926-P: Cardiovascular (CV) and Hypoglycemia Outcomes across Age Groups in People with Type 2 Diabetes (T2D) in the CAROLINA Trial

Abstract

Older people with T2D have a high prevalence of comorbidities, frailty and polypharmacy. We investigated the effects of linagliptin (LINA) 5 mg versus glimepiride (GLIM) 1-4 mg once daily across age groups in the CARdiovascular Outcome Study of LINAgliptin Versus Glimepiride in T2D (CAROLINA®). CAROLINA® recruited adults with relatively early T2D, HbA1c 6.5-8.5%, and elevated CV risk and its primary outcome was CV death, non-fatal myocardial infarction, or non-fatal stroke (3P-MACE), with secondary outcomes including mortality as well as change from baseline in HbA1c, weight and hypoglycemia. Of 6033 patients (median age 64 [range 36-85]), 846 (14.0%) were ≥75 years. During median follow-up of 6.3 years, CV and mortality outcomes rates did not differ between treatment groups overall and across age categories (interaction p-values >0.05). Over time, following some initial dynamics, changes in HbA1c levels were comparable between treatment-groups and across age, but hypoglycemia risk (Fig) and weight were significantly lower with LINA vs. GLIM overall and consistently across age groups. These data demonstrate that results for CV and mortality outcomes were consistent across age subgroups, but LINA has a modest benefit in weight and a significantly lower hypoglycemia burden than GLIM, which are important safety considerations when selecting therapy for the elderly. Disclosure M. Espeland: Other Relationship; Self; Boehringer Ingelheim International GmbH, Ironwood Pharmaceuticals. R.E. Pratley: Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Glytec, Janssen Scientific Affairs, LLC., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals Incorporated, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc., REMD Biotherapeutics. Other Relationship; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. T. Kadowaki: Research Support; Self; Astellas Pharma Inc., Daiichi Sankyo, Mitsubishi Tanabe Pharma Corporation, MSD Corporation, Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. Speaker’s Bureau; Self; Abbott, Astellas Pharma Inc., AstraZeneca K.K., Boehringer Ingelheim Pharmaceuticals, Inc., Cosmic Corporation, Daiichi Sankyo, Eli Lilly Japan K.K., FUJIFILM, Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Medscape Education, Medtronic, Mitsubishi Tanabe Pharma Corporation, MSD Corporation, NIPRO Medical Corporation, Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. Other Relationship; Self; Asahi Mutual Life Insurance. Y. Seino: Research Support; Self; ARKRAY, Bayer Yakuhin, Ltd., Boehringer Ingelheim International GmbH, Eli Lilly Japan K.K., Merck Sharp & Dohme Corp., Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. Speaker’s Bureau; Self; Becton, Dickinson and Company, Eli Lilly Japan K.K., Kao Corporation, Merck Sharp & Dohme Corp., Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk Inc., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. B. Zinman: Advisory Panel; Self; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis. N. Marx: Other Relationship; Self; Amgen, AstraZeneca, Bayer Vital, Boehringer Ingelheim International GmbH, Daiichi Sankyo, Kowa Research Institute, Inc., Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis. D.K. McGuire: Consultant; Self; Afimmune, Applied Therapeutics, Merck Sharp & Dohme Corp., Metavant. Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Co., Ltd., Eli Lilly and Company, Esperion Therapeutics, Inc., GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis. K.R. Andersen: None. M. Mattheus: None. A. Keller: Employee; Self; Boehringer Ingelheim International GmbH. O. Johansen: Employee; Self; Boehringer Ingelheim International GmbH. Funding Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance