John Sharretts, M.D., Director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA’s Center for Drug Evaluation and Research, hailed semaglutide's approval as a pivotal advancement in public health. He underscored the pivotal role of semaglutide as the inaugural weight loss medication authorised to mitigate the peril of life-threatening cardiovascular events in adults burdened by cardiovascular disease alongside obesity or overweight.
The prevalence of obesity or overweight in the United States encompasses around 70% of adults, signaling a widespread health concern associated with increased mortality risk and a plethora of health complications, including heart-related issues.
Evaluating semaglutide's efficacy and safety for this novel indication entailed a comprehensive multi-national, multi-center, placebo-controlled double-blind trial, involving over 17,600 participants randomly assigned to receive semaglutide or a placebo. Both groups received standard-of-care medical treatment, such as blood pressure and cholesterol management, coupled with healthy lifestyle counseling.
The trial's outcomes revealed semaglutide's remarkable efficacy in reducing the risk of major adverse cardiovascular events—comprising cardiovascular death, heart attack, and stroke. Notably, participants administered semaglutide exhibited a significant 1.5% lower incidence of such events compared to their counterparts receiving the placebo.
Despite its remarkable benefits, semaglutide comes with notable safety considerations, including a boxed warning concerning the risk of thyroid C-cell tumors. It is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.
