791-P: Ertugliflozin in Older Patients with Type 2 Diabetes (T2D): An Analysis from VERTIS CV

Abstract

VERTIS CV was a cardiovascular (CV) outcome trial of ertugliflozin vs. placebo in patients (pts) with T2D and atherosclerotic CV disease. Here we analyzed the cardiorenal outcomes and safety of ertugliflozin in older pts.Among 8238 pts randomized and treated with ertugliflozin 5 mg, 15 mg, or placebo, 4093 (49.7%) were <65 yrs, 4145 (50.3%) were ≥65 yrs, with 903 (11.0%) ≥75 yrs. Baseline characteristics were similar across treatment groups within each age group; mean eGFR was lower in older pts (82.2, 69.9, and 63.6 mL/min/1.73m2 for pts <65, ≥65, and ≥75 yrs, respectively). Cardiorenal outcomes for ertugliflozin vs. placebo did not differ between pts ≥65 and <65 yrs, with interaction P values >0.05 for all outcomes assessed (FIGURE). The incidences of adverse events (AEs), serious AEs (including deaths), and discontinuations due to an AE were higher in older vs. younger pts, but generally similar across treatment groups in pts ≥65 and ≥75 yrs. The incidence of renal-related AEs was similar across treatment groups in younger and older pts. The incidences of genital mycotic infection and urinary tract infection were higher with ertugliflozin vs. placebo in older pts. The incidences of hypovolemia AEs with ertugliflozin vs. placebo in pts ≥65 was 5.3% vs. 4.5% and in pts ≥75 yrs was 6.9% vs. 5.8%.Cardiorenal outcomes were similar in pts ≥65 and <65 yrs. Ertugliflozin was generally well tolerated in pts ≥65 and ≥75 yrs.View largeDownload slideView largeDownload slide DisclosureR. E. Pratley: Other Relationship; Self; Hanmi Pharmaceutical, Merck Sharp & Dohme Corp., Metavention, Monster Energy Company, Inc., Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. I. A. Adamsons: Employee; Self; Merck Sharp & Dohme Corp. D. Lawrence: Employee; Self; Pfizer Inc., Employee; Spouse/Partner; Becton, Dickinson and Company. W. J. Shih: None. C. P. Cannon: Advisory Panel; Self; Aegerion Pharmaceuticals Inc., Amarin Corporation plc, Corvidia Therapeutics, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer Inc., Sanofi, Consultant; Self; Alnylam Pharmaceuticals, Inc., Amgen Inc., Applied Therapeutics, Ascendis Pharma A/S, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, HLS Therapeutics Inc., Kowa Company, Ltd., Research Support; Self; Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Daiichi Sankyo, Janssen Research & Development, LLC, Kowa Company, Ltd., Merck & Co., Inc., Novo Nordisk Pharma Ltd., Pfizer Inc. S. Dagogo-jack: Consultant; Self; Abbott, AstraZeneca, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi US, Stock/Shareholder; Self; Aerami Therapeutics, Jana Care Inc. B. Charbonnel: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck & Co., Inc., Mundipharma International, Novo Nordisk, Sanofi, Speaker’s Bureau; Self; Takeda Pharmaceutical Company Limited. D. Cherney: Other Relationship; Self; AbbVie Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Scientific Affairs, LLC., Lilly Diabetes, Merck & Co., Inc., Mitsubishi-Tanabe, Maze Inc, Prometic, Novo Nordisk, Sanofi. F. Cosentino: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Pfizer Inc., Speaker’s Bureau; Self; Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Mundipharma International, Novo Nordisk. D. K. Mcguire: Consultant; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., CSL Behring, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pfizer Inc., Sanofi. M. N. Essex: Employee; Self; Pfizer Inc., Stock/Shareholder; Self; Pfizer Inc. P. L. S. Jones: Employee; Self; Pfizer Inc. J. Liu: Employee; Self; Merck Sharp & Dohme Corp.FundingMerck Sharp & Dohme Corp