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

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    hydrochlorothiazide
    Description

    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. This is a follow up to a prior query to include additional products in the denominator of the analysis.

    The study period includes data from January 1, 2017 to December 31, 2022. This request was ran on the Merative™ MarketScan® Research Databases on January 10, 2024. This analysis includes four reports:

    • Report 1: does not contain inclusion or exclusion criteria for history of skin cancer.
    • Report 2: contains inclusion or exclusion criteria for history of skin cancer.
    • Report 3: does not contain inclusion or exclusion criteria for history of skin cancer and presents the results from the Interrupted time series (ITS) analyses.
    • Report 4: contains inclusion or exclusion criteria for history of skin cancer and presents the results from the ITS analyses.
    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2017 - December 31, 2022
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    All individuals
    Data Sources
    Merative™ MarketScan® Research Databases