Hypoglycemic Events Following Use of Anti-Diabetic Agents (ADAs)

Project Title Hypoglycemic Events Following Use of Anti-Diabetic Agents (ADAs)
Date Posted
Wednesday, February 25, 2015
Project ID
MSY5_MPR07_v1
Status
Complete
Deliverables
Description

Modular program-based one-time assessment assessing hypoglycemic events following use of anti-diabetic agents (ADAs). The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2004 to December 31, 2012. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 6.0; click here for more information.  Queries were distributed in November 2013. This report includes data from 18 Data Partners. Part 1 (MSY5_MPR07_v1_part1) includes results for scenarios 1-17 which do not have a pre-existing dispensing requirement. Results for scenarios 18-30 are presented in Part 2 (MSY5_MPR07_V1_part2) and use different incidence criteria.

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Medical Product
anti-diabetic agent (ADA)
chlorpropamide
glimepiride
glipizide
glipizide/metformin
glyburide
glyburide/metformin
insulin
metformin
pioglitazone
pioglitazone/metformin
rosiglitazone maleate
rosiglitazone/metformin
tolazamide
Health Outcome
hypoglycemia
Time Period
2004 - 2012
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER