Novo Nordisk presented an exploratory post hoc analysis from the SELECT phase 3 cardiovascular outcomes trial that showed semaglutide 2.4 mg significantly reduced hospital admissions and overall length of hospital stay for adults with obesity or overweight with established cardiovascular disease (CVD) and without diabetes.¹ The results were presented during an oral session at the annual ObesityWeek^® conference and provide further insights based on data from SELECT– a large cardiovascular outcomes trial that evaluated the effect of semaglutide 2.4 mg on the risk of MACE (heart attack, stroke, or death) in this population.

CVD covers a wide range of conditions that, when combined, represent the leading cause of death globally and are associated with substantial healthcare costs.^2,5 Obesity directly increases the risk of CVD, including heart attack and stroke, while also contributing to the progression of other cardiovascular (CV) risk factors including elevated blood pressure and cholesterol.^3,5 Two in three patients with overweight or obesity die from CVD.⁶

"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," said Dr. Steven E. Kahn, M.D., Ch.B., 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."

According to this SELECT analysis, a lower percentage of patients taking semaglutide 2.4 mg experienced a first hospital admission for any indication versus placebo (33.4 vs 36.7%, hazard ratio [HR] 0.89 [0.84, 0.93], p<0.0001) and for serious adverse events (30.3 vs 33.4%, HR 0.88 [0.84, 0.93], p<0.0001).¹ In addition, the number of total hospitalizations was lower in the semaglutide 2.4 mg group versus placebo for all indications (18.3 vs 20.4 admissions per 100 patient years, HR 0.90 [0.85, 0.95], p=0.0002) and for serious adverse events (15.2 vs 17.1 admissions per 100 patient years, HR 0.89 [0.84, 0.94], p<0.0001).¹ The number of days hospitalized per 100 patient years was lower in the semaglutide 2.4 mg group for all hospitalizations (157.2 vs 176.2 days, risk ratio [RR] 0.89 [0.82, 0.98], p=0.01) and for hospitalizations related to serious adverse events (137.6 vs 153.9 days, RR 0.89 [0.81, 0.98], p=0.02).¹ The widths of the confidence intervals have not been adjusted for multiplicity and therefore the confidence intervals and p-values should not be used to infer definitive treatment effects for this exploratory post hoc analysis. Semaglutide is not approved in the U.S. for hospitalization-related outcomes.

Safety data collection in the SELECT trial was limited to serious adverse events (including death), adverse events leading to discontinuation, and adverse events of special interest.^4,7 In the SELECT trial, the proportion of patients for whom serious adverse events were reported was 33.4% in patients randomized to semaglutide 2.4 mg and 36.4% of patients receiving placebo.⁴ Sixteen percent (16%) of semaglutide 2.4 mg-treated patients and 8% of placebo-treated patients, respectively, discontinued study drug due to an adverse event.⁷ The most common adverse event leading to discontinuation was gastrointestinal disorders, occurring in 10% of patients in the semaglutide 2.4 mg group and 2% in the placebo group.⁴

"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," said Michelle Skinner, PharmD, Vice President, Medical Affairs at Novo Nordisk. "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."