786-P: Glycemic Efficacy and Safety of Ertugliflozin (ERTU) in Patients with Type 2 Diabetes (T2D) and Chronic Kidney Disease Stage 3 (CKD 3): An Analysis from VERTIS CV

Abstract

VERTIS CV was a cardiovascular (CV) outcome trial that evaluated the CV safety of ERTU in patients with T2D and atherosclerotic CV disease (ASCVD). This analysis assessed the glycemic efficacy and safety of ERTU in VERTIS CV patients with CKD 3. Among 8246 patients in VERTIS CV, 1776 patients with CKD 3 at baseline (BL) were identified based on an eGFR of 30-<60 mL/min/1.73 m2 (1319 patients with CKD 3A [eGFR 45-<60 mL/min/1.73 m2]), calculated via the MDRD equation. Efficacy endpoints were changes from BL in HbA1c, body weight (BW) and systolic blood pressure (SBP) to Week 18, when doses of background antihyperglycemics were to be held constant. Safety assessments included adverse event (AE) reports. BL characteristics did not differ across randomized groups in patients with CKD 3. At Week 18, significant HbA1c reductions from BL for ERTU 5 mg and 15 mg vs. placebo were observed in patients with CKD 3 and in the CKD 3A subgroup (Table). Significant placebo-subtracted reductions in BW (5 mg: −1.4 kg; 15 mg: −1.5 kg) and SBP (5 mg: −2.9 mm Hg; 15 mg: −3.2 mm Hg) occurred in the CKD 3 patients receiving ERTU. The incidence of overall AEs, symptomatic hypoglycemia, hypovolemia and kidney-related AEs did not differ between ERTU and placebo across CKD 3 subgroups. In patients with T2D, ASCVD and CKD 3, ERTU improved glycemic control, BW and SBP, and was generally well tolerated.View largeDownload slideView largeDownload slide DisclosureS. Dagogo-jack: Consultant; Self; Abbott, AstraZeneca, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi US, Stock/Shareholder; Self; Aerami Therapeutics, Jana Care Inc. J. P. Mancuso: Employee; Self; Pfizer Inc., Employee; Spouse/Partner; Pfizer Inc., Stock/Shareholder; Self; Pfizer Inc., Stock/Shareholder; Spouse/Partner; Pfizer Inc. A. Raji: Employee; Self; Merck & Co., Inc. I. Gantz: Employee; Self; Merck & Co., Inc. R. 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. 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. 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. 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. 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. W. J. Shih: None. J. Liu: Employee; Self; Merck Sharp & Dohme Corp. R. Frederich: Employee; Self; Pfizer Inc., Other Relationship; Self; Merck Sharp & Dohme Corp., Stock/Shareholder; Self; Bristol-Myers Squibb Company, Pfizer Inc.