LAUSR

A noninterventional postauthorization safety study in adult patients with type 2 diabetes compared the incidence of hospitalized diagnoses of acute kidney injury (hAKI) in new users of dapagliflozin and new users of comparator glucose-lowering drugs (GLDs), matched by index year, age, sex, 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 included. Incidence rates of hAKI were calculated by exposure group and compared with adjusted incidence rate ratios (aIRRs) with covariate adjustment by propensity score trimming and stratification. A pooled aIRR was estimated by the Mantel-Haenszel method. The number of included person-years of dapagliflozin and comparator exposure, respectively, was 12,389 and 30,737 in CPRD, 12,575 and 111,919 in HIRD, and 9,208 and 141,313 in Medicare. The mean age (years) was 57 in CPRD, 52 in HIRD, and 71 in Medicare. Approximately 41% in CPRD, 47% in HIRD, and 50% in Medicare were women. All aIRRs and upper 95% confidence limits (CI) were below the null (figure); the pooled aIRR was 0.70 (95% CI, 0.62-0.78). This real-world study shows a decreased risk of hAKI associated with dapagliflozin compared with other GLDs and aligns with results from dapagliflozin clinical trials. Disclosure C. Johannes: Other Relationship; Self; AstraZeneca. H. Chen: None. A. Gilsenan: Other Relationship; Self; AstraZeneca. J. Layton: Other Relationship; Self; AstraZeneca. D. C. Beachler: Employee; Self; Anthem Inc. (HealthCore). R. M. Ziemiecki: Research Support; Self; Astellas Pharma Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Pfizer Inc. L. Li: Other Relationship; Self; Pfizer Inc. H. E. Danysh: Other Relationship; Self; AstraZeneca. J. Dinh: None. P. R. Hunt: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. C. Karlsson: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca.