FDA Approves Semaglutide for Cardiovascular Risk Reduction
The FDA has approved Wegovy, an anti-obesity drug, for reducing cardiovascular risk in adults with overweight or obesity and established cardiovascular disease. The label expansion now allows for the once-weekly injection of semaglutide 2.4 mg to be used to reduce risks for major adverse cardiovascular events (MACEs). These events include cardiovascular death, nonfatal heart attack, or nonfatal stroke. The drug should be used in combination with a reduced-calorie diet and increased physical activity. This approval makes Wegovy the first weight loss medication to also help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight, according to the FDA with type 2 diabetes.
Several clinical trials, including the SUSTAIN and PIONEER trials, have demonstrated that semaglutide can reduce the risk of major adverse cardiovascular events (MACE) in people with type 2 diabetes who are at high risk for cardiovascular disease. These trials have shown a reduction in the risk of cardiovascular events such as heart attack, stroke, and cardiovascular death in participants treated with semaglutide compared to those treated with a placebo or other diabetes medications.
The exact mechanisms by which semaglutide reduces cardiovascular risk are not fully understood, but it is believed to be related to its effects on blood sugar control, body weight, blood pressure, and other metabolic factors. Additionally, semaglutide may have direct effects on the cardiovascular system, such as reducing inflammation and improving vascular function. Overall, the cardiovascular benefits of semaglutide make it an important treatment option for individuals with type 2 diabetes who are at high risk for cardiovascular disease. However, as with any medication, it’s essential to discuss the potential risks and benefits with your healthcare provider to determine if semaglutide is the right choice for you.
This patient population has a higher risk of cardiovascular death, heart attack, and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health, he added. The approval was based on results from the 3-year SELECT trial, which randomly assigned 17,604 patients with cardiovascular disease and body mass index 27 to weekly semaglutide or placebo. None of the patients had diabetes, although two-thirds met prediabetes criteria. The incidence of MACEs was reduced by 20% with the drug. The label will also reflect the risk reduction of 15% for cardiovascular death and 19% for death from any cause. Participants also lost a mean of 9.4% of body weight over the first 2 years with semaglutide vs 0.88% with placebo.
Adverse events leading to discontinuation of treatment occurred in 16.6% in the semaglutide group, mostly gastrointestinal effects, and in 8.2% in the placebo group. The maker of the weight loss medication, Novo Nordisk, has also filed for a label expansion in the European Union, with a decision expected in 2024.
Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight, This patient population has a higher risk of cardiovascular death, heart attack, and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor antagonist, a class of medications that has gathered much media attention as of late.1 The FDA said that semaglutide should not be used in combination with other medication containing semaglutide or other GLP-1 receptor agonists.
The approval was based on efficacy and safety in the multicentered, placebo-controlled, double-blind SELECT (NCT03574597) trial, which had over 17,600 individuals in the cohort. Treatment was randomized between semaglutide or the placebo, with both groups receiving standard-of-care treatment, including management of blood pressure and cholesterol, and healthy lifestyle counseling, including diet and physical activity, according to the FDA. Investigators of the study found that semaglutide significantly reduced the risk of major adverse cardiovascular events (MACE) such as CVD death, heart attack, and stroke, which occurred in 6.5% of individuals in the semaglutide group compared with 8% of those in the placebo group.
The FDA approved Wegovy (semaglutide) for a new use: reducing the risk of cardiovascular (CV) death, heart attack, and stroke in adults with both cardiovascular disease (CVD) and overweight or obesity. Wegovy is the first weight-loss medication approved for this specific purpose. It should be used alongside a reduced-calorie diet and increased physical activity.
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