Danish pharmaceutical giant Novo Nordisk announced that its weight-loss drug, Wegovy (semaglutide), significantly reduced the risk of major adverse cardiovascular events (MACE) by 20% in overweight or obese individuals with a history of heart disease. The findings from the SELECT trial, a five-year study involving over 17,600 patients, suggest that Wegovy offers substantial health benefits beyond its cosmetic applications.
The SELECT trial compared a weekly 2.4 mg injection of Wegovy to a placebo, both administered alongside standard preventative cardiovascular care. Participants were at least 45 years old and had pre-existing heart disease. The primary endpoint was the occurrence of major adverse cardiovascular events, including heart attack, stroke, and cardiovascular death.
Clinical Significance
The results of the SELECT trial could redefine the treatment landscape for obesity and its associated cardiovascular risks. Experts emphasize that obesity should be treated as a serious medical condition due to its contribution to heart disease and other health problems. The observed 20% reduction in MACE represents a clinically meaningful benefit that could translate to lower healthcare costs through reduced hospitalizations for heart attacks and strokes.
Andres J. Acosta, a gastroenterology and hepatology consultant at the Mayo Clinic, stated, "It matters because if you lose weight, your risk of dying is reduced." This perspective underscores the potential for weight-loss interventions to improve overall health outcomes and longevity.
Mechanism of Action
Wegovy, known generically as semaglutide, mimics the naturally occurring hormone glucagon-like peptide-1 (GLP-1). This mechanism increases insulin production, suppresses appetite, and slows gastric emptying, promoting satiety and reducing food intake. Previous research has demonstrated that another semaglutide drug, Ozempic, reduces the risk of heart problems in diabetes patients at high cardiovascular risk. The SELECT trial is the first large-scale study to evaluate semaglutide's cardiovascular effects in obese individuals without diabetes.
Market Impact and Future Directions
The positive results from the SELECT trial are expected to boost Novo Nordisk's financial performance and potentially benefit other manufacturers of similar medications. Analysts at TD Cowen described the results as "close to best case scenario for SELECT," anticipating increased momentum for Wegovy and the broader obesity market.
Martin Holst Lange, Executive Vice President for Development at Novo Nordisk, highlighted the significance of the SELECT trial, stating that it "has the potential to change how obesity is regarded and treated." The company intends to seek regulatory approval from U.S. and European authorities to include the cardiovascular benefits on Wegovy's drug label, enabling them to promote the drug for cardiovascular risk reduction.
Considerations and Ongoing Research
While the top-line results are promising, experts like Steven Nissen, a Cleveland Clinic cardiologist, emphasize the need for caution until the full, peer-reviewed publication is available. Nissen is leading a similar trial involving Eli Lilly’s Mounjaro (tirzepatide), another diabetes drug frequently used for weight loss, and awaits comprehensive data before drawing definitive conclusions.
Despite the potential benefits, the high cost of Wegovy (over $1,300 per month) and limited insurance coverage remain significant barriers to access. The SELECT trial findings may influence insurance companies and Medicare to broaden coverage for weight-loss medications, similar to the current coverage of bariatric surgeries.
Angela Fitch, an obesity doctor at Harvard Medical School and president of the Obesity Medicine Association, noted, "To deny [patients] access to treatment to prevent cardiovascular events is different than one that creates weight loss." She added, "This is a day to remember. This really a pivotal moment in the treatment of obesity."
