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Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Angioedema Events After Use of Angiotensin-Converting Enzyme (ACE) Inhibitors Versus Beta-blockers

Basic Details
Date Posted
Status
Complete
Medical Product
angiotensin-converting enzyme (ACE) inhibitor
beta blocker
Health Outcome(s)
angioedema
Description

This statistical methods project is one of four workgroups that used exposure/outcome pairs with known positive associations to test Mini-Sentinel (now Sentinel) routine querying tools. Specifically, these known positive associations tested the Cohort Identification and Descriptive Analysis (CIDA) tool in combination with the Propensity Score Analysis (PSA) tool.

This known positive test case assessed ACE inhibitors versus beta-blockers and risk of angioedema. The CIDA tool was used to identify new users of these medications. Information generated by the CIDA tool was used by the PSM tool to match cohort members based on propensity score. Propensity scores were calculated using a list of user-defined covariates. One run of the program was required. The time window was January 1st, 2008 to September 30th, 2013.

Deliverable(s) (1)
Mini-Sentinel Methods: Angioedema Events After Use of Angiotensin-Converting Enzyme (ACE) Inhibitors Versus Beta-blockers
Information
Time Period
January 1, 2008 - September 30, 2013
Population / Cohort
All individuals
Data Source(s)
Mini-Sentinel Distributed Database (MSDD)
Related Links
Related Link(s)
Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide Versus Glipizide
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium Difficile Events After Use of Oral Clindamycin Versus Penicllins
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins
Workgroup Member(s)

Patrick Archdeacon, MD; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Ryan Carnahan, PharmD, MS, BCPP; Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA

Elizabeth Chrischilles, MS, PhD; Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA

April Duddy, MS; Candace Fuller, PhD; Hannah Katcoff, MPH; Jennifer R. Popovic, DVM, MA; Darren Toh, ScD; Tiffany S. Woodworth, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 

Joshua Gagne, PharmD, ScD; Sebastian Schneeweiss, MD, ScD; Shirley V. Wang, PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA

Xu Han, PharmD, PhD, MS; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Sean Hennessy, PharmD, PhD; Charles E. Leonard, PharmD, MSCE; Center for Clinical Epidemiology and Biostatistics and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Jie Li, PhD, MBBS; Marsha Reichman, PhD; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Tamra E. Meyer, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD