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
Abstract
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).…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 657,134 participants or records.
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