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Renal Cell Carcinoma Following At Least 180 Days of Canagliflozin Use in Patients with Type 2 Diabetes Mellitus: A Clone-Censor-Weighted Analysis with Inverse Probability of Treatment Weighting for Active Comparators

    Basic Details
    Date Posted
    Status
    In progress
    Medical Product
    canagliflozin
    Health Outcome(s)
    renal cell carcinoma
    Description

    In this report, we examined characteristics of individuals with evidence of type 2 diabetes mellitus initiating canagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, or the comparator drug sitagliptin, a dipeptidyl peptidase-4 inhibitor. In addition, we estimated the association between use of these products for at least 180 days within a year of initiation and the risk of incident renal cell carcinoma (RCC) in the Sentinel Distributed Database (SDD). Inverse-probability-of-treatment weighting was applied to balance baseline covariates between canagliflozin and sitagliptin initiators. A clone-censor-weighting design was used to assess adherence to the treatment strategies of interest and account for potential selection of users with ≥180 days of exposure.

    The study period includes data from March 1, 2013 to March 31, 2025. We distributed this request to six Sentinel Data Partners on November 6, 2025.

    The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    CDER
    Time Period
    March 1, 2013 - March 31, 2025
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)