Risk of prostatitis in patients with type 2 diabetes mellitus: An observational retrospective cohort study of canagliflozin versus other antihyperglycemic agents using propensity score matching.

PURPOSE: Prostatitis has been reported in patients with type 2 diabetes mellitus (T2DM) receiving antihyperglycemic agents (AHAs). This study was conducted to evaluate the risk of prostatitis with canagliflozin in response to a specific Health Authority query. METHODS: This retrospective cohort study used data from adult male patients with T2DM who were new users of canagliflozin (target) or comparators (empagliflozin, dapagliflozin, sitagliptin, and liraglutide). Data were obtained from 8 global administrative claims databases, transformed to a Common Data Model for consistent analysis across databases. Pairwise comparisons were conducted using propensity scores to match canagliflozin users to users of each comparator at a 1:n ratio (maximum n = 100). Hazard ratios were estimated using a Cox proportional hazards model, conditioned on the matched set. RESULTS: A total of 388,893 adult male patients with T2DM received canagliflozin across databases (mean age, 51.2-71.7 years) and were matched to 657,134 patients receiving empagliflozin, 340,539 receiving dapagliflozin, 819,047 receiving sitagliptin, and 278,684 receiving liraglutide. On-treatment incidence rates showed that prostatitis was uncommon in the canagliflozin cohort in nearly all databases (4.2-7.7 per 1000 person-years) and were similar to those of the comparator treatments. The exception was a higher crude incidence rate in the Merative MarketScan® Medicare Supplemental Database (10.1-12.1 per 1000 person-years). Propensity score matching achieved good balance in all available covariates, and effect estimates were relatively close to a hazard ratio of 1.0, varying on both sides of the null effect. Minimum detectable relative risks were low in most databases, and meta-analytic estimates were near 1.0, with all upper bounds <1.50. No association (either increased or decreased risk) was found with canagliflozin versus other AHAs. CONCLUSIONS: This analysis found no evidence of a statistically significantly increased risk of prostatitis among adult male patients with T2DM receiving canagliflozin compared with the other AHAs evaluated in this study.