Trial Shows Semaglutide 2.4 mg Reduces Hospitalizations, Stays in Obese Adults with Cardiovascular Disease

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Results from an exploratory post hoc analysis of the Phase III SELECT trial show that semaglutide 2.4 mg significantly lowered hospital admissions and the length of overall hospital stays in adults with obesity or overweight and cardiovascular disease (CVD) but without diabetes. These findings, presented at the annual ObesityWeek conference, are the latest showcasing the potential of semaglutide to reduce healthcare costs and improve patient outcomes, according to trial investigators.¹

"People with obesity or overweight with established cardiovascular disease (CVD) and without diabetes are more likely to be admitted to the hospital for events like heart attack or stroke, contributing to reduced patient well-being, higher use of healthcare resources, and disease burden," Steven E. Kahn, MD, ChB, Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle. "In the SELECT trial, this cohort of patients had a high rate of hospital admissions, but for those given once-weekly semaglutide 2.4 mg, we observed significant reductions in hospital admissions and overall time they spent in the hospital. We are pleased to have this analysis that further examines the effects of semaglutide."¹

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist (RA), was initially approved in June 2021 for chronic weight management in those with obesity or overweight and at least one weight-related condition, including high blood pressure, type 2 diabetes, or high cholesterol, in addition to diet and increased exercise.² Semaglutide has been approved by the FDA in both long-acting injectable (Wegovy and Ozempic) and daily oral tablet (Rybelsus) formulations. In March 2024, Wegovy (semaglutide) was approved by the FDA to reduce the risk of MACE in adults with known heart disease and with obesity or overweight, in addition to a reduced calorie diet and increased physical activity.³

The multicenter, randomized, double-blind, placebo-controlled, event-driven SELECT superiority trial analyzed the efficacy of semaglutide 2.4 mg compared with placebo as an adjunct to cardiovascular standard of care in lowering the risk of major adverse cardiovascular events in patients with established CVD with overweight or obesity and no prior history of diabetes. Investigators enrolled 17,604 adult patients across more than 800 investigator sites in 41 countries.

The results show that 33.4% of patients administered semaglutide 2.4 mg experienced a first hospital admission for any indication compared with 36.7% of those given a placebo (hazard ratio [HR] 0.89 [0.84, 0.93], p<0.0001), with serious adverse events (SAEs) reported at rates of 30.3% in the semaglutide cohort compared with 33.4% in the placebo cohort (HR 0.88 [0.84, 0.93], p<0.0001). For total hospitalizations, there were 18.3 admissions per 100 patient years for all indications in the semaglutide 2.4 mg cohort compared with 20.4 admissions per 100 patient years in the placebo cohort, with SAEs at 15.2 admissions per 100 patient years in the semaglutide 2.4 mg cohort compared with 17.1 admissions per 100 patient years in the placebo cohort (HR 0.89 [0.84, 0.94], p<0.0001).

Further, the number of days hospitalized per 100 patient years was 157.2 in the semaglutide 2.4 mg cohort for all hospitalizations compared with 176.2 days in the placebo cohort (risk ratio [RR] 0.89 [0.82, 0.98], p=0.01). Hospitalizations related to SAEs were 137.6 in the semaglutide 2.4 mg cohort compared with 153.9 days in the placebo cohort (RR 0.89 [0.81, 0.98], p=0.02).

In terms of safety, 33.4% of patients randomly assigned to the semaglutide 2.4 mg cohort experienced an SAE compared with 36.4% of patients in the placebo cohort. SAEs leading to discontinuation were reported by 16% of patients administered semaglutide compared with 8% in the placebo cohort. The most common AEs causing discontinuation were gastrointestinal disorders, at 10% in the semaglutide 2.4 mg cohort compared with 2% in the placebo cohort.

"We are pleased to continue building on the strong foundation of SELECT trial data that demonstrated the effectiveness of semaglutide 2.4 mg in lowering CV risk in patients with obesity and established cardiovascular disease, and to continue our ongoing commitment to improve the lives of people facing serious chronic diseases," Michelle Skinner, PharmD, vice president, Medical Affairs at Novo Nordisk, said in the release. "This new SELECT analysis represents another step forward, exploring how semaglutide 2.4 mg impacted repeat hospitalizations and prolonged hospital stays, which are two pressing issues in terms of healthcare cost and quality."¹

References

1. New SELECT trial analysis with semaglutide 2.4 mg showed a significant reduction in hospital admissions in adults with known heart disease and obesity or overweight. News release. Novo Nordisk. November 3, 2024. Accessed November 4, 2024. https://prnmedia.prnewswire.com/news-releases/new-select-trial-analysis-with-semaglutide-2-4-mg-showed-a-significant-reduction-in-hospital-admissions-in-adults-with-known-heart-disease-and-obesity-or-overweight-302294828.html

2. FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014. FDA. News release. June 4, 2021. Accessed November 4, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014

3. Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity. Novo Nordisk. News release. March 8, 2024. Accessed November 4, 2024. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=167031