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Hydrochlorothiazide Use Following Labeling Update to Include the Risk of Non-Melanoma Skin Cancer: An Interrupted Time Series Analysis

    Basic Details
    Date Posted
    In progress
    Medical Product

    This analysis investigates utilization of hydrochlorothiazide (HCTZ)-containing diuretics, non HCTZ-containing diuretics, and antihypertensives over time in the Sentinel Distributed Database (SDD) to understand the impact of FDA labeling updates that were made on August 8, 2020 to inform health care professionals and patients about a small increased risk of non-melanoma skin cancer (basal and squamous cell skin cancer) with HCTZ. 

    The study period includes data from January 1, 2017 to June 30, 2023. We distributed this request to five Sentinel Data Partners on September 29, 2023. This analysis consists of two parts:

    • Part 1 (nsdp1): includes cohorts of all individuals with evidence of utilization of HCTZ-containing diuretics, non HCTZ-containing diuretics, and antihypertensives
    • Part 2 (nsdp2): includes separate cohorts of individuals with and without prior evidence of skin cancer 

    The analytic packages 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
    Time Period
    January 1, 2017 - June 30, 2023
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)