Incidence of type 2 diabetes mellitus in men receiving steroid 5alpha-reductase inhibitors: population based cohort study.
OBJECTIVE: To investigate the incidence of new onset type 2 diabetes mellitus in men receiving steroid 5alpha-reductase inhibitors (dutasteride or finasteride) for long term treatment of benign prostatic hyperplasia.
DESIGN: Population based cohort study.
SETTING: UK Clinical Practice Research Datalink (CPRD; 2003-14) and Taiwanese National Health Insurance Research Database (NHIRD; 2002-12).
PARTICIPANTS: Men in the CPRD who received dutasteride (n=8231), finasteride (n=30 774), or tamsulosin (n=16 270) were evaluated. Propensity score matching (2:1; dutasteride to finasteride or tamsulosin) produced cohorts of 2090, 3445, and 4018, respectively. In the NHIRD, initial numbers were 1251 (dutasteride), 4194 (finasteride), and 86 263 (tamsulosin), reducing to 1251, 2445, and 2502, respectively, after propensity score matching.
MAIN OUTCOMES MEASURE: Incident type 2 diabetes using a Cox proportional hazard model.
RESULTS: In the CPRD, 2081 new onset type 2 diabetes events (368 dutasteride, 1207 finasteride, and 506 tamsulosin) were recorded during a mean follow-up time of 5.2 years (SD 3.1 years). The event rate per 10 000 person years was 76.2 (95% confidence interval 68.4 to 84.0) for dutasteride, 76.6 (72.3 to 80.9) for finasteride, and 60.3 (55.1 to 65.5) for tamsulosin. There was a modest increased risk of type 2 diabetes for dutasteride (adjusted hazard ratio 1.32, 95% confidence interval 1.08 to 1.61) and finasteride (1.26, 1.10 to 1.45) compared with tamsulosin. Results for the NHIRD were consistent with the findings for the CPRD (adjusted hazard ratio 1.34, 95% confidence interval 1.17 to 1.54 for dutasteride, and 1.49, 1.38 to 1.61 for finasteride compared with tamsulosin). Propensity score matched analyses showed similar results.
CONCLUSIONS: The risk of developing new onset type 2 diabetes appears to be higher in men with benign prostatic hyperplasia exposed to 5alpha-reductase inhibitors than in men receiving tamsulosin, but did not differ between men receiving dutasteride and those receiving finasteride. Additional monitoring might be required for men starting these drugs, particularly in those with other risk factors for type 2 diabetes.
|ジャーナル名||BMJ (Clinical research ed.)|
|投稿者||Wei, Li; Lai, Edward Chia-Cheng; Kao-Yang, Yea-Huei; Walker, Brian R; MacDonald, Thomas M; Andrew, Ruth|
|組織名||Research Department of Practice and Policy, School of Pharmacy, University;College London, London, UK.;School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences,;College of Medicine, National Cheng Kung University, Tainan City, Taiwan.;University/BHF Centre for Cardiovascular Science, Queen's Medical Research;Institute, University of Edinburgh, Edinburgh EH16 4TJ, UK.;Institute of Genetic Medicine, International Centre for Life, Newcastle;University, Newcastle upon Tyne, UK.;Medicines Monitoring Unit, Ninewells Hospital and Medical School, Dundee, UK.;Institute, University of Edinburgh, Edinburgh EH16 4TJ, UK firstname.lastname@example.org.|