Document Detail


Review: Varenicline for tobacco cessation does not increase CV serious adverse events.
MedLine Citation:
PMID:  22910956     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
QUESTION Does use of varenicline for tobacco cessation increase risk for treatment-emergent, cardiovascular (CV) serious adverse events in adult tobacco users? REVIEW SCOPE Included studies compared varenicline with an inactive control in current adult tobacco users and reported adverse events. The primary outcome was treatment-emergent, CV serious adverse events defined as any ischemic or arrhythmic adverse CV event (myocardial infarction, unstable angina, coronary revascularization, coronary artery disease, arrhythmia, transient ischemic attack, stroke, sudden death or CV-related death, or congestive heart failure) occurring during drug treatment or within 30 days of drug discontinuation. REVIEW METHODS MEDLINE, Cochrane Library, ClinicalTrials.gov, and Clinical Study Results registry (all 2005 to Sep 2011), reviews. and reference lists were searched for randomized controlled trials (RCTs). 22 RCTs (n = 9232, 49% to 100% men, median treatment duration 12 wk, median follow-up for adverse events 16 wk, median study duration 25 wk) met selection criteria. For 3 RCTs, the drug manufacturer (Pfizer) or study authors were contacted for data on timing of CV serious adverse events. 20 RCTs included cigarette smokers, and 2 RCTs included smokeless tobacco users. 13 RCTs included patients with current or past CV disease; 9 RCTs excluded patients with history of CV disease or did not specify timing of CV history for exclusion. Varenicline dose was 1 mg twice daily in 21 RCTs, and 3 of these RCTs also included lower doses. 1 RCT assessed varenicline, 1 mg, once daily. All RCTs were double-blind and had adequate descriptions of randomization, loss to follow-up, and CV serious adverse events. MAIN RESULTS Varenicline did not increase CV serious adverse events compared with placebo (Table). CONCLUSION In adult tobacco users, varenicline for tobacco cessation did not increase treatment-emergent, cardiovascular serious adverse events compared with placebo.Varenicline vs placebo for tobacco cessation in adult tobacco users*OutcomeNumber of trials (n)Weighted event ratesAt a median 16 wkVareniclinePlaceboRRI (95% CI)Risk difference (CI)CV serious adverse events†22 (9232)0.66%0.47%40% (-18 to 139)0.27 (-0.10 to 0.63)*CV = cardiovascular; other abbreviations defined in Glossary. Weighted event rate, RRI, and CI calculated from control event rate and relative risk in article using a fixed-effect model. 8 randomized controlled trials (n = 1596) with 0 events in both groups were included in the calculation of the control event rate but not in the calculation of the RRI.†Any ischemic or arrhythmic adverse CV event (myocardial infarction, unstable angina, coronary revascularization, coronary artery disease, arrhythmia, transient ischemic attack, stroke, sudden death or CV-related death, or congestive heart failure) occurring during drug treatment or within 30 days of drug discontinuation.
Authors:
Paul Krebs; Scott E Sherman
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Annals of internal medicine     Volume:  157     ISSN:  1539-3704     ISO Abbreviation:  Ann. Intern. Med.     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-08-22     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372351     Medline TA:  Ann Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  JC2-2     Citation Subset:  AIM; IM    
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