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Niacin and Fenofibrate Use and Outcomes with Propensity Score Matching

Basic Details
Date Posted
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. 

Deliverables (1)
Mini-Sentinel Modular Program Report: Niacin and Fenofibrate Use
Additional Details
FDA Center
CDER
Time Period
January 1, 2007 - August 31, 2013
Analysis Type
Mini-Sentinel
Population / Cohort
Individuals 20 to 99 years of age
Data Sources
Mini-Sentinel Distributed Database (MSDD)
Related Links
Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel System
Niacin and Niacin Combination Products, Fenofibrates, and Omega-3 Products
Concomitant Use of Niacin and Statins and Concomitant Use of Fenofibrates and Statins