Semaglutide Consistently Reduces Cardiovascular Events in Both Male and Female Subjects with Type 2 Diabetes

Abstract

Semaglutide is a new GLP-1 analog for the once-weekly treatment of T2D. In the SUSTAIN 6 CV outcomes trial, subcutaneous semaglutide (0.5 mg and 1.0 mg) added to standard of care significantly reduced major adverse CV events (MACE: non-fatal MI, non-fatal stroke or CV death) vs. placebo over 2 years in subjects with T2D at high CV risk. This post-hoc analysis assessed whether this CV risk reduction was consistent in male and female subjects. Overall, 2,002 male and 1,295 female subjects were randomized. MACE was reported by fewer subjects with semaglutide vs. placebo in both sexes (p=0.45 for interaction); HR estimates were 0.68 (95% CI 0.50;0.92) in males, 0.84 (95% CI 0.54;1.31) in females and 0.74 (95% CI 0.58;0.95) in the overall study population. Overall, the pattern was similar across the individual MACE components (Table 1). AEs were reported by similar proportions of males and females across treatments. The most frequent AEs reported were gastrointestinal, with higher rates in females than in males. The proportions of subjects prematurely discontinuing treatment due to AEs were comparable for males and females (Table 1). MACE and its components was reported in consistent proportions of males and females, and generally lower with semaglutide vs. placebo regardless of sex. The HR estimates for MACE with semaglutide vs. placebo for males and females were consistent with that of the overall study population. Disclosure I. Hramiak: Advisory Panel; Self; AstraZeneca. Research Support; Self; AstraZeneca. Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Eli Lilly and Company. Advisory Panel; Self; GlaxoSmithKline plc.. Research Support; Self; GlaxoSmithKline plc.. Advisory Panel; Self; Roche Pharma, Insulet Corporation, Janssen Pharmaceuticals, Inc.. Research Support; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; Lexicon Pharmaceuticals, Inc., Medtronic. Advisory Panel; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Speaker's Bureau; Self; Merck & Co., Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Research Support; Self; Sanofi. C. Desouza: Consultant; Self; Novo Nordisk A/S, Sanofi. Research Support; Self; Merck & Co., Inc.. Advisory Panel; Self; Medscape. J. Seufert: Speaker's Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Boehringer Ingelheim GmbH, GI Dynamics Inc.. Research Support; Self; GI Dynamics Inc., GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Ipsen Biopharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation. Research Support; Self; Novartis Pharmaceuticals Corporation. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. Research Support; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi. Research Support; Self; Ypsomed AG. T. Hansen: None. D. Thielke: Employee; Self; Novo Nordisk A/S. I. Lingvay: Advisory Panel; Self; Novo Nordisk A/S, Eli Lilly and Company, AstraZeneca, Intarcia Therapeutics, Inc., Sanofi-Aventis. Research Support; Self; Novo Nordisk A/S, Merck Sharp & Dohme Corp., Pfizer Inc., GI Dynamics Inc., Novartis AG. Other Relationship; Self; Sanofi, AstraZeneca, Boehringer Ingelheim GmbH, Novo Nordisk A/S.