By Annette Pinder
The FDA has recently approved semaglutide (Wegovy) at a dose of 2.4 mg. to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight.
“Wegovy is the first weight loss medication that is approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” according to John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA’s Center for Drug Evaluation and Research. “This patient population has a higher risk of cardiovascular death, heart attack, and stroke,” says Dr. Sharretts. He adds, “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”
Approval of this dosage of Wegovy was based on the 17,600-patient SELECT trial, which included patients with overweight and obesity (both with and without diabetes) as well as those with pre-existing cardiovascular disease.
According to the FDA, the phase III study showed that semaglutide significantly reduced the degree of cardiovascular death, heart attack, and stroke in patients by 20%. During the 3-year study, both groups received standard-of-care medical treatment, and major adverse cardiac events occurred in 6.5% of patients on semaglutide, in contrast to 8% of those taking a placebo.
“Semaglutide is the first weight management therapy proven in a rigorous randomized trial to reduce the risk of cardiovascular events, which establishes overweight or obesity as a modifiable risk factor for cardiovascular disease,” says study investigator A. Michael Lincoff, MD, of the Cleveland Clinic, when the data were presented at the American Heart Association Annual Meeting last year.
Wegovy was first approved in June 2021 for chronic weight management in adults with obesity (BMI of 30 or greater) or for adults with overweight (BMI 27 or greater) with at least one weight-related condition. Approval was later expanded to include children with obesity ages 12 and up. Semaglutide is also approved for type 2 diabetes as an injectable and oral drug.
Common side effects associated with 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. Other warnings and precautions in the labeling include pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal behavior or thinking.
The FDA says, “The prescribing information for Wegovy contains a boxed warning to inform health care professionals and patients about the risk of thyroid C-cell tumors.” As a result, the FDA warns that Wegovy 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. Talk to your primary care physician about whether or not you may be a candidate for this treatment for cardiovascular disease and stroke.
