Cardiovascular safety of 5α-reductase inhibitors in people with benign prostatic hyperplasia and type 2 diabetes: a propensity score-matched analysis
Year: 2026
Type: article
Study design: Observational Study
Abstract: AIMS: 5α-Reductase inhibitors are prescribed for the treatment of benign prostatic hyperplasia (BPH) and their use is associated with increased risk of incident type 2 diabetes. This study assessed the long-term cardiovascular safety of 5α-reductase inhibitors in comparison with tamsulosin in people with co-existing BPH and type 2 diabetes. METHODS AND RESULTS: We performed a retrospective, population-based cohort study using Scottish Diabetes Research Network National Diabetes Dataset (SDRN-NDS) and IQVIA Medical Research Data (IMRD-UK). BPH patients ≥40 years with recorded type 2 diabetes mellitus and ≥2 prescriptions of 5α-reductase inhibitors or tamsulosin (2006-2021) were included. After 1:2 variable ratio propensity score matching, cause-specific Cox proportional-hazard models were used to compute the hazard ratio (HR) of incident major adverse cardiovascular events (MACE). A total of 11 969 patients were included in SDRN-NDS and 16 492 in IMRD-UK, with median follow-up durations of 3.8 (IQR: 1.7-6.8) and 4.8 (2.0-8.3) years, respectively. In SDRN-NDS, the HR of MACE in patients receiving 5α-reductase inhibitors relative to tamsulosin was 1.15 (95% CI 1.03-1.30, P = 0.007), driven by increased risk of myocardial infarction (MI) (HR 1.20, 1.03-1.40, P = 0.022). This was replicated in IMRD-UK, where HR was 1.26 (1.07-1.47, P = 0.008) for MACE and 1.33 (1.10-1.60, P = 0.005) for MI. We did not observe any increased risks in stroke, cardiovascular death, microvascular complications of diabetes, or faster progression to insulin-based therapies. CONCLUSION: Our retrospective data from two large cohorts suggest that the risk of MACE may be increased among patients with type 2 diabetes taking 5α-reductase inhibitors, potentially driven by increased risk of MI. This supports careful monitoring of macrovascular outcomes when prescribing 5α-reductase inhibitors in this population.
Authors: Haolan Tu, Chengsheng Ju, Stuart J McGurnaghan, Luke A K Blackbourn, Peter Hanlon, Robert Lindsay, David McAllister, John Petrie, Naveed Sattar, Brian Kennon, Sam Philip, Scott Cunningham, Ewan Pearson, Huan Wang, William Berthon, Luke Blackbourn, Helen Colhoun, Stuart McGurnaghan, Paul McKeigue, Sarah Wild, Ewan Pearson, Li Wei, Ruth Andrew
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,501
OpenAlex ID: W7124529770