432-P: Analyses of First plus Recurrent Cardiovascular and Hospitalization Events in the Cardiovascular and Renal Microvascular Outcome Study with Linagliptin (CARMELINA) in Patients with Type 2 Diabetes and Cardiorenal Disease

Abstract

CARMELINA was a randomized placebo-controlled clinical trial designed to demonstrate the cardiovascular (CV) safety of linagliptin in patients with T2D and concomitant cardiorenal disease. To characterize the effects of linagliptin on net CV disease and hospitalization burden of this population, we assessed the effects of linagliptin versus placebo on all first plus recurrent CV events and any-cause hospitalizations using a negative binomial model. A total of 6979 participants were enrolled (mean age 66 y, eGFR 54.6 ml/min/1.73m2, median UACR 162 mg/g, 58.5% with history of ischemic heart disease, 26.8% with heart failure). Adding recurrent events increased the number of events for analysis from 5.3-57.5% across CV/HF outcomes and 112.4% for hospitalizations. Results of analyses of first plus recurrent events for linagliptin vs. placebo are presented along with first-event analyses results for comparison (Figure). Linagliptin showed similar risk of either first or recurrent CV or hospitalization events compared with placebo in patients with T2D and cardiorenal disease. These data support the overall and CV safety of linagliptin and, considering the number of recurrent events, underscores the significant CV disease burden experienced by T2D patients and cardiorenal disease. Disclosure N. Marx: Advisory Panel; Self; Amgen Inc., AstraZeneca, Bayer Vital GmbH, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. Research Support; Self; Boehringer Ingelheim International GmbH. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. Other Relationship; Self; Boehringer Ingelheim International GmbH, Novo Nordisk A/S. D.K. McGuire: Consultant; Self; Eisai Co., Ltd., Eli Lilly and Company, Pfizer Inc. Research Support; Self; Janssen Pharmaceuticals, Inc. Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. O. Johansen: Employee; Self; Boehringer Ingelheim International GmbH. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. S.E. Kahn: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S. Consultant; Self; Neurimmune. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S. M.E. Cooper: Advisory Panel; Self; AstraZeneca, Lilly Diabetes. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Servier. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk A/S. Speaker's Bureau; Self; Bayer AG, Merck Sharp & Dohme Corp., Novartis AG. R.D. Toto: Advisory Panel; Self; Relypsa, Inc. Board Member; Self; Akebia Therapeutics. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Quest Diagnostics, Vifor Pharma, WebMD. Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. C. Wanner: Advisory Panel; Self; Bayer AG, Boehringer Ingelheim International GmbH, Merck Sharp & Dohme Corp. Board Member; Self; Boehringer Ingelheim International GmbH. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Mitsubishi Tanabe Pharma Corporation. E. Pfarr: None. S. Schnaidt: Employee; Self; Boehringer Ingelheim Pharma GmbH & Co. KG. J. George: Employee; Self; Boehringer Ingelheim International GmbH. M. von Eynatten: Employee; Self; Boehringer Ingelheim International GmbH. V. Perkovic: Advisory Panel; Self; AbbVie Inc., Astellas Pharma Inc., AstraZeneca, Baxter, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Durect Corporation, Eli Lilly and Company, Gilead Sciences, Inc., GlaxoSmithKline plc., Janssen Research & Development, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., Pharmalink, Relypsa, Inc., Roche Pharma, Sanofi, Servier, Vitae. Research Support; Self; Australian National Health and Medical Research Council. Other Relationship; Self; AbbVie Inc., Boehringer Ingelheim Pharmaceuticals, Inc., GlaxoSmithKline plc., Janssen Research & Development, Pfizer Inc. B. Zinman: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc. Consultant; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc. J.H. Alexander: Advisory Panel; Self; CSL Behring, Novo Nordisk A/S. Consultant; Self; AbbVie Inc., Bristol-Myers Squibb Company, Pfizer Inc., Quantum Genomics, Zafgen, Inc. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, CSL Behring, National Institutes of Health. Research Support; Spouse/Partner; Sanofi. Research Support; Self; U.S. Food and Drug Administration. Funding Boehringer Ingelheim; Eli Lilly and Company