User login
Nirmatrelvir-ritonavir ineffective at reducing most post-COVID conditions
TOPLINE:
Thromboembolic events are the exception.
METHODOLOGY:
- A retrospective study of 9,593 veterans older than 65 years examined the impact of nirmatrelvir-ritonavir in comparison with no treatment on post–COVID-19 conditions (PCCs).
- Researchers coded 31 conditions, including those that fell into cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, and endocrine categories.
- The incidence of PCCs was analyzed 31-180 days after treatment.
TAKEAWAY:
- The combined incidence of venous thromboembolism and pulmonary embolism was reduced among patients given nirmatrelvir-ritonavir.
- No statistically significant reduction of other conditions was found.
- Results differ from the conclusions of a smaller study that found that the incidence of 10 of 13 PCCs was lower.
IN PRACTICE:
“Our results suggest that considerations about PCCs may not be an important factor in COVID-19 treatment decisions,” the authors write.
SOURCE:
The study was funded by the Department of Veterans Affairs and was published online in Annals of Internal Medicine. George Ioannou, MD, director of hepatology at the VA Puget Sound Health Care System in Seattle, led the study.
LIMITATIONS:
A large number of outcomes were observed, so it’s possible that the association between treatment with nirmatrelvir-ritonavir and reduced incidence of thromboembolic events occurred by chance.
Data on COVID-19 treatments and PCCs may be incomplete. The long-term effects of PCCs may not have been fully captured by the ICD-10, which was used for diagnosis codes.
Electronic health records did not accurately capture the symptom burden or the date symptoms began. Patients in the treatment arm may have had more symptoms than matched control persons who were not treated.
DISCLOSURES:
The authors reported relationships with the Korean Diabetes Association, the American Diabetes Association, the International Society for the Diabetic Foot, Quality Insights, Brown University, and the Society for Women in Urology, among others.
A version of this article appeared on Medscape.com.
TOPLINE:
Thromboembolic events are the exception.
METHODOLOGY:
- A retrospective study of 9,593 veterans older than 65 years examined the impact of nirmatrelvir-ritonavir in comparison with no treatment on post–COVID-19 conditions (PCCs).
- Researchers coded 31 conditions, including those that fell into cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, and endocrine categories.
- The incidence of PCCs was analyzed 31-180 days after treatment.
TAKEAWAY:
- The combined incidence of venous thromboembolism and pulmonary embolism was reduced among patients given nirmatrelvir-ritonavir.
- No statistically significant reduction of other conditions was found.
- Results differ from the conclusions of a smaller study that found that the incidence of 10 of 13 PCCs was lower.
IN PRACTICE:
“Our results suggest that considerations about PCCs may not be an important factor in COVID-19 treatment decisions,” the authors write.
SOURCE:
The study was funded by the Department of Veterans Affairs and was published online in Annals of Internal Medicine. George Ioannou, MD, director of hepatology at the VA Puget Sound Health Care System in Seattle, led the study.
LIMITATIONS:
A large number of outcomes were observed, so it’s possible that the association between treatment with nirmatrelvir-ritonavir and reduced incidence of thromboembolic events occurred by chance.
Data on COVID-19 treatments and PCCs may be incomplete. The long-term effects of PCCs may not have been fully captured by the ICD-10, which was used for diagnosis codes.
Electronic health records did not accurately capture the symptom burden or the date symptoms began. Patients in the treatment arm may have had more symptoms than matched control persons who were not treated.
DISCLOSURES:
The authors reported relationships with the Korean Diabetes Association, the American Diabetes Association, the International Society for the Diabetic Foot, Quality Insights, Brown University, and the Society for Women in Urology, among others.
A version of this article appeared on Medscape.com.
TOPLINE:
Thromboembolic events are the exception.
METHODOLOGY:
- A retrospective study of 9,593 veterans older than 65 years examined the impact of nirmatrelvir-ritonavir in comparison with no treatment on post–COVID-19 conditions (PCCs).
- Researchers coded 31 conditions, including those that fell into cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, and endocrine categories.
- The incidence of PCCs was analyzed 31-180 days after treatment.
TAKEAWAY:
- The combined incidence of venous thromboembolism and pulmonary embolism was reduced among patients given nirmatrelvir-ritonavir.
- No statistically significant reduction of other conditions was found.
- Results differ from the conclusions of a smaller study that found that the incidence of 10 of 13 PCCs was lower.
IN PRACTICE:
“Our results suggest that considerations about PCCs may not be an important factor in COVID-19 treatment decisions,” the authors write.
SOURCE:
The study was funded by the Department of Veterans Affairs and was published online in Annals of Internal Medicine. George Ioannou, MD, director of hepatology at the VA Puget Sound Health Care System in Seattle, led the study.
LIMITATIONS:
A large number of outcomes were observed, so it’s possible that the association between treatment with nirmatrelvir-ritonavir and reduced incidence of thromboembolic events occurred by chance.
Data on COVID-19 treatments and PCCs may be incomplete. The long-term effects of PCCs may not have been fully captured by the ICD-10, which was used for diagnosis codes.
Electronic health records did not accurately capture the symptom burden or the date symptoms began. Patients in the treatment arm may have had more symptoms than matched control persons who were not treated.
DISCLOSURES:
The authors reported relationships with the Korean Diabetes Association, the American Diabetes Association, the International Society for the Diabetic Foot, Quality Insights, Brown University, and the Society for Women in Urology, among others.
A version of this article appeared on Medscape.com.
Antidepressants ‘don’t blunt’ semaglutide and weight loss
in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.
Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.
“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”
“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”
“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”
Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”
“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”
Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.
Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.
Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
36,000 Patients with obesity, 500 on antidepressants
Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.
However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.
The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.
The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.
Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m2, or ≥27 kg/m2 with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m2 with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.
They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.
From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:
- STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
- STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
- STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
- STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%.
The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:
- STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
- STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
- STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
- STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.
Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.
The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.
A version of this article appeared on Medscape.com.
in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.
Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.
“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”
“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”
“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”
Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”
“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”
Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.
Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.
Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
36,000 Patients with obesity, 500 on antidepressants
Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.
However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.
The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.
The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.
Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m2, or ≥27 kg/m2 with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m2 with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.
They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.
From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:
- STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
- STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
- STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
- STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%.
The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:
- STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
- STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
- STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
- STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.
Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.
The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.
A version of this article appeared on Medscape.com.
in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.
Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.
“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”
“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”
“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”
Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”
“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”
Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.
Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.
Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
36,000 Patients with obesity, 500 on antidepressants
Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.
However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.
The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.
The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.
Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m2, or ≥27 kg/m2 with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m2 with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.
They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.
From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:
- STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
- STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
- STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
- STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%.
The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:
- STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
- STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
- STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
- STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.
Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.
The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.
A version of this article appeared on Medscape.com.
FROM OBESITYWEEK® 2023
Taking a new obesity drug and birth control pills? Be careful
For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.
So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.
On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. , making an unintended pregnancy more likely.
Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to.
“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”
When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response.
“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
It’s all in the gut
One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills.
Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy.
And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn.
“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
Unanticipated outcomes, extra prevention
Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks.
“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”
It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system.
What can women do to help ensure that they don’t become pregnant while using these drugs?
“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.”
Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”
Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”
“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.
Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue.
“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”
She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”
In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.
“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to.
Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah.
Clear conversations are key.
A version of this article first appeared on WebMD.com.
For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.
So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.
On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. , making an unintended pregnancy more likely.
Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to.
“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”
When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response.
“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
It’s all in the gut
One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills.
Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy.
And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn.
“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
Unanticipated outcomes, extra prevention
Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks.
“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”
It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system.
What can women do to help ensure that they don’t become pregnant while using these drugs?
“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.”
Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”
Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”
“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.
Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue.
“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”
She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”
In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.
“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to.
Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah.
Clear conversations are key.
A version of this article first appeared on WebMD.com.
For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.
So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.
On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. , making an unintended pregnancy more likely.
Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to.
“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”
When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response.
“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
It’s all in the gut
One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills.
Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy.
And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn.
“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
Unanticipated outcomes, extra prevention
Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks.
“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”
It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system.
What can women do to help ensure that they don’t become pregnant while using these drugs?
“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.”
Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”
Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”
“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.
Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue.
“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”
She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”
In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.
“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to.
Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah.
Clear conversations are key.
A version of this article first appeared on WebMD.com.
FDA panel rejects implanted GLP1-RA dosing device for T2D
Sept. 21 from an advisory committee of the Food and Drug Administration.
The 19 voting panel members mostly cited concerning signals of both renal toxicity in the form of excess episodes of acute kidney injury (AKI) as well as increased cardiovascular events compared with placebo as their main reasons for voting that the developing company, Intarcia Therapeutics, had not shown adequate evidence that the benefits of the drug-device combination, known as ITCA 650, outweighed its risks for treating people with type 2 diabetes.
“I’m quite uncomfortable with the AKI safety,” said panel member Erica Brittain, PhD, deputy chief of the Biostatistics Research Branch of the National Institute of Allergy and Infectious Diseases in Bethesda, Md.
The case that ITCA 650 is ready for routine use was also undermined by uncertainty documented by FDA staff about the uniformity and reliability of exenatide delivery by the DUROS device, a matchstick-sized reservoir that’s placed subcutaneously and designed to deliver exenatide continuously for 6 months at a time, noted Cecilia C. Low Wang, MD, chair of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.
“No evidence of improved adherence”
Another shortcoming was no data on the impact that this form of drug delivery, first developed and FDA approved to treat patients with prostate cancer with leuprolide acetate, really accomplished its goal of improving adherence to a glycemic-control agent. Intarcia Therapeutics presented “no evidence of improved adherence,” said Dr. Low Wang, director of the Glucose Management Team at the University of Colorado Hospital.
However, she and several other panel members acknowledged the compelling comments from several patients and health care professionals experienced in using or administering the device who, during the public comment period, voiced anecdotal testimonials to its positive impact on treatment compliance.
Seven years of FDA review
This review of ITCA 650 capped a nearly 7-year effort by Intarcia Therapeutics to receive marketing approval for ITCA 650 from the FDA, which began with an application filed in November 2016 (and denied by the agency in September 2017). Intarcia resubmitted an amended application in 2019 that the FDA again rejected in 2020. The company’s persistence following that led to the current panel meeting, the first time the ITCA 650 evidence came before an advisory panel.
Committee members in general praised the concept of managing blood glucose by continuous release of a medication 6 months at a time. They also offered ideas on a path forward, such as a study that used an active competitor. Ideally, that could be another agent from the same class of GLP-1 receptor agonists such as Bydureon, an injected formulation of exenatide administered by subcutaneous injection once a week.
But the key, agreed panel members, was to bulk up the evidence that ITCA 650 is safe. “The data show concerning safety signals that need further investigation,” summed up Dr. Low Wong. “There are concerns about overall safety, all-cause mortality, AKI, cardiovascular events, and glycemic excursions.”
All voting members of the advisory committee met the FDA’s standard for having no relevant financial relationships.
A version of this article appeared on Medscape.com.
Sept. 21 from an advisory committee of the Food and Drug Administration.
The 19 voting panel members mostly cited concerning signals of both renal toxicity in the form of excess episodes of acute kidney injury (AKI) as well as increased cardiovascular events compared with placebo as their main reasons for voting that the developing company, Intarcia Therapeutics, had not shown adequate evidence that the benefits of the drug-device combination, known as ITCA 650, outweighed its risks for treating people with type 2 diabetes.
“I’m quite uncomfortable with the AKI safety,” said panel member Erica Brittain, PhD, deputy chief of the Biostatistics Research Branch of the National Institute of Allergy and Infectious Diseases in Bethesda, Md.
The case that ITCA 650 is ready for routine use was also undermined by uncertainty documented by FDA staff about the uniformity and reliability of exenatide delivery by the DUROS device, a matchstick-sized reservoir that’s placed subcutaneously and designed to deliver exenatide continuously for 6 months at a time, noted Cecilia C. Low Wang, MD, chair of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.
“No evidence of improved adherence”
Another shortcoming was no data on the impact that this form of drug delivery, first developed and FDA approved to treat patients with prostate cancer with leuprolide acetate, really accomplished its goal of improving adherence to a glycemic-control agent. Intarcia Therapeutics presented “no evidence of improved adherence,” said Dr. Low Wang, director of the Glucose Management Team at the University of Colorado Hospital.
However, she and several other panel members acknowledged the compelling comments from several patients and health care professionals experienced in using or administering the device who, during the public comment period, voiced anecdotal testimonials to its positive impact on treatment compliance.
Seven years of FDA review
This review of ITCA 650 capped a nearly 7-year effort by Intarcia Therapeutics to receive marketing approval for ITCA 650 from the FDA, which began with an application filed in November 2016 (and denied by the agency in September 2017). Intarcia resubmitted an amended application in 2019 that the FDA again rejected in 2020. The company’s persistence following that led to the current panel meeting, the first time the ITCA 650 evidence came before an advisory panel.
Committee members in general praised the concept of managing blood glucose by continuous release of a medication 6 months at a time. They also offered ideas on a path forward, such as a study that used an active competitor. Ideally, that could be another agent from the same class of GLP-1 receptor agonists such as Bydureon, an injected formulation of exenatide administered by subcutaneous injection once a week.
But the key, agreed panel members, was to bulk up the evidence that ITCA 650 is safe. “The data show concerning safety signals that need further investigation,” summed up Dr. Low Wong. “There are concerns about overall safety, all-cause mortality, AKI, cardiovascular events, and glycemic excursions.”
All voting members of the advisory committee met the FDA’s standard for having no relevant financial relationships.
A version of this article appeared on Medscape.com.
Sept. 21 from an advisory committee of the Food and Drug Administration.
The 19 voting panel members mostly cited concerning signals of both renal toxicity in the form of excess episodes of acute kidney injury (AKI) as well as increased cardiovascular events compared with placebo as their main reasons for voting that the developing company, Intarcia Therapeutics, had not shown adequate evidence that the benefits of the drug-device combination, known as ITCA 650, outweighed its risks for treating people with type 2 diabetes.
“I’m quite uncomfortable with the AKI safety,” said panel member Erica Brittain, PhD, deputy chief of the Biostatistics Research Branch of the National Institute of Allergy and Infectious Diseases in Bethesda, Md.
The case that ITCA 650 is ready for routine use was also undermined by uncertainty documented by FDA staff about the uniformity and reliability of exenatide delivery by the DUROS device, a matchstick-sized reservoir that’s placed subcutaneously and designed to deliver exenatide continuously for 6 months at a time, noted Cecilia C. Low Wang, MD, chair of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.
“No evidence of improved adherence”
Another shortcoming was no data on the impact that this form of drug delivery, first developed and FDA approved to treat patients with prostate cancer with leuprolide acetate, really accomplished its goal of improving adherence to a glycemic-control agent. Intarcia Therapeutics presented “no evidence of improved adherence,” said Dr. Low Wang, director of the Glucose Management Team at the University of Colorado Hospital.
However, she and several other panel members acknowledged the compelling comments from several patients and health care professionals experienced in using or administering the device who, during the public comment period, voiced anecdotal testimonials to its positive impact on treatment compliance.
Seven years of FDA review
This review of ITCA 650 capped a nearly 7-year effort by Intarcia Therapeutics to receive marketing approval for ITCA 650 from the FDA, which began with an application filed in November 2016 (and denied by the agency in September 2017). Intarcia resubmitted an amended application in 2019 that the FDA again rejected in 2020. The company’s persistence following that led to the current panel meeting, the first time the ITCA 650 evidence came before an advisory panel.
Committee members in general praised the concept of managing blood glucose by continuous release of a medication 6 months at a time. They also offered ideas on a path forward, such as a study that used an active competitor. Ideally, that could be another agent from the same class of GLP-1 receptor agonists such as Bydureon, an injected formulation of exenatide administered by subcutaneous injection once a week.
But the key, agreed panel members, was to bulk up the evidence that ITCA 650 is safe. “The data show concerning safety signals that need further investigation,” summed up Dr. Low Wong. “There are concerns about overall safety, all-cause mortality, AKI, cardiovascular events, and glycemic excursions.”
All voting members of the advisory committee met the FDA’s standard for having no relevant financial relationships.
A version of this article appeared on Medscape.com.
Exercise timing may dictate obesity, type 2 diabetes risk
Tongyu Ma, PhD, research assistant professor with the Health Sciences Department, Franklin Pierce University, Rindge, N.H., and colleagues studied data on almost 5,300 individuals, finding a strong association between moderate to vigorous physical activity (MVPA) and obesity.
The research, published in Obesity, showed that people who exercised in the morning had a lower body mass index than that of those who exercised at other times, even though they were more sedentary.
For the second study, Chirag J. Patel, PhD, associate professor of biomedical informatics at Harvard Medical School, Boston, and colleagues examined more than 93,000 individuals and found that morning and afternoon, but not evening, exercise reduced the risk for type 2 diabetes.
However, the results, published in Diabetologia, also indicated that people who undertook at least MVPA were protected against developing type 2 diabetes no matter what time of day they exercised.
Along with considering the timing of exercise, the authors suggest that it is “helpful to include some higher intensity activity to help reduce the risk of developing diabetes and other cardiovascular disease.”
Morning exercisers perform less physical activity
Dr. Ma and colleagues noted that “although a beneficial association among the levels of physical activity with obesity has been frequently reported, the optimal timing of physical activity for decreasing obesity remains controversial.”
The researchers analyzed data from the National Health and Nutrition Examination Survey for the 2003-2004 and 2005-2006 cycles, because accelerometry was implemented in those periods.
They included 5,285 individuals aged ≥ 20 years who had physical activity measured via an accelerometer worn on the right hip during waking hours for 7 consecutive days.
The diurnal pattern of MVPA was classified into three clusters by the established technique of K-means clustering analysis: morning (n = 642), midday (n = 2,456), and evening (n = 2,187).
The association between MVPA, diurnal pattern, and obesity was then assessed in linear regression models taking into account a range of potential confounding factors.
Overall, participants in the morning cluster were older and more likely to be female than those in the other clusters (P < .001 for both). They were also more likely to be nonsmokers (P = .007) and to have less than high school education (P = .0041).
Morning cluster individuals performed less physical activity and were more sedentary than those in the midday and evening groups (P < .001 for both), although they were more likely to be healthy eaters (P = .004), with a lower calorie intake (P < .001).
Individuals in the morning cluster had, on average, a lower body mass index than those in other clusters, at 27.4 vs. 28.4 in the midday cluster and 28.2 in the evening cluster (P for interaction = .02).
Morning cluster participants also had a lower waist circumference than participants in the midday or evening cluster: 95.9 cm, 97.9 cm, and 97.3 cm, respectively (P for interaction = .06).
The team reported that there was a strong linear association between MVPA and obesity in the morning cluster, whereas there was a weaker curvilinear association in the midday and evening clusters.
“This is exciting new research that is consistent with a common tip for meeting exercise goals – that is, schedule exercise in the morning before emails, phone calls, or meetings that might distract you,” Rebecca Krukowski, PhD, professor, public health sciences, University of Virginia, Charlottesville, said in a release.
However, she noted that the cross-sectional nature of the study means that it is “not known whether people who exercise consistently in the morning may be systematically different from those who exercise at other times, in ways that were not measured in this study.
“For example, people who exercise regularly in the morning could have more predictable schedules, such as being less likely to be shift workers or less likely to have caregiving responsibilities that impede morning exercise,” said Dr. Krukowski, who was not involved in the study.
No association between evening activity and type 2 diabetes risk
In the second study, the team studied 93,095 persons in the UK Biobank, with a mean age of 62 years and no history of type 2 diabetes, who wore a wrist accelerometer for 1 week.
The movement data were used to estimate the metabolic equivalent of task, which was then summed into the total physical activity completed in the morning, afternoon, and evening and linked to the development of incident type 2 diabetes.
After adjustment for potential confounding factors, both morning and afternoon physical activity were associated with a reduced risk of developing type 2 diabetes, at hazard ratios of 0.90 (P = 7 × 10-8) and 0.91 (P = 1 × 10-5), respectively.
However, there was no association between evening activity and the risk for type 2 diabetes, at a hazard ratio of 0.95 (P = .07).
The team found, however, that MVPA and vigorous physical activity were associated with a reduced risk for type 2 diabetes at all times of day.
Dr. Patel’s study was supported in part by National Institutes of Health grants. No other funding was declared. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
Tongyu Ma, PhD, research assistant professor with the Health Sciences Department, Franklin Pierce University, Rindge, N.H., and colleagues studied data on almost 5,300 individuals, finding a strong association between moderate to vigorous physical activity (MVPA) and obesity.
The research, published in Obesity, showed that people who exercised in the morning had a lower body mass index than that of those who exercised at other times, even though they were more sedentary.
For the second study, Chirag J. Patel, PhD, associate professor of biomedical informatics at Harvard Medical School, Boston, and colleagues examined more than 93,000 individuals and found that morning and afternoon, but not evening, exercise reduced the risk for type 2 diabetes.
However, the results, published in Diabetologia, also indicated that people who undertook at least MVPA were protected against developing type 2 diabetes no matter what time of day they exercised.
Along with considering the timing of exercise, the authors suggest that it is “helpful to include some higher intensity activity to help reduce the risk of developing diabetes and other cardiovascular disease.”
Morning exercisers perform less physical activity
Dr. Ma and colleagues noted that “although a beneficial association among the levels of physical activity with obesity has been frequently reported, the optimal timing of physical activity for decreasing obesity remains controversial.”
The researchers analyzed data from the National Health and Nutrition Examination Survey for the 2003-2004 and 2005-2006 cycles, because accelerometry was implemented in those periods.
They included 5,285 individuals aged ≥ 20 years who had physical activity measured via an accelerometer worn on the right hip during waking hours for 7 consecutive days.
The diurnal pattern of MVPA was classified into three clusters by the established technique of K-means clustering analysis: morning (n = 642), midday (n = 2,456), and evening (n = 2,187).
The association between MVPA, diurnal pattern, and obesity was then assessed in linear regression models taking into account a range of potential confounding factors.
Overall, participants in the morning cluster were older and more likely to be female than those in the other clusters (P < .001 for both). They were also more likely to be nonsmokers (P = .007) and to have less than high school education (P = .0041).
Morning cluster individuals performed less physical activity and were more sedentary than those in the midday and evening groups (P < .001 for both), although they were more likely to be healthy eaters (P = .004), with a lower calorie intake (P < .001).
Individuals in the morning cluster had, on average, a lower body mass index than those in other clusters, at 27.4 vs. 28.4 in the midday cluster and 28.2 in the evening cluster (P for interaction = .02).
Morning cluster participants also had a lower waist circumference than participants in the midday or evening cluster: 95.9 cm, 97.9 cm, and 97.3 cm, respectively (P for interaction = .06).
The team reported that there was a strong linear association between MVPA and obesity in the morning cluster, whereas there was a weaker curvilinear association in the midday and evening clusters.
“This is exciting new research that is consistent with a common tip for meeting exercise goals – that is, schedule exercise in the morning before emails, phone calls, or meetings that might distract you,” Rebecca Krukowski, PhD, professor, public health sciences, University of Virginia, Charlottesville, said in a release.
However, she noted that the cross-sectional nature of the study means that it is “not known whether people who exercise consistently in the morning may be systematically different from those who exercise at other times, in ways that were not measured in this study.
“For example, people who exercise regularly in the morning could have more predictable schedules, such as being less likely to be shift workers or less likely to have caregiving responsibilities that impede morning exercise,” said Dr. Krukowski, who was not involved in the study.
No association between evening activity and type 2 diabetes risk
In the second study, the team studied 93,095 persons in the UK Biobank, with a mean age of 62 years and no history of type 2 diabetes, who wore a wrist accelerometer for 1 week.
The movement data were used to estimate the metabolic equivalent of task, which was then summed into the total physical activity completed in the morning, afternoon, and evening and linked to the development of incident type 2 diabetes.
After adjustment for potential confounding factors, both morning and afternoon physical activity were associated with a reduced risk of developing type 2 diabetes, at hazard ratios of 0.90 (P = 7 × 10-8) and 0.91 (P = 1 × 10-5), respectively.
However, there was no association between evening activity and the risk for type 2 diabetes, at a hazard ratio of 0.95 (P = .07).
The team found, however, that MVPA and vigorous physical activity were associated with a reduced risk for type 2 diabetes at all times of day.
Dr. Patel’s study was supported in part by National Institutes of Health grants. No other funding was declared. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
Tongyu Ma, PhD, research assistant professor with the Health Sciences Department, Franklin Pierce University, Rindge, N.H., and colleagues studied data on almost 5,300 individuals, finding a strong association between moderate to vigorous physical activity (MVPA) and obesity.
The research, published in Obesity, showed that people who exercised in the morning had a lower body mass index than that of those who exercised at other times, even though they were more sedentary.
For the second study, Chirag J. Patel, PhD, associate professor of biomedical informatics at Harvard Medical School, Boston, and colleagues examined more than 93,000 individuals and found that morning and afternoon, but not evening, exercise reduced the risk for type 2 diabetes.
However, the results, published in Diabetologia, also indicated that people who undertook at least MVPA were protected against developing type 2 diabetes no matter what time of day they exercised.
Along with considering the timing of exercise, the authors suggest that it is “helpful to include some higher intensity activity to help reduce the risk of developing diabetes and other cardiovascular disease.”
Morning exercisers perform less physical activity
Dr. Ma and colleagues noted that “although a beneficial association among the levels of physical activity with obesity has been frequently reported, the optimal timing of physical activity for decreasing obesity remains controversial.”
The researchers analyzed data from the National Health and Nutrition Examination Survey for the 2003-2004 and 2005-2006 cycles, because accelerometry was implemented in those periods.
They included 5,285 individuals aged ≥ 20 years who had physical activity measured via an accelerometer worn on the right hip during waking hours for 7 consecutive days.
The diurnal pattern of MVPA was classified into three clusters by the established technique of K-means clustering analysis: morning (n = 642), midday (n = 2,456), and evening (n = 2,187).
The association between MVPA, diurnal pattern, and obesity was then assessed in linear regression models taking into account a range of potential confounding factors.
Overall, participants in the morning cluster were older and more likely to be female than those in the other clusters (P < .001 for both). They were also more likely to be nonsmokers (P = .007) and to have less than high school education (P = .0041).
Morning cluster individuals performed less physical activity and were more sedentary than those in the midday and evening groups (P < .001 for both), although they were more likely to be healthy eaters (P = .004), with a lower calorie intake (P < .001).
Individuals in the morning cluster had, on average, a lower body mass index than those in other clusters, at 27.4 vs. 28.4 in the midday cluster and 28.2 in the evening cluster (P for interaction = .02).
Morning cluster participants also had a lower waist circumference than participants in the midday or evening cluster: 95.9 cm, 97.9 cm, and 97.3 cm, respectively (P for interaction = .06).
The team reported that there was a strong linear association between MVPA and obesity in the morning cluster, whereas there was a weaker curvilinear association in the midday and evening clusters.
“This is exciting new research that is consistent with a common tip for meeting exercise goals – that is, schedule exercise in the morning before emails, phone calls, or meetings that might distract you,” Rebecca Krukowski, PhD, professor, public health sciences, University of Virginia, Charlottesville, said in a release.
However, she noted that the cross-sectional nature of the study means that it is “not known whether people who exercise consistently in the morning may be systematically different from those who exercise at other times, in ways that were not measured in this study.
“For example, people who exercise regularly in the morning could have more predictable schedules, such as being less likely to be shift workers or less likely to have caregiving responsibilities that impede morning exercise,” said Dr. Krukowski, who was not involved in the study.
No association between evening activity and type 2 diabetes risk
In the second study, the team studied 93,095 persons in the UK Biobank, with a mean age of 62 years and no history of type 2 diabetes, who wore a wrist accelerometer for 1 week.
The movement data were used to estimate the metabolic equivalent of task, which was then summed into the total physical activity completed in the morning, afternoon, and evening and linked to the development of incident type 2 diabetes.
After adjustment for potential confounding factors, both morning and afternoon physical activity were associated with a reduced risk of developing type 2 diabetes, at hazard ratios of 0.90 (P = 7 × 10-8) and 0.91 (P = 1 × 10-5), respectively.
However, there was no association between evening activity and the risk for type 2 diabetes, at a hazard ratio of 0.95 (P = .07).
The team found, however, that MVPA and vigorous physical activity were associated with a reduced risk for type 2 diabetes at all times of day.
Dr. Patel’s study was supported in part by National Institutes of Health grants. No other funding was declared. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
New evidence early treatment improves preclinical MS outcomes
TOPLINE:
new research shows.
METHODOLOGY:
Early use of DMTs is typically recommended for patients with established MS, but mounting evidence, including the ARISE trial, which assessed Tecfidera, suggests these agents benefit patients with RIS, the earliest detectable preclinical MS stage.
The new study, known as Teriflunomide in Radiologically Isolated Syndrome (TERIS), included 89 adult patients with RIS (mean age, 37.8 years) from centers in France, Switzerland, and Turkey. Participants were randomly assigned to receive placebo or teriflunomide 14 mg daily. Teriflunomide is an oral immunomodulator approved for treating relapsing remitting MS.
Investigators performed MRI at baseline and at weeks 48, 96, and 144 and at any time during the study if warranted.
Researchers adjusted for potential confounders, including sex, age at RIS diagnosis, MS family history, brain T2-weighted hyperintense lesion volume, and presence of Gd+/− lesions.
The primary outcome was time to a first acute or progressive neurologic event resulting from central nervous system demyelination, expressed as a rate of conversion to clinical MS.
TAKEAWAY:
Eighteen participants – nine in each group – discontinued the study, resulting in a dropout rate of 20%.
The risk of a first clinical event was significantly reduced in the teriflunomide arm (mean time to event, 128.2 weeks) with 8 clinical events (6 acute, 2 progressive) in comparison with the placebo arm (mean time to event, 109.6 weeks) with 20 clinical events (18 acute, 2 progressive) and an adjusted hazard ratio of 0.28 (95% CI, 0.11-0.71; P = .007).
All secondary MRI measures, including the cumulative number of new and/or newly enlarging T2 lesions and the cumulative number of Gd+ lesions, did not reach statistical significance, although these were numerically lower in the teriflunomide arm, possibly because participants with early events switched to the treatment arm.
The most common adverse events that occurred more often in patients treated with teriflunomide were gastrointestinal disorders (11.4%), dysmenorrhea (9.1%), benign respiratory infections (6.8%), general disorders/conditions (6.8%), and transient increase of transaminases (4.5%).
IN PRACTICE:
“These results suggest that for the first time, we may have an opportunity to better identify those at risk for a primary progressive clinical course at this preclinical stage and prevent or delay clinical progression from the onset, which is a clear unmet need in MS clinical practice,” wrote the authors.
SOURCE:
The study was carried out by Christine Lebrun-Frénay MD, PhD, head of the inflammatory neurological disorders clinical research unit and MS center at the University of Nice (France). It was published online in JAMA Neurology.
LIMITATIONS:
The investigators could not stratify at-risk subgroups according to risk factors for developing MS, mainly because of power issues. The study was prematurely discontinued by its financial sponsor (Sanofi), owing primarily to slow enrollment that resulted from national regulations on activating recruitment sites and the impact of the COVID-19 pandemic. Another challenge for the study was that some individuals with RIS had already been exposed to a DMT or hesitated to participate in a clinical trial. The financial sponsor, which provided the study drug and placebo tablets, terminated their availability, given the anticipated release of generic teriflunomide.
DISCLOSURES:
The study was supported by Sanofi, the University Hospital of Nice, University Cote d’Azur, and the Radiologically Isolated Syndrome Consortium. Lebrun-Frénay has no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
new research shows.
METHODOLOGY:
Early use of DMTs is typically recommended for patients with established MS, but mounting evidence, including the ARISE trial, which assessed Tecfidera, suggests these agents benefit patients with RIS, the earliest detectable preclinical MS stage.
The new study, known as Teriflunomide in Radiologically Isolated Syndrome (TERIS), included 89 adult patients with RIS (mean age, 37.8 years) from centers in France, Switzerland, and Turkey. Participants were randomly assigned to receive placebo or teriflunomide 14 mg daily. Teriflunomide is an oral immunomodulator approved for treating relapsing remitting MS.
Investigators performed MRI at baseline and at weeks 48, 96, and 144 and at any time during the study if warranted.
Researchers adjusted for potential confounders, including sex, age at RIS diagnosis, MS family history, brain T2-weighted hyperintense lesion volume, and presence of Gd+/− lesions.
The primary outcome was time to a first acute or progressive neurologic event resulting from central nervous system demyelination, expressed as a rate of conversion to clinical MS.
TAKEAWAY:
Eighteen participants – nine in each group – discontinued the study, resulting in a dropout rate of 20%.
The risk of a first clinical event was significantly reduced in the teriflunomide arm (mean time to event, 128.2 weeks) with 8 clinical events (6 acute, 2 progressive) in comparison with the placebo arm (mean time to event, 109.6 weeks) with 20 clinical events (18 acute, 2 progressive) and an adjusted hazard ratio of 0.28 (95% CI, 0.11-0.71; P = .007).
All secondary MRI measures, including the cumulative number of new and/or newly enlarging T2 lesions and the cumulative number of Gd+ lesions, did not reach statistical significance, although these were numerically lower in the teriflunomide arm, possibly because participants with early events switched to the treatment arm.
The most common adverse events that occurred more often in patients treated with teriflunomide were gastrointestinal disorders (11.4%), dysmenorrhea (9.1%), benign respiratory infections (6.8%), general disorders/conditions (6.8%), and transient increase of transaminases (4.5%).
IN PRACTICE:
“These results suggest that for the first time, we may have an opportunity to better identify those at risk for a primary progressive clinical course at this preclinical stage and prevent or delay clinical progression from the onset, which is a clear unmet need in MS clinical practice,” wrote the authors.
SOURCE:
The study was carried out by Christine Lebrun-Frénay MD, PhD, head of the inflammatory neurological disorders clinical research unit and MS center at the University of Nice (France). It was published online in JAMA Neurology.
LIMITATIONS:
The investigators could not stratify at-risk subgroups according to risk factors for developing MS, mainly because of power issues. The study was prematurely discontinued by its financial sponsor (Sanofi), owing primarily to slow enrollment that resulted from national regulations on activating recruitment sites and the impact of the COVID-19 pandemic. Another challenge for the study was that some individuals with RIS had already been exposed to a DMT or hesitated to participate in a clinical trial. The financial sponsor, which provided the study drug and placebo tablets, terminated their availability, given the anticipated release of generic teriflunomide.
DISCLOSURES:
The study was supported by Sanofi, the University Hospital of Nice, University Cote d’Azur, and the Radiologically Isolated Syndrome Consortium. Lebrun-Frénay has no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
new research shows.
METHODOLOGY:
Early use of DMTs is typically recommended for patients with established MS, but mounting evidence, including the ARISE trial, which assessed Tecfidera, suggests these agents benefit patients with RIS, the earliest detectable preclinical MS stage.
The new study, known as Teriflunomide in Radiologically Isolated Syndrome (TERIS), included 89 adult patients with RIS (mean age, 37.8 years) from centers in France, Switzerland, and Turkey. Participants were randomly assigned to receive placebo or teriflunomide 14 mg daily. Teriflunomide is an oral immunomodulator approved for treating relapsing remitting MS.
Investigators performed MRI at baseline and at weeks 48, 96, and 144 and at any time during the study if warranted.
Researchers adjusted for potential confounders, including sex, age at RIS diagnosis, MS family history, brain T2-weighted hyperintense lesion volume, and presence of Gd+/− lesions.
The primary outcome was time to a first acute or progressive neurologic event resulting from central nervous system demyelination, expressed as a rate of conversion to clinical MS.
TAKEAWAY:
Eighteen participants – nine in each group – discontinued the study, resulting in a dropout rate of 20%.
The risk of a first clinical event was significantly reduced in the teriflunomide arm (mean time to event, 128.2 weeks) with 8 clinical events (6 acute, 2 progressive) in comparison with the placebo arm (mean time to event, 109.6 weeks) with 20 clinical events (18 acute, 2 progressive) and an adjusted hazard ratio of 0.28 (95% CI, 0.11-0.71; P = .007).
All secondary MRI measures, including the cumulative number of new and/or newly enlarging T2 lesions and the cumulative number of Gd+ lesions, did not reach statistical significance, although these were numerically lower in the teriflunomide arm, possibly because participants with early events switched to the treatment arm.
The most common adverse events that occurred more often in patients treated with teriflunomide were gastrointestinal disorders (11.4%), dysmenorrhea (9.1%), benign respiratory infections (6.8%), general disorders/conditions (6.8%), and transient increase of transaminases (4.5%).
IN PRACTICE:
“These results suggest that for the first time, we may have an opportunity to better identify those at risk for a primary progressive clinical course at this preclinical stage and prevent or delay clinical progression from the onset, which is a clear unmet need in MS clinical practice,” wrote the authors.
SOURCE:
The study was carried out by Christine Lebrun-Frénay MD, PhD, head of the inflammatory neurological disorders clinical research unit and MS center at the University of Nice (France). It was published online in JAMA Neurology.
LIMITATIONS:
The investigators could not stratify at-risk subgroups according to risk factors for developing MS, mainly because of power issues. The study was prematurely discontinued by its financial sponsor (Sanofi), owing primarily to slow enrollment that resulted from national regulations on activating recruitment sites and the impact of the COVID-19 pandemic. Another challenge for the study was that some individuals with RIS had already been exposed to a DMT or hesitated to participate in a clinical trial. The financial sponsor, which provided the study drug and placebo tablets, terminated their availability, given the anticipated release of generic teriflunomide.
DISCLOSURES:
The study was supported by Sanofi, the University Hospital of Nice, University Cote d’Azur, and the Radiologically Isolated Syndrome Consortium. Lebrun-Frénay has no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA NEUROLOGY
FDA clears new capabilities for diabetes app BlueStar
The latest clearance, announced on Aug. 23, enables the app-based platform to provide bolus insulin dose recommendations that are based on glucose and trend data from a compatible continuous glucose monitoring (CGM) device. On Aug. 15, the FDA cleared the BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations.
“Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin,” according to a company statement.
“With this clearance, Welldoc is filling a significant gap for people who require complex insulin regimens. By connecting directly with CGM data and using both glucose values and trend arrows, the BlueStar solution will provide precise and in-the-moment insulin dosing guidance directly to individuals, helping them reach their glucose targets,” endocrinologist Grazia Aleppo, MD, of Northwestern University, Chicago, said in the statement.
The new features extend the platform’s existing digital diet and lifestyle coaching capabilities. Previous FDA clearances included expansions to use most types of available insulins, including bolus and premixed insulin titration for patients with type 2 diabetes, in September 2021 and for basal insulin adjustment in June 2020.
Dr. Aleppo was a principal investigator in Welldoc’s clinical validation study for BlueStar.
A version of this article first appeared on Medscape.com.
The latest clearance, announced on Aug. 23, enables the app-based platform to provide bolus insulin dose recommendations that are based on glucose and trend data from a compatible continuous glucose monitoring (CGM) device. On Aug. 15, the FDA cleared the BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations.
“Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin,” according to a company statement.
“With this clearance, Welldoc is filling a significant gap for people who require complex insulin regimens. By connecting directly with CGM data and using both glucose values and trend arrows, the BlueStar solution will provide precise and in-the-moment insulin dosing guidance directly to individuals, helping them reach their glucose targets,” endocrinologist Grazia Aleppo, MD, of Northwestern University, Chicago, said in the statement.
The new features extend the platform’s existing digital diet and lifestyle coaching capabilities. Previous FDA clearances included expansions to use most types of available insulins, including bolus and premixed insulin titration for patients with type 2 diabetes, in September 2021 and for basal insulin adjustment in June 2020.
Dr. Aleppo was a principal investigator in Welldoc’s clinical validation study for BlueStar.
A version of this article first appeared on Medscape.com.
The latest clearance, announced on Aug. 23, enables the app-based platform to provide bolus insulin dose recommendations that are based on glucose and trend data from a compatible continuous glucose monitoring (CGM) device. On Aug. 15, the FDA cleared the BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations.
“Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin,” according to a company statement.
“With this clearance, Welldoc is filling a significant gap for people who require complex insulin regimens. By connecting directly with CGM data and using both glucose values and trend arrows, the BlueStar solution will provide precise and in-the-moment insulin dosing guidance directly to individuals, helping them reach their glucose targets,” endocrinologist Grazia Aleppo, MD, of Northwestern University, Chicago, said in the statement.
The new features extend the platform’s existing digital diet and lifestyle coaching capabilities. Previous FDA clearances included expansions to use most types of available insulins, including bolus and premixed insulin titration for patients with type 2 diabetes, in September 2021 and for basal insulin adjustment in June 2020.
Dr. Aleppo was a principal investigator in Welldoc’s clinical validation study for BlueStar.
A version of this article first appeared on Medscape.com.
Lower is better for blood glucose to reduce heart disease
in a large, 12-year observational study of UK Biobank data.
The results highlight “the need for strategies to reduce risk of CVD across the [glycemic] spectrum,” Christopher T. Rentsch, MPH, PhD, and colleagues wrote in their study, which was published in the The Lancet Regional Health – Europe.
The findings suggest “that excess [CVD] risks in both men and women were largely explained by modifiable factors and could be ameliorated by attention to weight reduction strategies and greater use of antihypertensive and statin medications.
“Addressing these risk factors could reduce sex disparities in [glycemia]-related risks of CVD,” according to the researchers.
After the researchers accounted for age, the absolute rate of CVD events was higher among men than women (16.9 vs. 9.1 events per 1,000 person-years); however, the relative risk was higher among women than men.
Compared with men, women were more likely to have obesity (63% vs. 53%) and were less likely to be using antihypertensive medications (64% vs. 69%) or a statin (71% vs. 75%).
“This is the largest study to date to investigate sex differences in the risk of CVD across the glycemic spectrum,” the researchers noted.
“The lower the better”
“We uncovered compelling evidence that for blood sugar levels within the ‘normal’ range, it was a case of ‘the lower the better’ in protecting against heart disease,” Dr. Rentsch, assistant professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, told this news organization.
Compared with people with normal blood glucose levels, those with lower than normal levels were at 10% lower risk of developing any form of heart disease, he noted.
The study findings “support women being proactive in asking about medications like statins and antihypertensives as an option to help lower their [CVD] risk, if clinically appropriate,” Dr. Rentsch added.
“We found that men and women with diagnosed diabetes remained at elevated risk for three types of heart disease – coronary artery disease, stroke, and heart failure – even after accounting for a large number of sociodemographic, lifestyle, and clinical characteristics,” he pointed out.
However, “total cholesterol, family history of CVD, estimated glomerular filtration rate, and C-reactive protein had relatively little impact on explaining the risk of heart disease associated with blood sugar.”
“It is well established that being overweight can lead to higher blood sugar levels as well as higher blood pressure, these being factors that contribute to higher risk of heart attack and stroke,” Robert Storey, DM, professor of cardiology, University of Sheffield (England), told the UK Science Media Centre.
“This very large UK Biobank study,” he said, “shows that the higher heart risk associated with blood sugar can be detected at a very early stage along the path towards the abnormally high blood sugar levels associated with diabetes.
“The study provides support for a strategy of assessing cardiovascular risk in people who are overweight, including assessment of blood sugar, cholesterol, and blood pressure levels, all of which can be effectively managed to markedly reduce the risk of future heart attack and stroke,” according to Dr. Storey.
More than 400,000 men, women
The researchers enrolled men and women aged 40-69 between 2006 to 2010 who were living in England, Scotland, and Wales. After excluding people with type 1 diabetes or those whose A1c data were missing, the current study included 427,435 people (46% of whom were men).
The participants were classified as having low-normal A1c (< 35 mmol/mol or < 5.5%), normal A1c (35-41 mmol/mol or 5.5%-5.9%), prediabetes (42-47 mmol/mol or 6.0%-6.4%), undiagnosed diabetes (≥ 48 mmol/mol or ≥ 6.5%), or diagnosed type 2 diabetes (medical history and in receipt of glucose-lowering medication).
The researchers determined the incidence of six CVD outcomes during a median 11.8-year follow-up: coronary artery disease, atrial fibrillation, deep vein thrombosis, pulmonary embolism, stroke, and heart failure.
Few participants (5%) had any of these outcomes prior to study enrollment.
During the follow-up, there were 51,288 incident CVD events.
After adjustment for age, compared to having normal A1c, having prediabetes or undiagnosed diabetes was associated with an increased risk of CVD for women and men (hazard ratio [HR], 1.30-1.47).
Among individuals with diagnosed type 2 diabetes, the age-adjusted risk of CVD was greater for women (HR, 2.00) than for men (HR, 1.55).
After further adjustment for clinical and lifestyle factors, especially obesity and antihypertensive or statin use, the risk of CVD decreased and became similar among men and women. The fully adjusted HR for CVD was 1.17 for women and 1.06 for men with diagnosed diabetes.
Compared with having normal A1c, women and men with low-normal A1c were at decreased risk of CVD (HR, 0.86 for both).
The study was funded by Diabetes UK and the British Heart Foundation. Dr. Rentsch and Dr. Storey have disclosed no relevant financial relationships. The disclosures of the other study authors are listed in the original article.
A version of this article appeared on Medscape.com.
in a large, 12-year observational study of UK Biobank data.
The results highlight “the need for strategies to reduce risk of CVD across the [glycemic] spectrum,” Christopher T. Rentsch, MPH, PhD, and colleagues wrote in their study, which was published in the The Lancet Regional Health – Europe.
The findings suggest “that excess [CVD] risks in both men and women were largely explained by modifiable factors and could be ameliorated by attention to weight reduction strategies and greater use of antihypertensive and statin medications.
“Addressing these risk factors could reduce sex disparities in [glycemia]-related risks of CVD,” according to the researchers.
After the researchers accounted for age, the absolute rate of CVD events was higher among men than women (16.9 vs. 9.1 events per 1,000 person-years); however, the relative risk was higher among women than men.
Compared with men, women were more likely to have obesity (63% vs. 53%) and were less likely to be using antihypertensive medications (64% vs. 69%) or a statin (71% vs. 75%).
“This is the largest study to date to investigate sex differences in the risk of CVD across the glycemic spectrum,” the researchers noted.
“The lower the better”
“We uncovered compelling evidence that for blood sugar levels within the ‘normal’ range, it was a case of ‘the lower the better’ in protecting against heart disease,” Dr. Rentsch, assistant professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, told this news organization.
Compared with people with normal blood glucose levels, those with lower than normal levels were at 10% lower risk of developing any form of heart disease, he noted.
The study findings “support women being proactive in asking about medications like statins and antihypertensives as an option to help lower their [CVD] risk, if clinically appropriate,” Dr. Rentsch added.
“We found that men and women with diagnosed diabetes remained at elevated risk for three types of heart disease – coronary artery disease, stroke, and heart failure – even after accounting for a large number of sociodemographic, lifestyle, and clinical characteristics,” he pointed out.
However, “total cholesterol, family history of CVD, estimated glomerular filtration rate, and C-reactive protein had relatively little impact on explaining the risk of heart disease associated with blood sugar.”
“It is well established that being overweight can lead to higher blood sugar levels as well as higher blood pressure, these being factors that contribute to higher risk of heart attack and stroke,” Robert Storey, DM, professor of cardiology, University of Sheffield (England), told the UK Science Media Centre.
“This very large UK Biobank study,” he said, “shows that the higher heart risk associated with blood sugar can be detected at a very early stage along the path towards the abnormally high blood sugar levels associated with diabetes.
“The study provides support for a strategy of assessing cardiovascular risk in people who are overweight, including assessment of blood sugar, cholesterol, and blood pressure levels, all of which can be effectively managed to markedly reduce the risk of future heart attack and stroke,” according to Dr. Storey.
More than 400,000 men, women
The researchers enrolled men and women aged 40-69 between 2006 to 2010 who were living in England, Scotland, and Wales. After excluding people with type 1 diabetes or those whose A1c data were missing, the current study included 427,435 people (46% of whom were men).
The participants were classified as having low-normal A1c (< 35 mmol/mol or < 5.5%), normal A1c (35-41 mmol/mol or 5.5%-5.9%), prediabetes (42-47 mmol/mol or 6.0%-6.4%), undiagnosed diabetes (≥ 48 mmol/mol or ≥ 6.5%), or diagnosed type 2 diabetes (medical history and in receipt of glucose-lowering medication).
The researchers determined the incidence of six CVD outcomes during a median 11.8-year follow-up: coronary artery disease, atrial fibrillation, deep vein thrombosis, pulmonary embolism, stroke, and heart failure.
Few participants (5%) had any of these outcomes prior to study enrollment.
During the follow-up, there were 51,288 incident CVD events.
After adjustment for age, compared to having normal A1c, having prediabetes or undiagnosed diabetes was associated with an increased risk of CVD for women and men (hazard ratio [HR], 1.30-1.47).
Among individuals with diagnosed type 2 diabetes, the age-adjusted risk of CVD was greater for women (HR, 2.00) than for men (HR, 1.55).
After further adjustment for clinical and lifestyle factors, especially obesity and antihypertensive or statin use, the risk of CVD decreased and became similar among men and women. The fully adjusted HR for CVD was 1.17 for women and 1.06 for men with diagnosed diabetes.
Compared with having normal A1c, women and men with low-normal A1c were at decreased risk of CVD (HR, 0.86 for both).
The study was funded by Diabetes UK and the British Heart Foundation. Dr. Rentsch and Dr. Storey have disclosed no relevant financial relationships. The disclosures of the other study authors are listed in the original article.
A version of this article appeared on Medscape.com.
in a large, 12-year observational study of UK Biobank data.
The results highlight “the need for strategies to reduce risk of CVD across the [glycemic] spectrum,” Christopher T. Rentsch, MPH, PhD, and colleagues wrote in their study, which was published in the The Lancet Regional Health – Europe.
The findings suggest “that excess [CVD] risks in both men and women were largely explained by modifiable factors and could be ameliorated by attention to weight reduction strategies and greater use of antihypertensive and statin medications.
“Addressing these risk factors could reduce sex disparities in [glycemia]-related risks of CVD,” according to the researchers.
After the researchers accounted for age, the absolute rate of CVD events was higher among men than women (16.9 vs. 9.1 events per 1,000 person-years); however, the relative risk was higher among women than men.
Compared with men, women were more likely to have obesity (63% vs. 53%) and were less likely to be using antihypertensive medications (64% vs. 69%) or a statin (71% vs. 75%).
“This is the largest study to date to investigate sex differences in the risk of CVD across the glycemic spectrum,” the researchers noted.
“The lower the better”
“We uncovered compelling evidence that for blood sugar levels within the ‘normal’ range, it was a case of ‘the lower the better’ in protecting against heart disease,” Dr. Rentsch, assistant professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, told this news organization.
Compared with people with normal blood glucose levels, those with lower than normal levels were at 10% lower risk of developing any form of heart disease, he noted.
The study findings “support women being proactive in asking about medications like statins and antihypertensives as an option to help lower their [CVD] risk, if clinically appropriate,” Dr. Rentsch added.
“We found that men and women with diagnosed diabetes remained at elevated risk for three types of heart disease – coronary artery disease, stroke, and heart failure – even after accounting for a large number of sociodemographic, lifestyle, and clinical characteristics,” he pointed out.
However, “total cholesterol, family history of CVD, estimated glomerular filtration rate, and C-reactive protein had relatively little impact on explaining the risk of heart disease associated with blood sugar.”
“It is well established that being overweight can lead to higher blood sugar levels as well as higher blood pressure, these being factors that contribute to higher risk of heart attack and stroke,” Robert Storey, DM, professor of cardiology, University of Sheffield (England), told the UK Science Media Centre.
“This very large UK Biobank study,” he said, “shows that the higher heart risk associated with blood sugar can be detected at a very early stage along the path towards the abnormally high blood sugar levels associated with diabetes.
“The study provides support for a strategy of assessing cardiovascular risk in people who are overweight, including assessment of blood sugar, cholesterol, and blood pressure levels, all of which can be effectively managed to markedly reduce the risk of future heart attack and stroke,” according to Dr. Storey.
More than 400,000 men, women
The researchers enrolled men and women aged 40-69 between 2006 to 2010 who were living in England, Scotland, and Wales. After excluding people with type 1 diabetes or those whose A1c data were missing, the current study included 427,435 people (46% of whom were men).
The participants were classified as having low-normal A1c (< 35 mmol/mol or < 5.5%), normal A1c (35-41 mmol/mol or 5.5%-5.9%), prediabetes (42-47 mmol/mol or 6.0%-6.4%), undiagnosed diabetes (≥ 48 mmol/mol or ≥ 6.5%), or diagnosed type 2 diabetes (medical history and in receipt of glucose-lowering medication).
The researchers determined the incidence of six CVD outcomes during a median 11.8-year follow-up: coronary artery disease, atrial fibrillation, deep vein thrombosis, pulmonary embolism, stroke, and heart failure.
Few participants (5%) had any of these outcomes prior to study enrollment.
During the follow-up, there were 51,288 incident CVD events.
After adjustment for age, compared to having normal A1c, having prediabetes or undiagnosed diabetes was associated with an increased risk of CVD for women and men (hazard ratio [HR], 1.30-1.47).
Among individuals with diagnosed type 2 diabetes, the age-adjusted risk of CVD was greater for women (HR, 2.00) than for men (HR, 1.55).
After further adjustment for clinical and lifestyle factors, especially obesity and antihypertensive or statin use, the risk of CVD decreased and became similar among men and women. The fully adjusted HR for CVD was 1.17 for women and 1.06 for men with diagnosed diabetes.
Compared with having normal A1c, women and men with low-normal A1c were at decreased risk of CVD (HR, 0.86 for both).
The study was funded by Diabetes UK and the British Heart Foundation. Dr. Rentsch and Dr. Storey have disclosed no relevant financial relationships. The disclosures of the other study authors are listed in the original article.
A version of this article appeared on Medscape.com.
FROM THE LANCET REGIONAL HEALTH – EUROPE
Children and long COVID: How many are affected?
Long COVID most often strikes seniors and adults, but children are also affected, even though they get less attention, new research shows.
Experts noted that the disease poses particular challenges for children and the doctors who treat them.
Parents and doctors need to be on the lookout for symptoms of long COVID in children and teens that might be easily missed or misdiagnosed, according to physicians and family groups.
Children are at lower risk for contracting COVID and often experience milder symptoms. But the virus is now widespread, and a recent study found that around 16% of pediatric patients with COVID go on to develop symptoms that last more than 3 months – the working definition of long COVID.
Parents and doctors are calling for more studies and more awareness.
Diane Sheehan, who lives outside Charlotte, N.C., says she was an active person and is now permanently disabled from long COVID. Her teenage son has it too and is still recovering.
He contracted COVID after a school event, she said. He had a mild case, but then he started experiencing dizziness and would even experience loss of consciousness when he stood up suddenly. After he contracted the virus a second time, he was bedridden for 8 months.
The staff at Hackensack Meridian Health, a pediatric long COVID clinic in New Jersey, has been working with area schools to help teachers and school nurses recognize possible long COVID in children and young people. The clinic is one of about a dozen in the United States that specializes in pediatric cases.
Katherine Clouser, MD, a pediatric hospital medicine specialist, has been with the clinic since it opened in 2021, and she’s seen a steady flow of patients. Some get better, but she sees a few new cases each week.
“We are seeing children who are having a difficult time returning to school and sports,” she said.
The clinic is having success with a mix of approaches, including intensive rehabilitation, talk therapy, and some off-label use of nirmatrelvir (Paxlovid), an antiviral now being studied as a treatment for long COVID through a National Institutes of Health clinical trials initiative that was announced last month.
Treatment depends on symptoms and is determined on a case-by-case basis, Dr. Clouser said.
Families of her patients are grateful, she added.
“We hear a lot of parents who were desperate for someone to believe them – or someone who knows about it,” she said.
A recent review of more than 30 studies with about 15,000 participants concluded that 16.2% (95% confidence interval, 8.5%-28.6%) of the pediatric participants experienced one or more persistent symptoms of long COVID at least 3 months after acute infection.
Estimates of the number of children and youth with long COVID have varied widely. A 2022 study put the number at more than 25% of cases, but the American Academy of Pediatrics notes that estimates of the percentage of children infected with SARS-CoV-2 who go on to have long COVID range from 2% to 66%.
The federal Recover Initiative has enrolled more than 10,000 children and youth – a number it plans to double – and studies of electronic health records are underway. The Recover pediatric team is also setting up a cohort that they plan to follow into 2025.
Some clinics are having luck treating young people with approaches ranging from special diets to off-label medication.
David W. Miller, MD, who runs the long COVID clinic at the UH Rainbow Babies and Children’s Hospital, Cleveland, said he’s seen about 250 patients.
A warning sign of long COVID in children is profound fatigue, he said.
“It’s the most common symptom,” Dr. Miller said. “They feel like they have the flu all the time.”
Many also experience orthostatic hypotension on standing, triggering dizziness.
He said his team targets symptom groups. Initial management consists of a diet without sugar or refined carbohydrates. Skipping pasta and sweets can be hard for young people, but Dr. Miller said sometimes the diet alone helps.
Many have vitamin D and iron deficiencies. Others need help getting a good night’s sleep. He’s treated 50 with off-label low-dose naltrexone.
Some people with long COVID – both young and old – complain about being misdiagnosed as having depression. Dr. Miller says he see a lot of anxiety – some situational and some biochemical – in pediatric patients. But he cautions doctors not to treat their illness solely as a mental health problem.
His advice: If a young person or child experiences a major change in his or her regular level of functioning or has multiple COVID symptoms that don’t go away after several months, parents and doctors should consider long COVID as a possible cause.
Dr. Miller said most of his patients get better over time with some treatments: “We see improvement in the majority of kids who can stick to the regimen,” such as a sugar-free diet, supplements, and adequate sleep. Recovery has been slow and incomplete for Diane Sheehan and her son. She was training as a permanent make-up artist, she said, but now has hand tremors that make work impossible.
She has found doctors who treat some of her symptoms with antihistamines, and her son has benefited from physical therapy.
But for now, her son is passing on a scholarship he was awarded to attend North Carolina State University this year. Instead, he’s living at home and going to a local college.
Ms. Sheehan urges parents to be on the alert for signs that their children might have long COVID, which can be confused with many other conditions.
A version of this article first appeared on Medscape.com.
Long COVID most often strikes seniors and adults, but children are also affected, even though they get less attention, new research shows.
Experts noted that the disease poses particular challenges for children and the doctors who treat them.
Parents and doctors need to be on the lookout for symptoms of long COVID in children and teens that might be easily missed or misdiagnosed, according to physicians and family groups.
Children are at lower risk for contracting COVID and often experience milder symptoms. But the virus is now widespread, and a recent study found that around 16% of pediatric patients with COVID go on to develop symptoms that last more than 3 months – the working definition of long COVID.
Parents and doctors are calling for more studies and more awareness.
Diane Sheehan, who lives outside Charlotte, N.C., says she was an active person and is now permanently disabled from long COVID. Her teenage son has it too and is still recovering.
He contracted COVID after a school event, she said. He had a mild case, but then he started experiencing dizziness and would even experience loss of consciousness when he stood up suddenly. After he contracted the virus a second time, he was bedridden for 8 months.
The staff at Hackensack Meridian Health, a pediatric long COVID clinic in New Jersey, has been working with area schools to help teachers and school nurses recognize possible long COVID in children and young people. The clinic is one of about a dozen in the United States that specializes in pediatric cases.
Katherine Clouser, MD, a pediatric hospital medicine specialist, has been with the clinic since it opened in 2021, and she’s seen a steady flow of patients. Some get better, but she sees a few new cases each week.
“We are seeing children who are having a difficult time returning to school and sports,” she said.
The clinic is having success with a mix of approaches, including intensive rehabilitation, talk therapy, and some off-label use of nirmatrelvir (Paxlovid), an antiviral now being studied as a treatment for long COVID through a National Institutes of Health clinical trials initiative that was announced last month.
Treatment depends on symptoms and is determined on a case-by-case basis, Dr. Clouser said.
Families of her patients are grateful, she added.
“We hear a lot of parents who were desperate for someone to believe them – or someone who knows about it,” she said.
A recent review of more than 30 studies with about 15,000 participants concluded that 16.2% (95% confidence interval, 8.5%-28.6%) of the pediatric participants experienced one or more persistent symptoms of long COVID at least 3 months after acute infection.
Estimates of the number of children and youth with long COVID have varied widely. A 2022 study put the number at more than 25% of cases, but the American Academy of Pediatrics notes that estimates of the percentage of children infected with SARS-CoV-2 who go on to have long COVID range from 2% to 66%.
The federal Recover Initiative has enrolled more than 10,000 children and youth – a number it plans to double – and studies of electronic health records are underway. The Recover pediatric team is also setting up a cohort that they plan to follow into 2025.
Some clinics are having luck treating young people with approaches ranging from special diets to off-label medication.
David W. Miller, MD, who runs the long COVID clinic at the UH Rainbow Babies and Children’s Hospital, Cleveland, said he’s seen about 250 patients.
A warning sign of long COVID in children is profound fatigue, he said.
“It’s the most common symptom,” Dr. Miller said. “They feel like they have the flu all the time.”
Many also experience orthostatic hypotension on standing, triggering dizziness.
He said his team targets symptom groups. Initial management consists of a diet without sugar or refined carbohydrates. Skipping pasta and sweets can be hard for young people, but Dr. Miller said sometimes the diet alone helps.
Many have vitamin D and iron deficiencies. Others need help getting a good night’s sleep. He’s treated 50 with off-label low-dose naltrexone.
Some people with long COVID – both young and old – complain about being misdiagnosed as having depression. Dr. Miller says he see a lot of anxiety – some situational and some biochemical – in pediatric patients. But he cautions doctors not to treat their illness solely as a mental health problem.
His advice: If a young person or child experiences a major change in his or her regular level of functioning or has multiple COVID symptoms that don’t go away after several months, parents and doctors should consider long COVID as a possible cause.
Dr. Miller said most of his patients get better over time with some treatments: “We see improvement in the majority of kids who can stick to the regimen,” such as a sugar-free diet, supplements, and adequate sleep. Recovery has been slow and incomplete for Diane Sheehan and her son. She was training as a permanent make-up artist, she said, but now has hand tremors that make work impossible.
She has found doctors who treat some of her symptoms with antihistamines, and her son has benefited from physical therapy.
But for now, her son is passing on a scholarship he was awarded to attend North Carolina State University this year. Instead, he’s living at home and going to a local college.
Ms. Sheehan urges parents to be on the alert for signs that their children might have long COVID, which can be confused with many other conditions.
A version of this article first appeared on Medscape.com.
Long COVID most often strikes seniors and adults, but children are also affected, even though they get less attention, new research shows.
Experts noted that the disease poses particular challenges for children and the doctors who treat them.
Parents and doctors need to be on the lookout for symptoms of long COVID in children and teens that might be easily missed or misdiagnosed, according to physicians and family groups.
Children are at lower risk for contracting COVID and often experience milder symptoms. But the virus is now widespread, and a recent study found that around 16% of pediatric patients with COVID go on to develop symptoms that last more than 3 months – the working definition of long COVID.
Parents and doctors are calling for more studies and more awareness.
Diane Sheehan, who lives outside Charlotte, N.C., says she was an active person and is now permanently disabled from long COVID. Her teenage son has it too and is still recovering.
He contracted COVID after a school event, she said. He had a mild case, but then he started experiencing dizziness and would even experience loss of consciousness when he stood up suddenly. After he contracted the virus a second time, he was bedridden for 8 months.
The staff at Hackensack Meridian Health, a pediatric long COVID clinic in New Jersey, has been working with area schools to help teachers and school nurses recognize possible long COVID in children and young people. The clinic is one of about a dozen in the United States that specializes in pediatric cases.
Katherine Clouser, MD, a pediatric hospital medicine specialist, has been with the clinic since it opened in 2021, and she’s seen a steady flow of patients. Some get better, but she sees a few new cases each week.
“We are seeing children who are having a difficult time returning to school and sports,” she said.
The clinic is having success with a mix of approaches, including intensive rehabilitation, talk therapy, and some off-label use of nirmatrelvir (Paxlovid), an antiviral now being studied as a treatment for long COVID through a National Institutes of Health clinical trials initiative that was announced last month.
Treatment depends on symptoms and is determined on a case-by-case basis, Dr. Clouser said.
Families of her patients are grateful, she added.
“We hear a lot of parents who were desperate for someone to believe them – or someone who knows about it,” she said.
A recent review of more than 30 studies with about 15,000 participants concluded that 16.2% (95% confidence interval, 8.5%-28.6%) of the pediatric participants experienced one or more persistent symptoms of long COVID at least 3 months after acute infection.
Estimates of the number of children and youth with long COVID have varied widely. A 2022 study put the number at more than 25% of cases, but the American Academy of Pediatrics notes that estimates of the percentage of children infected with SARS-CoV-2 who go on to have long COVID range from 2% to 66%.
The federal Recover Initiative has enrolled more than 10,000 children and youth – a number it plans to double – and studies of electronic health records are underway. The Recover pediatric team is also setting up a cohort that they plan to follow into 2025.
Some clinics are having luck treating young people with approaches ranging from special diets to off-label medication.
David W. Miller, MD, who runs the long COVID clinic at the UH Rainbow Babies and Children’s Hospital, Cleveland, said he’s seen about 250 patients.
A warning sign of long COVID in children is profound fatigue, he said.
“It’s the most common symptom,” Dr. Miller said. “They feel like they have the flu all the time.”
Many also experience orthostatic hypotension on standing, triggering dizziness.
He said his team targets symptom groups. Initial management consists of a diet without sugar or refined carbohydrates. Skipping pasta and sweets can be hard for young people, but Dr. Miller said sometimes the diet alone helps.
Many have vitamin D and iron deficiencies. Others need help getting a good night’s sleep. He’s treated 50 with off-label low-dose naltrexone.
Some people with long COVID – both young and old – complain about being misdiagnosed as having depression. Dr. Miller says he see a lot of anxiety – some situational and some biochemical – in pediatric patients. But he cautions doctors not to treat their illness solely as a mental health problem.
His advice: If a young person or child experiences a major change in his or her regular level of functioning or has multiple COVID symptoms that don’t go away after several months, parents and doctors should consider long COVID as a possible cause.
Dr. Miller said most of his patients get better over time with some treatments: “We see improvement in the majority of kids who can stick to the regimen,” such as a sugar-free diet, supplements, and adequate sleep. Recovery has been slow and incomplete for Diane Sheehan and her son. She was training as a permanent make-up artist, she said, but now has hand tremors that make work impossible.
She has found doctors who treat some of her symptoms with antihistamines, and her son has benefited from physical therapy.
But for now, her son is passing on a scholarship he was awarded to attend North Carolina State University this year. Instead, he’s living at home and going to a local college.
Ms. Sheehan urges parents to be on the alert for signs that their children might have long COVID, which can be confused with many other conditions.
A version of this article first appeared on Medscape.com.
Long COVID–induced activity limitations persist
Approximately one-quarter of adults who experience long COVID report activity limitations that do not change over time, based on data from national sample of nonhospitalized individuals.
Symptoms of long COVID, an ongoing medical condition that occurs in the wake of COVID-19 infection, include respiratory, neurologic, cardiovascular, or other complications that may last for weeks, months, or years after infection.
Current estimates of the incidence of long COVID in the United States range from 7.5% to 41%, according to Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Long COVID has shown a significant effect on patients’ quality of life, functional status, and ability to work, but the impact on activity limitation in particular has not been examined, the researchers said.
In a study published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (MMWR), the researchers reviewed data from surveys conducted between June 1 and 13, 2022, and June 7 and 19, 2023. The data came from the Census Bureau’s Household Pulse Survey (HPS), a cross-sectional national survey designed to measure the social and economic effects of COVID-19 on U.S. households. Surveys were conducted in 2-week cycles (2 weeks on, 2 weeks off). Questions about long COVID were added to the survey beginning on June 1, 2022, and questions about activity limitations from long COVID were added on Sept. 14, 2022, including questions about participants’ abilities to perform daily activities before and after COVID-19 infection.
Overall, the prevalence of long COVID decreased from 7.5% to 6.0% in U.S. adults aged 18 years and older during the study period. However, when stratified by age group, the decline was significant only in adults older than 60 years, and 1 in 10 adults with a history of COVID-19 reported long COVID at the end of the study period.
Among respondents with long COVID, 26.4% of respondents for time period of June 7-19, 2023, reported significant activity limitations, which remained unchanged over time, with no clear pattern in activity limitations across age groups, the researchers said.
Prevalence of long COVID was highest for individuals in middle adulthood (aged 30-39 years, 40-49 years, and 50-59 years) and lowest for younger adults (18-29 years) and older adults (aged 60 years and older). The prevalence of long COVID decreased by 1.16% per survey cycle between the June 1-13 and Jan. 4-16 cycles, but then remained stable, with a decrease of 0.01% per cycle between June 1-13, 2022, and Jan. 4-16, 2023.
Previous studies have shown that activity limitations resulting from long COVID can significantly affect quality of life and functional status, as well as the ability to work or care for others. A recent study in the United Kingdom showed that quality of life scores among long COVID patients were similar to those of individuals with advanced cancer, and more than half of the long COVID patients reported moderately severe functional impairment. “The larger economic and societal impact of long COVID could be far-reaching if working-age adults are unable to maintain employment or care for children or aging parents,” the researchers said.
The current study findings were limited by several factors including potential coverage bias in the survey sample, the relatively low survey response rate, and the inability to collect data on duration of symptoms, COVID-19 vaccination status, treatment during acute infection, and time since COVID-19 illness; any of these factors could affect the reported prevalence of long COVID, the researchers noted.
However, the results suggest the need for continued attention to COVID-19 prevention efforts, including not only staying current with recommended COVID-19 vaccination, but also planning for symptom management and health care service needs of long COVID patients, they concluded.
More data are needed to tease out patterns
“Physicians and patients are still trying to understand long COVID and its implications for the health of affected individuals,” said Noel Deep, MD, in an interview.
The current study shows a prevalence of long COVID in approximately 11% of COVID patients, which is a significant number, said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The study also was useful to illustrate a decline in the incidence of people affected by long COVID symptoms in the United States and in other countries, he said.
Dr. Deep noted that despite the persistent prevalence of long COVID symptoms overall, he was encouraged by the findings that older adults “who tend to have other underlying health conditions that could put them at a higher risk for adverse health outcomes” reported fewer long COVID symptoms than younger adults.
However, he noted that the high incidence of long COVID symptoms in able-bodied individuals in their 30s and 40s may affect their the economic situations as well as their ability to care for elderly relatives and children who might be dependent on them.
“Physicians and other clinicians should be aware of the symptoms and impacts caused by long COVID,” Dr. Deep said in an interview. “These individuals usually present with a myriad of vague and varying symptoms. Physicians should be cognizant of this situation, ask about previous infection with COVID-19, and utilize the resources of long COVID clinics where available,” he said.
Several factors can affect the assessment and management of patients with long COVID symptoms in primary care practices, said Dr. Deep. First and foremost are the time constraints of detailed evaluation and testing, he said.
Second, primary care clinicians need to be aware of the different symptoms that may be indicative of long COVID including fatigue, neurocognitive symptoms such as brain fog or memory disturbance, respiratory symptoms, and cardiovascular symptoms, as well as olfactory and gustatory symptoms. “These symptoms can be confounded by underlying health conditions, especially in elderly individuals,” he noted.
“Recommendations and guidelines are evolving regarding the evaluation and management of patients with long COVID that should help physicians and other clinicians in the future,” said Dr. Deep.
In the meantime, having a high index of suspicion, paying attention to the symptoms described by the patient, and taking a proper history with regard to previous COVID-19 infection should help overcome some of these challenges, he said.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.
Approximately one-quarter of adults who experience long COVID report activity limitations that do not change over time, based on data from national sample of nonhospitalized individuals.
Symptoms of long COVID, an ongoing medical condition that occurs in the wake of COVID-19 infection, include respiratory, neurologic, cardiovascular, or other complications that may last for weeks, months, or years after infection.
Current estimates of the incidence of long COVID in the United States range from 7.5% to 41%, according to Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Long COVID has shown a significant effect on patients’ quality of life, functional status, and ability to work, but the impact on activity limitation in particular has not been examined, the researchers said.
In a study published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (MMWR), the researchers reviewed data from surveys conducted between June 1 and 13, 2022, and June 7 and 19, 2023. The data came from the Census Bureau’s Household Pulse Survey (HPS), a cross-sectional national survey designed to measure the social and economic effects of COVID-19 on U.S. households. Surveys were conducted in 2-week cycles (2 weeks on, 2 weeks off). Questions about long COVID were added to the survey beginning on June 1, 2022, and questions about activity limitations from long COVID were added on Sept. 14, 2022, including questions about participants’ abilities to perform daily activities before and after COVID-19 infection.
Overall, the prevalence of long COVID decreased from 7.5% to 6.0% in U.S. adults aged 18 years and older during the study period. However, when stratified by age group, the decline was significant only in adults older than 60 years, and 1 in 10 adults with a history of COVID-19 reported long COVID at the end of the study period.
Among respondents with long COVID, 26.4% of respondents for time period of June 7-19, 2023, reported significant activity limitations, which remained unchanged over time, with no clear pattern in activity limitations across age groups, the researchers said.
Prevalence of long COVID was highest for individuals in middle adulthood (aged 30-39 years, 40-49 years, and 50-59 years) and lowest for younger adults (18-29 years) and older adults (aged 60 years and older). The prevalence of long COVID decreased by 1.16% per survey cycle between the June 1-13 and Jan. 4-16 cycles, but then remained stable, with a decrease of 0.01% per cycle between June 1-13, 2022, and Jan. 4-16, 2023.
Previous studies have shown that activity limitations resulting from long COVID can significantly affect quality of life and functional status, as well as the ability to work or care for others. A recent study in the United Kingdom showed that quality of life scores among long COVID patients were similar to those of individuals with advanced cancer, and more than half of the long COVID patients reported moderately severe functional impairment. “The larger economic and societal impact of long COVID could be far-reaching if working-age adults are unable to maintain employment or care for children or aging parents,” the researchers said.
The current study findings were limited by several factors including potential coverage bias in the survey sample, the relatively low survey response rate, and the inability to collect data on duration of symptoms, COVID-19 vaccination status, treatment during acute infection, and time since COVID-19 illness; any of these factors could affect the reported prevalence of long COVID, the researchers noted.
However, the results suggest the need for continued attention to COVID-19 prevention efforts, including not only staying current with recommended COVID-19 vaccination, but also planning for symptom management and health care service needs of long COVID patients, they concluded.
More data are needed to tease out patterns
“Physicians and patients are still trying to understand long COVID and its implications for the health of affected individuals,” said Noel Deep, MD, in an interview.
The current study shows a prevalence of long COVID in approximately 11% of COVID patients, which is a significant number, said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The study also was useful to illustrate a decline in the incidence of people affected by long COVID symptoms in the United States and in other countries, he said.
Dr. Deep noted that despite the persistent prevalence of long COVID symptoms overall, he was encouraged by the findings that older adults “who tend to have other underlying health conditions that could put them at a higher risk for adverse health outcomes” reported fewer long COVID symptoms than younger adults.
However, he noted that the high incidence of long COVID symptoms in able-bodied individuals in their 30s and 40s may affect their the economic situations as well as their ability to care for elderly relatives and children who might be dependent on them.
“Physicians and other clinicians should be aware of the symptoms and impacts caused by long COVID,” Dr. Deep said in an interview. “These individuals usually present with a myriad of vague and varying symptoms. Physicians should be cognizant of this situation, ask about previous infection with COVID-19, and utilize the resources of long COVID clinics where available,” he said.
Several factors can affect the assessment and management of patients with long COVID symptoms in primary care practices, said Dr. Deep. First and foremost are the time constraints of detailed evaluation and testing, he said.
Second, primary care clinicians need to be aware of the different symptoms that may be indicative of long COVID including fatigue, neurocognitive symptoms such as brain fog or memory disturbance, respiratory symptoms, and cardiovascular symptoms, as well as olfactory and gustatory symptoms. “These symptoms can be confounded by underlying health conditions, especially in elderly individuals,” he noted.
“Recommendations and guidelines are evolving regarding the evaluation and management of patients with long COVID that should help physicians and other clinicians in the future,” said Dr. Deep.
In the meantime, having a high index of suspicion, paying attention to the symptoms described by the patient, and taking a proper history with regard to previous COVID-19 infection should help overcome some of these challenges, he said.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.
Approximately one-quarter of adults who experience long COVID report activity limitations that do not change over time, based on data from national sample of nonhospitalized individuals.
Symptoms of long COVID, an ongoing medical condition that occurs in the wake of COVID-19 infection, include respiratory, neurologic, cardiovascular, or other complications that may last for weeks, months, or years after infection.
Current estimates of the incidence of long COVID in the United States range from 7.5% to 41%, according to Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Long COVID has shown a significant effect on patients’ quality of life, functional status, and ability to work, but the impact on activity limitation in particular has not been examined, the researchers said.
In a study published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (MMWR), the researchers reviewed data from surveys conducted between June 1 and 13, 2022, and June 7 and 19, 2023. The data came from the Census Bureau’s Household Pulse Survey (HPS), a cross-sectional national survey designed to measure the social and economic effects of COVID-19 on U.S. households. Surveys were conducted in 2-week cycles (2 weeks on, 2 weeks off). Questions about long COVID were added to the survey beginning on June 1, 2022, and questions about activity limitations from long COVID were added on Sept. 14, 2022, including questions about participants’ abilities to perform daily activities before and after COVID-19 infection.
Overall, the prevalence of long COVID decreased from 7.5% to 6.0% in U.S. adults aged 18 years and older during the study period. However, when stratified by age group, the decline was significant only in adults older than 60 years, and 1 in 10 adults with a history of COVID-19 reported long COVID at the end of the study period.
Among respondents with long COVID, 26.4% of respondents for time period of June 7-19, 2023, reported significant activity limitations, which remained unchanged over time, with no clear pattern in activity limitations across age groups, the researchers said.
Prevalence of long COVID was highest for individuals in middle adulthood (aged 30-39 years, 40-49 years, and 50-59 years) and lowest for younger adults (18-29 years) and older adults (aged 60 years and older). The prevalence of long COVID decreased by 1.16% per survey cycle between the June 1-13 and Jan. 4-16 cycles, but then remained stable, with a decrease of 0.01% per cycle between June 1-13, 2022, and Jan. 4-16, 2023.
Previous studies have shown that activity limitations resulting from long COVID can significantly affect quality of life and functional status, as well as the ability to work or care for others. A recent study in the United Kingdom showed that quality of life scores among long COVID patients were similar to those of individuals with advanced cancer, and more than half of the long COVID patients reported moderately severe functional impairment. “The larger economic and societal impact of long COVID could be far-reaching if working-age adults are unable to maintain employment or care for children or aging parents,” the researchers said.
The current study findings were limited by several factors including potential coverage bias in the survey sample, the relatively low survey response rate, and the inability to collect data on duration of symptoms, COVID-19 vaccination status, treatment during acute infection, and time since COVID-19 illness; any of these factors could affect the reported prevalence of long COVID, the researchers noted.
However, the results suggest the need for continued attention to COVID-19 prevention efforts, including not only staying current with recommended COVID-19 vaccination, but also planning for symptom management and health care service needs of long COVID patients, they concluded.
More data are needed to tease out patterns
“Physicians and patients are still trying to understand long COVID and its implications for the health of affected individuals,” said Noel Deep, MD, in an interview.
The current study shows a prevalence of long COVID in approximately 11% of COVID patients, which is a significant number, said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The study also was useful to illustrate a decline in the incidence of people affected by long COVID symptoms in the United States and in other countries, he said.
Dr. Deep noted that despite the persistent prevalence of long COVID symptoms overall, he was encouraged by the findings that older adults “who tend to have other underlying health conditions that could put them at a higher risk for adverse health outcomes” reported fewer long COVID symptoms than younger adults.
However, he noted that the high incidence of long COVID symptoms in able-bodied individuals in their 30s and 40s may affect their the economic situations as well as their ability to care for elderly relatives and children who might be dependent on them.
“Physicians and other clinicians should be aware of the symptoms and impacts caused by long COVID,” Dr. Deep said in an interview. “These individuals usually present with a myriad of vague and varying symptoms. Physicians should be cognizant of this situation, ask about previous infection with COVID-19, and utilize the resources of long COVID clinics where available,” he said.
Several factors can affect the assessment and management of patients with long COVID symptoms in primary care practices, said Dr. Deep. First and foremost are the time constraints of detailed evaluation and testing, he said.
Second, primary care clinicians need to be aware of the different symptoms that may be indicative of long COVID including fatigue, neurocognitive symptoms such as brain fog or memory disturbance, respiratory symptoms, and cardiovascular symptoms, as well as olfactory and gustatory symptoms. “These symptoms can be confounded by underlying health conditions, especially in elderly individuals,” he noted.
“Recommendations and guidelines are evolving regarding the evaluation and management of patients with long COVID that should help physicians and other clinicians in the future,” said Dr. Deep.
In the meantime, having a high index of suspicion, paying attention to the symptoms described by the patient, and taking a proper history with regard to previous COVID-19 infection should help overcome some of these challenges, he said.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.
FROM MMWR