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

Basic Details
Date Posted
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.

Deliverables (1)
Mini-Sentinel AMI and Anti-Diabetic Agents Protocol
Additional Details
FDA Center
CDER
Analysis Type
Mini-Sentinel
Population / Cohort
All diabetic individuals
Data Sources
Mini-Sentinel Distributed Dataset (MSDD)
Related Links
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee: Saxagliptin and Cardiovascular Outcomes
A Protocol for Active Surveillance of Acute Myocardial Infarction in Association with the use of a New Antidiabetic Pharmaceutical Agent
Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study
Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study
Sentinel Initiative Public Workshop - Ninth Annual
Mini-Sentinel Drug Assessment: Onglyza (Saxagliptin) and Januvia (Sitagliptin) & Hospitalized Heart Failure and Acute Myocardial Infarction (AMI)
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