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Health Outcomes Among Individuals Exposed to Medical Products Details

Results from Assessments of Health Outcomes Among Individuals Exposed to Medical Products Search
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Project TitleAnti-diabetes Drugs & Acute Myocardial Infarction Protocol v4.0
Date Posted 1-08-2014
Project StatusIn progress
Assessment TypeProtocol
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.
Medical Productanti-diabetic agents, hypoglycemics, DPP-4 inhibitors, sulfonylureas, thiazolidinediones, saxagliptin, sitagliptin, pioglitazone, glimepiride, glipizide, glyburide, long-acting insulin
Health Outcomeacute myocardial infarction (AMI)
Population / Cohortdiabetics
Time Period 
Workgroup Leader(s) Bruce Fireman, MA, Kaiser Permanente Northern California, Oakland, CA; Melissa Butler, PharmD, PhD, Kaiser Permanente Southeast, Atlanta, GA; Darren Toh, ScD, Harvard Pilgrim Health Care Institute, Boston, MA; David J. Graham, MD, MPH, Marsha E. Reichman, PhD, and Mary Ross Southworth, PharmD, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Workgroup Members Protocol Development Group: Denise Boudreau, PhD, Andrea Cook, PhD, and Jennifer Nelson, PhD, Group Health Research Institute; Lesley Curtis, PhD, Duke Clinical Research Institute; Greg Daniel, PhD, MPH, RPH, HealthCore, Inc.; Alan Go, MD, and Joe Selby, MD, MPH, Kaiser Permanente Northern California; Marie Griffin, MD, MPH, Vanderbilt University; William Herman, MD, MPH, University of Michigan; Bruce Psaty, MD, PhD, University of Washington; Marsha Raebel, PharmD, Kaiser Permanente Colorado; Sebastian Schneeweiss, MD, ScD, Brigham and Women’s Hospital; Hylton Joffe, MD, MMSc, and Judith Racoosin, MD, MPH, FDA, Silver Spring, MD
Data SourcesMini-Sentinel Distributed Dataset (MSDD)
Deliverables Mini-Sentinel AMI and Anti-Diabetic Agents Protocol v4.0
Related Links
Keywordsactive surveillance protocol, pharmacovigilance, diabetes mellitus, acute myocardial infarction, anti-diabetic agents, hypoglycemics, DPP-4 inhibitors, thiazolidinediones, sulfonylureas, saxagliptin, sitagliptin, pioglitazone, glimepiride, glipizide, glyburide, long-acting insulin, Boudreau, Butler, Cook, Curtis, Daniel, Fireman, Go, Graham, Griffin, Herman, Joffe, Nelson, Psaty, Racoosin, Raebel, Reichman, Schneeweiss, Selby, Southworth, Toh

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Page Updated: 9/18/2014