A noninterventional postauthorization safety study in patients with type 2 diabetes compared the sex-specific incidence of severe complications of urinary tract infections (sUTI) (pyelonephritis or urosepsis) in new users of dapagliflozin and new users of other comparator glucose-lowering drugs (GLDs), matched by index year, age, and region. Comparators included GLDs other than SGLT2 inhibitors, or monotherapy of insulin, metformin, or sulfonylureas. Data from US Medicare (2014-2017), US HealthCore Integrated Research Database (HIRD) (2014-2019), and UK Clinical Practice Research Datalink (CPRD) (2012-2018) were analyzed. Incidence rates of sUTI were compared by exposure group with adjusted incidence rate ratios (aIRRs) with covariate adjustment by propensity score trimming and stratification. Pooled aIRRs were estimated by the Mantel-Haenszel method. The total number of person-years of dapagliflozin and comparator exposure, respectively, was 17,265 and 161,176 for females and 22,594 and 194,388 for males. Mean age (years) in CPRD, HIRD, and Medicare was 58, 52, and 72 in females and 59, 52, and 71 in males, respectively. All aIRR estimates were below the null but imprecise (figure). The pooled aIRR was 0.76 (95% CI, 0.60-0.96) in females and 0.74 (95% CI, 0.56-1.00) in males. This real-world study did not find an increased risk of sUTI in females or males with dapagliflozin compared with other GLDs.
