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Comparative Study
. 2019 Apr 10:365:l1204.
doi: 10.1136/bmj.l1204.

Incidence of type 2 diabetes mellitus in men receiving steroid 5α-reductase inhibitors: population based cohort study

Li Wei  1 , Edward Chia-Cheng Lai  2 , Yea-Huei Kao-Yang  2 , Brian R Walker  3   4 , Thomas M MacDonald  5 , Ruth Andrew  6
Affiliations
Comparative Study

Incidence of type 2 diabetes mellitus in men receiving steroid 5α-reductase inhibitors: population based cohort study

Li Wei et al. BMJ. .

Abstract

Objective: To investigate the incidence of new onset type 2 diabetes mellitus in men receiving steroid 5α-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 5α-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.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1
Fig 1
Flow chart showing UK Clinical Practice Research Datalink (CPRD) study cohorts
Fig 2
Fig 2
Cumulative incidence of type 2 diabetes in Clinical Practice Research Datalink cohort over study period: main cohort (adjusted), and adjusted for propensity score
Fig 3
Fig 3
Flow chart showing Taiwanese National Health Insurance Research Database (NHIRD) study cohorts
Fig 4
Fig 4
Cumulative incidence of type 2 diabetes mellitus in Taiwanese National Health Insurance Research Database cohort over study period: main cohort (adjusted), and adjusted for propensity score
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