In this episode, hosts take a deep dive into the study’s results, including secondary endpoints, and what it means for the care of patients with overweight or obesity and preexisting cardiovascular disease in real-world settings.
With topline data announced in August and the full study released at the American Heart Association Scientific Sessions 2023, the results of the SELECT trial serve as the signal for a new age in cardiovascular risk management.
Results of the trial, which enrolled more than 17,000 patients with overweight or obesity and preexisting cardiovascular disease, indicate use of semaglutide 2.4 mg (Wegovy) was associated with a 20% reduction in risk of cardiovascular events relative to placebo therapy. Coming less than 3 years after semaglutide 2.4 mg received a historic indication from the US Food and Drug Administration as the first agent approved for chronic weight management in adults with general obesity or overweight since 2014, results of the double-blind, randomized, placebo-controlled, event-driven superiority trial provide evidence the cardiovascular protective benefits of extend beyond patients with type 2 diabetes.
“Our findings expand the opportunity to treat patients who have overweight or obesity and existing heart disease without Type 1 or Type 2 diabetes, and we have a chance to significantly reduce their risk of a secondary cardiovascular event including death,” said principal investigator A. Michael Lincoff, MD, vice chairman for research of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine and an interventional cardiologist in the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at the Cleveland Clinic.
The largest and longest trial of semaglutide in adults without type 1 or type 2 diabetes, the trial’s primary endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke in a time-to-first-event analysis. Inclusion criteria required patients to be 45 years of age or older, have no history of type 1 or type 2 diabetes, have a BMI of 27 kg/m2 or greater, and established cardiovascular disease, which was defined as previous myocardial infarction, previous stroke, or symptomatic peripheral arterial disease.
Analysis of the primary outcome suggested an event occurred among 6.5% of the semaglutide group and 8.0% of the placebo group (HR, 0.80; 95% Confidence interval [CI], 0.72 to 0.90; P <.001). Further analysis indicated the mean change in body weight observed in the trial was –9.39% with semaglutide and –0.88% with placebo (estimated treatment difference, –8.51 percentage points; 95% CI, –8.75 to –8.27). When assessing secondary endpoints, results detailed nonsignificant trends towards benefit for cardiovascular death (HR, 0.85; 95% CI, 0.71 to 1.01; P=.07), heart failure hospitalization or urgent medical visit (HR, 0.82; 95% CI, 0.71 to 0.96), all-cause mortality (HR, 0.81; 95% CI, 0.71 to 0.93), an HbA1c of 6.5% or greater (HR, 0.27; 95% CI, 0.24 to 0.31).
To celebrate the ushering in of this new era and discuss what it means for the future of care, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, sat down to record a special edition episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives. In the episode, Isaacs and Bellini take a deep dive into the study’s results, including secondary endpoints, and what it means for the care of patients with overweight or obesity and preexisting cardiovascular disease in real-world settings.