Niacin and Fenofibrate Use and Outcomes with Propensity Score Matching

Basic Details
Date Posted
Sunday, November 5, 2017
Status
Complete
Medical Product
extended-release (ER) niacin
fenofibrate
Health Outcome(s)
gastrointestinal (GI) bleed
intracranial hemorrhage
ischemic stroke
Description

This report investigates major gastrointestinal (GI) bleeding, intracranial hemorrhage, and ischemic stroke events following new use of extended-release niacin and fenofibrates. 

Additional Details
FDA Center
CDER
Time Period
January 1, 2007 - August 31, 2013
Study Type
Modular Program
Assessment Type
Safety Analyses
Population / Cohort
Individuals 20 to 99 years of age
Data Sources
Mini-Sentinel Distributed Database (MSDD)