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Risk of Severe Hyperglycemia Following Systemic Corticosteroids and Azithromycin Use in COVID-19 Patients with Type 2 Diabetes: A Sequential Surveillance Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    azithromycin
    corticosteroids
    Health Outcome(s)
    severe hyperglycemia
    Description

    In this request, we assessed the comparative risk of severe hyperglycemia in COVID-19 patients with type 2 diabetes treated with systemic corticosteroids and azithromycin compared to COVID-19 patients treated with azithromycin alone. This analysis contains two reports:

    • Report 1: This report contains the results of the first analysis or "look" in a sequential analysis. The study period includes data from May 1, 2021 to August 31, 2023. We distributed this request to five Sentinel Data Partners on February 14, 2024. 
    • Report 2: This report contains the results of the second analysis or "look" of a sequential analysis. The study period includes data from May 1, 2021 to October 1, 2023. We distributed this request to five Sentinel Data Partners on July 26, 2024. 
    Additional Details
    FDA Center
    CDER
    Time Period
    May 1, 2021 - August 31, 2023; May 1, 2021 - October 1, 2023
    Analysis Type
    Prospective Sequential Inferential
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database