Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide

Basic Details
Date Posted
Tuesday, July 18, 2017
Status
Complete
Medical Product
glipizide
glyburide
Health Outcome(s)
hyperglyceridemia
hypoglycemia
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 severe hypoglycemia events following new use of glyburide versus glipizide. The query was run against the Sentinel Distributed Database (SDD) for the time period of January 1, 2008 to September 30, 2014. The queries were distributed in February 2015. 

Report 1 contains results for severe hypoglycemia events in any diagnosis position for emergency department encounters or first-listed diagnosis for inpatient encounters. This report includes results from the 5 Data Partners for which the high-dimensional propensity score (hdPS) analysis ran successfully and converged.

Report 2 contains results for severe hypoglycemia events in any diagnosis position for emergency department encounters or first-listed diagnosis for inpatient encounters. This report includes results from 13 Data Partners.

Report 3 contains results for severe hypoglycemia events in any diagnosis position for emergency department encounters only. This report includes results from the 5 Data Partners for which the high-dimensional propensity score (hdPS) analysis ran successfully and converged.

Report 4 contains results for severe hypoglycemia events in any diagnosis position for emergency department encounters only. This report includes results from 13 Data Partners.

Workgroup Leader(s)

Christian Hampp, PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Sean Hennessy, PharmD, PhD; Meijia Zhou, MHS; Center for Pharmacoepidemiology Research and Training, Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA

Workgroup Member(s)

Candace C. Fuller, PhD; Darren Toh, ScD; Austin Cosgrove, BS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA