. Baldomero noted. “Additionally, it is essential to ensure that these devices accurately capture sleep patterns and continue to validate their data against gold standard measures of sleep disturbances,” she said.

The study was based on work that was partially funded by an unrestricted gift from Google, and the study itself was supported by National Institutes of Health. Dr. Brittain disclosed received research funds unrelated to this work from United Therapeutics. Dr. Baldomero had no financial conflicts to disclose.

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

Approximately half of adults with idiopathic pulmonary arterial hypertension (IPAH) had nonplexiform vasculopathy characterized in part by severe pulmonary microvascular remodeling, based on data from 50 individuals.

The clinical phenotype of IPAH was historically described as a rapidly progressive rare disease in young women and characterized by plexiform lesions, wrote Esther J. Nossent, MD, of Amsterdam University Medical Centers, Amsterdam, the Netherlands, and colleagues. However, the patient population with IPAH has become older and predominantly men, and the nature of vascular phenotypes and histologic patterns in patients with contemporary IPAH has not been well studied, the researchers said.

In a cross-sectional study published in CHEST, the researchers reviewed lung histology data from 50 adults with IPAH that had been assessed by two experienced pathologists. The mean age of the patients was 52 years and 58% were women. Based on a histopathologic evaluation, 24 patients had nonplexiform vasculopathy (48%) and 26 had plexiform vasculopathy (52%). Notably, microvascular remodeling involving arterioles and venules was substantial in patients with nonplexiform vasculopathy but mild or absent in those with plexiform vasculopathy, the researchers wrote.

The researchers also compared the clinical characteristics of patients with plexiform vs nonplexiform vasculopathy. Hemodynamic parameters were similar in both patient groups. However, those with nonplexiform vasculopathy were significantly older than those with plexiform vasculopathy (60 years vs 44 years), were more likely to be men (67% vs 20%), and had a lower diffusing capacity of the lungs for carbon monoxide (DLCO) at diagnosis (all P < .001). Patients with nonplexiform vasculopathy also were significantly more likely than those with plexiform vasculopathy to have a history of smoking (P = .03). Genetic testing revealed no mutations in established PAH genes in the nonplexiform group.

Low DLCO has been associated with worse outcomes regardless of hemodynamic response, the researchers noted. In the current study, “a DLCO of < 45% almost perfectly identified patients with nonplexiform vasculopathy with prominent pulmonary microvascular disease,” they said.

The findings were limited by several factors, including the small study population and the higher frequency of surgical lung biopsies in the nonplexiform group vs the plexiform group, which is not part of the general workup of patients with IPAH, the researchers noted.

More research is needed to better define the subgroup of patients with IPAH with nonplexiform vasculopathy and to identify the causes, biological features, and treatment approaches for these patients, they said. However, the results suggest that differences between patients with IPAH with plexiform vasculopathy and those with nonplexiform vasculopathy could ultimately inform targeted treatment strategies.

“Recognizing these clinical phenotypes allows revisiting current datasets to understand better the potential future clinical consequences of the vascular phenotypes for treatment response and clinical outcome,” the researchers concluded.
 

Findings May Inform More Targeted Therapy

“Any investigation that adds substantive insight into a complex disease that can translate into a better understanding of clinical patient phenotypes and eventually into improved treatments and patient outcomes has relevance at any time,” Paul Forfia, MD, professor of medicine at the Lewis Katz School of Medicine at Temple University, Philadelphia, said in an interview.

“There is focus on the antiproliferative forms of pulmonary arterial hypertension–specific therapy, and the results of the current study may have implications to these therapies,” said Dr. Forfia, who was not involved in the current study.

“In the current study, the investigators show that 48% of patients that were traditionally categorized as IPAH had a vascular phenotype that is not considered ‘typical’ or classic for IPAH,” Dr. Forfia told this news organization. “These findings highlight a significant heterogeneity of the pulmonary vascular phenotype within IPAH, which raises the question of whether the nonplexiform patient would be less responsive to the novel, antiproliferative forms of therapy,” he said.

The new findings are quite interesting but not surprising, Dr. Forfia said. “The World Symposia diagnostic groupings for pulmonary hypertension are a very important and necessary form of categorization and differentiation amongst forms of PH [pulmonary hypertension], and these groupings make a best attempt based on available evidence to separate patients of varying PH pathophysiology, both in terms of diagnosis and in how PH patients are treated,” he explained.

“However, clinical experts in PH have known that subphenotypes of PH pathophysiology exist within group I PAH, as well as in PH related to left heart disease (group 2), chronic respiratory disease (group 3), and chronic thromboembolic disease (group 4),” he said.

Findings from the current study reinforce the importance of clinical and physiological phenotyping of each patient, which can help in terms of therapy selection and in managing expectations in response to therapy, Dr. Forfia added.

“Perhaps the most evident and important clinical implication from the current study is to remind clinicians treating patients with PH that heterogeneity exists within the vascular phenotype and clinical makeup of patients even within the same type of PAH,” Dr. Forfia said. “With this insight, clinicians are more informed and thus more apt to consider nuances in the diagnosis, treatment, and expectations for treatment response within PAH,” he said.

Dr. Forfia also highlighted the potential implications of the association between cigarette smoking and the nonplexiform vascular phenotype. “This association was present in the absence of radiographic evidence of emphysema and raises the provocative notion that cigarette smoking may lead to pulmonary vascular abnormalities, perhaps even PAH, in patients without a diagnosis of emphysema,” he said.

“An important limitation from the current study is that the vascular phenotypes observed within their cohort of IPAH patients were obtained from histopathology specimens at the time of autopsy, explant at the time of lung transplantation, and surgical lung biopsy spanning over a 22-year period,” Dr. Forfia noted. Additional research is needed to explore how vascular phenotypic differences can be appreciated in the absence of histopathology and how these differences could impact therapy selection and patient outcomes, he said.

The study received no outside funding. Dr. Nossent disclosed receiving speaker fees from Janssen, MSD, and United Therapeutics/Ferrer and consulting fees from Janssen and United Therapeutics/Ferrer. Dr. Forfia had no financial conflicts to disclose.

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

Approximately half of adults with idiopathic pulmonary arterial hypertension (IPAH) had nonplexiform vasculopathy characterized in part by severe pulmonary microvascular remodeling, based on data from 50 individuals.

The clinical phenotype of IPAH was historically described as a rapidly progressive rare disease in young women and characterized by plexiform lesions, wrote Esther J. Nossent, MD, of Amsterdam University Medical Centers, Amsterdam, the Netherlands, and colleagues. However, the patient population with IPAH has become older and predominantly men, and the nature of vascular phenotypes and histologic patterns in patients with contemporary IPAH has not been well studied, the researchers said.

In a cross-sectional study published in CHEST, the researchers reviewed lung histology data from 50 adults with IPAH that had been assessed by two experienced pathologists. The mean age of the patients was 52 years and 58% were women. Based on a histopathologic evaluation, 24 patients had nonplexiform vasculopathy (48%) and 26 had plexiform vasculopathy (52%). Notably, microvascular remodeling involving arterioles and venules was substantial in patients with nonplexiform vasculopathy but mild or absent in those with plexiform vasculopathy, the researchers wrote.

The researchers also compared the clinical characteristics of patients with plexiform vs nonplexiform vasculopathy. Hemodynamic parameters were similar in both patient groups. However, those with nonplexiform vasculopathy were significantly older than those with plexiform vasculopathy (60 years vs 44 years), were more likely to be men (67% vs 20%), and had a lower diffusing capacity of the lungs for carbon monoxide (DLCO) at diagnosis (all P < .001). Patients with nonplexiform vasculopathy also were significantly more likely than those with plexiform vasculopathy to have a history of smoking (P = .03). Genetic testing revealed no mutations in established PAH genes in the nonplexiform group.

Low DLCO has been associated with worse outcomes regardless of hemodynamic response, the researchers noted. In the current study, “a DLCO of < 45% almost perfectly identified patients with nonplexiform vasculopathy with prominent pulmonary microvascular disease,” they said.

The findings were limited by several factors, including the small study population and the higher frequency of surgical lung biopsies in the nonplexiform group vs the plexiform group, which is not part of the general workup of patients with IPAH, the researchers noted.

More research is needed to better define the subgroup of patients with IPAH with nonplexiform vasculopathy and to identify the causes, biological features, and treatment approaches for these patients, they said. However, the results suggest that differences between patients with IPAH with plexiform vasculopathy and those with nonplexiform vasculopathy could ultimately inform targeted treatment strategies.

“Recognizing these clinical phenotypes allows revisiting current datasets to understand better the potential future clinical consequences of the vascular phenotypes for treatment response and clinical outcome,” the researchers concluded.
 

Findings May Inform More Targeted Therapy

“Any investigation that adds substantive insight into a complex disease that can translate into a better understanding of clinical patient phenotypes and eventually into improved treatments and patient outcomes has relevance at any time,” Paul Forfia, MD, professor of medicine at the Lewis Katz School of Medicine at Temple University, Philadelphia, said in an interview.

“There is focus on the antiproliferative forms of pulmonary arterial hypertension–specific therapy, and the results of the current study may have implications to these therapies,” said Dr. Forfia, who was not involved in the current study.

“In the current study, the investigators show that 48% of patients that were traditionally categorized as IPAH had a vascular phenotype that is not considered ‘typical’ or classic for IPAH,” Dr. Forfia told this news organization. “These findings highlight a significant heterogeneity of the pulmonary vascular phenotype within IPAH, which raises the question of whether the nonplexiform patient would be less responsive to the novel, antiproliferative forms of therapy,” he said.

The new findings are quite interesting but not surprising, Dr. Forfia said. “The World Symposia diagnostic groupings for pulmonary hypertension are a very important and necessary form of categorization and differentiation amongst forms of PH [pulmonary hypertension], and these groupings make a best attempt based on available evidence to separate patients of varying PH pathophysiology, both in terms of diagnosis and in how PH patients are treated,” he explained.

“However, clinical experts in PH have known that subphenotypes of PH pathophysiology exist within group I PAH, as well as in PH related to left heart disease (group 2), chronic respiratory disease (group 3), and chronic thromboembolic disease (group 4),” he said.

Findings from the current study reinforce the importance of clinical and physiological phenotyping of each patient, which can help in terms of therapy selection and in managing expectations in response to therapy, Dr. Forfia added.

“Perhaps the most evident and important clinical implication from the current study is to remind clinicians treating patients with PH that heterogeneity exists within the vascular phenotype and clinical makeup of patients even within the same type of PAH,” Dr. Forfia said. “With this insight, clinicians are more informed and thus more apt to consider nuances in the diagnosis, treatment, and expectations for treatment response within PAH,” he said.

Dr. Forfia also highlighted the potential implications of the association between cigarette smoking and the nonplexiform vascular phenotype. “This association was present in the absence of radiographic evidence of emphysema and raises the provocative notion that cigarette smoking may lead to pulmonary vascular abnormalities, perhaps even PAH, in patients without a diagnosis of emphysema,” he said.

“An important limitation from the current study is that the vascular phenotypes observed within their cohort of IPAH patients were obtained from histopathology specimens at the time of autopsy, explant at the time of lung transplantation, and surgical lung biopsy spanning over a 22-year period,” Dr. Forfia noted. Additional research is needed to explore how vascular phenotypic differences can be appreciated in the absence of histopathology and how these differences could impact therapy selection and patient outcomes, he said.

The study received no outside funding. Dr. Nossent disclosed receiving speaker fees from Janssen, MSD, and United Therapeutics/Ferrer and consulting fees from Janssen and United Therapeutics/Ferrer. Dr. Forfia had no financial conflicts to disclose.

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

Approximately half of adults with idiopathic pulmonary arterial hypertension (IPAH) had nonplexiform vasculopathy characterized in part by severe pulmonary microvascular remodeling, based on data from 50 individuals.

The clinical phenotype of IPAH was historically described as a rapidly progressive rare disease in young women and characterized by plexiform lesions, wrote Esther J. Nossent, MD, of Amsterdam University Medical Centers, Amsterdam, the Netherlands, and colleagues. However, the patient population with IPAH has become older and predominantly men, and the nature of vascular phenotypes and histologic patterns in patients with contemporary IPAH has not been well studied, the researchers said.

In a cross-sectional study published in CHEST, the researchers reviewed lung histology data from 50 adults with IPAH that had been assessed by two experienced pathologists. The mean age of the patients was 52 years and 58% were women. Based on a histopathologic evaluation, 24 patients had nonplexiform vasculopathy (48%) and 26 had plexiform vasculopathy (52%). Notably, microvascular remodeling involving arterioles and venules was substantial in patients with nonplexiform vasculopathy but mild or absent in those with plexiform vasculopathy, the researchers wrote.

The researchers also compared the clinical characteristics of patients with plexiform vs nonplexiform vasculopathy. Hemodynamic parameters were similar in both patient groups. However, those with nonplexiform vasculopathy were significantly older than those with plexiform vasculopathy (60 years vs 44 years), were more likely to be men (67% vs 20%), and had a lower diffusing capacity of the lungs for carbon monoxide (DLCO) at diagnosis (all P < .001). Patients with nonplexiform vasculopathy also were significantly more likely than those with plexiform vasculopathy to have a history of smoking (P = .03). Genetic testing revealed no mutations in established PAH genes in the nonplexiform group.

Low DLCO has been associated with worse outcomes regardless of hemodynamic response, the researchers noted. In the current study, “a DLCO of < 45% almost perfectly identified patients with nonplexiform vasculopathy with prominent pulmonary microvascular disease,” they said.

The findings were limited by several factors, including the small study population and the higher frequency of surgical lung biopsies in the nonplexiform group vs the plexiform group, which is not part of the general workup of patients with IPAH, the researchers noted.

More research is needed to better define the subgroup of patients with IPAH with nonplexiform vasculopathy and to identify the causes, biological features, and treatment approaches for these patients, they said. However, the results suggest that differences between patients with IPAH with plexiform vasculopathy and those with nonplexiform vasculopathy could ultimately inform targeted treatment strategies.

“Recognizing these clinical phenotypes allows revisiting current datasets to understand better the potential future clinical consequences of the vascular phenotypes for treatment response and clinical outcome,” the researchers concluded.
 

Findings May Inform More Targeted Therapy

“Any investigation that adds substantive insight into a complex disease that can translate into a better understanding of clinical patient phenotypes and eventually into improved treatments and patient outcomes has relevance at any time,” Paul Forfia, MD, professor of medicine at the Lewis Katz School of Medicine at Temple University, Philadelphia, said in an interview.

“There is focus on the antiproliferative forms of pulmonary arterial hypertension–specific therapy, and the results of the current study may have implications to these therapies,” said Dr. Forfia, who was not involved in the current study.

“In the current study, the investigators show that 48% of patients that were traditionally categorized as IPAH had a vascular phenotype that is not considered ‘typical’ or classic for IPAH,” Dr. Forfia told this news organization. “These findings highlight a significant heterogeneity of the pulmonary vascular phenotype within IPAH, which raises the question of whether the nonplexiform patient would be less responsive to the novel, antiproliferative forms of therapy,” he said.

The new findings are quite interesting but not surprising, Dr. Forfia said. “The World Symposia diagnostic groupings for pulmonary hypertension are a very important and necessary form of categorization and differentiation amongst forms of PH [pulmonary hypertension], and these groupings make a best attempt based on available evidence to separate patients of varying PH pathophysiology, both in terms of diagnosis and in how PH patients are treated,” he explained.

“However, clinical experts in PH have known that subphenotypes of PH pathophysiology exist within group I PAH, as well as in PH related to left heart disease (group 2), chronic respiratory disease (group 3), and chronic thromboembolic disease (group 4),” he said.

Findings from the current study reinforce the importance of clinical and physiological phenotyping of each patient, which can help in terms of therapy selection and in managing expectations in response to therapy, Dr. Forfia added.

“Perhaps the most evident and important clinical implication from the current study is to remind clinicians treating patients with PH that heterogeneity exists within the vascular phenotype and clinical makeup of patients even within the same type of PAH,” Dr. Forfia said. “With this insight, clinicians are more informed and thus more apt to consider nuances in the diagnosis, treatment, and expectations for treatment response within PAH,” he said.

Dr. Forfia also highlighted the potential implications of the association between cigarette smoking and the nonplexiform vascular phenotype. “This association was present in the absence of radiographic evidence of emphysema and raises the provocative notion that cigarette smoking may lead to pulmonary vascular abnormalities, perhaps even PAH, in patients without a diagnosis of emphysema,” he said.

“An important limitation from the current study is that the vascular phenotypes observed within their cohort of IPAH patients were obtained from histopathology specimens at the time of autopsy, explant at the time of lung transplantation, and surgical lung biopsy spanning over a 22-year period,” Dr. Forfia noted. Additional research is needed to explore how vascular phenotypic differences can be appreciated in the absence of histopathology and how these differences could impact therapy selection and patient outcomes, he said.

The study received no outside funding. Dr. Nossent disclosed receiving speaker fees from Janssen, MSD, and United Therapeutics/Ferrer and consulting fees from Janssen and United Therapeutics/Ferrer. Dr. Forfia had no financial conflicts to disclose.

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

Increased levels of the cytokine resistin were significantly associated with an increased risk for death in adults with pulmonary arterial hypertension (PAH), based on data from more than 1000 individuals.

Resistin, a cytokine expressed in adipocytes, has been associated with poor clinical outcomes in heart failure and cardiovascular disease, Li Gao, MD, of Johns Hopkins University, Baltimore, Maryland, and colleagues wrote. While mouse studies have shown that human resistin drives pulmonary vascular remodeling and the development of PAH, the role of resistin as a biomarker for PAH remains unclear.

In a study published in Respiratory Research, the researchers reviewed biospecimens and clinical and genetic data from 1121 adults with PAH, 808 with idiopathic PAH (IPAH), and 313 with scleroderma-associated PAH (SSc-PAH). They examined the associations between serum resistin levels and PAH outcomes in multivariate regression models, using machine-learning algorithms to develop models to predict mortality.

Resistin levels were significantly higher in all patients with PAH and patients with the two subtypes than in control participants (all P < .0001). Resistin was also associated with significant discriminative properties, with area under the curve (AUC) measures of 0.84, 0.82, and 0.91 for PAH overall, IPAH, and SSc-PAH, respectively.

Elevated resistin levels (defined as > 4.54 ng/mL) were significantly associated with an increased risk for death (hazard ratio, 2.6; P < .0087) as well as with older age and shorter distance on the 6-minute walk test (P = .001 for both) and reduced cardiac capacity based on the New York Heart Association functional class (P < .014).

Survival models derived from machine learning confirmed the prognostic value of resistin for mortality in PAH as seen in the random forest model, with an AUC of 0.70. “When we used the AUC values of the ROC curve as criteria to evaluate how well resistin levels discerned the presence of PAH, all three tests had excellent discriminative ability (AUCs were 0.84, 0.82, and 0.91 for all PAH, IPAH, and SSc-PAH, respectively),” the researchers wrote.

The researchers also evaluated three RETN genetic variants (rs7408174, rs3219175, and rs3745367) for a specific association with serum resistin levels and measures of PAH severity. Resistin levels were highest among individuals who were carriers of either the rs3219175 or rs3745367 mutation, the researchers noted.

The findings were limited by several factors, including missing data on the 6-minute walk test from several centers, which led to the elimination of that item from the survival analysis. Other limitations included the inability to control for PAH therapy at the time of assessment and the collection of serum at a different time from other clinical variables.

However, “our study provides evidence to support the use of circulating biomarkers as objective and accessible tools for noninvasive PAH risk stratification,” the researchers said. Additional research is needed to strengthen the association, but the findings suggest that resistin represents a novel biomarker for PAH prognostication and risk stratification and may have implications for the development of new treatments.
 

Biomarker Research Expands Diagnosis and Treatment Horizons

“It is a dynamic time in PAH research and clinical management, given the recent approval and use of the BMP/TGF beta balancing agent sotatercept (Winrevair) as an effective agent to target the molecular origins of this disease,” Stephen Chan, MD, professor of medicine and director of the Vascular Medicine Institute at the University of Pittsburgh, Pittsburgh, Pennsylvania, said in an interview.

The growing number of medications that can be used to treat patients with PAH will likely be more effective if patients are identified and treated early, said Dr. Chan, who was not involved in the study.

However, the time to diagnosis for patients with PAH is still more than 3 years from the start of symptoms, he said. Factors contributing to the delay include the requirement of an invasive cardiac catheterization procedure to make the final diagnosis, the status of PAH as a borderline orphan disease, and the often nonspecific nature of the initial symptoms of PAH.

Consequently, “there is an unmet need to develop effective and preferably noninvasive tools to aid in early diagnosis of PAH,” Dr. Chan added.

The power of the study is in the number of patients included, as much of previous PAH research has involved small studies of patients that could not be replicated or did not generalize to the larger patient population, Dr. Chan said.

The use of the PAH Biobank allows researchers to access a larger population of patients with PAH. “With that in mind, it is not surprising that some markers would emerge as potentially powerful and clinically meaningful,” he said.

“Currently, we do not have a reliable blood-based biomarker that we use in clinical PAH practice, although there are emerging studies that suggest other markers such as metabolites, RNA molecules, and proteins that may serve in the same capacity. If these studies turn out to be reproducible, generalizable, and specific to PAH in larger populations, measuring resistin could be helpful in making early diagnosis, particularly in areas that do not have invasive catheterization facilities (and globally) and for nonspecialists who are puzzled about the nonspecificity of initial symptoms of PAH,” Dr. Chan said.

Resistin could also be incorporated into existing risk stratification scores, such as the REVEAL risk score, that are already used in PAH clinical practice as guidance for when and how to use currently approved medications, he added.

Limitations of the study included the focus only on resistin alone, not in combination with other molecules that might perform better. Also, no independent validation cohort was used, he noted. “While PAH Biobank certainly offered larger numbers than we typically see, we would have to see validation in large independent cohorts for us to be convinced that measurements of resistin should be used in clinical practice.”

Resistin is not specific to PAH, which makes interpretation of the results more complicated, said Dr. Chan. “In this study, the authors used a smaller healthy control cohort of 50 patients as a comparison to their PAH cohort. However, they did not compare their PAH cohort with other cohorts that represent these other ‘resistin-relevant diseases’ and thus do not know whether they can distinguish PAH from any of these other diseases based on simply the resistin levels.” The frequency of comorbidities in patients with PAH, such as obesity, other inflammatory diseases, and cardiovascular disease, could confound the resistin levels.

The study was supported by the National Institutes of Health. Neither the researchers nor Dr. Chan had financial conflicts to disclose.

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

Increased levels of the cytokine resistin were significantly associated with an increased risk for death in adults with pulmonary arterial hypertension (PAH), based on data from more than 1000 individuals.

Resistin, a cytokine expressed in adipocytes, has been associated with poor clinical outcomes in heart failure and cardiovascular disease, Li Gao, MD, of Johns Hopkins University, Baltimore, Maryland, and colleagues wrote. While mouse studies have shown that human resistin drives pulmonary vascular remodeling and the development of PAH, the role of resistin as a biomarker for PAH remains unclear.

In a study published in Respiratory Research, the researchers reviewed biospecimens and clinical and genetic data from 1121 adults with PAH, 808 with idiopathic PAH (IPAH), and 313 with scleroderma-associated PAH (SSc-PAH). They examined the associations between serum resistin levels and PAH outcomes in multivariate regression models, using machine-learning algorithms to develop models to predict mortality.

Resistin levels were significantly higher in all patients with PAH and patients with the two subtypes than in control participants (all P < .0001). Resistin was also associated with significant discriminative properties, with area under the curve (AUC) measures of 0.84, 0.82, and 0.91 for PAH overall, IPAH, and SSc-PAH, respectively.

Elevated resistin levels (defined as > 4.54 ng/mL) were significantly associated with an increased risk for death (hazard ratio, 2.6; P < .0087) as well as with older age and shorter distance on the 6-minute walk test (P = .001 for both) and reduced cardiac capacity based on the New York Heart Association functional class (P < .014).

Survival models derived from machine learning confirmed the prognostic value of resistin for mortality in PAH as seen in the random forest model, with an AUC of 0.70. “When we used the AUC values of the ROC curve as criteria to evaluate how well resistin levels discerned the presence of PAH, all three tests had excellent discriminative ability (AUCs were 0.84, 0.82, and 0.91 for all PAH, IPAH, and SSc-PAH, respectively),” the researchers wrote.

The researchers also evaluated three RETN genetic variants (rs7408174, rs3219175, and rs3745367) for a specific association with serum resistin levels and measures of PAH severity. Resistin levels were highest among individuals who were carriers of either the rs3219175 or rs3745367 mutation, the researchers noted.

The findings were limited by several factors, including missing data on the 6-minute walk test from several centers, which led to the elimination of that item from the survival analysis. Other limitations included the inability to control for PAH therapy at the time of assessment and the collection of serum at a different time from other clinical variables.

However, “our study provides evidence to support the use of circulating biomarkers as objective and accessible tools for noninvasive PAH risk stratification,” the researchers said. Additional research is needed to strengthen the association, but the findings suggest that resistin represents a novel biomarker for PAH prognostication and risk stratification and may have implications for the development of new treatments.
 

Biomarker Research Expands Diagnosis and Treatment Horizons

“It is a dynamic time in PAH research and clinical management, given the recent approval and use of the BMP/TGF beta balancing agent sotatercept (Winrevair) as an effective agent to target the molecular origins of this disease,” Stephen Chan, MD, professor of medicine and director of the Vascular Medicine Institute at the University of Pittsburgh, Pittsburgh, Pennsylvania, said in an interview.

The growing number of medications that can be used to treat patients with PAH will likely be more effective if patients are identified and treated early, said Dr. Chan, who was not involved in the study.

However, the time to diagnosis for patients with PAH is still more than 3 years from the start of symptoms, he said. Factors contributing to the delay include the requirement of an invasive cardiac catheterization procedure to make the final diagnosis, the status of PAH as a borderline orphan disease, and the often nonspecific nature of the initial symptoms of PAH.

Consequently, “there is an unmet need to develop effective and preferably noninvasive tools to aid in early diagnosis of PAH,” Dr. Chan added.

The power of the study is in the number of patients included, as much of previous PAH research has involved small studies of patients that could not be replicated or did not generalize to the larger patient population, Dr. Chan said.

The use of the PAH Biobank allows researchers to access a larger population of patients with PAH. “With that in mind, it is not surprising that some markers would emerge as potentially powerful and clinically meaningful,” he said.

“Currently, we do not have a reliable blood-based biomarker that we use in clinical PAH practice, although there are emerging studies that suggest other markers such as metabolites, RNA molecules, and proteins that may serve in the same capacity. If these studies turn out to be reproducible, generalizable, and specific to PAH in larger populations, measuring resistin could be helpful in making early diagnosis, particularly in areas that do not have invasive catheterization facilities (and globally) and for nonspecialists who are puzzled about the nonspecificity of initial symptoms of PAH,” Dr. Chan said.

Resistin could also be incorporated into existing risk stratification scores, such as the REVEAL risk score, that are already used in PAH clinical practice as guidance for when and how to use currently approved medications, he added.

Limitations of the study included the focus only on resistin alone, not in combination with other molecules that might perform better. Also, no independent validation cohort was used, he noted. “While PAH Biobank certainly offered larger numbers than we typically see, we would have to see validation in large independent cohorts for us to be convinced that measurements of resistin should be used in clinical practice.”

Resistin is not specific to PAH, which makes interpretation of the results more complicated, said Dr. Chan. “In this study, the authors used a smaller healthy control cohort of 50 patients as a comparison to their PAH cohort. However, they did not compare their PAH cohort with other cohorts that represent these other ‘resistin-relevant diseases’ and thus do not know whether they can distinguish PAH from any of these other diseases based on simply the resistin levels.” The frequency of comorbidities in patients with PAH, such as obesity, other inflammatory diseases, and cardiovascular disease, could confound the resistin levels.

The study was supported by the National Institutes of Health. Neither the researchers nor Dr. Chan had financial conflicts to disclose.

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

Increased levels of the cytokine resistin were significantly associated with an increased risk for death in adults with pulmonary arterial hypertension (PAH), based on data from more than 1000 individuals.

Resistin, a cytokine expressed in adipocytes, has been associated with poor clinical outcomes in heart failure and cardiovascular disease, Li Gao, MD, of Johns Hopkins University, Baltimore, Maryland, and colleagues wrote. While mouse studies have shown that human resistin drives pulmonary vascular remodeling and the development of PAH, the role of resistin as a biomarker for PAH remains unclear.

In a study published in Respiratory Research, the researchers reviewed biospecimens and clinical and genetic data from 1121 adults with PAH, 808 with idiopathic PAH (IPAH), and 313 with scleroderma-associated PAH (SSc-PAH). They examined the associations between serum resistin levels and PAH outcomes in multivariate regression models, using machine-learning algorithms to develop models to predict mortality.

Resistin levels were significantly higher in all patients with PAH and patients with the two subtypes than in control participants (all P < .0001). Resistin was also associated with significant discriminative properties, with area under the curve (AUC) measures of 0.84, 0.82, and 0.91 for PAH overall, IPAH, and SSc-PAH, respectively.

Elevated resistin levels (defined as > 4.54 ng/mL) were significantly associated with an increased risk for death (hazard ratio, 2.6; P < .0087) as well as with older age and shorter distance on the 6-minute walk test (P = .001 for both) and reduced cardiac capacity based on the New York Heart Association functional class (P < .014).

Survival models derived from machine learning confirmed the prognostic value of resistin for mortality in PAH as seen in the random forest model, with an AUC of 0.70. “When we used the AUC values of the ROC curve as criteria to evaluate how well resistin levels discerned the presence of PAH, all three tests had excellent discriminative ability (AUCs were 0.84, 0.82, and 0.91 for all PAH, IPAH, and SSc-PAH, respectively),” the researchers wrote.

The researchers also evaluated three RETN genetic variants (rs7408174, rs3219175, and rs3745367) for a specific association with serum resistin levels and measures of PAH severity. Resistin levels were highest among individuals who were carriers of either the rs3219175 or rs3745367 mutation, the researchers noted.

The findings were limited by several factors, including missing data on the 6-minute walk test from several centers, which led to the elimination of that item from the survival analysis. Other limitations included the inability to control for PAH therapy at the time of assessment and the collection of serum at a different time from other clinical variables.

However, “our study provides evidence to support the use of circulating biomarkers as objective and accessible tools for noninvasive PAH risk stratification,” the researchers said. Additional research is needed to strengthen the association, but the findings suggest that resistin represents a novel biomarker for PAH prognostication and risk stratification and may have implications for the development of new treatments.
 

Biomarker Research Expands Diagnosis and Treatment Horizons

“It is a dynamic time in PAH research and clinical management, given the recent approval and use of the BMP/TGF beta balancing agent sotatercept (Winrevair) as an effective agent to target the molecular origins of this disease,” Stephen Chan, MD, professor of medicine and director of the Vascular Medicine Institute at the University of Pittsburgh, Pittsburgh, Pennsylvania, said in an interview.

The growing number of medications that can be used to treat patients with PAH will likely be more effective if patients are identified and treated early, said Dr. Chan, who was not involved in the study.

However, the time to diagnosis for patients with PAH is still more than 3 years from the start of symptoms, he said. Factors contributing to the delay include the requirement of an invasive cardiac catheterization procedure to make the final diagnosis, the status of PAH as a borderline orphan disease, and the often nonspecific nature of the initial symptoms of PAH.

Consequently, “there is an unmet need to develop effective and preferably noninvasive tools to aid in early diagnosis of PAH,” Dr. Chan added.

The power of the study is in the number of patients included, as much of previous PAH research has involved small studies of patients that could not be replicated or did not generalize to the larger patient population, Dr. Chan said.

The use of the PAH Biobank allows researchers to access a larger population of patients with PAH. “With that in mind, it is not surprising that some markers would emerge as potentially powerful and clinically meaningful,” he said.

“Currently, we do not have a reliable blood-based biomarker that we use in clinical PAH practice, although there are emerging studies that suggest other markers such as metabolites, RNA molecules, and proteins that may serve in the same capacity. If these studies turn out to be reproducible, generalizable, and specific to PAH in larger populations, measuring resistin could be helpful in making early diagnosis, particularly in areas that do not have invasive catheterization facilities (and globally) and for nonspecialists who are puzzled about the nonspecificity of initial symptoms of PAH,” Dr. Chan said.

Resistin could also be incorporated into existing risk stratification scores, such as the REVEAL risk score, that are already used in PAH clinical practice as guidance for when and how to use currently approved medications, he added.

Limitations of the study included the focus only on resistin alone, not in combination with other molecules that might perform better. Also, no independent validation cohort was used, he noted. “While PAH Biobank certainly offered larger numbers than we typically see, we would have to see validation in large independent cohorts for us to be convinced that measurements of resistin should be used in clinical practice.”

Resistin is not specific to PAH, which makes interpretation of the results more complicated, said Dr. Chan. “In this study, the authors used a smaller healthy control cohort of 50 patients as a comparison to their PAH cohort. However, they did not compare their PAH cohort with other cohorts that represent these other ‘resistin-relevant diseases’ and thus do not know whether they can distinguish PAH from any of these other diseases based on simply the resistin levels.” The frequency of comorbidities in patients with PAH, such as obesity, other inflammatory diseases, and cardiovascular disease, could confound the resistin levels.

The study was supported by the National Institutes of Health. Neither the researchers nor Dr. Chan had financial conflicts to disclose.

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

Individuals with preexisting sleep disturbances including obstructive sleep apnea (OSA), insomnia, and abnormal sleep duration showed significantly increased vulnerability to COVID-19, as well as an increased risk for hospitalization, mortality, and long COVID, according to new data from more than 8 million individuals.

Sleep disturbances, though common in the general population, are generally overlooked as a risk factor for COVID-19, wrote Jiawei Zhou, MD, of The First Hospital of China Medical University, Shenyang, China, and colleagues. Most previous research has focused on the impact of COVID-19 on sleep disturbances, not the impact of sleep disturbances on COVID-19, and most studies on the latter topic have focused only on OSA, the researchers wrote.

In a meta-analysis published in eClinicalMedicine, part of The Lancet Discovery Science, the researchers identified 48 observational studies published between October 27, 2023, and May 8, 2024, that involved COVID-19 and sleep disturbances including OSA, insomnia, abnormal sleep duration, and night shift work, among others. The study population included 8,664,026 adults.

The primary outcomes were COVID-19 susceptibility, hospitalization, mortality, and long COVID. Overall, the presence of preexisting sleep disturbances was associated with a significantly increased risk for each of these outcomes, with odds ratios (ORs) of 1.12, 1.25, 1.45, and 1.36, respectively.

In subgroup analyses, the association between preexisting sleep disturbances and greater susceptibility and hospitalization was higher in younger adults (younger than 60 years) than in older adults (aged 60 years and older), but the risk for death was lower in younger adults with sleep disturbances than in older adults with sleep disturbances (OR, 1.22 vs OR, 2.07, respectively). Men with sleep disturbances had a higher risk for COVID-19 mortality than women with sleep disturbances.

Preexisting sleep disturbances overall were significantly associated with long COVID and more so in a subgroup analysis of patients whose definition of long COVID was symptoms lasting 3 or more months vs those lasting 1 month (P = .029).

When the researchers broke down associations with COVID-19 outcomes and specific sleep disturbances, they found significant associations between OSA and all four primary outcomes. Abnormal sleep duration was associated with an increased risk for COVID-19 susceptibility, hospitalization, and long COVID. Night shift work was associated with an increased risk for COVID-19 susceptibility and hospitalization, and insomnia was associated with an increased risk for long COVID.

Although the exact mechanism behind the associations between preexisting sleep disturbances and COVID-19 outcomes is uncertain, persistent sleep deprivation could set the stage in various ways, including the promotion of elevated C-reactive protein and interleukin-6 levels, the researchers wrote.

“Overall, the compromised innate and adaptive immune functions combined with a persistent inflammatory state may explain the higher risk of susceptibility, severity, and longer recovery time observed in patients with sleep disturbances. Fortunately, early intervention for sleep disturbances could attenuate the adverse effects of COVID-19,” they noted in their discussion.

The findings were limited by several factors including the observational nature of the studies and the heterogeneity of outcomes, the researchers wrote. Looking ahead, randomized, controlled trials are needed to examine the effect of interventions for sleep disturbances in the prevention and course of COVID-19, they said.

However, the study is the first known to examine multiple types of sleep disturbances and their possible influences on the full clinical course of COVID-19 and support the need for early evaluation and intervention for individuals with sleep disturbances to reduce short-term and long-term effects of the disease, the researchers concluded.
 

Findings Reflect the Need to Address Sleep Issues Early

Although the results of the current study were not surprising, “it is always worth doing meta-analyses to see if there is a potential signal in the published data to suggest a need for a new study,” Arun Chatterjee, MD, professor of pulmonary, critical care, allergy, and immunologic diseases at Wake Forest University, Winston-Salem, North Carolina, said in an interview.

“Lack of sleep, whether acute active deprivation (zero sleep for one night) or subacute/chronic sleep debt, such as only 5 hours per night, has been demonstrated to affect lymphocyte proliferation, reduce immune globulin levels, increase inflammatory markers, shorten telomeres, and affect the immune system in various ways,” said Dr. Chatterjee, who was not involved in the meta-analysis.

The clinical takeaway from the current meta-analysis is that adequate sleep is important for various reasons, Dr. Chatterjee said. “Sleep disruption affects health across a spectrum of systems; adding an annual sleep wellness and screening event to healthcare visits is probably worth the investment,” he noted.

Much more is needed in the way of additional research, Dr. Chatterjee told this news organization. Notably, studies are needed to examine what sleep disruption does to immune status, as well as all other physiologic and mental health systems, he said.

The study was supported by the National Natural Science Foundation of China and the Key Laboratory of Respiratory Diseases of Liaoning Province. The researchers had no financial conflicts to disclose. Chatterjee had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Individuals with preexisting sleep disturbances including obstructive sleep apnea (OSA), insomnia, and abnormal sleep duration showed significantly increased vulnerability to COVID-19, as well as an increased risk for hospitalization, mortality, and long COVID, according to new data from more than 8 million individuals.

Sleep disturbances, though common in the general population, are generally overlooked as a risk factor for COVID-19, wrote Jiawei Zhou, MD, of The First Hospital of China Medical University, Shenyang, China, and colleagues. Most previous research has focused on the impact of COVID-19 on sleep disturbances, not the impact of sleep disturbances on COVID-19, and most studies on the latter topic have focused only on OSA, the researchers wrote.

In a meta-analysis published in eClinicalMedicine, part of The Lancet Discovery Science, the researchers identified 48 observational studies published between October 27, 2023, and May 8, 2024, that involved COVID-19 and sleep disturbances including OSA, insomnia, abnormal sleep duration, and night shift work, among others. The study population included 8,664,026 adults.

The primary outcomes were COVID-19 susceptibility, hospitalization, mortality, and long COVID. Overall, the presence of preexisting sleep disturbances was associated with a significantly increased risk for each of these outcomes, with odds ratios (ORs) of 1.12, 1.25, 1.45, and 1.36, respectively.

In subgroup analyses, the association between preexisting sleep disturbances and greater susceptibility and hospitalization was higher in younger adults (younger than 60 years) than in older adults (aged 60 years and older), but the risk for death was lower in younger adults with sleep disturbances than in older adults with sleep disturbances (OR, 1.22 vs OR, 2.07, respectively). Men with sleep disturbances had a higher risk for COVID-19 mortality than women with sleep disturbances.

Preexisting sleep disturbances overall were significantly associated with long COVID and more so in a subgroup analysis of patients whose definition of long COVID was symptoms lasting 3 or more months vs those lasting 1 month (P = .029).

When the researchers broke down associations with COVID-19 outcomes and specific sleep disturbances, they found significant associations between OSA and all four primary outcomes. Abnormal sleep duration was associated with an increased risk for COVID-19 susceptibility, hospitalization, and long COVID. Night shift work was associated with an increased risk for COVID-19 susceptibility and hospitalization, and insomnia was associated with an increased risk for long COVID.

Although the exact mechanism behind the associations between preexisting sleep disturbances and COVID-19 outcomes is uncertain, persistent sleep deprivation could set the stage in various ways, including the promotion of elevated C-reactive protein and interleukin-6 levels, the researchers wrote.

“Overall, the compromised innate and adaptive immune functions combined with a persistent inflammatory state may explain the higher risk of susceptibility, severity, and longer recovery time observed in patients with sleep disturbances. Fortunately, early intervention for sleep disturbances could attenuate the adverse effects of COVID-19,” they noted in their discussion.

The findings were limited by several factors including the observational nature of the studies and the heterogeneity of outcomes, the researchers wrote. Looking ahead, randomized, controlled trials are needed to examine the effect of interventions for sleep disturbances in the prevention and course of COVID-19, they said.

However, the study is the first known to examine multiple types of sleep disturbances and their possible influences on the full clinical course of COVID-19 and support the need for early evaluation and intervention for individuals with sleep disturbances to reduce short-term and long-term effects of the disease, the researchers concluded.
 

Findings Reflect the Need to Address Sleep Issues Early

Although the results of the current study were not surprising, “it is always worth doing meta-analyses to see if there is a potential signal in the published data to suggest a need for a new study,” Arun Chatterjee, MD, professor of pulmonary, critical care, allergy, and immunologic diseases at Wake Forest University, Winston-Salem, North Carolina, said in an interview.

“Lack of sleep, whether acute active deprivation (zero sleep for one night) or subacute/chronic sleep debt, such as only 5 hours per night, has been demonstrated to affect lymphocyte proliferation, reduce immune globulin levels, increase inflammatory markers, shorten telomeres, and affect the immune system in various ways,” said Dr. Chatterjee, who was not involved in the meta-analysis.

The clinical takeaway from the current meta-analysis is that adequate sleep is important for various reasons, Dr. Chatterjee said. “Sleep disruption affects health across a spectrum of systems; adding an annual sleep wellness and screening event to healthcare visits is probably worth the investment,” he noted.

Much more is needed in the way of additional research, Dr. Chatterjee told this news organization. Notably, studies are needed to examine what sleep disruption does to immune status, as well as all other physiologic and mental health systems, he said.

The study was supported by the National Natural Science Foundation of China and the Key Laboratory of Respiratory Diseases of Liaoning Province. The researchers had no financial conflicts to disclose. Chatterjee had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Individuals with preexisting sleep disturbances including obstructive sleep apnea (OSA), insomnia, and abnormal sleep duration showed significantly increased vulnerability to COVID-19, as well as an increased risk for hospitalization, mortality, and long COVID, according to new data from more than 8 million individuals.

Sleep disturbances, though common in the general population, are generally overlooked as a risk factor for COVID-19, wrote Jiawei Zhou, MD, of The First Hospital of China Medical University, Shenyang, China, and colleagues. Most previous research has focused on the impact of COVID-19 on sleep disturbances, not the impact of sleep disturbances on COVID-19, and most studies on the latter topic have focused only on OSA, the researchers wrote.

In a meta-analysis published in eClinicalMedicine, part of The Lancet Discovery Science, the researchers identified 48 observational studies published between October 27, 2023, and May 8, 2024, that involved COVID-19 and sleep disturbances including OSA, insomnia, abnormal sleep duration, and night shift work, among others. The study population included 8,664,026 adults.

The primary outcomes were COVID-19 susceptibility, hospitalization, mortality, and long COVID. Overall, the presence of preexisting sleep disturbances was associated with a significantly increased risk for each of these outcomes, with odds ratios (ORs) of 1.12, 1.25, 1.45, and 1.36, respectively.

In subgroup analyses, the association between preexisting sleep disturbances and greater susceptibility and hospitalization was higher in younger adults (younger than 60 years) than in older adults (aged 60 years and older), but the risk for death was lower in younger adults with sleep disturbances than in older adults with sleep disturbances (OR, 1.22 vs OR, 2.07, respectively). Men with sleep disturbances had a higher risk for COVID-19 mortality than women with sleep disturbances.

Preexisting sleep disturbances overall were significantly associated with long COVID and more so in a subgroup analysis of patients whose definition of long COVID was symptoms lasting 3 or more months vs those lasting 1 month (P = .029).

When the researchers broke down associations with COVID-19 outcomes and specific sleep disturbances, they found significant associations between OSA and all four primary outcomes. Abnormal sleep duration was associated with an increased risk for COVID-19 susceptibility, hospitalization, and long COVID. Night shift work was associated with an increased risk for COVID-19 susceptibility and hospitalization, and insomnia was associated with an increased risk for long COVID.

Although the exact mechanism behind the associations between preexisting sleep disturbances and COVID-19 outcomes is uncertain, persistent sleep deprivation could set the stage in various ways, including the promotion of elevated C-reactive protein and interleukin-6 levels, the researchers wrote.

“Overall, the compromised innate and adaptive immune functions combined with a persistent inflammatory state may explain the higher risk of susceptibility, severity, and longer recovery time observed in patients with sleep disturbances. Fortunately, early intervention for sleep disturbances could attenuate the adverse effects of COVID-19,” they noted in their discussion.

The findings were limited by several factors including the observational nature of the studies and the heterogeneity of outcomes, the researchers wrote. Looking ahead, randomized, controlled trials are needed to examine the effect of interventions for sleep disturbances in the prevention and course of COVID-19, they said.

However, the study is the first known to examine multiple types of sleep disturbances and their possible influences on the full clinical course of COVID-19 and support the need for early evaluation and intervention for individuals with sleep disturbances to reduce short-term and long-term effects of the disease, the researchers concluded.
 

Findings Reflect the Need to Address Sleep Issues Early

Although the results of the current study were not surprising, “it is always worth doing meta-analyses to see if there is a potential signal in the published data to suggest a need for a new study,” Arun Chatterjee, MD, professor of pulmonary, critical care, allergy, and immunologic diseases at Wake Forest University, Winston-Salem, North Carolina, said in an interview.

“Lack of sleep, whether acute active deprivation (zero sleep for one night) or subacute/chronic sleep debt, such as only 5 hours per night, has been demonstrated to affect lymphocyte proliferation, reduce immune globulin levels, increase inflammatory markers, shorten telomeres, and affect the immune system in various ways,” said Dr. Chatterjee, who was not involved in the meta-analysis.

The clinical takeaway from the current meta-analysis is that adequate sleep is important for various reasons, Dr. Chatterjee said. “Sleep disruption affects health across a spectrum of systems; adding an annual sleep wellness and screening event to healthcare visits is probably worth the investment,” he noted.

Much more is needed in the way of additional research, Dr. Chatterjee told this news organization. Notably, studies are needed to examine what sleep disruption does to immune status, as well as all other physiologic and mental health systems, he said.

The study was supported by the National Natural Science Foundation of China and the Key Laboratory of Respiratory Diseases of Liaoning Province. The researchers had no financial conflicts to disclose. Chatterjee had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Preconception and prenatal care are more complicated in women with chronic health conditions but attention to disease management and promoting the adoption of a healthier lifestyle can improve outcomes for mothers and infants, according to a growing body of research.

The latest version of the International Federation of Gynecology and Obstetrics Preconception Checklist, published in the International Journal of Gynecology & Obstetrics, highlights preexisting chronic medical conditions such as diabetes, lupus, and obesity as key factors to address in preconception care through disease management. A growing number of studies support the impact of these strategies on short- and long-term outcomes for mothers and babies, according to the authors.
 

Meet Glycemic Control Goals Prior to Pregnancy

“Women with diabetes can have healthy pregnancies but need to prepare for pregnancy in advance,” Ellen W. Seely, MD, professor of medicine at Harvard Medical School and director of clinical research in the endocrinology, diabetes, and hypertension division of Brigham and Women’s Hospital, Boston, said in an interview.

“If glucose levels are running high in the first trimester, this is associated with an increased risk of birth defects, some of which are very serious,” said Dr. Seely. Getting glucose levels under control reduces the risk of birth defects in women with diabetes close to that of the general population, she said.

The American Diabetes Association has set a goal for women to attain an HbA1c of less than 6.5% before conception, Dr. Seely said. “In addition, some women with diabetes may be on medications that should be changed to another class prior to pregnancy,” she noted. Women with type 1 or type 2 diabetes often have hypertension as well, but ACE inhibitors are associated with an increased risk of fetal renal damage that can result in neonatal death; therefore, these medications should be stopped prior to pregnancy, Dr. Seely emphasized.

“If a woman with type 2 diabetes is on medications other than insulin, recommendations from the ADA are to change to insulin prior to pregnancy, since we have the most data on the safety profile of insulin use in pregnancy,” she said.

To help women with diabetes improve glycemic control prior to pregnancy, Dr. Seely recommends home glucose monitoring, with checks of glucose four times a day, fasting, and 2 hours after each meal, and adjustment of insulin accordingly.

A healthy diet and physical activity remain important components of glycemic control as well. A barrier to proper preconception and prenatal care for women with diabetes is not knowing that a pregnancy should be planned, Dr. Seely said. Discussions about pregnancy should start at puberty for women with diabetes, according to the ADA, and the topic should be raised yearly so women can optimize their health and adjust medications prior to conception.

Although studies of drugs have been done to inform preconception care for women with diabetes, research is lacking in several areas, notably the safety of GLP-1 agonists in pregnancy, said Dr. Seely. “This class of drug is commonly used in type 2 diabetes and the current recommendation is to stop these agents 2 months prior to conception,” she said.
 

Conceive in Times of Lupus Remission

Advance planning also is important for a healthy pregnancy in women with systemic lupus erythematosus (SLE), Sayna Norouzi, MD, director of the glomerular disease clinic and polycystic kidney disease clinic of Loma Linda University Medical Center, California, said in an interview.

“Lupus mostly affects women of childbearing age and can create many challenges during pregnancy,” said Dr. Norouzi, the corresponding author of a recent review on managing lupus nephritis during pregnancy.

“Women with lupus face an increased risk of pregnancy complications such as preeclampsia, problems with fetal growth, stillbirth, and premature birth, and these risks increase based on factors such as disease activity, certain antibodies in the body, and other baseline existing conditions such as high blood pressure,” she said.

“It can be difficult to distinguish between a lupus flare and pregnancy-related issues, so proper management is important,” she noted. The Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Syndrome and Systemic Lupus Erythematosus (PROMISSE) study findings indicated a lupus nephritis relapse rate of 7.8% of patients in complete remission and 21% of those in partial remission during pregnancy, said Dr. Norouzi. “Current evidence has shown that SLE patients without lupus nephritis flare in the preconception period have a small risk of relapse during pregnancy,” she said.

Before and during pregnancy, women with lupus should work with their treating physicians to adjust medications for safety, watch for signs of flare, and aim to conceive during a period of lupus remission.

Preconception care for women with lupus nephritis involves a careful review of the medications used to control the disease and protect the kidneys and other organs, said Dr. Norouzi.

“Adjustments,” she said, “should be personalized, taking into account the mother’s health and the safety of the baby. Managing the disease actively during pregnancy may require changes to the treatment plan while minimizing risks,” she noted. However, changing medications can cause challenges for patients, as medications that are safer for pregnancy may lead to new symptoms and side effects, and patients will need to work closely with their healthcare providers to overcome new issues that arise, she added.

Preconception lifestyle changes such as increasing exercise and adopting a healthier diet can help with blood pressure control for kidney disease patients, said Dr. Norouzi.

In the review article, Dr. Norouzi and colleagues noted that preconception counseling for patients with lupus should address common comorbidities such as hypertension, diabetes, obesity, and dyslipidemia, and the risk for immediate and long-term cardiovascular complications.
 

Benefits of Preconception Obesity Care Extend to Infants

Current guidelines from the American College of Obstetricians and Gynecologists and the Institute of Medicine advise lifestyle interventions to reduce excessive weight gain during pregnancy and reduce the risk of inflammation, oxidative stress, insulin resistance, and lipotoxicity that can promote complications in the mother and fetus during pregnancy.

In addition, a growing number of studies suggest that women with obesity who make healthy lifestyle changes prior to conception can reduce obesity-associated risks to their infants.

Adults born to women with obesity are at increased risk of cardiovascular disease and early signs of heart remodeling are identifiable in newborns, Samuel J. Burden, PhD, a research associate in the department of women and children’s health, Kings’ College, London, said in an interview. “It is therefore important to investigate whether intervening either before or during pregnancy by promoting a healthy lifestyle can reduce this adverse impact on the heart and blood vessels,” he said.

In a recent study published in the International Journal of Obesity, Dr. Burden and colleagues examined data from eight studies based on data from five randomized, controlled trials including children of mothers with obesity who engaged in healthy lifestyle interventions of improved diet and increased physical activity prior to and during pregnancy. The study population included children ranging in age from less than 2 months to 3-7 years.

Lifestyle interventions for mothers both before conception and during pregnancy were associated with significant changes in cardiac remodeling in the children, notably reduced interventricular septal wall thickness. Additionally, five studies of cardiac systolic function and three studies of diastolic function showed improvement in blood pressure in children of mothers who took part in the interventions.

Dr. Burden acknowledged that lifestyle changes in women with obesity before conception and during pregnancy can be challenging, but should be encouraged. “During pregnancy, it may also seem unnatural to increase daily physical activity or change the way you are eating.” He emphasized that patients should consult their physicians and follow an established program. More randomized, controlled trials are needed from the preconception period to examine whether the health benefits are greater if the intervention begins prior to pregnancy, said Dr. Burden. However, “the current findings indeed indicate that women with obesity who lead a healthy lifestyle before and during their pregnancy can reduce the degree of unhealthy heart remodeling in their children,” he said.

Dr. Seely, Dr. Norouzi, and Dr. Burden had no financial conflicts to disclose.

Preconception and prenatal care are more complicated in women with chronic health conditions but attention to disease management and promoting the adoption of a healthier lifestyle can improve outcomes for mothers and infants, according to a growing body of research.

The latest version of the International Federation of Gynecology and Obstetrics Preconception Checklist, published in the International Journal of Gynecology & Obstetrics, highlights preexisting chronic medical conditions such as diabetes, lupus, and obesity as key factors to address in preconception care through disease management. A growing number of studies support the impact of these strategies on short- and long-term outcomes for mothers and babies, according to the authors.
 

Meet Glycemic Control Goals Prior to Pregnancy

“Women with diabetes can have healthy pregnancies but need to prepare for pregnancy in advance,” Ellen W. Seely, MD, professor of medicine at Harvard Medical School and director of clinical research in the endocrinology, diabetes, and hypertension division of Brigham and Women’s Hospital, Boston, said in an interview.

“If glucose levels are running high in the first trimester, this is associated with an increased risk of birth defects, some of which are very serious,” said Dr. Seely. Getting glucose levels under control reduces the risk of birth defects in women with diabetes close to that of the general population, she said.

The American Diabetes Association has set a goal for women to attain an HbA1c of less than 6.5% before conception, Dr. Seely said. “In addition, some women with diabetes may be on medications that should be changed to another class prior to pregnancy,” she noted. Women with type 1 or type 2 diabetes often have hypertension as well, but ACE inhibitors are associated with an increased risk of fetal renal damage that can result in neonatal death; therefore, these medications should be stopped prior to pregnancy, Dr. Seely emphasized.

“If a woman with type 2 diabetes is on medications other than insulin, recommendations from the ADA are to change to insulin prior to pregnancy, since we have the most data on the safety profile of insulin use in pregnancy,” she said.

To help women with diabetes improve glycemic control prior to pregnancy, Dr. Seely recommends home glucose monitoring, with checks of glucose four times a day, fasting, and 2 hours after each meal, and adjustment of insulin accordingly.

A healthy diet and physical activity remain important components of glycemic control as well. A barrier to proper preconception and prenatal care for women with diabetes is not knowing that a pregnancy should be planned, Dr. Seely said. Discussions about pregnancy should start at puberty for women with diabetes, according to the ADA, and the topic should be raised yearly so women can optimize their health and adjust medications prior to conception.

Although studies of drugs have been done to inform preconception care for women with diabetes, research is lacking in several areas, notably the safety of GLP-1 agonists in pregnancy, said Dr. Seely. “This class of drug is commonly used in type 2 diabetes and the current recommendation is to stop these agents 2 months prior to conception,” she said.
 

Conceive in Times of Lupus Remission

Advance planning also is important for a healthy pregnancy in women with systemic lupus erythematosus (SLE), Sayna Norouzi, MD, director of the glomerular disease clinic and polycystic kidney disease clinic of Loma Linda University Medical Center, California, said in an interview.

“Lupus mostly affects women of childbearing age and can create many challenges during pregnancy,” said Dr. Norouzi, the corresponding author of a recent review on managing lupus nephritis during pregnancy.

“Women with lupus face an increased risk of pregnancy complications such as preeclampsia, problems with fetal growth, stillbirth, and premature birth, and these risks increase based on factors such as disease activity, certain antibodies in the body, and other baseline existing conditions such as high blood pressure,” she said.

“It can be difficult to distinguish between a lupus flare and pregnancy-related issues, so proper management is important,” she noted. The Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Syndrome and Systemic Lupus Erythematosus (PROMISSE) study findings indicated a lupus nephritis relapse rate of 7.8% of patients in complete remission and 21% of those in partial remission during pregnancy, said Dr. Norouzi. “Current evidence has shown that SLE patients without lupus nephritis flare in the preconception period have a small risk of relapse during pregnancy,” she said.

Before and during pregnancy, women with lupus should work with their treating physicians to adjust medications for safety, watch for signs of flare, and aim to conceive during a period of lupus remission.

Preconception care for women with lupus nephritis involves a careful review of the medications used to control the disease and protect the kidneys and other organs, said Dr. Norouzi.

“Adjustments,” she said, “should be personalized, taking into account the mother’s health and the safety of the baby. Managing the disease actively during pregnancy may require changes to the treatment plan while minimizing risks,” she noted. However, changing medications can cause challenges for patients, as medications that are safer for pregnancy may lead to new symptoms and side effects, and patients will need to work closely with their healthcare providers to overcome new issues that arise, she added.

Preconception lifestyle changes such as increasing exercise and adopting a healthier diet can help with blood pressure control for kidney disease patients, said Dr. Norouzi.

In the review article, Dr. Norouzi and colleagues noted that preconception counseling for patients with lupus should address common comorbidities such as hypertension, diabetes, obesity, and dyslipidemia, and the risk for immediate and long-term cardiovascular complications.
 

Benefits of Preconception Obesity Care Extend to Infants

Current guidelines from the American College of Obstetricians and Gynecologists and the Institute of Medicine advise lifestyle interventions to reduce excessive weight gain during pregnancy and reduce the risk of inflammation, oxidative stress, insulin resistance, and lipotoxicity that can promote complications in the mother and fetus during pregnancy.

In addition, a growing number of studies suggest that women with obesity who make healthy lifestyle changes prior to conception can reduce obesity-associated risks to their infants.

Adults born to women with obesity are at increased risk of cardiovascular disease and early signs of heart remodeling are identifiable in newborns, Samuel J. Burden, PhD, a research associate in the department of women and children’s health, Kings’ College, London, said in an interview. “It is therefore important to investigate whether intervening either before or during pregnancy by promoting a healthy lifestyle can reduce this adverse impact on the heart and blood vessels,” he said.

In a recent study published in the International Journal of Obesity, Dr. Burden and colleagues examined data from eight studies based on data from five randomized, controlled trials including children of mothers with obesity who engaged in healthy lifestyle interventions of improved diet and increased physical activity prior to and during pregnancy. The study population included children ranging in age from less than 2 months to 3-7 years.

Lifestyle interventions for mothers both before conception and during pregnancy were associated with significant changes in cardiac remodeling in the children, notably reduced interventricular septal wall thickness. Additionally, five studies of cardiac systolic function and three studies of diastolic function showed improvement in blood pressure in children of mothers who took part in the interventions.

Dr. Burden acknowledged that lifestyle changes in women with obesity before conception and during pregnancy can be challenging, but should be encouraged. “During pregnancy, it may also seem unnatural to increase daily physical activity or change the way you are eating.” He emphasized that patients should consult their physicians and follow an established program. More randomized, controlled trials are needed from the preconception period to examine whether the health benefits are greater if the intervention begins prior to pregnancy, said Dr. Burden. However, “the current findings indeed indicate that women with obesity who lead a healthy lifestyle before and during their pregnancy can reduce the degree of unhealthy heart remodeling in their children,” he said.

Dr. Seely, Dr. Norouzi, and Dr. Burden had no financial conflicts to disclose.

Preconception and prenatal care are more complicated in women with chronic health conditions but attention to disease management and promoting the adoption of a healthier lifestyle can improve outcomes for mothers and infants, according to a growing body of research.

The latest version of the International Federation of Gynecology and Obstetrics Preconception Checklist, published in the International Journal of Gynecology & Obstetrics, highlights preexisting chronic medical conditions such as diabetes, lupus, and obesity as key factors to address in preconception care through disease management. A growing number of studies support the impact of these strategies on short- and long-term outcomes for mothers and babies, according to the authors.
 

Meet Glycemic Control Goals Prior to Pregnancy

“Women with diabetes can have healthy pregnancies but need to prepare for pregnancy in advance,” Ellen W. Seely, MD, professor of medicine at Harvard Medical School and director of clinical research in the endocrinology, diabetes, and hypertension division of Brigham and Women’s Hospital, Boston, said in an interview.

“If glucose levels are running high in the first trimester, this is associated with an increased risk of birth defects, some of which are very serious,” said Dr. Seely. Getting glucose levels under control reduces the risk of birth defects in women with diabetes close to that of the general population, she said.

The American Diabetes Association has set a goal for women to attain an HbA1c of less than 6.5% before conception, Dr. Seely said. “In addition, some women with diabetes may be on medications that should be changed to another class prior to pregnancy,” she noted. Women with type 1 or type 2 diabetes often have hypertension as well, but ACE inhibitors are associated with an increased risk of fetal renal damage that can result in neonatal death; therefore, these medications should be stopped prior to pregnancy, Dr. Seely emphasized.

“If a woman with type 2 diabetes is on medications other than insulin, recommendations from the ADA are to change to insulin prior to pregnancy, since we have the most data on the safety profile of insulin use in pregnancy,” she said.

To help women with diabetes improve glycemic control prior to pregnancy, Dr. Seely recommends home glucose monitoring, with checks of glucose four times a day, fasting, and 2 hours after each meal, and adjustment of insulin accordingly.

A healthy diet and physical activity remain important components of glycemic control as well. A barrier to proper preconception and prenatal care for women with diabetes is not knowing that a pregnancy should be planned, Dr. Seely said. Discussions about pregnancy should start at puberty for women with diabetes, according to the ADA, and the topic should be raised yearly so women can optimize their health and adjust medications prior to conception.

Although studies of drugs have been done to inform preconception care for women with diabetes, research is lacking in several areas, notably the safety of GLP-1 agonists in pregnancy, said Dr. Seely. “This class of drug is commonly used in type 2 diabetes and the current recommendation is to stop these agents 2 months prior to conception,” she said.
 

Conceive in Times of Lupus Remission

Advance planning also is important for a healthy pregnancy in women with systemic lupus erythematosus (SLE), Sayna Norouzi, MD, director of the glomerular disease clinic and polycystic kidney disease clinic of Loma Linda University Medical Center, California, said in an interview.

“Lupus mostly affects women of childbearing age and can create many challenges during pregnancy,” said Dr. Norouzi, the corresponding author of a recent review on managing lupus nephritis during pregnancy.

“Women with lupus face an increased risk of pregnancy complications such as preeclampsia, problems with fetal growth, stillbirth, and premature birth, and these risks increase based on factors such as disease activity, certain antibodies in the body, and other baseline existing conditions such as high blood pressure,” she said.

“It can be difficult to distinguish between a lupus flare and pregnancy-related issues, so proper management is important,” she noted. The Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Syndrome and Systemic Lupus Erythematosus (PROMISSE) study findings indicated a lupus nephritis relapse rate of 7.8% of patients in complete remission and 21% of those in partial remission during pregnancy, said Dr. Norouzi. “Current evidence has shown that SLE patients without lupus nephritis flare in the preconception period have a small risk of relapse during pregnancy,” she said.

Before and during pregnancy, women with lupus should work with their treating physicians to adjust medications for safety, watch for signs of flare, and aim to conceive during a period of lupus remission.

Preconception care for women with lupus nephritis involves a careful review of the medications used to control the disease and protect the kidneys and other organs, said Dr. Norouzi.

“Adjustments,” she said, “should be personalized, taking into account the mother’s health and the safety of the baby. Managing the disease actively during pregnancy may require changes to the treatment plan while minimizing risks,” she noted. However, changing medications can cause challenges for patients, as medications that are safer for pregnancy may lead to new symptoms and side effects, and patients will need to work closely with their healthcare providers to overcome new issues that arise, she added.

Preconception lifestyle changes such as increasing exercise and adopting a healthier diet can help with blood pressure control for kidney disease patients, said Dr. Norouzi.

In the review article, Dr. Norouzi and colleagues noted that preconception counseling for patients with lupus should address common comorbidities such as hypertension, diabetes, obesity, and dyslipidemia, and the risk for immediate and long-term cardiovascular complications.
 

Benefits of Preconception Obesity Care Extend to Infants

Current guidelines from the American College of Obstetricians and Gynecologists and the Institute of Medicine advise lifestyle interventions to reduce excessive weight gain during pregnancy and reduce the risk of inflammation, oxidative stress, insulin resistance, and lipotoxicity that can promote complications in the mother and fetus during pregnancy.

In addition, a growing number of studies suggest that women with obesity who make healthy lifestyle changes prior to conception can reduce obesity-associated risks to their infants.

Adults born to women with obesity are at increased risk of cardiovascular disease and early signs of heart remodeling are identifiable in newborns, Samuel J. Burden, PhD, a research associate in the department of women and children’s health, Kings’ College, London, said in an interview. “It is therefore important to investigate whether intervening either before or during pregnancy by promoting a healthy lifestyle can reduce this adverse impact on the heart and blood vessels,” he said.

In a recent study published in the International Journal of Obesity, Dr. Burden and colleagues examined data from eight studies based on data from five randomized, controlled trials including children of mothers with obesity who engaged in healthy lifestyle interventions of improved diet and increased physical activity prior to and during pregnancy. The study population included children ranging in age from less than 2 months to 3-7 years.

Lifestyle interventions for mothers both before conception and during pregnancy were associated with significant changes in cardiac remodeling in the children, notably reduced interventricular septal wall thickness. Additionally, five studies of cardiac systolic function and three studies of diastolic function showed improvement in blood pressure in children of mothers who took part in the interventions.

Dr. Burden acknowledged that lifestyle changes in women with obesity before conception and during pregnancy can be challenging, but should be encouraged. “During pregnancy, it may also seem unnatural to increase daily physical activity or change the way you are eating.” He emphasized that patients should consult their physicians and follow an established program. More randomized, controlled trials are needed from the preconception period to examine whether the health benefits are greater if the intervention begins prior to pregnancy, said Dr. Burden. However, “the current findings indeed indicate that women with obesity who lead a healthy lifestyle before and during their pregnancy can reduce the degree of unhealthy heart remodeling in their children,” he said.

Dr. Seely, Dr. Norouzi, and Dr. Burden had no financial conflicts to disclose.

The recent Food and Drug Administration (FDA) approval of ensifentrine marks the first new treatment for patients with persistent chronic obstructive pulmonary disease (COPD) in more than a decade, according to manufacturer Verona Pharma.

Ensifentrine offers a new medication and a new delivery method, according to a company press release. Ensifentrine is the first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE 3) and PDE 4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer.
 

Disease Management Made Easier

Although currently approved therapies for COPD, such as bronchodilators and inhaled corticosteroids (ICS), have benefited many patients, additional treatment options are still needed to help those who remain symptomatic and suffer from frequent exacerbations, said Diego J. Maselli, MD, of the University of Texas Health Science Center, San Antonio.

“Ensifentrine is a new class of medication that inhibits both PDE 3 and PDE 4; this results in both bronchodilation and suppression of the inflammatory response in COPD,” said Dr. Maselli, who was not involved in studies of ensifentrine.

“Large phase III, double-blind, randomized, placebo-controlled studies have demonstrated that ensifentrine improved lung function and reduced the risk of exacerbations in patients with symptomatic moderate to severe COPD,” he said. The study participants were on no long-acting maintenance therapy, or they were receiving long-acting beta agonist (LABA) or long-acting muscarinic antagonist (LAMA) with or without inhaled corticosteroids, he noted.

The FDA approval was supported by data from the phase 3 ENHANCE 1 and 2 trials, which included 760 and 789 adults aged 40-80 years with moderate to severe symptomatic COPD, respectively. Participants were randomized to 3 mg ensifentrine delivered via nebulizer or a placebo twice daily.

In the studies, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume per second within 0-12 hours of administration compared with placebo in both studies. In ENHANCE 1, ensifentrine significantly improved symptoms and quality of life compared with placebo at 24 weeks. The ENHANCE 2 results showed similar trends in favor of ensifentrine, although the differences were not significant at 24 weeks. However, the effects of ensifentrine vs placebo were consistent overall across all symptom and quality of life endpoints at all assessments during the study period, the researchers wrote.

In addition, the inhaled drug was well tolerated, with similar proportions of ensifentrine and placebo patients reporting treatment-emergent adverse events (38.4% and 36.4%, respectively, in ENHANCE 1 and 35.3% and 35.4%, respectively, in ENHANCE 2). The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group.

The safety profile of ensifentrine is a plus for patients, said Dr. Maselli. “Ensifentrine was well tolerated in these studies, and the side effect profile was similar to placebo,” he said. The “ensifentrine is delivered via nebulizer and dosed every 12 hours. Some patients may still prefer the use of inhalers, while others may feel more comfortable with this mode of delivery,” he said. 

In clinical practice, “ensifentrine is a welcome addition to the current armamentarium of therapies for COPD as an option for patients who are symptomatic or who have frequent exacerbations,” Dr. Maselli emphasized.

Looking ahead, more studies are needed to evaluate ensifentrine in broader populations of COPD patients, Dr. Maselli said. For example, ensifentrine could be used as an add-on therapy for patients receiving triple therapy (ICS/LABA/LAMA) and for patients with other obstructive inflammatory diseases such as asthma, bronchiectasis, and cystic fibrosis, he noted.

Dr. Maselli disclosed serving as a consultant for GlaxoSmithKline, AstraZeneca, Amgen, and Sanofi/Regeneron; he also serves on the Editorial Board of CHEST Physician.
 

A version of this article appeared on Medscape.com.

The recent Food and Drug Administration (FDA) approval of ensifentrine marks the first new treatment for patients with persistent chronic obstructive pulmonary disease (COPD) in more than a decade, according to manufacturer Verona Pharma.

Ensifentrine offers a new medication and a new delivery method, according to a company press release. Ensifentrine is the first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE 3) and PDE 4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer.
 

Disease Management Made Easier

Although currently approved therapies for COPD, such as bronchodilators and inhaled corticosteroids (ICS), have benefited many patients, additional treatment options are still needed to help those who remain symptomatic and suffer from frequent exacerbations, said Diego J. Maselli, MD, of the University of Texas Health Science Center, San Antonio.

“Ensifentrine is a new class of medication that inhibits both PDE 3 and PDE 4; this results in both bronchodilation and suppression of the inflammatory response in COPD,” said Dr. Maselli, who was not involved in studies of ensifentrine.

“Large phase III, double-blind, randomized, placebo-controlled studies have demonstrated that ensifentrine improved lung function and reduced the risk of exacerbations in patients with symptomatic moderate to severe COPD,” he said. The study participants were on no long-acting maintenance therapy, or they were receiving long-acting beta agonist (LABA) or long-acting muscarinic antagonist (LAMA) with or without inhaled corticosteroids, he noted.

The FDA approval was supported by data from the phase 3 ENHANCE 1 and 2 trials, which included 760 and 789 adults aged 40-80 years with moderate to severe symptomatic COPD, respectively. Participants were randomized to 3 mg ensifentrine delivered via nebulizer or a placebo twice daily.

In the studies, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume per second within 0-12 hours of administration compared with placebo in both studies. In ENHANCE 1, ensifentrine significantly improved symptoms and quality of life compared with placebo at 24 weeks. The ENHANCE 2 results showed similar trends in favor of ensifentrine, although the differences were not significant at 24 weeks. However, the effects of ensifentrine vs placebo were consistent overall across all symptom and quality of life endpoints at all assessments during the study period, the researchers wrote.

In addition, the inhaled drug was well tolerated, with similar proportions of ensifentrine and placebo patients reporting treatment-emergent adverse events (38.4% and 36.4%, respectively, in ENHANCE 1 and 35.3% and 35.4%, respectively, in ENHANCE 2). The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group.

The safety profile of ensifentrine is a plus for patients, said Dr. Maselli. “Ensifentrine was well tolerated in these studies, and the side effect profile was similar to placebo,” he said. The “ensifentrine is delivered via nebulizer and dosed every 12 hours. Some patients may still prefer the use of inhalers, while others may feel more comfortable with this mode of delivery,” he said. 

In clinical practice, “ensifentrine is a welcome addition to the current armamentarium of therapies for COPD as an option for patients who are symptomatic or who have frequent exacerbations,” Dr. Maselli emphasized.

Looking ahead, more studies are needed to evaluate ensifentrine in broader populations of COPD patients, Dr. Maselli said. For example, ensifentrine could be used as an add-on therapy for patients receiving triple therapy (ICS/LABA/LAMA) and for patients with other obstructive inflammatory diseases such as asthma, bronchiectasis, and cystic fibrosis, he noted.

Dr. Maselli disclosed serving as a consultant for GlaxoSmithKline, AstraZeneca, Amgen, and Sanofi/Regeneron; he also serves on the Editorial Board of CHEST Physician.
 

A version of this article appeared on Medscape.com.

The recent Food and Drug Administration (FDA) approval of ensifentrine marks the first new treatment for patients with persistent chronic obstructive pulmonary disease (COPD) in more than a decade, according to manufacturer Verona Pharma.

Ensifentrine offers a new medication and a new delivery method, according to a company press release. Ensifentrine is the first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE 3) and PDE 4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer.
 

Disease Management Made Easier

Although currently approved therapies for COPD, such as bronchodilators and inhaled corticosteroids (ICS), have benefited many patients, additional treatment options are still needed to help those who remain symptomatic and suffer from frequent exacerbations, said Diego J. Maselli, MD, of the University of Texas Health Science Center, San Antonio.

“Ensifentrine is a new class of medication that inhibits both PDE 3 and PDE 4; this results in both bronchodilation and suppression of the inflammatory response in COPD,” said Dr. Maselli, who was not involved in studies of ensifentrine.

“Large phase III, double-blind, randomized, placebo-controlled studies have demonstrated that ensifentrine improved lung function and reduced the risk of exacerbations in patients with symptomatic moderate to severe COPD,” he said. The study participants were on no long-acting maintenance therapy, or they were receiving long-acting beta agonist (LABA) or long-acting muscarinic antagonist (LAMA) with or without inhaled corticosteroids, he noted.

The FDA approval was supported by data from the phase 3 ENHANCE 1 and 2 trials, which included 760 and 789 adults aged 40-80 years with moderate to severe symptomatic COPD, respectively. Participants were randomized to 3 mg ensifentrine delivered via nebulizer or a placebo twice daily.

In the studies, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume per second within 0-12 hours of administration compared with placebo in both studies. In ENHANCE 1, ensifentrine significantly improved symptoms and quality of life compared with placebo at 24 weeks. The ENHANCE 2 results showed similar trends in favor of ensifentrine, although the differences were not significant at 24 weeks. However, the effects of ensifentrine vs placebo were consistent overall across all symptom and quality of life endpoints at all assessments during the study period, the researchers wrote.

In addition, the inhaled drug was well tolerated, with similar proportions of ensifentrine and placebo patients reporting treatment-emergent adverse events (38.4% and 36.4%, respectively, in ENHANCE 1 and 35.3% and 35.4%, respectively, in ENHANCE 2). The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group.

The safety profile of ensifentrine is a plus for patients, said Dr. Maselli. “Ensifentrine was well tolerated in these studies, and the side effect profile was similar to placebo,” he said. The “ensifentrine is delivered via nebulizer and dosed every 12 hours. Some patients may still prefer the use of inhalers, while others may feel more comfortable with this mode of delivery,” he said. 

In clinical practice, “ensifentrine is a welcome addition to the current armamentarium of therapies for COPD as an option for patients who are symptomatic or who have frequent exacerbations,” Dr. Maselli emphasized.

Looking ahead, more studies are needed to evaluate ensifentrine in broader populations of COPD patients, Dr. Maselli said. For example, ensifentrine could be used as an add-on therapy for patients receiving triple therapy (ICS/LABA/LAMA) and for patients with other obstructive inflammatory diseases such as asthma, bronchiectasis, and cystic fibrosis, he noted.

Dr. Maselli disclosed serving as a consultant for GlaxoSmithKline, AstraZeneca, Amgen, and Sanofi/Regeneron; he also serves on the Editorial Board of CHEST Physician.
 

A version of this article appeared on Medscape.com.

Philips Respironics Inc. has issued updated instructions for the use of its OmniLab Advanced+ (OLA+) Ventilator because of its demonstrated failure in the ventilator inoperative alarm that can cause an interruption or loss of therapy, according to a recall statement from the US Food and Drug Administration (FDA).

The OLA+ Ventilator is designed for use by individuals with obstructive sleep apnea, breathing problems, and mixed apnea and is approved for children aged 7 years and older, as well as adults.

The recall does not involve removal of the devices from where they are used or sold but does update the instructions for use, and its use without following the updated instructions could result in serious injury or death, according to the statement.

Following an alarm failure, the device may fail in one of two ways: By entering a ventilator inoperative state after three reboots within 24 hours (with no therapy and audible and visual alarms present) or by entering a ventilator inoperative state without rebooting first.

According to the statement, the alarm issue may be corrected with a software patch, available from Philips, or the company will offer a replacement device for patients until the affected devices are repaired. The statement updates an April 1, 2024, urgent recall from Philips urging the immediate removal of a patient from an OLA+ Ventilator and connecting them to alternative ventilation if possible if the ventilator’s inoperative alarm occurs.

The device failures may cause interruption or loss of therapy with effects including anxiety, confusion/disorientation, changes in respiratory rate, dyspnea, tachycardia, respiratory failure, and even death in especially vulnerable individuals. One death and 15 injuries have been reported as a result of the alarm failure, according to the FDA.

US customers can contact Philips Respironics Inc. at 1-800-345-6443 or [email protected] with questions, according to the FDA, and clinicians and patients may report adverse reactions or other problems with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

A version of this article appeared on Medscape.com.

Philips Respironics Inc. has issued updated instructions for the use of its OmniLab Advanced+ (OLA+) Ventilator because of its demonstrated failure in the ventilator inoperative alarm that can cause an interruption or loss of therapy, according to a recall statement from the US Food and Drug Administration (FDA).

The OLA+ Ventilator is designed for use by individuals with obstructive sleep apnea, breathing problems, and mixed apnea and is approved for children aged 7 years and older, as well as adults.

The recall does not involve removal of the devices from where they are used or sold but does update the instructions for use, and its use without following the updated instructions could result in serious injury or death, according to the statement.

Following an alarm failure, the device may fail in one of two ways: By entering a ventilator inoperative state after three reboots within 24 hours (with no therapy and audible and visual alarms present) or by entering a ventilator inoperative state without rebooting first.

According to the statement, the alarm issue may be corrected with a software patch, available from Philips, or the company will offer a replacement device for patients until the affected devices are repaired. The statement updates an April 1, 2024, urgent recall from Philips urging the immediate removal of a patient from an OLA+ Ventilator and connecting them to alternative ventilation if possible if the ventilator’s inoperative alarm occurs.

The device failures may cause interruption or loss of therapy with effects including anxiety, confusion/disorientation, changes in respiratory rate, dyspnea, tachycardia, respiratory failure, and even death in especially vulnerable individuals. One death and 15 injuries have been reported as a result of the alarm failure, according to the FDA.

US customers can contact Philips Respironics Inc. at 1-800-345-6443 or [email protected] with questions, according to the FDA, and clinicians and patients may report adverse reactions or other problems with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

A version of this article appeared on Medscape.com.

Philips Respironics Inc. has issued updated instructions for the use of its OmniLab Advanced+ (OLA+) Ventilator because of its demonstrated failure in the ventilator inoperative alarm that can cause an interruption or loss of therapy, according to a recall statement from the US Food and Drug Administration (FDA).

The OLA+ Ventilator is designed for use by individuals with obstructive sleep apnea, breathing problems, and mixed apnea and is approved for children aged 7 years and older, as well as adults.

The recall does not involve removal of the devices from where they are used or sold but does update the instructions for use, and its use without following the updated instructions could result in serious injury or death, according to the statement.

Following an alarm failure, the device may fail in one of two ways: By entering a ventilator inoperative state after three reboots within 24 hours (with no therapy and audible and visual alarms present) or by entering a ventilator inoperative state without rebooting first.

According to the statement, the alarm issue may be corrected with a software patch, available from Philips, or the company will offer a replacement device for patients until the affected devices are repaired. The statement updates an April 1, 2024, urgent recall from Philips urging the immediate removal of a patient from an OLA+ Ventilator and connecting them to alternative ventilation if possible if the ventilator’s inoperative alarm occurs.

The device failures may cause interruption or loss of therapy with effects including anxiety, confusion/disorientation, changes in respiratory rate, dyspnea, tachycardia, respiratory failure, and even death in especially vulnerable individuals. One death and 15 injuries have been reported as a result of the alarm failure, according to the FDA.

US customers can contact Philips Respironics Inc. at 1-800-345-6443 or [email protected] with questions, according to the FDA, and clinicians and patients may report adverse reactions or other problems with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

A version of this article appeared on Medscape.com.

Children with asthma who were insured by Medicaid were significantly less likely to receive specialist care over a 1-year period than children with private insurance, based on claims data from nearly 200,000 children.

Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.

Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.

“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.

In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
 

Outpatient Visit Outcome

The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.

A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.

Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).

Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).

The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.

“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.

The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.

However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
 

Takeaways and Next Steps

“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.

As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.

“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.

“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
 

Improve Access and Expand Analysis

Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.

Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.

More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.

The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.

“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.

The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
 

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

Children with asthma who were insured by Medicaid were significantly less likely to receive specialist care over a 1-year period than children with private insurance, based on claims data from nearly 200,000 children.

Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.

Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.

“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.

In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
 

Outpatient Visit Outcome

The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.

A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.

Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).

Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).

The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.

“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.

The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.

However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
 

Takeaways and Next Steps

“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.

As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.

“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.

“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
 

Improve Access and Expand Analysis

Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.

Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.

More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.

The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.

“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.

The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
 

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

Children with asthma who were insured by Medicaid were significantly less likely to receive specialist care over a 1-year period than children with private insurance, based on claims data from nearly 200,000 children.

Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.

Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.

“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.

In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
 

Outpatient Visit Outcome

The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.

A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.

Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).

Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).

The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.

“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.

The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.

However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
 

Takeaways and Next Steps

“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.

As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.

“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.

“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
 

Improve Access and Expand Analysis

Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.

Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.

More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.

The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.

“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.

The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
 

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