Smoking Cessation Drugs and Cardiovascular Outcomes

Project Title Smoking Cessation Drugs and Cardiovascular Outcomes
Date Posted
Sunday, January 15, 2012
Status
Complete
Deliverables
Mini-Sentinel Smoking Cessation Drugs and Selected Cardiovascular Outcomes
Related Links
Rapid Assessment of Cardiovascular Risk Among Users of Smoking Cessation Drugs Within the US Food and Drug Administration's Mini-Sentinel Program
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.

Medical Product
bupropion
varenicline
Health Outcome
acute coronary occlusion without myocardial infarction
acute myocardial infarction (AMI)
cardiovascular outcome
intermediate coronary syndrome
unstable angina
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER
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