Anti-Diabetes Drugs and Acute Myocardial Infarction, Hospitalized Heart Failure

    Basic Details
    Date Posted
    Tuesday, January 26, 2016
    Status
    Complete
    Medical Product
    anti-diabetic agent (ADA)
    dipeptidyl peptidase-4 (DPP-4) inhibitor
    glimepiride
    glipizide
    glyburide
    hypoglycemic drug
    long-acting insulin
    pioglitazone
    saxagliptin
    sitagliptin
    sulfonylurea
    thiazolidinedione
    Health Outcome(s)
    acute myocardial infarction (AMI)
    heart failure
    Description

    Protocol-based repeated assessment of accumulating experience analyzed at pre-defined intervals concerning the risk of acute myocardial infarction associated with new use of anti-diabetes medications. Protocols are customized study designs.

    Workgroup Leader(s)

    Bruce Fireman MA; Kaiser Permanente Northern California, Oakland, CA

    Melissa Butler PharmD, PhD; Kaiser Permanente Southeast, Atlanta, GA

    Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    David J. Graham MD, MPH; Marsha E. Reichman PhD; Mary Ross Southworth PharmD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Workgroup Members

    Denise Boudreau PhD; Andrea Cook PhD; Jennifer Nelson PhD; Group Health Research Institute,Seattle, WA

    Lesley Curtis PhD; Duke Clinical Research Institute, Durham, NC

    Greg Daniel PhD, MPH, RPH; HealthCore, Inc., Alexandra, VA

    Alan Go MD; Joe Selby MD, MPH; Kaiser Permanente Northern California, Oakland, CA

    Marie Griffin MD, MPH; Vanderbilt University, Nashville, TN

    William Herman MD, MPH; University of Michigan, Ann Arbor, MI

    Bruce Psaty MD, PhD; University of Washington, Seattle, WA

    Marsha Raebel PharmD; Kaiser Permanente Colorado, Denver, CO

    Sebastian Schneeweiss MD, ScD; Brigham and Women’s Hospital, Boston, MA

    Hylton Joffe MD, MMSc; Judith Racoosin MD, MPH; FDA, Silver Spring, MD