Linagliptin and cardiorenal outcomes in Asians with type 2 diabetes mellitus and established cardiovascular and/or kidney disease: subgroup analysis of the randomized CARMELINA((R)) trial
单位：[1]Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, 54 Kawahara‑cho, Shogoin, Sakyo‑ku, Kyoto 606‑8507, Japan [2]Department of Endocrinology, China-Japan Friendship Hospital, Beijing, People’s Republic of China [3]Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan [4]Department of Endocrinology and Metabolism, Peking University People’s Hospital, Beijing, People’s Republic of China [5]Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany [6]Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany [7]Nippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan [8]Boehringer Ingelheim Norway KS, Asker, Norway [9]Boehringer Ingelheim International GmbH, Ingelheim, Germany [10]Dallas Diabetes Research Center at Medical City, University of Texas Southwestern Medical Center, Dallas, TX, USA [11]George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia [12]Division of Nephrology, Department of Medicine, Würzburg University Clinic, Würzburg, Germany [13]Department of Diabetes, Central Clinical School, Monash University, Melbourne, Australia [14]Duke Clinical Research Institute, Duke Health, Durham, NC, USA [15]Department of Cardiovascular Medicine, University of Tokyo Hospital, Tokyo, Japan [16]Division of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan
ObjectiveLinagliptin, a dipeptidyl peptidase-4 inhibitor, demonstrated cardiovascular and renal safety in type 2 diabetes mellitus (T2DM) patients with established cardiovascular disease (CVD) with albuminuria and/or kidney disease in the multinational CARMELINA((R)) trial. We investigated the effects of linagliptin in Asian patients in CARMELINA((R)).MethodsT2DM patients with HbA1c 6.5-10.0% and established CVD with urinary albumin-to-creatinine ratio (UACR)>30 mg/g, and/or prevalent kidney disease (estimated glomerular filtration rate [eGFR] 15-<45 ml/min/1.73 m(2) or >= 45-75 with UACR >200 mg/g), were randomized to linagliptin or placebo added to usual care. The primary endpoint was time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (3-point MACE).ResultsOf the 6979 patients, 555 (8.0%) were Asians living in Asia. During a median follow-up of 2.2 years, 3-point MACE occurred in 29/272 (10.7%) and 33/283 (11.7%) of linagliptin and placebo patients, respectively (hazard ratio [HR] 0.90; 95% confidence interval [CI] 0.55-1.48), consistent with the overall population (HR 1.02; 95% CI 0.89-1.17; P value for treatment-by-region interaction: 0.3349). Similar neutrality in Asian patients was seen for other cardiorenal events including the secondary kidney endpoint of death from renal failure, progression to end-stage kidney disease, or >= 40% eGFR decrease (HR 0.96; 95% CI 0.58-1.59). Linagliptin was associated with a nominal decrease in the risk of hospitalization for heart failure (HR 0.47; 95% CI 0.24-0.95). Overall in Asian patients, linagliptin had an adverse event rate similar to placebo, consistent with the overall population.ConclusionsLinagliptin showed cardiovascular and renal safety in Asian patients with T2DM and established CVD with albuminuria and/or kidney disease.
基金：
Boehringer IngelheimBoehringer Ingelheim; Eli Lilly and Company Diabetes AllianceEli Lilly
第一作者单位：[1]Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, 54 Kawahara‑cho, Shogoin, Sakyo‑ku, Kyoto 606‑8507, Japan
通讯作者：
推荐引用方式(GB/T 7714)：
Nobuya Inagaki,Wenying Yang,Hirotaka Watada,et al.Linagliptin and cardiorenal outcomes in Asians with type 2 diabetes mellitus and established cardiovascular and/or kidney disease: subgroup analysis of the randomized CARMELINA((R)) trial[J].DIABETOLOGY INTERNATIONAL.2020,11(2):129-141.doi:10.1007/s13340-019-00412-x.
APA：
Nobuya Inagaki,Wenying Yang,Hirotaka Watada,Linong Ji,Sven Schnaidt...&Masaomi Nangaku.(2020).Linagliptin and cardiorenal outcomes in Asians with type 2 diabetes mellitus and established cardiovascular and/or kidney disease: subgroup analysis of the randomized CARMELINA((R)) trial.DIABETOLOGY INTERNATIONAL,11,(2)
MLA：
Nobuya Inagaki,et al."Linagliptin and cardiorenal outcomes in Asians with type 2 diabetes mellitus and established cardiovascular and/or kidney disease: subgroup analysis of the randomized CARMELINA((R)) trial".DIABETOLOGY INTERNATIONAL 11..2(2020):129-141
