Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting

Catherine B. Johannes (), Daniel C. Beachler, J. Bradley Layton, Heather E. Danysh, Ryan Ziemiecki, Alejandro Arana, Jade Dinh, Ling Li, Brian Calingaert, Manel Pladevall-Vila, Phillip R. Hunt, Hungta Chen, Cecilia Karlsson, Kristina Johnsson and Alicia Gilsenan
Additional contact information
Catherine B. Johannes: RTI Health Solutions
Daniel C. Beachler: HealthCore, Inc.
J. Bradley Layton: RTI Health Solutions
Heather E. Danysh: RTI Health Solutions
Ryan Ziemiecki: RTI Health Solutions
Alejandro Arana: RTI Health Solutions
Jade Dinh: HealthCore, Inc.
Ling Li: HealthCore, Inc.
Brian Calingaert: RTI Health Solutions
Manel Pladevall-Vila: RTI Health Solutions
Phillip R. Hunt: AstraZeneca
Hungta Chen: AstraZeneca
Cecilia Karlsson: AstraZeneca
Kristina Johnsson: AstraZeneca
Alicia Gilsenan: RTI Health Solutions

Drug Safety, 2023, vol. 46, issue 2, No 5, 157-174

Abstract: Abstract Introduction Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor approved to treat type 2 diabetes mellitus (T2DM), among other conditions. When dapagliflozin was approved in Europe for treating T2DM (2012), potential safety concerns regarding its effect on kidney function resulted in this post-authorization safety study to assess hospitalization for acute kidney injury (hAKI) among dapagliflozin initiators in a real-world setting. Objective The aim of this study was to evaluate the incidence of hAKI in adults with T2DM initiating dapagliflozin compared with other glucose-lowering drugs (GLDs). Methods This noninterventional cohort study identified new users of dapagliflozin and comparator GLDs from November 2012 to February 2019 from three longitudinal, population-based data sources: Clinical Practice Research Datalink (CPRD; United Kingdom), the HealthCore Integrated Research Database (HIRD; United States [US]), and Medicare (US). Electronic algorithms identified occurrences of hAKI, from which a sample underwent validation. Incidence rates for hAKI were calculated, and incidence rate ratios (IRRs) compared hAKI in dapagliflozin with comparator GLDs. Propensity score trimming and stratification were conducted for confounding adjustment. Results In all data sources, dapagliflozin initiators had a lower hAKI incidence rate than comparator GLD initiators (adjusted IRRs: CPRD, 0.44 [95% confidence interval (CI), 0.22–0.86]; HIRD, 0.76 [95% CI, 0.62–0.93]; Medicare, 0.69 [95% CI, 0.59–0.79]). The adjusted IRR pooled across the data sources was 0.70 (95% CI, 0.62–0.78). Results from sensitivity and stratified analyses were consistent with the primary analysis. Conclusions This study, with > 34,000 person-years of real-world dapagliflozin exposure, suggests a decreased risk of hAKI in patients with T2DM exposed to dapagliflozin, aligning with results from dapagliflozin clinical trials. Study registration European Union Post-Authorisation Studies Register, EUPAS 11684; ClinicalTrials.gov, NCT02695082.

Date: 2023
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DOI: 10.1007/s40264-022-01263-3

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