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Authors: Li Wei, associate professor in epidemiology and medical statistics1,, Edward Chia-Cheng Lai, assistant professor2, Yea-Huei Kao-Yang, professor2, Brian R Walker, pro vice chancellor (research strategy & resources), Thomas M MacDonald, professor of clinical pharmacology and pharmacoepidemiology5, Ruth Andrew, professor of pharmaceutical endocrinology3
Author affiliations Correspondence to: R Andrew ruth.andrew@ed.ac.uk (or @RuthAndrewMSEd on Twitter)
- Accepted 11 March 2019
Abstract
Objective To investigate the incidence of new onset type 2 diabetes mellitus in men receiving steroid 5?-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 5?-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.