Observational evidence suggests that patients with type 2 diabetes mellitus (T2DM) are at increased risk of AP. A small number of AP events were reported in clinical trials of the SGLT2 inhibitor CANA, with no imbalances noted between treatment groups. This observational study evaluated the risk of AP among new users of CANA vs. 6 classes of other AHAs. Three U.S. claims databases were analyzed based on a prespecified protocol approved by the European Medicines Agency. Propensity score adjustment controlled for imbalances in baseline covariates. Cox regression models were used to estimate the hazard ratio of AP with CANA vs. other AHAs using on-treatment and intent-to-treat (ITT) approaches. Sensitivity analyses assessed the robustness of study findings. Across the 3 databases, there were between 12,023 to 80,986 new users of CANA and the crude incidence rates of AP (events per 1000 person-years) were between 1.5 to 2.2 for CANA and 1.1 to 6.6 for other AHAs. AP risk in patients newly treated with CANA or other AHAs was generally similar (Table). Findings from the ITT approach and sensitivity analyses were qualitatively consistent with the on-treatment approach. In this large observational study, incidence rates of AP in patients with T2DM treated with CANA or other AHAs were generally similar, with no evidence to suggest that CANA is associated with an increased risk of AP compared with other AHAs.

Disclosure

Z. Yuan: Employee; Self; Janssen Research & Development. F. Defalco: Employee; Self; Janssen Research & Development. L. Wang: Employee; Self; Johnson & Johnson. L.L. Hester: Employee; Self; Janssen Research & Development. J.N. Swerdel: Employee; Self; Janssen Pharmaceuticals, Inc. A. Freedman: Employee; Self; Janssen Research & Development. P. Ryan: Employee; Self; Janssen Research & Development. M. Schuemie: Employee; Self; Janssen Research & Development. R. Qiu: Employee; Self; Janssen Research & Development. J. Yee: Employee; Self; Janssen Research & Development. G. Meininger: Employee; Self; Janssen Research & Development. J.A. Berlin: Employee; Self; Janssen Research & Development. Stock/Shareholder; Self; Janssen Research & Development. N. Rosenthal: Employee; Self; Janssen Research & Development.

Funding

Janssen Research & Development, LLC

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