FDA Approves Semaglutide For Reducing Serious Cardiovascular Events Among Adults With Heart Disease and Obesity, Overweight
In early March 2024, the FDA approved the injectable weight loss medication, semaglutide, to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight, becoming the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in this patient population.
The FDA previously approved semaglutide 2.4 mg in 2021 for chronic weight management in adults with obesity and at least one weight-related comorbidity. Obesity or overweight remain serious health issues that affect approximately 70% of American adults. As such, the FDA recommended using semaglutide as part of a reduced calorie diet and increased physical activity.
“This patient population has a higher risk of cardiovascular death, heart attack and stroke,” John Sharretts, MD, Director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health”
The FDA’s approval follows a multinational, multicenter, placebo-controlled, double-blind trial that randomly assigned more than 17,600 participants to receive either semaglutide or placebo. The results of the trial indicated that semaglutide reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack and stroke), which occurred in 6.5% vs 8% of participants who received placebo.
As a glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide should not be used in combination with other semaglutide-containing products or other GLP-1 receptor agonists.
The prescribing information also includes a boxed warning on the risk of thyroid C-cell tumors. Considering this, semaglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2.
The most common side effects of semaglutide include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with diabetes, flatulence, and gastroesophageal reflux disease.
Reference:
FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight. News release. US Food and Drug Administration; March 8, 2024. Accessed March 14, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or.