Studies have shown links between statin use and type 2 diabetes (T2D) for more than a decade. A U.S. Food and Drug Administration label change for the drugs warned in 2012 about reports of increased risks of high blood glucose and glycosylated hemoglobin (A1c) levels. However, in the same warning, the FDA said it “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

Indeed, although the warning triggered much discussion at the time and a number of meta-analyses and other observational studies in more recent years, that conclusion seems to hold among clinicians and society guidelines.

For example, in a recent practice pointer on the risk of diabetes with statins published in the BMJ, Ishak Mansi, MD, of the Orlando VA Health Care System, and colleagues write, “This potential adverse effect of diabetes with statin use should not be a barrier to starting statin treatment when indicated.”

They also called for further research to answer such questions as, “Is statin-associated diabetes reversible upon statin discontinuation? Would intermittent use minimize this risk while maintaining cardiovascular benefits?”

An earlier study among individuals at high risk for diabetes found significantly higher rates of incident diabetes at 10 years among patients on placebo, metformin, or lifestyle intervention who also initiated statin therapy. Jill Crandall, MD, Albert Einstein College of Medicine, New York, and colleagues conclude, “For individual patients, a potential modest increase in diabetes risk clearly needs to be balanced against the consistent and highly significant reductions in myocardial infarction, stroke, and cardiovascular death associated with statin treatment.”

In the same vein, a recent review by Byron Hoogwerf, MD, Emeritus, department of endocrinology, diabetes, and metabolism, Cleveland Clinic, is titled, “Statins may increase diabetes, but benefit still outweighs risk.”
 

Rosuvastatin versus Atorvastatin

The latest study in this arena is an analysis of the LODESTAR randomized controlled trial of 4,400 patients with coronary artery disease in 12 hospitals in Korea which compares the risks associated with individual statins.

Senior author Myeong-Ki Hong, MD, PhD, Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, South Korea, said in an interview that the study was prompted by the “limited” studies evaluating clinical outcomes, including diabetes risk, according to statin type.

Dr. Hong and colleagues compared the risk of developing diabetes among those taking rosuvastatin (mean daily dose, 17.1 mg) or atorvastatin (mean daily dose 36 mg) for 3 years. While both statins effectively prevented myocardial infarction, stroke, and death, those taking rosuvastatin had a higher incidence of new-onset T2D requiring initiation of antidiabetic drugs (7.2% vs. 5.3%; hazard ratio, 1.39) and cataract surgery (2.5% vs. 1.5%; HR, 1.66).

Overall, the HR of new-onset T2D was 1.29 (95% confidence interval, 1.01-1.63; P = .04).

“The percentages of new-onset diabetes and cataract are in line with previous studies regarding statin therapy in patients with atherosclerotic cardiovascular disease,” Dr. Hong said. “Additional research specifically focusing on these outcomes is required, with more frequent measurement of glucose and A1c levels to detect new-onset diabetes and regular ophthalmologic examinations to detect cataracts.”

“However,” he added, “when using rosuvastatin over atorvastatin, we ... emphasize the importance of meticulous monitoring and appropriate lifestyle interventions to mitigate the risk of new-onset diabetes or cataracts.”

Steven Nissen, MD, chief academic officer of Cleveland Clinic’s Heart and Vascular Institute, was not convinced, and said the study “does not provide useful insights into the use of these drugs.”

The investigators used whatever dose they wanted, “and the authors report only the median dose after 3 years,” he said in an interview. “Because there was a slightly greater reduction in low-density lipoprotein (LDL) cholesterol with rosuvastatin, the relative dose was actually higher.”

“We know that new-onset diabetes with statins is dose-dependent,” he said. “The P-values for diabetes incidence were marginal (very close to P = .05). Accordingly, the diabetes data are unconvincing. ... The similar efficacy is not surprising given the open-label dosing with relatively similar effects on lipids.”

Seth Shay Martin, MD, MHS, director of the Advanced Lipid Disorders Program and Digital Health Lab, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins Medicine, Baltimore, also commented on the results. The findings are “in line with existing knowledge and current guidelines,” he said. “Therefore, the study should not influence prescribing.”

“Although the study suggests that rosuvastatin was associated with a higher risk of new-onset diabetes mellitus requiring antidiabetics and cataract surgery, compared with atorvastatin, these findings should be interpreted with caution given the open-label nature of the study and require further investigation,” he said.

“The mean daily doses of statins were somewhat below target for secondary prevention,” he noted. “Ideally, patients with coronary artery disease (CAD) take 20-40 mg daily of rosuvastatin or 40-80 mg daily of atorvastatin.”

“Furthermore, the LDL cholesterol levels were not optimized in the patients,” he said. “The mean LDL-C was 1.8-1.9 mmol/L, which is equivalent to 70-73 mg/dL. In the current treatment era, we generally treat to LDL-C levels less than 70 mg/dL and often less than 55 mg/dL in CAD patients.”

“The cataracts finding is particularly odd,” he added. “There was historic concern for cataracts with statin therapy, initially because of studies in beagle dogs. However, high-quality evidence from statin trials has not shown a risk for cataracts.” 

So which statin has the lowest risk of triggering new-onset diabetes? As Dr. Hong noted, the literature is sparse when it comes to comparing the risk among specific statins. Some studies suggest that the risk may depend on the individual and their specific risk factors, as well as the dose and intensity of the prescribed statin.

One recent study suggests that while the overall chance of developing diabetes is small, when looking at risk by years of exposure, atorvastatin, rosuvastatin, and lovastatin carried the largest risk, whereas the risk was lower with pravastatin and simvastatin.

Risks also seemed lower with fluvastatin and pitavastatin, but there were too few study patients taking those drugs long-term to include in the subanalysis.

With input from the latest guidelines from the American Heart Association and the American Diabetes Association, as well as findings from a clinical guide on statin-associated diabetes, Dr. Hoogwerf suggests in his review that shared decision-making before starting statin therapy of any type include the following considerations/discussion points:

• For all patients: Screening to determine baseline glycemic status; nonstatin therapies to lower cholesterol; and variables associated with an increased risk of diabetes, including antihypertensive drugs.
• For patients without T2D: The possibility of developing T2D, types and doses of statins, and the fact that statin benefits “generally far outweigh” risks of developing diabetes.
• For patients with T2D: Possible small adverse effects on glycemic control; statin benefits in reducing risk for atherosclerotic cardiovascular disease, which “significantly outweigh” the small increase in A1c; and mitigation of adverse glycemic effects of statins with glucose-lowering therapies.

It’s worth noting that the AHA and ADA guidelines, among others, also emphasize that such discussions should include the importance of weight loss, regular exercise, and adhering to a healthy lifestyle to mitigate risks of both diabetes and heart disease, with or without statins.

Dr. Hong, Dr. Nissen, and Dr. Martin report no relevant financial relationships. Dr. Hoogwerf has disclosed ownership interest in Eli Lilly and consulting for MannKind and Zealand Pharmaceuticals.

A version of this article appeared on Medscape.com.

Studies have shown links between statin use and type 2 diabetes (T2D) for more than a decade. A U.S. Food and Drug Administration label change for the drugs warned in 2012 about reports of increased risks of high blood glucose and glycosylated hemoglobin (A1c) levels. However, in the same warning, the FDA said it “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

Indeed, although the warning triggered much discussion at the time and a number of meta-analyses and other observational studies in more recent years, that conclusion seems to hold among clinicians and society guidelines.

For example, in a recent practice pointer on the risk of diabetes with statins published in the BMJ, Ishak Mansi, MD, of the Orlando VA Health Care System, and colleagues write, “This potential adverse effect of diabetes with statin use should not be a barrier to starting statin treatment when indicated.”

They also called for further research to answer such questions as, “Is statin-associated diabetes reversible upon statin discontinuation? Would intermittent use minimize this risk while maintaining cardiovascular benefits?”

An earlier study among individuals at high risk for diabetes found significantly higher rates of incident diabetes at 10 years among patients on placebo, metformin, or lifestyle intervention who also initiated statin therapy. Jill Crandall, MD, Albert Einstein College of Medicine, New York, and colleagues conclude, “For individual patients, a potential modest increase in diabetes risk clearly needs to be balanced against the consistent and highly significant reductions in myocardial infarction, stroke, and cardiovascular death associated with statin treatment.”

In the same vein, a recent review by Byron Hoogwerf, MD, Emeritus, department of endocrinology, diabetes, and metabolism, Cleveland Clinic, is titled, “Statins may increase diabetes, but benefit still outweighs risk.”
 

Rosuvastatin versus Atorvastatin

The latest study in this arena is an analysis of the LODESTAR randomized controlled trial of 4,400 patients with coronary artery disease in 12 hospitals in Korea which compares the risks associated with individual statins.

Senior author Myeong-Ki Hong, MD, PhD, Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, South Korea, said in an interview that the study was prompted by the “limited” studies evaluating clinical outcomes, including diabetes risk, according to statin type.

Dr. Hong and colleagues compared the risk of developing diabetes among those taking rosuvastatin (mean daily dose, 17.1 mg) or atorvastatin (mean daily dose 36 mg) for 3 years. While both statins effectively prevented myocardial infarction, stroke, and death, those taking rosuvastatin had a higher incidence of new-onset T2D requiring initiation of antidiabetic drugs (7.2% vs. 5.3%; hazard ratio, 1.39) and cataract surgery (2.5% vs. 1.5%; HR, 1.66).

Overall, the HR of new-onset T2D was 1.29 (95% confidence interval, 1.01-1.63; P = .04).

“The percentages of new-onset diabetes and cataract are in line with previous studies regarding statin therapy in patients with atherosclerotic cardiovascular disease,” Dr. Hong said. “Additional research specifically focusing on these outcomes is required, with more frequent measurement of glucose and A1c levels to detect new-onset diabetes and regular ophthalmologic examinations to detect cataracts.”

“However,” he added, “when using rosuvastatin over atorvastatin, we ... emphasize the importance of meticulous monitoring and appropriate lifestyle interventions to mitigate the risk of new-onset diabetes or cataracts.”

Steven Nissen, MD, chief academic officer of Cleveland Clinic’s Heart and Vascular Institute, was not convinced, and said the study “does not provide useful insights into the use of these drugs.”

The investigators used whatever dose they wanted, “and the authors report only the median dose after 3 years,” he said in an interview. “Because there was a slightly greater reduction in low-density lipoprotein (LDL) cholesterol with rosuvastatin, the relative dose was actually higher.”

“We know that new-onset diabetes with statins is dose-dependent,” he said. “The P-values for diabetes incidence were marginal (very close to P = .05). Accordingly, the diabetes data are unconvincing. ... The similar efficacy is not surprising given the open-label dosing with relatively similar effects on lipids.”

Seth Shay Martin, MD, MHS, director of the Advanced Lipid Disorders Program and Digital Health Lab, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins Medicine, Baltimore, also commented on the results. The findings are “in line with existing knowledge and current guidelines,” he said. “Therefore, the study should not influence prescribing.”

“Although the study suggests that rosuvastatin was associated with a higher risk of new-onset diabetes mellitus requiring antidiabetics and cataract surgery, compared with atorvastatin, these findings should be interpreted with caution given the open-label nature of the study and require further investigation,” he said.

“The mean daily doses of statins were somewhat below target for secondary prevention,” he noted. “Ideally, patients with coronary artery disease (CAD) take 20-40 mg daily of rosuvastatin or 40-80 mg daily of atorvastatin.”

“Furthermore, the LDL cholesterol levels were not optimized in the patients,” he said. “The mean LDL-C was 1.8-1.9 mmol/L, which is equivalent to 70-73 mg/dL. In the current treatment era, we generally treat to LDL-C levels less than 70 mg/dL and often less than 55 mg/dL in CAD patients.”

“The cataracts finding is particularly odd,” he added. “There was historic concern for cataracts with statin therapy, initially because of studies in beagle dogs. However, high-quality evidence from statin trials has not shown a risk for cataracts.” 

So which statin has the lowest risk of triggering new-onset diabetes? As Dr. Hong noted, the literature is sparse when it comes to comparing the risk among specific statins. Some studies suggest that the risk may depend on the individual and their specific risk factors, as well as the dose and intensity of the prescribed statin.

One recent study suggests that while the overall chance of developing diabetes is small, when looking at risk by years of exposure, atorvastatin, rosuvastatin, and lovastatin carried the largest risk, whereas the risk was lower with pravastatin and simvastatin.

Risks also seemed lower with fluvastatin and pitavastatin, but there were too few study patients taking those drugs long-term to include in the subanalysis.

With input from the latest guidelines from the American Heart Association and the American Diabetes Association, as well as findings from a clinical guide on statin-associated diabetes, Dr. Hoogwerf suggests in his review that shared decision-making before starting statin therapy of any type include the following considerations/discussion points:

• For all patients: Screening to determine baseline glycemic status; nonstatin therapies to lower cholesterol; and variables associated with an increased risk of diabetes, including antihypertensive drugs.
• For patients without T2D: The possibility of developing T2D, types and doses of statins, and the fact that statin benefits “generally far outweigh” risks of developing diabetes.
• For patients with T2D: Possible small adverse effects on glycemic control; statin benefits in reducing risk for atherosclerotic cardiovascular disease, which “significantly outweigh” the small increase in A1c; and mitigation of adverse glycemic effects of statins with glucose-lowering therapies.

It’s worth noting that the AHA and ADA guidelines, among others, also emphasize that such discussions should include the importance of weight loss, regular exercise, and adhering to a healthy lifestyle to mitigate risks of both diabetes and heart disease, with or without statins.

Dr. Hong, Dr. Nissen, and Dr. Martin report no relevant financial relationships. Dr. Hoogwerf has disclosed ownership interest in Eli Lilly and consulting for MannKind and Zealand Pharmaceuticals.

A version of this article appeared on Medscape.com.

Studies have shown links between statin use and type 2 diabetes (T2D) for more than a decade. A U.S. Food and Drug Administration label change for the drugs warned in 2012 about reports of increased risks of high blood glucose and glycosylated hemoglobin (A1c) levels. However, in the same warning, the FDA said it “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

Indeed, although the warning triggered much discussion at the time and a number of meta-analyses and other observational studies in more recent years, that conclusion seems to hold among clinicians and society guidelines.

For example, in a recent practice pointer on the risk of diabetes with statins published in the BMJ, Ishak Mansi, MD, of the Orlando VA Health Care System, and colleagues write, “This potential adverse effect of diabetes with statin use should not be a barrier to starting statin treatment when indicated.”

They also called for further research to answer such questions as, “Is statin-associated diabetes reversible upon statin discontinuation? Would intermittent use minimize this risk while maintaining cardiovascular benefits?”

An earlier study among individuals at high risk for diabetes found significantly higher rates of incident diabetes at 10 years among patients on placebo, metformin, or lifestyle intervention who also initiated statin therapy. Jill Crandall, MD, Albert Einstein College of Medicine, New York, and colleagues conclude, “For individual patients, a potential modest increase in diabetes risk clearly needs to be balanced against the consistent and highly significant reductions in myocardial infarction, stroke, and cardiovascular death associated with statin treatment.”

In the same vein, a recent review by Byron Hoogwerf, MD, Emeritus, department of endocrinology, diabetes, and metabolism, Cleveland Clinic, is titled, “Statins may increase diabetes, but benefit still outweighs risk.”
 

Rosuvastatin versus Atorvastatin

The latest study in this arena is an analysis of the LODESTAR randomized controlled trial of 4,400 patients with coronary artery disease in 12 hospitals in Korea which compares the risks associated with individual statins.

Senior author Myeong-Ki Hong, MD, PhD, Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, South Korea, said in an interview that the study was prompted by the “limited” studies evaluating clinical outcomes, including diabetes risk, according to statin type.

Dr. Hong and colleagues compared the risk of developing diabetes among those taking rosuvastatin (mean daily dose, 17.1 mg) or atorvastatin (mean daily dose 36 mg) for 3 years. While both statins effectively prevented myocardial infarction, stroke, and death, those taking rosuvastatin had a higher incidence of new-onset T2D requiring initiation of antidiabetic drugs (7.2% vs. 5.3%; hazard ratio, 1.39) and cataract surgery (2.5% vs. 1.5%; HR, 1.66).

Overall, the HR of new-onset T2D was 1.29 (95% confidence interval, 1.01-1.63; P = .04).

“The percentages of new-onset diabetes and cataract are in line with previous studies regarding statin therapy in patients with atherosclerotic cardiovascular disease,” Dr. Hong said. “Additional research specifically focusing on these outcomes is required, with more frequent measurement of glucose and A1c levels to detect new-onset diabetes and regular ophthalmologic examinations to detect cataracts.”

“However,” he added, “when using rosuvastatin over atorvastatin, we ... emphasize the importance of meticulous monitoring and appropriate lifestyle interventions to mitigate the risk of new-onset diabetes or cataracts.”

Steven Nissen, MD, chief academic officer of Cleveland Clinic’s Heart and Vascular Institute, was not convinced, and said the study “does not provide useful insights into the use of these drugs.”

The investigators used whatever dose they wanted, “and the authors report only the median dose after 3 years,” he said in an interview. “Because there was a slightly greater reduction in low-density lipoprotein (LDL) cholesterol with rosuvastatin, the relative dose was actually higher.”

“We know that new-onset diabetes with statins is dose-dependent,” he said. “The P-values for diabetes incidence were marginal (very close to P = .05). Accordingly, the diabetes data are unconvincing. ... The similar efficacy is not surprising given the open-label dosing with relatively similar effects on lipids.”

Seth Shay Martin, MD, MHS, director of the Advanced Lipid Disorders Program and Digital Health Lab, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins Medicine, Baltimore, also commented on the results. The findings are “in line with existing knowledge and current guidelines,” he said. “Therefore, the study should not influence prescribing.”

“Although the study suggests that rosuvastatin was associated with a higher risk of new-onset diabetes mellitus requiring antidiabetics and cataract surgery, compared with atorvastatin, these findings should be interpreted with caution given the open-label nature of the study and require further investigation,” he said.

“The mean daily doses of statins were somewhat below target for secondary prevention,” he noted. “Ideally, patients with coronary artery disease (CAD) take 20-40 mg daily of rosuvastatin or 40-80 mg daily of atorvastatin.”

“Furthermore, the LDL cholesterol levels were not optimized in the patients,” he said. “The mean LDL-C was 1.8-1.9 mmol/L, which is equivalent to 70-73 mg/dL. In the current treatment era, we generally treat to LDL-C levels less than 70 mg/dL and often less than 55 mg/dL in CAD patients.”

“The cataracts finding is particularly odd,” he added. “There was historic concern for cataracts with statin therapy, initially because of studies in beagle dogs. However, high-quality evidence from statin trials has not shown a risk for cataracts.” 

So which statin has the lowest risk of triggering new-onset diabetes? As Dr. Hong noted, the literature is sparse when it comes to comparing the risk among specific statins. Some studies suggest that the risk may depend on the individual and their specific risk factors, as well as the dose and intensity of the prescribed statin.

One recent study suggests that while the overall chance of developing diabetes is small, when looking at risk by years of exposure, atorvastatin, rosuvastatin, and lovastatin carried the largest risk, whereas the risk was lower with pravastatin and simvastatin.

Risks also seemed lower with fluvastatin and pitavastatin, but there were too few study patients taking those drugs long-term to include in the subanalysis.

With input from the latest guidelines from the American Heart Association and the American Diabetes Association, as well as findings from a clinical guide on statin-associated diabetes, Dr. Hoogwerf suggests in his review that shared decision-making before starting statin therapy of any type include the following considerations/discussion points:

• For all patients: Screening to determine baseline glycemic status; nonstatin therapies to lower cholesterol; and variables associated with an increased risk of diabetes, including antihypertensive drugs.
• For patients without T2D: The possibility of developing T2D, types and doses of statins, and the fact that statin benefits “generally far outweigh” risks of developing diabetes.
• For patients with T2D: Possible small adverse effects on glycemic control; statin benefits in reducing risk for atherosclerotic cardiovascular disease, which “significantly outweigh” the small increase in A1c; and mitigation of adverse glycemic effects of statins with glucose-lowering therapies.

It’s worth noting that the AHA and ADA guidelines, among others, also emphasize that such discussions should include the importance of weight loss, regular exercise, and adhering to a healthy lifestyle to mitigate risks of both diabetes and heart disease, with or without statins.

Dr. Hong, Dr. Nissen, and Dr. Martin report no relevant financial relationships. Dr. Hoogwerf has disclosed ownership interest in Eli Lilly and consulting for MannKind and Zealand Pharmaceuticals.

A version of this article appeared on Medscape.com.

TOPLINE:

Nirmatrelvir-ritonavir doesn’t reduce the incidence of most post-COVID conditions, according to a new study. 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:

Nirmatrelvir-ritonavir doesn’t reduce the incidence of most post-COVID conditions, according to a new study. 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:

Nirmatrelvir-ritonavir doesn’t reduce the incidence of most post-COVID conditions, according to a new study. 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.

Flohr and colleagues present the results of a controlled trial of cyclosporine vs methotrexate for severe atopic dermatitis ("Efficacy and Safety of Ciclosporin Versus Methotrexate in the Treatment of Severe Atopic Dermatitis in Children and Young People"). Cyclosporine worked faster, yet methotrexate was a bit more effective in the long run. Both treatments had considerable side effects; 10% and 14% had serious events with cyclosporine and methotrexate, respectively. My only quibble is with the first word of the abstract background section; the authors call cyclosporine and methotrexate "conventional" systemic drugs for atopic dermatitis. At this point, considering safety and efficacy, I would consider drugs like dupilumab to be the "conventional" systemic treatment for atopic dermatitis.

Wan and colleagues ("Neuropsychiatric Disorders in Adults With Atopic Dermatitis") present an exceptionally well-done study with a huge patient population. The study compared about 600,000 adults with atopic dermatitis vs over 2,000,000 adults without the disease. A sample size like that offers a lot of power to detect very small differences between groups. The researchers report higher rates of anxiety and depression in patients with atopic dermatitis compared to those without. Are those differences clinically meaningfully different? The rates of depression were 14 and 17 cases per 1000 patient-years for those without and those with severe atopic dermatitis, respectively. That's a difference of 3 per 1000 patient-years. So maybe roughly 300 patients with atopic dermatitis would need to be seen to observe one patient with depression due to atopic dermatitis (assuming that the observed differences in rates between those with and those without atopic dermatitis were due to the dermatitis). The authors conclude, "Clinicians should inquire about mental health in patients with AD." I don't think their data support such a conclusion. We'd need to see a cost-effectiveness study to know if that's an intervention that we should do. Given the very small difference between the rates in those with and those without atopic dermatitis, it might be reasonable to conclude that we should inquire about mental health in patients with atopic dermatitis about as much as we should in patients without atopic dermatitis.

Some years ago, there was an over-the-counter topical product for psoriasis based on a banana peel extract. I think it was marketed as "FDA approved" for psoriasis (which was legal to say because the product also contained tar) and as being as effective as topical calcipotriene as published in the Journal of Investigational Dermatology (JID). I went to look for the article; the "publication" was the abstract of a poster presentation. The study followed a very small study population for a short period of time. The study was, I believe, underpowered to detect differences between the banana peel extract and the vitamin D analog. Those data were presented as a poster, the poster abstracts were printed in JID, and, voilà, the product was marketed as being as effective as topical calcipotriene as published in JID.

Sowlati and colleagues ("Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children") randomly assigned 42 patients to receive either a xyloglucan/pea protein topical therapy or hydrocortisone. The participants were followed for 2 weeks. Both groups improved. We don't know whether they improved more than they would have with moisturizer. This study doesn't make me excited about prescribing the xyloglucan/pea protein topical.

The study by Mohamed and colleagues comparing tacrolimus and hydrocortisone reminds me that we have an effective generic topical anti-inflammatory for our patients with atopic dermatitis. Given the safety of topical tacrolimus, I prefer prescribing the 0.1% ointment for all my patients, though I give the lower concentration, approved for children, if the insurer makes me.

Simpson and colleagues' post hoc analysis of tralokinumab tells us that, with continued use, some patients who don't respond well initially will have greater improvement. But what I'd really like to see is a head-to-head study comparing tralokinumab vs dupilumab. Dupilumab seems to have stronger efficacy based on their reported trial numbers, but a head-to-head trial would give us greater confidence in their relative benefits.

I have trouble getting excited about this study by Cork and colleagues ("Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age With Severe Atopic Dermatitis"). I feel very comfortable with dupilumab already.

Flohr and colleagues present the results of a controlled trial of cyclosporine vs methotrexate for severe atopic dermatitis ("Efficacy and Safety of Ciclosporin Versus Methotrexate in the Treatment of Severe Atopic Dermatitis in Children and Young People"). Cyclosporine worked faster, yet methotrexate was a bit more effective in the long run. Both treatments had considerable side effects; 10% and 14% had serious events with cyclosporine and methotrexate, respectively. My only quibble is with the first word of the abstract background section; the authors call cyclosporine and methotrexate "conventional" systemic drugs for atopic dermatitis. At this point, considering safety and efficacy, I would consider drugs like dupilumab to be the "conventional" systemic treatment for atopic dermatitis.

Wan and colleagues ("Neuropsychiatric Disorders in Adults With Atopic Dermatitis") present an exceptionally well-done study with a huge patient population. The study compared about 600,000 adults with atopic dermatitis vs over 2,000,000 adults without the disease. A sample size like that offers a lot of power to detect very small differences between groups. The researchers report higher rates of anxiety and depression in patients with atopic dermatitis compared to those without. Are those differences clinically meaningfully different? The rates of depression were 14 and 17 cases per 1000 patient-years for those without and those with severe atopic dermatitis, respectively. That's a difference of 3 per 1000 patient-years. So maybe roughly 300 patients with atopic dermatitis would need to be seen to observe one patient with depression due to atopic dermatitis (assuming that the observed differences in rates between those with and those without atopic dermatitis were due to the dermatitis). The authors conclude, "Clinicians should inquire about mental health in patients with AD." I don't think their data support such a conclusion. We'd need to see a cost-effectiveness study to know if that's an intervention that we should do. Given the very small difference between the rates in those with and those without atopic dermatitis, it might be reasonable to conclude that we should inquire about mental health in patients with atopic dermatitis about as much as we should in patients without atopic dermatitis.

Some years ago, there was an over-the-counter topical product for psoriasis based on a banana peel extract. I think it was marketed as "FDA approved" for psoriasis (which was legal to say because the product also contained tar) and as being as effective as topical calcipotriene as published in the Journal of Investigational Dermatology (JID). I went to look for the article; the "publication" was the abstract of a poster presentation. The study followed a very small study population for a short period of time. The study was, I believe, underpowered to detect differences between the banana peel extract and the vitamin D analog. Those data were presented as a poster, the poster abstracts were printed in JID, and, voilà, the product was marketed as being as effective as topical calcipotriene as published in JID.

Sowlati and colleagues ("Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children") randomly assigned 42 patients to receive either a xyloglucan/pea protein topical therapy or hydrocortisone. The participants were followed for 2 weeks. Both groups improved. We don't know whether they improved more than they would have with moisturizer. This study doesn't make me excited about prescribing the xyloglucan/pea protein topical.

The study by Mohamed and colleagues comparing tacrolimus and hydrocortisone reminds me that we have an effective generic topical anti-inflammatory for our patients with atopic dermatitis. Given the safety of topical tacrolimus, I prefer prescribing the 0.1% ointment for all my patients, though I give the lower concentration, approved for children, if the insurer makes me.

Simpson and colleagues' post hoc analysis of tralokinumab tells us that, with continued use, some patients who don't respond well initially will have greater improvement. But what I'd really like to see is a head-to-head study comparing tralokinumab vs dupilumab. Dupilumab seems to have stronger efficacy based on their reported trial numbers, but a head-to-head trial would give us greater confidence in their relative benefits.

I have trouble getting excited about this study by Cork and colleagues ("Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age With Severe Atopic Dermatitis"). I feel very comfortable with dupilumab already.

Flohr and colleagues present the results of a controlled trial of cyclosporine vs methotrexate for severe atopic dermatitis ("Efficacy and Safety of Ciclosporin Versus Methotrexate in the Treatment of Severe Atopic Dermatitis in Children and Young People"). Cyclosporine worked faster, yet methotrexate was a bit more effective in the long run. Both treatments had considerable side effects; 10% and 14% had serious events with cyclosporine and methotrexate, respectively. My only quibble is with the first word of the abstract background section; the authors call cyclosporine and methotrexate "conventional" systemic drugs for atopic dermatitis. At this point, considering safety and efficacy, I would consider drugs like dupilumab to be the "conventional" systemic treatment for atopic dermatitis.

Wan and colleagues ("Neuropsychiatric Disorders in Adults With Atopic Dermatitis") present an exceptionally well-done study with a huge patient population. The study compared about 600,000 adults with atopic dermatitis vs over 2,000,000 adults without the disease. A sample size like that offers a lot of power to detect very small differences between groups. The researchers report higher rates of anxiety and depression in patients with atopic dermatitis compared to those without. Are those differences clinically meaningfully different? The rates of depression were 14 and 17 cases per 1000 patient-years for those without and those with severe atopic dermatitis, respectively. That's a difference of 3 per 1000 patient-years. So maybe roughly 300 patients with atopic dermatitis would need to be seen to observe one patient with depression due to atopic dermatitis (assuming that the observed differences in rates between those with and those without atopic dermatitis were due to the dermatitis). The authors conclude, "Clinicians should inquire about mental health in patients with AD." I don't think their data support such a conclusion. We'd need to see a cost-effectiveness study to know if that's an intervention that we should do. Given the very small difference between the rates in those with and those without atopic dermatitis, it might be reasonable to conclude that we should inquire about mental health in patients with atopic dermatitis about as much as we should in patients without atopic dermatitis.

Some years ago, there was an over-the-counter topical product for psoriasis based on a banana peel extract. I think it was marketed as "FDA approved" for psoriasis (which was legal to say because the product also contained tar) and as being as effective as topical calcipotriene as published in the Journal of Investigational Dermatology (JID). I went to look for the article; the "publication" was the abstract of a poster presentation. The study followed a very small study population for a short period of time. The study was, I believe, underpowered to detect differences between the banana peel extract and the vitamin D analog. Those data were presented as a poster, the poster abstracts were printed in JID, and, voilà, the product was marketed as being as effective as topical calcipotriene as published in JID.

Sowlati and colleagues ("Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children") randomly assigned 42 patients to receive either a xyloglucan/pea protein topical therapy or hydrocortisone. The participants were followed for 2 weeks. Both groups improved. We don't know whether they improved more than they would have with moisturizer. This study doesn't make me excited about prescribing the xyloglucan/pea protein topical.

The study by Mohamed and colleagues comparing tacrolimus and hydrocortisone reminds me that we have an effective generic topical anti-inflammatory for our patients with atopic dermatitis. Given the safety of topical tacrolimus, I prefer prescribing the 0.1% ointment for all my patients, though I give the lower concentration, approved for children, if the insurer makes me.

Simpson and colleagues' post hoc analysis of tralokinumab tells us that, with continued use, some patients who don't respond well initially will have greater improvement. But what I'd really like to see is a head-to-head study comparing tralokinumab vs dupilumab. Dupilumab seems to have stronger efficacy based on their reported trial numbers, but a head-to-head trial would give us greater confidence in their relative benefits.

I have trouble getting excited about this study by Cork and colleagues ("Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age With Severe Atopic Dermatitis"). I feel very comfortable with dupilumab already.

Patients with hand osteoarthritis (OA) and MRI-detected synovitis who took methotrexate (MTX) 20 mg weekly over a 6-month period had a significant and potentially clinically meaningful reduction in pain and stiffness over those who received placebo in the first randomized controlled trial of its kind to show positive results with the drug.

Patients who were randomly assigned to MTX took 10 mg orally for the first 4 weeks then increased to 20 mg for the rest of the trial, with differences in the primary outcome of pain measured by visual analog scale (VAS) first becoming significant over placebo at 3 months.

Senior author of the METHODS study (Methotrexate to Treat Hand Osteoarthritis with Synovitis), Flavia Cicuttini, PhD, MSc, head of the musculoskeletal unit at Monash University and head of rheumatology at Alfred Hospital, Melbourne, Australia, noted that the effect of MTX was higher than effect sizes that have been reported for NSAIDs on pain in hip or knee OA.

Astrid Gast/Thinkstock

The study was published online October 12 in The Lancet.

METHODS makes improvements on past studies

While OA is traditionally categorized as a noninflammatory process, it’s known that there are some patients who have a clinical phenotype characterized by joint swelling (synovitis) and others develop erosive disease. MTX is one of the most common therapies for inflammatory arthritis and standard of care for rheumatoid arthritis (RA) management. Previous studies of methotrexate showed lack of efficacy in hand OA but may have been because of the use of a low dose, poor power due to moderate sample size, and failure to target the specific inflammatory OA phenotype.

Dr. Cicuttini

In an interview, Dr. Cicuttini noted the selection of methotrexate for this trial was intentional. “We considered the evidence and decided to test methotrexate because we know it is effective in inflammatory arthritis, and its mode of action is broader than the more selective anti-TNF [tumor necrosis factor] agents,” which she noted have failed in prior hand OA trials. She also noted that the only previous randomized controlled trial of MTX tested a dose of 10 mg/week, rather than the 20 mg/week dose used in METHODS. 
 

Study details and results

METHODS was a randomized, double-blind, placebo-controlled trial at multiple sites within Australia. Patients were recruited from 2017 to 2022, with a temporary pause in 2020 during the COVID-19 pandemic because of safety concerns regarding MTX use. Participants included in this study were aged 40-75 years, had pain in hand joints for most days in the past 3 months, and a pain score of at least 40 mm on a 100-mm VAS in the past 7 days.

The participants’ hand OA fulfilled American College of Rheumatology criteria, radiographic osteoarthritis (Kellgren and Lawrence grade 2 or more) in at least one joint, and MRI-detected synovitis of grade 1 or more in at least one joint. They excluded patients with concomitant rheumatic disease, gout, psoriasis, positive rheumatoid factor or anti-cyclic citrullinated peptides, or elevated inflammatory markers (erythrocyte sedimentation rate or C-reactive protein), as well as those with contraindication to methotrexate or MRI.

The trials’ 97 participants were assigned 1:1 to MTX or placebo using block randomization. The MTX group started on oral MTX 10 mg weekly for the first 4 weeks, followed by 20 mg weekly for the remainder of the study. Participants took folic acid 5 mg once a day to reduce risk of MTX-related side effects.

The mean age of the participants was 61 years, with 70% female. Baseline characteristics were generally well-balanced, except for higher mean BMI in the MTX group. At 6 months, the MTX group had a greater reduction in mean VAS pain than the placebo group (–15.2 mm vs. –7.7 mm; adjusted between-group difference, –9.9 mm). The minimally clinically important difference for OA trials is a 15-mm change (out of 100) in VAS pain.

The MTX group also had greater reduction in mean Australian Canadian OA Hand Index (AUSCAN) score for pain and stiffness at 6 months, compared with placebo, but there were no differences in other secondary outcomes (mean AUSCAN, Functional Index for Hand Osteoarthritis, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, or grip strength).

MTX was well-tolerated with no serious adverse events related to treatment; only 5 of 50 participants in the MTX group and 4 of 47 in the placebo group discontinued study medication. Incidence of adverse events was similar in the two groups throughout the trial, including mild leukopenia, elevated liver enzymes, mild reduction of hemoglobin, and raised creatinine. None of the laboratory abnormalities required change in medication dosage or affected ability to continue in the study. 
 

Qualifications and considerations for MTX use

Commenting on the study, OA researcher Amanda E. Nelson, MD, MSCR, associate professor of medicine at the University of North Carolina at Chapel Hill’s Thurston Arthritis Research Center, said that its overall design was “excellent,” including appropriate masking, controls, randomization, and power and sample size calculations, contributing to “the trial’s relatively positive, although still modest, results.” Dr. Nelson was not involved with the METHODS study.

Dr. Nelson

Several factors may have contributed to the study’s success, including the broader mechanism of action of methotrexate and higher dose used, Ida K. Haugen, MD, PhD, senior researcher at Diakonhjemmet Hospital’s Center for Treatment of Rheumatic and Musculoskeletal Diseases in Oslo, Norway, told this news organization.

She noted that the MTX 20 mg/week dosage is similar to what is used in treatment of RA and may be key to better targeting inflammation.

Nicolas Tourrenc

“Furthermore, the study included individuals with hand OA and synovitis by MRI, and thus may have found the right patient population in comparison to prior studies,” Dr. Haugen said.

Dr. Cicuttini agreed, noting that “previous trials [of MTX] did not target the inflammatory phenotype of hand osteoarthritis that would be expected to respond.” In the previous randomized controlled trial of MTX in hand OA, only 29 of a total 1024 joints had synovitis, she explained. “Their inclusion criteria were individuals with severe erosive hand osteoarthritis, suggesting that this later-stage disease is less likely to respond.”

Dr. Cicuttini said that she saw no specific issues in regard to potential use of MTX in the OA population in the clinic. “The data we have, together with the large experience we have with using methotrexate and the fact that treatments for hand OA are not very effective, means that it would be reasonable to offer this to patients with hand OA and inflammation,” she said. “The level of evidence for an effect of methotrexate would need to be discussed with the patient. The discussion around the use of methotrexate would then need to proceed in the same way we discuss the use of methotrexate with patients when used for other inflammatory joint diseases, and the decision is then made with the patient.”

In contrast, Dr. Nelson expressed some concerns regarding the immediate use of MTX for this population. “Many individuals with hand OA have multiple medical comorbidities and polypharmacy, which are important when considering additional treatments, particularly those with modest benefit and potential adverse effects over the long term,” she said. “I do not think this single study provides enough evidence to suggest that all such patients should be treated with methotrexate, and more data, particularly about long-term use and optimal risk stratification, is needed.” 

While MTX use in refractory inflammatory hand OA is not yet recommended in international guidelines, Dr. Haugen believes this study supports use of MTX in this patient population. Given that MRI and ultrasound may not always be available to identify synovitis, Dr. Nelson and Dr. Haugen suggested identifying patients who may benefit through careful history and clinical examination for evidence of swollen joints. In addition, Dr. Cicuttini explained that she would not necessarily use MTX in patients with erosive OA radiographically because it may be a later stage of disease that is less likely to respond.

The authors highlighted potential limitations of the METHODS trial. They initially planned to study whether MTX reduced pain and improved radiographic progression at 2 years, but since they paused the study for 7 months during the COVID-19 pandemic, they amended the trial protocol and focused on pain reduction at 6 months as the primary endpoint instead.

Tender and swollen joint counts were initially going to be included, but this was modified given the use of virtual telemedicine visits during the pandemic. Dr. Cicuttini said that further studies are underway to identify potential subpopulations who may benefit from immunosuppression, and others are needed to determine whether MTX reduces joint damage and slows disease progression in hand OA with inflammation.

Dr. Cicuttini said her research group is interested to see whether women who develop hand OA around the time of menopause (“menopausal OA”) are a group that could benefit. Dr. Haugen noted that she is involved in a study testing MTX in erosive hand OA (the MERINO trial). 

The study was funded by a project grant from the National Health and Medical Research Council of Australia. The authors reported no relevant financial relationships.
 

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

Patients with hand osteoarthritis (OA) and MRI-detected synovitis who took methotrexate (MTX) 20 mg weekly over a 6-month period had a significant and potentially clinically meaningful reduction in pain and stiffness over those who received placebo in the first randomized controlled trial of its kind to show positive results with the drug.

Patients who were randomly assigned to MTX took 10 mg orally for the first 4 weeks then increased to 20 mg for the rest of the trial, with differences in the primary outcome of pain measured by visual analog scale (VAS) first becoming significant over placebo at 3 months.

Senior author of the METHODS study (Methotrexate to Treat Hand Osteoarthritis with Synovitis), Flavia Cicuttini, PhD, MSc, head of the musculoskeletal unit at Monash University and head of rheumatology at Alfred Hospital, Melbourne, Australia, noted that the effect of MTX was higher than effect sizes that have been reported for NSAIDs on pain in hip or knee OA.

Astrid Gast/Thinkstock

The study was published online October 12 in The Lancet.

METHODS makes improvements on past studies

While OA is traditionally categorized as a noninflammatory process, it’s known that there are some patients who have a clinical phenotype characterized by joint swelling (synovitis) and others develop erosive disease. MTX is one of the most common therapies for inflammatory arthritis and standard of care for rheumatoid arthritis (RA) management. Previous studies of methotrexate showed lack of efficacy in hand OA but may have been because of the use of a low dose, poor power due to moderate sample size, and failure to target the specific inflammatory OA phenotype.

Dr. Cicuttini

In an interview, Dr. Cicuttini noted the selection of methotrexate for this trial was intentional. “We considered the evidence and decided to test methotrexate because we know it is effective in inflammatory arthritis, and its mode of action is broader than the more selective anti-TNF [tumor necrosis factor] agents,” which she noted have failed in prior hand OA trials. She also noted that the only previous randomized controlled trial of MTX tested a dose of 10 mg/week, rather than the 20 mg/week dose used in METHODS. 
 

Study details and results

METHODS was a randomized, double-blind, placebo-controlled trial at multiple sites within Australia. Patients were recruited from 2017 to 2022, with a temporary pause in 2020 during the COVID-19 pandemic because of safety concerns regarding MTX use. Participants included in this study were aged 40-75 years, had pain in hand joints for most days in the past 3 months, and a pain score of at least 40 mm on a 100-mm VAS in the past 7 days.

The participants’ hand OA fulfilled American College of Rheumatology criteria, radiographic osteoarthritis (Kellgren and Lawrence grade 2 or more) in at least one joint, and MRI-detected synovitis of grade 1 or more in at least one joint. They excluded patients with concomitant rheumatic disease, gout, psoriasis, positive rheumatoid factor or anti-cyclic citrullinated peptides, or elevated inflammatory markers (erythrocyte sedimentation rate or C-reactive protein), as well as those with contraindication to methotrexate or MRI.

The trials’ 97 participants were assigned 1:1 to MTX or placebo using block randomization. The MTX group started on oral MTX 10 mg weekly for the first 4 weeks, followed by 20 mg weekly for the remainder of the study. Participants took folic acid 5 mg once a day to reduce risk of MTX-related side effects.

The mean age of the participants was 61 years, with 70% female. Baseline characteristics were generally well-balanced, except for higher mean BMI in the MTX group. At 6 months, the MTX group had a greater reduction in mean VAS pain than the placebo group (–15.2 mm vs. –7.7 mm; adjusted between-group difference, –9.9 mm). The minimally clinically important difference for OA trials is a 15-mm change (out of 100) in VAS pain.

The MTX group also had greater reduction in mean Australian Canadian OA Hand Index (AUSCAN) score for pain and stiffness at 6 months, compared with placebo, but there were no differences in other secondary outcomes (mean AUSCAN, Functional Index for Hand Osteoarthritis, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, or grip strength).

MTX was well-tolerated with no serious adverse events related to treatment; only 5 of 50 participants in the MTX group and 4 of 47 in the placebo group discontinued study medication. Incidence of adverse events was similar in the two groups throughout the trial, including mild leukopenia, elevated liver enzymes, mild reduction of hemoglobin, and raised creatinine. None of the laboratory abnormalities required change in medication dosage or affected ability to continue in the study. 
 

Qualifications and considerations for MTX use

Commenting on the study, OA researcher Amanda E. Nelson, MD, MSCR, associate professor of medicine at the University of North Carolina at Chapel Hill’s Thurston Arthritis Research Center, said that its overall design was “excellent,” including appropriate masking, controls, randomization, and power and sample size calculations, contributing to “the trial’s relatively positive, although still modest, results.” Dr. Nelson was not involved with the METHODS study.

Dr. Nelson

Several factors may have contributed to the study’s success, including the broader mechanism of action of methotrexate and higher dose used, Ida K. Haugen, MD, PhD, senior researcher at Diakonhjemmet Hospital’s Center for Treatment of Rheumatic and Musculoskeletal Diseases in Oslo, Norway, told this news organization.

She noted that the MTX 20 mg/week dosage is similar to what is used in treatment of RA and may be key to better targeting inflammation.

Nicolas Tourrenc

“Furthermore, the study included individuals with hand OA and synovitis by MRI, and thus may have found the right patient population in comparison to prior studies,” Dr. Haugen said.

Dr. Cicuttini agreed, noting that “previous trials [of MTX] did not target the inflammatory phenotype of hand osteoarthritis that would be expected to respond.” In the previous randomized controlled trial of MTX in hand OA, only 29 of a total 1024 joints had synovitis, she explained. “Their inclusion criteria were individuals with severe erosive hand osteoarthritis, suggesting that this later-stage disease is less likely to respond.”

Dr. Cicuttini said that she saw no specific issues in regard to potential use of MTX in the OA population in the clinic. “The data we have, together with the large experience we have with using methotrexate and the fact that treatments for hand OA are not very effective, means that it would be reasonable to offer this to patients with hand OA and inflammation,” she said. “The level of evidence for an effect of methotrexate would need to be discussed with the patient. The discussion around the use of methotrexate would then need to proceed in the same way we discuss the use of methotrexate with patients when used for other inflammatory joint diseases, and the decision is then made with the patient.”

In contrast, Dr. Nelson expressed some concerns regarding the immediate use of MTX for this population. “Many individuals with hand OA have multiple medical comorbidities and polypharmacy, which are important when considering additional treatments, particularly those with modest benefit and potential adverse effects over the long term,” she said. “I do not think this single study provides enough evidence to suggest that all such patients should be treated with methotrexate, and more data, particularly about long-term use and optimal risk stratification, is needed.” 

While MTX use in refractory inflammatory hand OA is not yet recommended in international guidelines, Dr. Haugen believes this study supports use of MTX in this patient population. Given that MRI and ultrasound may not always be available to identify synovitis, Dr. Nelson and Dr. Haugen suggested identifying patients who may benefit through careful history and clinical examination for evidence of swollen joints. In addition, Dr. Cicuttini explained that she would not necessarily use MTX in patients with erosive OA radiographically because it may be a later stage of disease that is less likely to respond.

The authors highlighted potential limitations of the METHODS trial. They initially planned to study whether MTX reduced pain and improved radiographic progression at 2 years, but since they paused the study for 7 months during the COVID-19 pandemic, they amended the trial protocol and focused on pain reduction at 6 months as the primary endpoint instead.

Tender and swollen joint counts were initially going to be included, but this was modified given the use of virtual telemedicine visits during the pandemic. Dr. Cicuttini said that further studies are underway to identify potential subpopulations who may benefit from immunosuppression, and others are needed to determine whether MTX reduces joint damage and slows disease progression in hand OA with inflammation.

Dr. Cicuttini said her research group is interested to see whether women who develop hand OA around the time of menopause (“menopausal OA”) are a group that could benefit. Dr. Haugen noted that she is involved in a study testing MTX in erosive hand OA (the MERINO trial). 

The study was funded by a project grant from the National Health and Medical Research Council of Australia. The authors reported no relevant financial relationships.
 

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

Patients with hand osteoarthritis (OA) and MRI-detected synovitis who took methotrexate (MTX) 20 mg weekly over a 6-month period had a significant and potentially clinically meaningful reduction in pain and stiffness over those who received placebo in the first randomized controlled trial of its kind to show positive results with the drug.

Patients who were randomly assigned to MTX took 10 mg orally for the first 4 weeks then increased to 20 mg for the rest of the trial, with differences in the primary outcome of pain measured by visual analog scale (VAS) first becoming significant over placebo at 3 months.

Senior author of the METHODS study (Methotrexate to Treat Hand Osteoarthritis with Synovitis), Flavia Cicuttini, PhD, MSc, head of the musculoskeletal unit at Monash University and head of rheumatology at Alfred Hospital, Melbourne, Australia, noted that the effect of MTX was higher than effect sizes that have been reported for NSAIDs on pain in hip or knee OA.

Astrid Gast/Thinkstock

The study was published online October 12 in The Lancet.

METHODS makes improvements on past studies

While OA is traditionally categorized as a noninflammatory process, it’s known that there are some patients who have a clinical phenotype characterized by joint swelling (synovitis) and others develop erosive disease. MTX is one of the most common therapies for inflammatory arthritis and standard of care for rheumatoid arthritis (RA) management. Previous studies of methotrexate showed lack of efficacy in hand OA but may have been because of the use of a low dose, poor power due to moderate sample size, and failure to target the specific inflammatory OA phenotype.

Dr. Cicuttini

In an interview, Dr. Cicuttini noted the selection of methotrexate for this trial was intentional. “We considered the evidence and decided to test methotrexate because we know it is effective in inflammatory arthritis, and its mode of action is broader than the more selective anti-TNF [tumor necrosis factor] agents,” which she noted have failed in prior hand OA trials. She also noted that the only previous randomized controlled trial of MTX tested a dose of 10 mg/week, rather than the 20 mg/week dose used in METHODS. 
 

Study details and results

METHODS was a randomized, double-blind, placebo-controlled trial at multiple sites within Australia. Patients were recruited from 2017 to 2022, with a temporary pause in 2020 during the COVID-19 pandemic because of safety concerns regarding MTX use. Participants included in this study were aged 40-75 years, had pain in hand joints for most days in the past 3 months, and a pain score of at least 40 mm on a 100-mm VAS in the past 7 days.

The participants’ hand OA fulfilled American College of Rheumatology criteria, radiographic osteoarthritis (Kellgren and Lawrence grade 2 or more) in at least one joint, and MRI-detected synovitis of grade 1 or more in at least one joint. They excluded patients with concomitant rheumatic disease, gout, psoriasis, positive rheumatoid factor or anti-cyclic citrullinated peptides, or elevated inflammatory markers (erythrocyte sedimentation rate or C-reactive protein), as well as those with contraindication to methotrexate or MRI.

The trials’ 97 participants were assigned 1:1 to MTX or placebo using block randomization. The MTX group started on oral MTX 10 mg weekly for the first 4 weeks, followed by 20 mg weekly for the remainder of the study. Participants took folic acid 5 mg once a day to reduce risk of MTX-related side effects.

The mean age of the participants was 61 years, with 70% female. Baseline characteristics were generally well-balanced, except for higher mean BMI in the MTX group. At 6 months, the MTX group had a greater reduction in mean VAS pain than the placebo group (–15.2 mm vs. –7.7 mm; adjusted between-group difference, –9.9 mm). The minimally clinically important difference for OA trials is a 15-mm change (out of 100) in VAS pain.

The MTX group also had greater reduction in mean Australian Canadian OA Hand Index (AUSCAN) score for pain and stiffness at 6 months, compared with placebo, but there were no differences in other secondary outcomes (mean AUSCAN, Functional Index for Hand Osteoarthritis, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, or grip strength).

MTX was well-tolerated with no serious adverse events related to treatment; only 5 of 50 participants in the MTX group and 4 of 47 in the placebo group discontinued study medication. Incidence of adverse events was similar in the two groups throughout the trial, including mild leukopenia, elevated liver enzymes, mild reduction of hemoglobin, and raised creatinine. None of the laboratory abnormalities required change in medication dosage or affected ability to continue in the study. 
 

Qualifications and considerations for MTX use

Commenting on the study, OA researcher Amanda E. Nelson, MD, MSCR, associate professor of medicine at the University of North Carolina at Chapel Hill’s Thurston Arthritis Research Center, said that its overall design was “excellent,” including appropriate masking, controls, randomization, and power and sample size calculations, contributing to “the trial’s relatively positive, although still modest, results.” Dr. Nelson was not involved with the METHODS study.

Dr. Nelson

Several factors may have contributed to the study’s success, including the broader mechanism of action of methotrexate and higher dose used, Ida K. Haugen, MD, PhD, senior researcher at Diakonhjemmet Hospital’s Center for Treatment of Rheumatic and Musculoskeletal Diseases in Oslo, Norway, told this news organization.

She noted that the MTX 20 mg/week dosage is similar to what is used in treatment of RA and may be key to better targeting inflammation.

Nicolas Tourrenc

“Furthermore, the study included individuals with hand OA and synovitis by MRI, and thus may have found the right patient population in comparison to prior studies,” Dr. Haugen said.

Dr. Cicuttini agreed, noting that “previous trials [of MTX] did not target the inflammatory phenotype of hand osteoarthritis that would be expected to respond.” In the previous randomized controlled trial of MTX in hand OA, only 29 of a total 1024 joints had synovitis, she explained. “Their inclusion criteria were individuals with severe erosive hand osteoarthritis, suggesting that this later-stage disease is less likely to respond.”

Dr. Cicuttini said that she saw no specific issues in regard to potential use of MTX in the OA population in the clinic. “The data we have, together with the large experience we have with using methotrexate and the fact that treatments for hand OA are not very effective, means that it would be reasonable to offer this to patients with hand OA and inflammation,” she said. “The level of evidence for an effect of methotrexate would need to be discussed with the patient. The discussion around the use of methotrexate would then need to proceed in the same way we discuss the use of methotrexate with patients when used for other inflammatory joint diseases, and the decision is then made with the patient.”

In contrast, Dr. Nelson expressed some concerns regarding the immediate use of MTX for this population. “Many individuals with hand OA have multiple medical comorbidities and polypharmacy, which are important when considering additional treatments, particularly those with modest benefit and potential adverse effects over the long term,” she said. “I do not think this single study provides enough evidence to suggest that all such patients should be treated with methotrexate, and more data, particularly about long-term use and optimal risk stratification, is needed.” 

While MTX use in refractory inflammatory hand OA is not yet recommended in international guidelines, Dr. Haugen believes this study supports use of MTX in this patient population. Given that MRI and ultrasound may not always be available to identify synovitis, Dr. Nelson and Dr. Haugen suggested identifying patients who may benefit through careful history and clinical examination for evidence of swollen joints. In addition, Dr. Cicuttini explained that she would not necessarily use MTX in patients with erosive OA radiographically because it may be a later stage of disease that is less likely to respond.

The authors highlighted potential limitations of the METHODS trial. They initially planned to study whether MTX reduced pain and improved radiographic progression at 2 years, but since they paused the study for 7 months during the COVID-19 pandemic, they amended the trial protocol and focused on pain reduction at 6 months as the primary endpoint instead.

Tender and swollen joint counts were initially going to be included, but this was modified given the use of virtual telemedicine visits during the pandemic. Dr. Cicuttini said that further studies are underway to identify potential subpopulations who may benefit from immunosuppression, and others are needed to determine whether MTX reduces joint damage and slows disease progression in hand OA with inflammation.

Dr. Cicuttini said her research group is interested to see whether women who develop hand OA around the time of menopause (“menopausal OA”) are a group that could benefit. Dr. Haugen noted that she is involved in a study testing MTX in erosive hand OA (the MERINO trial). 

The study was funded by a project grant from the National Health and Medical Research Council of Australia. The authors reported no relevant financial relationships.
 

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

Key abstracts on multiple sclerosis treatment from the 2023 European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) meeting are reported by Dr Ellen Mowry of Johns Hopkins University.

Dr Mowry begins with a convenient alternative method of drug administration in patients with multiple sclerosis (MS). The phase 3 OCARINA II randomized trial showed promising results in safety and efficacy of subcutaneous ocrelizumab vs traditional longer intravenous infusion. Ocrelizumab is pending US Food and Drug Administration approval.

Next, Dr Mowry highlights two studies that examined known increased risks associated with anti-CD20 therapies. Dr Mowry discusses the importance of continued research into monitoring immunoglobin levels to determine dose escalation or extended interval dosing in patients with MS.

She then discusses the NEXT MS trial that looked at personalized dosing of natalizumab. The interim data indicate a dosing schedule that aims to maintain blood levels of the drug above a certain threshold appears as effective in controlling disease activity in relapsing-remitting MS (RRMS) as the approved 4-week dosing schedule.

Finally, Dr Mowry discusses a phase 2 randomized trial of the gold nanoparticle CNM-Au8, which has been used to treat other autoimmune diseases, to determine its potential benefits in RRMS.

--

Ellen Mowry, MD, MCR, Professor of Neurology & Epidemiology, Johns Hopkins University, Baltimore, Maryland

Ellen Mowry, MD, MCR, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: BeCareLink, LLC

Received research grant from: Biogen; Genentech

Received royalties from: UpToDate

Key abstracts on multiple sclerosis treatment from the 2023 European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) meeting are reported by Dr Ellen Mowry of Johns Hopkins University.

Dr Mowry begins with a convenient alternative method of drug administration in patients with multiple sclerosis (MS). The phase 3 OCARINA II randomized trial showed promising results in safety and efficacy of subcutaneous ocrelizumab vs traditional longer intravenous infusion. Ocrelizumab is pending US Food and Drug Administration approval.

Next, Dr Mowry highlights two studies that examined known increased risks associated with anti-CD20 therapies. Dr Mowry discusses the importance of continued research into monitoring immunoglobin levels to determine dose escalation or extended interval dosing in patients with MS.

She then discusses the NEXT MS trial that looked at personalized dosing of natalizumab. The interim data indicate a dosing schedule that aims to maintain blood levels of the drug above a certain threshold appears as effective in controlling disease activity in relapsing-remitting MS (RRMS) as the approved 4-week dosing schedule.

Finally, Dr Mowry discusses a phase 2 randomized trial of the gold nanoparticle CNM-Au8, which has been used to treat other autoimmune diseases, to determine its potential benefits in RRMS.

--

Ellen Mowry, MD, MCR, Professor of Neurology & Epidemiology, Johns Hopkins University, Baltimore, Maryland

Ellen Mowry, MD, MCR, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: BeCareLink, LLC

Received research grant from: Biogen; Genentech

Received royalties from: UpToDate

Key abstracts on multiple sclerosis treatment from the 2023 European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) meeting are reported by Dr Ellen Mowry of Johns Hopkins University.

Dr Mowry begins with a convenient alternative method of drug administration in patients with multiple sclerosis (MS). The phase 3 OCARINA II randomized trial showed promising results in safety and efficacy of subcutaneous ocrelizumab vs traditional longer intravenous infusion. Ocrelizumab is pending US Food and Drug Administration approval.

Next, Dr Mowry highlights two studies that examined known increased risks associated with anti-CD20 therapies. Dr Mowry discusses the importance of continued research into monitoring immunoglobin levels to determine dose escalation or extended interval dosing in patients with MS.

She then discusses the NEXT MS trial that looked at personalized dosing of natalizumab. The interim data indicate a dosing schedule that aims to maintain blood levels of the drug above a certain threshold appears as effective in controlling disease activity in relapsing-remitting MS (RRMS) as the approved 4-week dosing schedule.

Finally, Dr Mowry discusses a phase 2 randomized trial of the gold nanoparticle CNM-Au8, which has been used to treat other autoimmune diseases, to determine its potential benefits in RRMS.

--

Ellen Mowry, MD, MCR, Professor of Neurology & Epidemiology, Johns Hopkins University, Baltimore, Maryland

Ellen Mowry, MD, MCR, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: BeCareLink, LLC

Received research grant from: Biogen; Genentech

Received royalties from: UpToDate

TOPLINE:

Treatment with two naturally occurring psychedelics was associated with reduced depressive and anxiety symptoms in trauma-exposed U.S. Special Operations Forces Veterans (SOFVs), according to a new study. Perhaps most surprising to investigators, however, was that treatment was also associated with improved cognitive scores in the veterans, many of whom had traumatic brain injuries.

METHODOLOGY:

• Investigators reviewed clinical charts of 86 SOFVs who received psychedelic-assisted treatment at a therapeutic program in Mexico, 86% of whom sustained head injuries during deployment.
• On the first day of the study, participants received a single oral dose (10 mg/kg) of ibogaine hydrochloride in a group setting with two to five other attendees and spent the next day reflecting on their experience with program staff.
• On the third day, participants inhaled 5-MeO-DMT in three incremental doses for a total of 50 mg and were then invited to reflect on their experience both individually and with the group of peers who shared the experience.
• Follow-up surveys at 1, 3, and 6 months posttreatment between September 2019 to March 2021 measured symptoms of posttraumatic stress disorder, cognitive functioning, generalized anxiety disorder, depression, and quality of life.

TAKEAWAY:

• There were significant improvements in self-reported PTSD symptoms, depression, anxiety, insomnia severity, anger, and a large improvement in self-reported satisfaction with life (P < .001 for all).
• Participants reported significant increases in psychological flexibility (P < .001), cognitive functioning (P < .001), and postconcussive symptoms (P < .001).
• Treatment was also associated with a significant reduction in suicidal ideation from pretreatment to 1-month follow-up (P < .01).

IN PRACTICE:

“If consistently replicated, this could have major implications for the landscape of mental health care if people are able to experience significant and sustained healing with 3 days of intensive treatment, relative to our traditionally available interventions that require 8-12 weeks of weekly therapy (for example, gold standard talk therapies such as [prolonged exposure] or [cognitive processing therapy]), or daily use of a pharmacotherapy such as [a selective serotonin reuptake inhibitor] for months to years,” study authors write.

SOURCE:

Alan Kooi Davis, PhD, of the Center for Psychedelic Drug Research and Education at Ohio State University, led the study, which was published online  in the American Journal of Drug and Alcohol Abuse.

LIMITATIONS:

Study assessments are based solely on self-report measures. Future research should implement carefully designed batteries that include both self-report and gold-standard clinician-administered measures to better capture symptom improvement and other information. The sample also lacked diversity with regard to race, religion, and socioeconomic status.

DISCLOSURES:

The study was funded by Veterans Exploring Treatment Solutions. Dr. Davis is a board member at Source Resource Foundation and a lead trainer at Fluence. Full disclosures are included in the original article.

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

TOPLINE:

Treatment with two naturally occurring psychedelics was associated with reduced depressive and anxiety symptoms in trauma-exposed U.S. Special Operations Forces Veterans (SOFVs), according to a new study. Perhaps most surprising to investigators, however, was that treatment was also associated with improved cognitive scores in the veterans, many of whom had traumatic brain injuries.

METHODOLOGY:

• Investigators reviewed clinical charts of 86 SOFVs who received psychedelic-assisted treatment at a therapeutic program in Mexico, 86% of whom sustained head injuries during deployment.
• On the first day of the study, participants received a single oral dose (10 mg/kg) of ibogaine hydrochloride in a group setting with two to five other attendees and spent the next day reflecting on their experience with program staff.
• On the third day, participants inhaled 5-MeO-DMT in three incremental doses for a total of 50 mg and were then invited to reflect on their experience both individually and with the group of peers who shared the experience.
• Follow-up surveys at 1, 3, and 6 months posttreatment between September 2019 to March 2021 measured symptoms of posttraumatic stress disorder, cognitive functioning, generalized anxiety disorder, depression, and quality of life.

TAKEAWAY:

• There were significant improvements in self-reported PTSD symptoms, depression, anxiety, insomnia severity, anger, and a large improvement in self-reported satisfaction with life (P < .001 for all).
• Participants reported significant increases in psychological flexibility (P < .001), cognitive functioning (P < .001), and postconcussive symptoms (P < .001).
• Treatment was also associated with a significant reduction in suicidal ideation from pretreatment to 1-month follow-up (P < .01).

IN PRACTICE:

“If consistently replicated, this could have major implications for the landscape of mental health care if people are able to experience significant and sustained healing with 3 days of intensive treatment, relative to our traditionally available interventions that require 8-12 weeks of weekly therapy (for example, gold standard talk therapies such as [prolonged exposure] or [cognitive processing therapy]), or daily use of a pharmacotherapy such as [a selective serotonin reuptake inhibitor] for months to years,” study authors write.

SOURCE:

Alan Kooi Davis, PhD, of the Center for Psychedelic Drug Research and Education at Ohio State University, led the study, which was published online  in the American Journal of Drug and Alcohol Abuse.

LIMITATIONS:

Study assessments are based solely on self-report measures. Future research should implement carefully designed batteries that include both self-report and gold-standard clinician-administered measures to better capture symptom improvement and other information. The sample also lacked diversity with regard to race, religion, and socioeconomic status.

DISCLOSURES:

The study was funded by Veterans Exploring Treatment Solutions. Dr. Davis is a board member at Source Resource Foundation and a lead trainer at Fluence. Full disclosures are included in the original article.

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

TOPLINE:

Treatment with two naturally occurring psychedelics was associated with reduced depressive and anxiety symptoms in trauma-exposed U.S. Special Operations Forces Veterans (SOFVs), according to a new study. Perhaps most surprising to investigators, however, was that treatment was also associated with improved cognitive scores in the veterans, many of whom had traumatic brain injuries.

METHODOLOGY:

• Investigators reviewed clinical charts of 86 SOFVs who received psychedelic-assisted treatment at a therapeutic program in Mexico, 86% of whom sustained head injuries during deployment.
• On the first day of the study, participants received a single oral dose (10 mg/kg) of ibogaine hydrochloride in a group setting with two to five other attendees and spent the next day reflecting on their experience with program staff.
• On the third day, participants inhaled 5-MeO-DMT in three incremental doses for a total of 50 mg and were then invited to reflect on their experience both individually and with the group of peers who shared the experience.
• Follow-up surveys at 1, 3, and 6 months posttreatment between September 2019 to March 2021 measured symptoms of posttraumatic stress disorder, cognitive functioning, generalized anxiety disorder, depression, and quality of life.

TAKEAWAY:

• There were significant improvements in self-reported PTSD symptoms, depression, anxiety, insomnia severity, anger, and a large improvement in self-reported satisfaction with life (P < .001 for all).
• Participants reported significant increases in psychological flexibility (P < .001), cognitive functioning (P < .001), and postconcussive symptoms (P < .001).
• Treatment was also associated with a significant reduction in suicidal ideation from pretreatment to 1-month follow-up (P < .01).

IN PRACTICE:

“If consistently replicated, this could have major implications for the landscape of mental health care if people are able to experience significant and sustained healing with 3 days of intensive treatment, relative to our traditionally available interventions that require 8-12 weeks of weekly therapy (for example, gold standard talk therapies such as [prolonged exposure] or [cognitive processing therapy]), or daily use of a pharmacotherapy such as [a selective serotonin reuptake inhibitor] for months to years,” study authors write.

SOURCE:

Alan Kooi Davis, PhD, of the Center for Psychedelic Drug Research and Education at Ohio State University, led the study, which was published online  in the American Journal of Drug and Alcohol Abuse.

LIMITATIONS:

Study assessments are based solely on self-report measures. Future research should implement carefully designed batteries that include both self-report and gold-standard clinician-administered measures to better capture symptom improvement and other information. The sample also lacked diversity with regard to race, religion, and socioeconomic status.

DISCLOSURES:

The study was funded by Veterans Exploring Treatment Solutions. Dr. Davis is a board member at Source Resource Foundation and a lead trainer at Fluence. Full disclosures are included in the original article.

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

TOPLINE:

New research suggests that long-term exposure to air pollution during and after pregnancy increases the risk of postpartum depression (PPD), adding to prior research linking air pollution to mental health issues.

METHODOLOGY:

• Researchers analyzed data on 340,679 women who had singleton live births at Kaiser Permanente Southern California facilities between 2008 and 2016.
• Ambient air pollution exposures were assessed based on maternal residential addresses using monthly averages of particulate matter ≤ 2.5 mcm (PM_2.5), PM ≤ 10 mcm (PM₁₀), nitrogen dioxide, and ozone from Environmental Protection Agency monitoring stations.
• Constituents of PM_2.5 (sulfate, nitrate, ammonium, organic matter, and black carbon) were obtained from models based on satellite, ground-based monitor, and chemical transport modeling data.
• Women with an Edinburgh Postnatal Depression Scale score of at least 10 during the first 6 months postpartum were referred for further assessment, including diagnosis and treatment.

TAKEAWAY:

• A total of 25,674 women had PPD (7.5%).
• Positive associations were observed between PPD ozone (adjusted odds ratio, 1.09), PM₁₀ (aOR, 1.02), and PM_2.5 (aOR, 1.02), with no statistically significant association with nitrogen dioxide.
• Among PM_2.5 constituents, black carbon had the strongest association with PPD (OR 1.04).
• Overall, a higher risk of PPD was associated with ozone exposure during the entire pregnancy and postpartum periods and with PM exposure during the late pregnancy and postpartum periods.

IN PRACTICE:

“These findings suggest that long-term antepartum and postpartum air pollution exposure is a potentially modifiable environmental risk factor for PPD and an important public health issue to address for improved maternal mental health,” the authors wrote.

SOURCE:

The study, with first author Yi Sun, PhD, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, was published online in JAMA Network Open.

LIMITATIONS:

Postpartum exposures were estimated using only maternal address at delivery, which may have led to exposure misclassification. Potential exposure misclassifications may also exist since indoor and personal exposure levels could not be estimated. Although several covariates were adjusted for, some residual or unmeasured covariates were inevitable due to data unavailability, such as psychiatric history, adverse life events, and marital status, which may affect mental health.

DISCLOSURES:

This study was supported by a grant from the National Institute of Environmental Health Sciences. The authors report no relevant financial relationships.

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

TOPLINE:

New research suggests that long-term exposure to air pollution during and after pregnancy increases the risk of postpartum depression (PPD), adding to prior research linking air pollution to mental health issues.

METHODOLOGY:

• Researchers analyzed data on 340,679 women who had singleton live births at Kaiser Permanente Southern California facilities between 2008 and 2016.
• Ambient air pollution exposures were assessed based on maternal residential addresses using monthly averages of particulate matter ≤ 2.5 mcm (PM_2.5), PM ≤ 10 mcm (PM₁₀), nitrogen dioxide, and ozone from Environmental Protection Agency monitoring stations.
• Constituents of PM_2.5 (sulfate, nitrate, ammonium, organic matter, and black carbon) were obtained from models based on satellite, ground-based monitor, and chemical transport modeling data.
• Women with an Edinburgh Postnatal Depression Scale score of at least 10 during the first 6 months postpartum were referred for further assessment, including diagnosis and treatment.

TAKEAWAY:

• A total of 25,674 women had PPD (7.5%).
• Positive associations were observed between PPD ozone (adjusted odds ratio, 1.09), PM₁₀ (aOR, 1.02), and PM_2.5 (aOR, 1.02), with no statistically significant association with nitrogen dioxide.
• Among PM_2.5 constituents, black carbon had the strongest association with PPD (OR 1.04).
• Overall, a higher risk of PPD was associated with ozone exposure during the entire pregnancy and postpartum periods and with PM exposure during the late pregnancy and postpartum periods.

IN PRACTICE:

“These findings suggest that long-term antepartum and postpartum air pollution exposure is a potentially modifiable environmental risk factor for PPD and an important public health issue to address for improved maternal mental health,” the authors wrote.

SOURCE:

The study, with first author Yi Sun, PhD, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, was published online in JAMA Network Open.

LIMITATIONS:

Postpartum exposures were estimated using only maternal address at delivery, which may have led to exposure misclassification. Potential exposure misclassifications may also exist since indoor and personal exposure levels could not be estimated. Although several covariates were adjusted for, some residual or unmeasured covariates were inevitable due to data unavailability, such as psychiatric history, adverse life events, and marital status, which may affect mental health.

DISCLOSURES:

This study was supported by a grant from the National Institute of Environmental Health Sciences. The authors report no relevant financial relationships.

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

TOPLINE:

New research suggests that long-term exposure to air pollution during and after pregnancy increases the risk of postpartum depression (PPD), adding to prior research linking air pollution to mental health issues.

METHODOLOGY:

• Researchers analyzed data on 340,679 women who had singleton live births at Kaiser Permanente Southern California facilities between 2008 and 2016.
• Ambient air pollution exposures were assessed based on maternal residential addresses using monthly averages of particulate matter ≤ 2.5 mcm (PM_2.5), PM ≤ 10 mcm (PM₁₀), nitrogen dioxide, and ozone from Environmental Protection Agency monitoring stations.
• Constituents of PM_2.5 (sulfate, nitrate, ammonium, organic matter, and black carbon) were obtained from models based on satellite, ground-based monitor, and chemical transport modeling data.
• Women with an Edinburgh Postnatal Depression Scale score of at least 10 during the first 6 months postpartum were referred for further assessment, including diagnosis and treatment.

TAKEAWAY:

• A total of 25,674 women had PPD (7.5%).
• Positive associations were observed between PPD ozone (adjusted odds ratio, 1.09), PM₁₀ (aOR, 1.02), and PM_2.5 (aOR, 1.02), with no statistically significant association with nitrogen dioxide.
• Among PM_2.5 constituents, black carbon had the strongest association with PPD (OR 1.04).
• Overall, a higher risk of PPD was associated with ozone exposure during the entire pregnancy and postpartum periods and with PM exposure during the late pregnancy and postpartum periods.

IN PRACTICE:

“These findings suggest that long-term antepartum and postpartum air pollution exposure is a potentially modifiable environmental risk factor for PPD and an important public health issue to address for improved maternal mental health,” the authors wrote.

SOURCE:

The study, with first author Yi Sun, PhD, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, was published online in JAMA Network Open.

LIMITATIONS:

Postpartum exposures were estimated using only maternal address at delivery, which may have led to exposure misclassification. Potential exposure misclassifications may also exist since indoor and personal exposure levels could not be estimated. Although several covariates were adjusted for, some residual or unmeasured covariates were inevitable due to data unavailability, such as psychiatric history, adverse life events, and marital status, which may affect mental health.

DISCLOSURES:

This study was supported by a grant from the National Institute of Environmental Health Sciences. The authors report no relevant financial relationships.

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

The anti-inflammatory agent colchicine, started within 24 hours of acute ischemic stroke or a transient ischemic attack (TIA), was not associated with a reduction in subsequent strokes or other vascular events at 90 days in the CHANCE-3 trial.

The results were presented by Yongjun Wang, MD, Beijing Tiantan Hospital, Capital Medical University, at the annual World Stroke Congress, sponsored by the World Stroke Organization.

Dr. Wang noted that inflammation may be a key factor involved in the residual risk for recurrent stroke, with data from previous CHANCE trials suggesting a higher stroke recurrence rate in patients with higher levels of high-sensitivity C-reactive protein (hsCRP), a key marker of inflammation.

Low-dose colchicine, which acts as an anti-inflammatory agent, has recently been approved in many countries for patients with established atherosclerotic disease or multiple risk factors for cardiovascular disease to reduce the risk for future cardiovascular events. This follows benefits seen in those populations in the LoDoCo-2 and COLCOT trials.

The CHANCE-3 study was conducted to evaluate whether similar benefits could be found in patients with acute ischemic stroke.

The trial involved 8,369 Chinese patients with minor to moderate ischemic stroke (National Institutes of Health Stroke Scale score ≤ 5) or high-risk TIA (ABCD2 score ≥ 4) who had an hsCRP level of at least 2 mg/L.

Patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive colchicine (1 mg daily on days 1-3, followed by 0.5 mg daily for a total of 90 days) or placebo, on a background of optimal medical therapy.

The primary outcome was any stroke within 90 days. The key secondary outcomes included a composite of stroke, TIA, myocardial infarction, and vascular death within 90 days, and Modified Rankin Scale score greater than 1 at 90 days.

Results showed that the primary outcome of any stroke at 90 days occurred in 6.3% of the colchicine group versus 6.5% of the placebo group, a nonsignificant difference (P = .79).

All secondary outcomes were also neutral, with no differences between the two groups.

Addressing the different results in CHANCE-3, compared with those of the cardiovascular trials of colchicine, Dr. Wang pointed out that the cardiovascular trials had a much longer treatment and follow-up time (an average of 22 months), compared with just 3 months in CHANCE-3.

“Clinical trials with longer treatment times are needed to further assess the effects of colchicine after cerebrovascular events, but it may be that ischemic cerebrovascular disease and ischemic heart disease respond differently to colchicine treatment,” he concluded.

Commenting on the study, cochair of the WSC session at which it was presented, Ashkan Shoamanesh, MD, associate professor of medicine at McMaster University, Hamilton, Ont., said CHANCE-3 was a well-designed large phase 3 randomized trial and the first such trial to test colchicine for secondary stroke prevention. 

He agreed with Dr. Wang that the follow-up duration for this initial analysis of 3-month outcomes may have been too short to see an effect.

“So, we require randomized trials with longer follow-up prior to abandoning this potential treatment,” he added. 

Dr. Shoamanesh noted that several additional trials are currently ongoing testing colchicine for secondary prevention in patients with stroke. These include the CONVINCE, CASPER, CoVasc-ICH, and RIISC-THETIS trials.

He also pointed out that, in contrast to ischemic heart disease, which results from atherosclerosis, the mechanisms underlying ischemic stroke are more heterogeneous and include various vascular and cardioembolic pathologies.

The CHANCE-3 study was funded by grants from the National Natural Science Foundation of China, the Ministry of Science and Technology of China, the Chinese Academy of Medical Sciences, and the Beijing Municipal Health Commission.

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

The anti-inflammatory agent colchicine, started within 24 hours of acute ischemic stroke or a transient ischemic attack (TIA), was not associated with a reduction in subsequent strokes or other vascular events at 90 days in the CHANCE-3 trial.

The results were presented by Yongjun Wang, MD, Beijing Tiantan Hospital, Capital Medical University, at the annual World Stroke Congress, sponsored by the World Stroke Organization.

Dr. Wang noted that inflammation may be a key factor involved in the residual risk for recurrent stroke, with data from previous CHANCE trials suggesting a higher stroke recurrence rate in patients with higher levels of high-sensitivity C-reactive protein (hsCRP), a key marker of inflammation.

Low-dose colchicine, which acts as an anti-inflammatory agent, has recently been approved in many countries for patients with established atherosclerotic disease or multiple risk factors for cardiovascular disease to reduce the risk for future cardiovascular events. This follows benefits seen in those populations in the LoDoCo-2 and COLCOT trials.

The CHANCE-3 study was conducted to evaluate whether similar benefits could be found in patients with acute ischemic stroke.

The trial involved 8,369 Chinese patients with minor to moderate ischemic stroke (National Institutes of Health Stroke Scale score ≤ 5) or high-risk TIA (ABCD2 score ≥ 4) who had an hsCRP level of at least 2 mg/L.

Patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive colchicine (1 mg daily on days 1-3, followed by 0.5 mg daily for a total of 90 days) or placebo, on a background of optimal medical therapy.

The primary outcome was any stroke within 90 days. The key secondary outcomes included a composite of stroke, TIA, myocardial infarction, and vascular death within 90 days, and Modified Rankin Scale score greater than 1 at 90 days.

Results showed that the primary outcome of any stroke at 90 days occurred in 6.3% of the colchicine group versus 6.5% of the placebo group, a nonsignificant difference (P = .79).

All secondary outcomes were also neutral, with no differences between the two groups.

Addressing the different results in CHANCE-3, compared with those of the cardiovascular trials of colchicine, Dr. Wang pointed out that the cardiovascular trials had a much longer treatment and follow-up time (an average of 22 months), compared with just 3 months in CHANCE-3.

“Clinical trials with longer treatment times are needed to further assess the effects of colchicine after cerebrovascular events, but it may be that ischemic cerebrovascular disease and ischemic heart disease respond differently to colchicine treatment,” he concluded.

Commenting on the study, cochair of the WSC session at which it was presented, Ashkan Shoamanesh, MD, associate professor of medicine at McMaster University, Hamilton, Ont., said CHANCE-3 was a well-designed large phase 3 randomized trial and the first such trial to test colchicine for secondary stroke prevention. 

He agreed with Dr. Wang that the follow-up duration for this initial analysis of 3-month outcomes may have been too short to see an effect.

“So, we require randomized trials with longer follow-up prior to abandoning this potential treatment,” he added. 

Dr. Shoamanesh noted that several additional trials are currently ongoing testing colchicine for secondary prevention in patients with stroke. These include the CONVINCE, CASPER, CoVasc-ICH, and RIISC-THETIS trials.

He also pointed out that, in contrast to ischemic heart disease, which results from atherosclerosis, the mechanisms underlying ischemic stroke are more heterogeneous and include various vascular and cardioembolic pathologies.

The CHANCE-3 study was funded by grants from the National Natural Science Foundation of China, the Ministry of Science and Technology of China, the Chinese Academy of Medical Sciences, and the Beijing Municipal Health Commission.

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

The anti-inflammatory agent colchicine, started within 24 hours of acute ischemic stroke or a transient ischemic attack (TIA), was not associated with a reduction in subsequent strokes or other vascular events at 90 days in the CHANCE-3 trial.

The results were presented by Yongjun Wang, MD, Beijing Tiantan Hospital, Capital Medical University, at the annual World Stroke Congress, sponsored by the World Stroke Organization.

Dr. Wang noted that inflammation may be a key factor involved in the residual risk for recurrent stroke, with data from previous CHANCE trials suggesting a higher stroke recurrence rate in patients with higher levels of high-sensitivity C-reactive protein (hsCRP), a key marker of inflammation.

Low-dose colchicine, which acts as an anti-inflammatory agent, has recently been approved in many countries for patients with established atherosclerotic disease or multiple risk factors for cardiovascular disease to reduce the risk for future cardiovascular events. This follows benefits seen in those populations in the LoDoCo-2 and COLCOT trials.

The CHANCE-3 study was conducted to evaluate whether similar benefits could be found in patients with acute ischemic stroke.

The trial involved 8,369 Chinese patients with minor to moderate ischemic stroke (National Institutes of Health Stroke Scale score ≤ 5) or high-risk TIA (ABCD2 score ≥ 4) who had an hsCRP level of at least 2 mg/L.

Patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive colchicine (1 mg daily on days 1-3, followed by 0.5 mg daily for a total of 90 days) or placebo, on a background of optimal medical therapy.

The primary outcome was any stroke within 90 days. The key secondary outcomes included a composite of stroke, TIA, myocardial infarction, and vascular death within 90 days, and Modified Rankin Scale score greater than 1 at 90 days.

Results showed that the primary outcome of any stroke at 90 days occurred in 6.3% of the colchicine group versus 6.5% of the placebo group, a nonsignificant difference (P = .79).

All secondary outcomes were also neutral, with no differences between the two groups.

Addressing the different results in CHANCE-3, compared with those of the cardiovascular trials of colchicine, Dr. Wang pointed out that the cardiovascular trials had a much longer treatment and follow-up time (an average of 22 months), compared with just 3 months in CHANCE-3.

“Clinical trials with longer treatment times are needed to further assess the effects of colchicine after cerebrovascular events, but it may be that ischemic cerebrovascular disease and ischemic heart disease respond differently to colchicine treatment,” he concluded.

Commenting on the study, cochair of the WSC session at which it was presented, Ashkan Shoamanesh, MD, associate professor of medicine at McMaster University, Hamilton, Ont., said CHANCE-3 was a well-designed large phase 3 randomized trial and the first such trial to test colchicine for secondary stroke prevention. 

He agreed with Dr. Wang that the follow-up duration for this initial analysis of 3-month outcomes may have been too short to see an effect.

“So, we require randomized trials with longer follow-up prior to abandoning this potential treatment,” he added. 

Dr. Shoamanesh noted that several additional trials are currently ongoing testing colchicine for secondary prevention in patients with stroke. These include the CONVINCE, CASPER, CoVasc-ICH, and RIISC-THETIS trials.

He also pointed out that, in contrast to ischemic heart disease, which results from atherosclerosis, the mechanisms underlying ischemic stroke are more heterogeneous and include various vascular and cardioembolic pathologies.

The CHANCE-3 study was funded by grants from the National Natural Science Foundation of China, the Ministry of Science and Technology of China, the Chinese Academy of Medical Sciences, and the Beijing Municipal Health Commission.

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

CARLSBAD, CALIF. – In the opinion of Swati Kannan, MD, deciding whether or not to establish a presence on social media starts with a gut-check about your intentions.

“Why use it?” Dr. Kannan, a dermatologist and Mohs surgeon at the University of California, San Diego, asked attendees at the annual symposium of the California Society of Dermatology & Dermatologic Surgery. “Isn’t being an MD or DO enough? Not anymore. Social media allows you to reach a much larger audience. You’re able to market yourself and market dermatology. It establishes us as the authority in dermatology [topics], showcases our expertise and knowledge, and differentiates us from other nondermatology providers.”

Dr. Swati Kannan

Her favorite part about using Instagram and other social media platforms, she said, is connecting with other dermatologists and other specialists. “I’ve learned a lot from communicating with other dermatologists on different platforms, not just for social media but for changing how I practice as well.”

Dr. Kannan offered the following tips and considerations for building and maintaining a presence on social media:

Know the demographics of your practice and your target audience. In general, individuals in their 20s have a presence on many platforms, mainly TikTok for entertainment. Those in their 30s and 40s mainly use Facebook, Instagram, and YouTube, and those in their 40s-60s primarily use Facebook and YouTube. “Men tend to use YouTube, Twitter (X), Reddit, and LinkedIn, while women prefer more photo or video content platforms like Instagram, TikTok, and Facebook,” she said. In addition, knowing your target audience will help select which social media platforms to be active on.

Think about your goal. Is it a side hustle? Is it to raise awareness of various dermatologic conditions? Is it to grow your business? “Knowing this goal will help you determine how much time you’re going to commit to it.”

Do you have the time? To be effective, being active on social media can take 10-15 hours a week, especially for beginners, “so it’s like another job,” she said.

Devise a social media strategy. “Ideally, pick one to three social media platforms that you are going to be active on,” Dr. Kannan advised. “I’m active on Instagram and YouTube, and I cross-post on TikTok and Facebook. That means when I’m making content, it’s geared toward the audience on Instagram. If it hits a few people on TikTok, that’s fine, too, but the TikTok audience is not my target.”

Stick to a posting schedule. Ideally, post three to five times per week.

Create a content strategy. This includes a variety of photos, diagrams, videos, “and you want to use relevant hashtags,” she said.

Find your niche and style. This comes with time. If you specialize in a specific dermatologic condition such as psoriasis, hair loss, or vitiligo, emphasize that in your content.

Find your voice. This also comes with time. But be a professional version of yourself.

Have a plan for how to handle complaints or bad comments. “Avoid posting content that would make you a target,” she advised. “When I get a rude comment, I delete it. If the comment is racist or sexist, I will report it.”

Learn how to review the stats on your accounts. This will provide information on which posts or videos are being well received, which can serve as the basis of creating content that’s similar going forward.

Follow certain social media strategists. This can help grow followers and learn how to find trending audio or music to accompany your content. On Instagram, for example, Dr. Kannan follows @creators and @instagramforbusiness. On YouTube, she follows the Think Media channel.

Avoid posting content that would make you a target. Limit photos about partying/alcohol consumption or anything considered unprofessional. “If you can’t say it or do it in front of a patient, then you shouldn’t post it on your professional social media page,” she said.

Protect yourself. Don’t provide individual medical advice. “All of my home pages contain the statement, ‘this page is not for medical advice,’” Dr. Kannan said. “Get photo and video consent from all patients, even if you’re posting a zoomed-in version of their face. Deidentify patients as much as possible, and watermark your before and after photos and videos so that they’re not easily used by others.”

Be consistent and patient as you engage on social media platforms. Being a good digital citizen includes networking with other creators by liking and commenting on their posts, and responding to and liking comments that people make to your posts. “Remember: it’s not just about the number of followers, but also about engagement,” she said.

Dr. Kannan reported having no relevant disclosures.

CARLSBAD, CALIF. – In the opinion of Swati Kannan, MD, deciding whether or not to establish a presence on social media starts with a gut-check about your intentions.

“Why use it?” Dr. Kannan, a dermatologist and Mohs surgeon at the University of California, San Diego, asked attendees at the annual symposium of the California Society of Dermatology & Dermatologic Surgery. “Isn’t being an MD or DO enough? Not anymore. Social media allows you to reach a much larger audience. You’re able to market yourself and market dermatology. It establishes us as the authority in dermatology [topics], showcases our expertise and knowledge, and differentiates us from other nondermatology providers.”

Dr. Swati Kannan

Her favorite part about using Instagram and other social media platforms, she said, is connecting with other dermatologists and other specialists. “I’ve learned a lot from communicating with other dermatologists on different platforms, not just for social media but for changing how I practice as well.”

Dr. Kannan offered the following tips and considerations for building and maintaining a presence on social media:

Know the demographics of your practice and your target audience. In general, individuals in their 20s have a presence on many platforms, mainly TikTok for entertainment. Those in their 30s and 40s mainly use Facebook, Instagram, and YouTube, and those in their 40s-60s primarily use Facebook and YouTube. “Men tend to use YouTube, Twitter (X), Reddit, and LinkedIn, while women prefer more photo or video content platforms like Instagram, TikTok, and Facebook,” she said. In addition, knowing your target audience will help select which social media platforms to be active on.

Think about your goal. Is it a side hustle? Is it to raise awareness of various dermatologic conditions? Is it to grow your business? “Knowing this goal will help you determine how much time you’re going to commit to it.”

Do you have the time? To be effective, being active on social media can take 10-15 hours a week, especially for beginners, “so it’s like another job,” she said.

Devise a social media strategy. “Ideally, pick one to three social media platforms that you are going to be active on,” Dr. Kannan advised. “I’m active on Instagram and YouTube, and I cross-post on TikTok and Facebook. That means when I’m making content, it’s geared toward the audience on Instagram. If it hits a few people on TikTok, that’s fine, too, but the TikTok audience is not my target.”

Stick to a posting schedule. Ideally, post three to five times per week.

Create a content strategy. This includes a variety of photos, diagrams, videos, “and you want to use relevant hashtags,” she said.

Find your niche and style. This comes with time. If you specialize in a specific dermatologic condition such as psoriasis, hair loss, or vitiligo, emphasize that in your content.

Find your voice. This also comes with time. But be a professional version of yourself.

Have a plan for how to handle complaints or bad comments. “Avoid posting content that would make you a target,” she advised. “When I get a rude comment, I delete it. If the comment is racist or sexist, I will report it.”

Learn how to review the stats on your accounts. This will provide information on which posts or videos are being well received, which can serve as the basis of creating content that’s similar going forward.

Follow certain social media strategists. This can help grow followers and learn how to find trending audio or music to accompany your content. On Instagram, for example, Dr. Kannan follows @creators and @instagramforbusiness. On YouTube, she follows the Think Media channel.

Avoid posting content that would make you a target. Limit photos about partying/alcohol consumption or anything considered unprofessional. “If you can’t say it or do it in front of a patient, then you shouldn’t post it on your professional social media page,” she said.

Protect yourself. Don’t provide individual medical advice. “All of my home pages contain the statement, ‘this page is not for medical advice,’” Dr. Kannan said. “Get photo and video consent from all patients, even if you’re posting a zoomed-in version of their face. Deidentify patients as much as possible, and watermark your before and after photos and videos so that they’re not easily used by others.”

Be consistent and patient as you engage on social media platforms. Being a good digital citizen includes networking with other creators by liking and commenting on their posts, and responding to and liking comments that people make to your posts. “Remember: it’s not just about the number of followers, but also about engagement,” she said.

Dr. Kannan reported having no relevant disclosures.

CARLSBAD, CALIF. – In the opinion of Swati Kannan, MD, deciding whether or not to establish a presence on social media starts with a gut-check about your intentions.

“Why use it?” Dr. Kannan, a dermatologist and Mohs surgeon at the University of California, San Diego, asked attendees at the annual symposium of the California Society of Dermatology & Dermatologic Surgery. “Isn’t being an MD or DO enough? Not anymore. Social media allows you to reach a much larger audience. You’re able to market yourself and market dermatology. It establishes us as the authority in dermatology [topics], showcases our expertise and knowledge, and differentiates us from other nondermatology providers.”

Dr. Swati Kannan

Her favorite part about using Instagram and other social media platforms, she said, is connecting with other dermatologists and other specialists. “I’ve learned a lot from communicating with other dermatologists on different platforms, not just for social media but for changing how I practice as well.”

Dr. Kannan offered the following tips and considerations for building and maintaining a presence on social media:

Know the demographics of your practice and your target audience. In general, individuals in their 20s have a presence on many platforms, mainly TikTok for entertainment. Those in their 30s and 40s mainly use Facebook, Instagram, and YouTube, and those in their 40s-60s primarily use Facebook and YouTube. “Men tend to use YouTube, Twitter (X), Reddit, and LinkedIn, while women prefer more photo or video content platforms like Instagram, TikTok, and Facebook,” she said. In addition, knowing your target audience will help select which social media platforms to be active on.

Think about your goal. Is it a side hustle? Is it to raise awareness of various dermatologic conditions? Is it to grow your business? “Knowing this goal will help you determine how much time you’re going to commit to it.”

Do you have the time? To be effective, being active on social media can take 10-15 hours a week, especially for beginners, “so it’s like another job,” she said.

Devise a social media strategy. “Ideally, pick one to three social media platforms that you are going to be active on,” Dr. Kannan advised. “I’m active on Instagram and YouTube, and I cross-post on TikTok and Facebook. That means when I’m making content, it’s geared toward the audience on Instagram. If it hits a few people on TikTok, that’s fine, too, but the TikTok audience is not my target.”

Stick to a posting schedule. Ideally, post three to five times per week.

Create a content strategy. This includes a variety of photos, diagrams, videos, “and you want to use relevant hashtags,” she said.

Find your niche and style. This comes with time. If you specialize in a specific dermatologic condition such as psoriasis, hair loss, or vitiligo, emphasize that in your content.

Find your voice. This also comes with time. But be a professional version of yourself.

Have a plan for how to handle complaints or bad comments. “Avoid posting content that would make you a target,” she advised. “When I get a rude comment, I delete it. If the comment is racist or sexist, I will report it.”

Learn how to review the stats on your accounts. This will provide information on which posts or videos are being well received, which can serve as the basis of creating content that’s similar going forward.

Follow certain social media strategists. This can help grow followers and learn how to find trending audio or music to accompany your content. On Instagram, for example, Dr. Kannan follows @creators and @instagramforbusiness. On YouTube, she follows the Think Media channel.

Avoid posting content that would make you a target. Limit photos about partying/alcohol consumption or anything considered unprofessional. “If you can’t say it or do it in front of a patient, then you shouldn’t post it on your professional social media page,” she said.

Protect yourself. Don’t provide individual medical advice. “All of my home pages contain the statement, ‘this page is not for medical advice,’” Dr. Kannan said. “Get photo and video consent from all patients, even if you’re posting a zoomed-in version of their face. Deidentify patients as much as possible, and watermark your before and after photos and videos so that they’re not easily used by others.”

Be consistent and patient as you engage on social media platforms. Being a good digital citizen includes networking with other creators by liking and commenting on their posts, and responding to and liking comments that people make to your posts. “Remember: it’s not just about the number of followers, but also about engagement,” she said.

Dr. Kannan reported having no relevant disclosures.

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.