Niacin and Fenofibrate Use and Outcomes with Propensity Score Matching

    Basic Details
    Date Posted
    Sunday, November 5, 2017
    Status
    Complete
    Medical Product
    extended-release (ER) niacin
    fenofibrate
    Health Outcome(s)
    gastrointestinal (GI) bleed
    intracranial hemorrhage
    ischemic stroke
    Description

    This report investigates major gastrointestinal (GI) bleeding, intracranial hemorrhage, and ischemic stroke events following new use of extended-release niacin and fenofibrates. 

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2007 - August 31, 2013
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Population / Cohort
    Individuals 20 to 99 years of age
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)