Smoking Cessation Drugs and Cardiovascular Outcomes

Basic Details
Date Posted
Sunday, January 15, 2012
Status
Complete
Medical Product
bupropion
varenicline
Health Outcome(s)
acute coronary occlusion without myocardial infarction
acute myocardial infarction (AMI)
cardiovascular outcome
intermediate coronary syndrome
unstable angina
Description

Modular program-based one-time assessment of the risk of a composite cardiovascular outcome associated with new use of smoking cessation drugs, including varenicline and bupropion. Modular programs are adaptable standardized programs.

Additional Details
FDA Center
CDER
Study Type
Modular Program
Assessment Type
Safety Analyses
Data Sources
Mini-Sentinel Distributed Database (MSDD)