Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis

Singh, S.; Loke, Y. K.; Spangler, J. G.; Furberg, C. D.

doi:10.1503/cmaj.110218

Cited by 286Smoking Behavior and CessationPharmacovigilance and Adverse Drug ReactionsCardiac Health and Mental Health

Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis

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Singh, S., Loke, Y. K., Spangler, J. G., Furberg, C. D.·2011·Canadian Medical Association Journal

DOI 10.1503/cmaj.110218PMC PMC3168618

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Abstract

BACKGROUND: There have been postmarketing reports of adverse cardiovascular events associated with the use of varenicline, a widely used smoking cessation drug. We conducted a systematic review and meta-analysis of randomized controlled trials to ascertain the serious adverse cardiovascular effects of varenicline compared with placebo among tobacco users. METHODS: We searched MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, websites of regulatory authorities and registries of clinical trials, with no date or language restrictions, through September 2010 (updated March 2011) for published and unpublished studies. We selected double-blind randomized controlled trials of at least one week's duration involving smokers or people who used smokeless tobacco that reported on cardiovascular events (ischemia, arrhythmia, congestive heart failure, sudden death or cardiovascular-related death) as serious adverse events asociated with the use of varenicline. RESULTS: We analyzed data from 14 double-blind randomized controlled trials involving 8216 participants. The trials ranged in duration from 7 to 52 weeks. Varenicline was associated with a significantly increased risk of serious adverse cardiovascular events compared with placebo (1.06% [52/4908] in varenicline group v. 0.82% [27/3308] in placebo group; Peto odds ratio [OR] 1.72, 95% confidence interval [CI] 1.09-2.71; I(2) = 0%). The results of various sensitivity analyses were consistent with those of the main analysis, and a funnel plot showed no publication bias. There were too few deaths to allow meaningful comparisons of mortality. INTERPRETATION: Our meta-analysis raises safety concerns about the potential for an increased risk of serious adverse cardiovascular events associated with the use of varenicline among tobacco users.

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A meta-analysis of 14 randomized trials (8216 patients) found a small but significant rise in cardiovascular events with varenicline.
“A meta-analysis based on 14 RCTs including 8216 patients has indicated a small but significantly increased risk of cardiovascular events associated with the use of varenicline.262”
From European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) (2012) · cites this paper as [262]

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Authors: Singh, S., Loke, Y. K., Spangler, J. G., & Furberg, C. D.
Affiliations: Johns Hopkins University (US)
ORCID: Singh, S.
Loke, Y. K.
Spangler, J. G.
Venue: Canadian Medical Association Journal
Publisher: CMA Joule Inc.
Published: 2011-07-04
Volume: 183
Issue: 12
Pages: 1359-1366
ISSN: 0820-3946 (ISSN-L)
1488-2329
DOI: 10.1503/cmaj.110218
PMC: PMC3168618
OpenAlex: W2160161905
Cited by: 286
References: 33
Citations by year: 2026: 3 · 2025: 4 · 2024: 4 · 2023: 2 · 2022: 3 · 2021: 6 · 2020: 7 · 2019: 8 · 2018: 12 · 2017: 18 · 2016: 23 · 2015: 29 · 2014: 31 · 2013: 52 · 2012: 56
FWCI: 5.63
Type: journal article
Language: en
Open access: gold
doi.org
Locations: Canadian Medical Association Journal (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
UEA Digital Repository (University of East Anglia) (submittedVersion)
Funders: National Center for Research Resources (KL2RR025006)
Topics: Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
Keywords: varenicline, cardiovascular adverse events, smoking cessation, nicotine replacement therapy, myocardial ischemia, cardiac arrhythmias, congestive heart failure, sudden death, tobacco users, drug safety
MeSH terms: Varenicline, Benzazepines, Cardiovascular Diseases, Humans, Product Surveillance, Postmarketing, Quinoxalines, Risk, Randomized Controlled Trials as Topic, Nicotinic Agonists

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Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis

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