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Fri, 20 Jun 2025 13:30:00 -0400
Fri, 20 Jun 2025 13:30:00 -0400
PLAINSBORO, N.J., June 20, 2025 – Novo Nordisk today announced new data showing patients using once-weekly Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg, experienced a 23% reduction in risk in A1C-adjusted three-point major adverse cardiovascular events (MACE) (defined as a composite of nonfatal stroke, nonfatal myocardial infarction, or all-cause death) (HR: 0.77; 95% CI [0.69, 0.86]; p<0.001), relative to those using dulaglutide in a claims analysis.1 In the retrospective, observational REACH study of over 40,000 semaglutide patients and over 30,000 dulaglutide patients with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD), A1C-adjusted three-point MACE events occurred in 932 individuals (2.2%) using semaglutide and 953 individuals (2.9%) using dulaglutide.1
Results also showed patients using semaglutide experienced a 20% reduced risk of stroke (472 events; 1.1%) and a 24% reduced risk of myocardial infarction (MI) (435 events; 1.0%), compared to those using dulaglutide (474 stroke events; 1.4% and 442 MI events; 1.3%).
“Building on the cardiovascular benefit demonstrated in the SUSTAIN 6 trial, these real-world findings further underscore the efficacy of semaglutide to help manage CV risk in people with type 2 diabetes and atherosclerotic cardiovascular disease,” said Michael Radin, MD, Executive Medical Director, Diabetes Medical Affairs at Novo Nordisk, Inc. “This REACH study and analysis were rigorous, with tens of thousands of patients using advanced statistical methods, including adjusting for A1C, to portray a true head-to-head assessment in a real-world environment.”
After weighting, demographic and clinical characteristics were similar, with an average observational period of 10 months across the two groups.1 Novo Nordisk intends to present detailed results from REACH at a scientific conference later this year.
Real-world study data can provide valuable insights into how treatments work outside of controlled clinical trial settings. Real-world data analyses also have several limitations; results may reflect residual unmeasured confounding, and while associations can be demonstrated, causal relationships cannot be definitively established. As with all real-world evidence studies, the lack of randomization in the REACH study limits control over treatment assignment. Additionally, use of retrospective claims data may exclude patients with intermittent coverage or underserved populations, potentially limiting generalizability.
About Ozempic®
Ozempic® (semaglutide) injection 0.5 mg, 1 mg or 2 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve blood sugar (glucose), along with diet and exercise, in adults with type 2 diabetes, to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease, and to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.2
It is important to note that Ozempic® contains a Boxed Warning for possible thyroid tumors, including cancer and should not be used in those with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).2
About real-world evidence (RWE) and the REACH Study Program
Real-world studies are conducted to complement randomized control trials, which are the gold standard for evaluating the safety and efficacy of a treatment.3
The comprehensive REACH study program is a series of studies assessing the atherosclerotic cardiovascular disease (ASCVD)-related outcomes of the once-weekly GLP-1 class, including semaglutide, compared to active antidiabetic medications such as DPP4 inhibitors, SGLT2 inhibitors, and GLP-1 compounds, from multiple electronic medical record (EMR) databases. The results from this series of studies have been published in peer-reviewed journals and presented at major scientific congresses, further supporting semaglutide for cardiovascular (CV) risk in a real-world setting. The REACH study program aims to evaluate large samples, over observational periods, using methodological advancements such as entropy balancing and inverse probability of treatment weighting, to ensure we are representing the real-world patient setting in the most accurate way.
This most recent REACH study is a real-world evidence analysis evaluating CV risk reduction with GLP-1 receptor agonists – semaglutide and dulaglutide – in people with type 2 diabetes (T2D) and ASCVD. REACH was designed to complement evidence from the SUSTAIN 6 randomized clinical trial and to measure the occurrence of A1C-adjusted three-point major adverse cardiovascular events (MACE) (defined as a composite of nonfatal stroke, nonfatal myocardial infarction, or all-cause death) in individuals with T2D who received once-weekly semaglutide or dulaglutide. The study draws from a large U.S. national health plan dataset with pharmacy claims, linked medical records, and Medicare Advantage, allowing for a broad, diverse patient population, similar to the SUSTAIN 6 trial, with long observational periods (average over 10 months, up to 48 months).1,4 Advanced statistical methods were also used to adjust for baseline differences and glycemic control (A1C), providing insights relevant to everyday clinical practice.
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 a U.S. presence spanning 40 years, Novo Nordisk U.S. is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D, and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
References
1. Data on file. Novo Nordisk Inc; Plainsboro, NJ.
2. Ozempic® (semaglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2024.
3. Blonde L, Khunti K, Harris SB, et al. Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician. Adv Ther. 2018;35(11):1763-1774. doi:10.1007/s12325-018-0805-y.
4. Marso, S. P., Bain, S. C., Consoli, A., Eliaschewitz, F. G., Jódar, E., Leiter, L. A., Lingvay, I., Rosenstock, J., Seufert, J., Warren, M. L., Woo, V., Hansen, O., Holst, A. G., Pettersson, J., & Vilsbøll, T. (2016a). SEMAGLUTIDE and cardiovascular outcomes in patients with type 2 diabetes. New England Journal of Medicine, 375(19), 1834–1844. https://doi.org/10.1056/nejmoa1607141
This information is intended for US media audiences only.
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