Smoking Cessation Drugs and Cardiovascular Outcomes

    Basic Details
    Date Posted
    Sunday, January 15, 2012
    Status
    Complete
    Medical Product
    bupropion
    varenicline
    Health Outcome(s)
    acute coronary occlusion without myocardial infarction
    acute myocardial infarction (AMI)
    cardiovascular outcome
    intermediate coronary syndrome
    unstable angina
    Description

    Modular program-based one-time assessment of the risk of a composite cardiovascular outcome associated with new use of smoking cessation drugs, including varenicline and bupropion. Modular programs are adaptable standardized programs.

    Additional Details
    FDA Center
    CDER
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)