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

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Nov 03, 2024, 15:30 ET

Results from Novo Nordisk, presented at ObesityWeek^®, showed treatment with semaglutide injection 2.4 mg resulted in significant reductions in hospital admissions as well as overall time spent in the hospital¹
Cardiovascular disease represents the leading cause of death globally,² and adults with obesity are at a higher risk of developing cardiovascular disease³
The analysis is based on 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 adults with overweight or obesity and known heart disease⁴

PLAINSBORO, N.J., Nov. 3, 2024 /PRNewswire/ -- Today, 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.^2,5Obesity 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.^3,5Two 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).¹The 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).¹The 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.^4,7In 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."

About the SELECT trial
SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) was a multicenter, randomized, double-blind, placebo-controlled, event-driven superiority trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo as an adjunct to cardiovascular standard of care for reducing the risk of major adverse cardiovascular events in people with established CVD with overweight or obesity with no prior history of diabetes.⁴

The trial, initiated in 2018, enrolled 17,604 adults and was conducted in 41 countries at more than 800 investigator sites.⁴

About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and commercial, production, and research facilities in seven states plus Washington DC, Novo Nordisk employs approximately 8,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, X, LinkedIn, and YouTube.

References:

Nicholls SJ, Ryan D, Deanfield J, et al. Semaglutide Reduces Hospital Admissions in Patients with Obesity or Overweight and Established CVD. Presented at ObesityWeek^® 2024, Nov 3, 2024.
World Health Organization. Cardiovascular diseases (cvds). Accessed October 31, 2024. https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
Powell-Wiley TM, Poirier P, Burke LE, et al. Obesity and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2021;143(21):e984-e1010. doi:10.1161/CIR.0000000000000973.
Lincoff MA, Brown-Frandson K, Colhoun HM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389:2221-2232.
Reiter-Brennan C, Dzaye O, Davis D, et al. Comprehensive care models for cardiometabolic disease. Curr Cardiol Rep. 2021;23(3):22. Published 2021 Feb 24. doi:10.1007/s11886-021-01450-1.
The GBD 2015 Obesity Collaborators. Health effects of overweight and obesity in 195 countries over 25 years. N Engl J Med. 2017;377(1):13-27. doi:10.1056/nejmoa1614362.
Wegovy^® (semaglutide) injection 2.4 mg Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.