Suicide and Intentional Self-Harm among Older Men Treated with 5-Alpha Reductase Inhibitor or Alpha-Blockers for Benign Prostatic Hyperplasia.

To compare the risk of intentional self-harm (ISH) and suicide in older men using 5-α reductase inhibitors (5-ARIs) and alpha-blockers for benign prostatic hyperplasia (BPH). Observational research of older men with BPH suggested an increase in ISH with 5-ARI use compared with nonuse; we aimed to address potential confounding by indication with an active comparator reference group. Using Medicare data linked to the National Death Index (NDI) from 2007-2016, we implemented a retrospective cohort design in males aged ≥65 years who initiated 5-ARI or alpha-blocker use for BPH. ISH was identified using ICD-9-CM and ICD-10-CM diagnosis codes. Suicides were identified through cause-of-death information from the NDI. We used inverse probability of treatment weighted Cox proportional hazards regression to compare time-to-event between treatment groups, with robust variance estimation. The event rates for ISH and suicide, respectively, were 0.314 and 0.308 per 1000 person-years (PY) among 5-ARI users (n=181,675), and 0.364 and 0.382 per 1000PY among alpha-blocker users (n=850,476). For 5-ARI use relative to alpha-blocker use, hazard ratios (HRs) for ISH and suicide, respectively, were 0.88 (95% CI:0.62-1.25) and 0.82 (95% CI:0.54-1.24); for the composite outcome (non-fatal ISH or suicide), the HR was 0.88 (95% CI:0.66-1.16). Subgroup and sensitivity analyses supported these results. 5-ARI use was not associated with an increased risk for ISH or suicide compared to alpha-blocker use in older men with BPH. Study limitations included low event rates and potentially low sensitivity for ISH events.

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Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of Competing Interests The authors have no conflict of interest to declare. SA, KBN, NF, MW and TEC were employees of Acumen, LLC at the time the study was conducted. This study was funded in full by the U.S. Food and Drug Administration, through an interagency agreement with the Centers for Medicare & Medicaid Services, for which Acumen, LLC is a contractor.