The DOI matches its Crossref record; 34 of the 34 references it cites were found in a registry or an index.
Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis
Open accessAbstract
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clinical trials, with no date or language restrictions, through September 2010 (updated March 2011) for published and unpublished studies.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 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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Measuring inconsistency in meta-analyses
Higgins, J. P. T., Thompson, S. G., Deeks, J. J., & Altman, D. G. (2003) · BMJ · doi:10.1136/bmj.327.7414.557 · Cited by 63,139
What to add to nothing? Use and avoidance of continuity corrections in meta‐analysis of sparse data
J. Sweeting, M., J. Sutton, A., & C. Lambert, P. (2004) · Statistics in Medicine · doi:10.1002/sim.1761 · Cited by 1,734
The Effects of a Smoking Cessation Intervention on 14.5-Year Mortality: A Randomized Clinical Trial
Anthonisen, N. R., Skeans, M. A., Wise, R. A., Manfreda, J., Kanner, R. E., Connett, J. E., & for the Lung Health Study Research Group* (2005) · Annals of Internal Medicine · doi:10.7326/0003-4819-142-4-200502150-00005 · Cited by 1,237
Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events
Bradburn, M. J., Deeks, J. J., Berlin, J. A., & Russell Localio, A. (2007) · Statistics in Medicine · doi:10.1002/sim.2528 · Cited by 938
Nicotine receptor partial agonists for smoking cessation
Hey, K., Lancaster, T., & Bala, M. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103 · Cited by 866
Nicotine receptor partial agonists for smoking cessation
Cahill, K., Stead, L., & Lancaster, T. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103.pub2 · Cited by 747
Tonstad, S. (2006) · JAMA · doi:10.1001/jama.296.1.64 · Cited by 660
Varenicline Is a Partial Agonist at α4β2 and a Full Agonist at α7 Neuronal Nicotinic Receptors
Mihalak, K. B., Carroll, F. I., & Luetje, C. W. (2006) · Molecular Pharmacology · doi:10.1124/mol.106.025130 · Cited by 558
Research works printed but not linked: 2
- Josefberg H. Approval package for: application number NDA 21- 928 [clinical safety review: varenicline tartrate]. Rockville (MD): US Food and Drug Administration, Center for Drug Evaluation and Research; 2006. p. 277, 402. Available: www .accessdata .fda .gov /drugsatfda _docs /nda /2006 /021928 _s000 _Chantix _MedR .pdf (ac cessed 2011 Apr. 14).
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European Guidelines on cardiovascular disease prevention in clinical practice (version 2012)
Authors/Task Force Members:, Perk, J., De Backer, G., Gohlke, H., Graham, I., Reiner, Ž., Verschuren, M., Albus, C., Benlian, P., Boysen, G., et al. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs092 · Cited by 8,490
2013 ESC guidelines on the management of stable coronary artery disease
Task Force Members, Montalescot, G., Sechtem, U., Achenbach, S., Andreotti, F., Arden, C., Budaj, A., Bugiardini, R., Crea, F., Cuisset, T., et al. (2013) · European Heart Journal · doi:10.1093/eurheartj/eht296 · Cited by 4,510
European guidelines on cardiovascular disease prevention in clinical practice: executive summary
Graham, I., Atar, D., Borch‐Johnsen, K., Boysen, G., Burell, G. K., Cífková, R., Dallongeville, J., Backer, G. D., Ebrahim, S. B. J., Gjelsvik, B., et al. (2007) · European Heart Journal · doi:10.1093/eurheartj/ehm316 · Cited by 3,865
Breast Cancer, Version 4.2017, NCCN Clinical Practice Guidelines in Oncology
Gradishar, W. J., Anderson, B. O., Balassanian, R., Blair, S. L., Burstein, H. J., Cyr, A. E., ELIAS, A. D., Farrar, W. B., Forero, A., Giordano, S. H., et al. (2018) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2018.0012 · Cited by 1,612
2016 European Guidelines on cardiovascular disease prevention in clinical practice
Authors/Task Force Members, Piepoli, M. F., Hoes, A. W., Agewall, S., Albus, C., Brotons, C., Catapano, A. L., Cooney, M. T., Corrà, U., Cosyns, B., et al. (2016) · European Journal of Preventive Cardiology · doi:10.1177/2047487316653709 · Cited by 1,435
Metadata
- Authors
- Singh, S., Loke, Y. K., Spangler, J. G., & Furberg, C. D.
- Affiliations
- Johns Hopkins University (US)
- 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
- 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 › Public Health, Environmental and Occupational Health › 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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