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

Singh, Sonal; Loke, Yoon K.; Spangler, John G.; Furberg, Curt D.

doi:10.1503/cmaj.110218

Cited by 247 publications

(206 citation statements)

References 30 publications

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“…Shortly after, the first of several meta‐analyses examining the cardiovascular safety of varenicline was published. In their meta‐analysis, Singh et al reported an increased incidence of cardiovascular SAEs when comparing varenicline with placebo 3. However, the Singh et al meta‐analysis was criticized for its choice of statistical approach, exclusion of zero event trials, and inclusion of events that occurred >30 days after drug discontinuation 4, 50, 51.…”

Section: Discussionmentioning

confidence: 99%

“…However, concerns exist regarding the cardiovascular safety of varenicline. Previous meta‐analyses provided conflicting results regarding the association between varenicline and adverse cardiovascular events 3, 4, 5, 6. In addition, the US Food and Drug Administration (FDA) has issued a warning regarding serious cardiovascular events that may occur in patients taking the drug 7.…”

Section: Introductionmentioning

confidence: 99%

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Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Sterling

Windle

Filion

et al. 2016

JAHA

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BackgroundVarenicline is an efficacious smoking‐cessation drug. However, previous meta‐analyses provide conflicting results regarding its cardiovascular safety. The publication of several new randomized controlled trials (RCTs) provides an opportunity to reassess this potential adverse drug reaction.Methods and ResultsWe searched MEDLINE, EMBASE, and the Cochrane Library for RCTs that compare varenicline with placebo for smoking cessation. RCTs reporting cardiovascular serious adverse events and/or all‐cause mortality during the treatment period or within 30 days of treatment discontinuation were eligible for inclusion. Relative risks (RRs) with 95% CIs were generated by using DerSimonian–Laird random‐effects models. Thirty‐eight RCTs met our inclusion criteria (N=12 706). Events were rare in both varenicline (57/7213) and placebo (43/5493) arms. No difference was observed for cardiovascular serious adverse events when comparing varenicline with placebo (RR 1.03, 95% CI 0.72–1.49). Similar findings were obtained when examining cardiovascular (RR 1.04, 95% CI 0.57–1.89) and noncardiovascular patients (RR 1.03, 95% CI 0.64–1.64). Deaths were rare in both varenicline (11/7213) and placebo (9/5493) arms. Although 95% CIs were wide, pooling of all‐cause mortality found no difference between groups (RR 0.88, 95% CI 0.50–1.52), including when stratified by participants with (RR 1.24, 95% CI 0.40–3.83) and without (RR 0.77, 95% CI 0.40–1.48) cardiovascular disease.ConclusionsWe found no evidence that varenicline increases the rate of cardiovascular serious adverse events. Results were similar among those with and without cardiovascular disease. Given varenicline's efficacy as a smoking cessation drug and the long‐term cardiovascular benefits of cessation, it should continue to be prescribed for smoking cessation.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Sterling

Windle

Filion

et al. 2016

JAHA

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“…[29,34] Recent studies have also reported that varenicline appears to be safe in patients with schizophrenia [35] and in patients with cardiac disease. [29,[36][37][38] Nevertheless, it should be used with caution and under supervision. Champix is a schedule 5 drug in SA and patients should be monitored regularly with particular attention to changes in their emotional state, unusual behaviour and suicidal ideation.…”

Section: Nicotine Receptors Agonistsmentioning

confidence: 99%

South African tobacco smoking cessation clinical practice guideline

et al. 2013

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“…При наличии сопутствующих заболеваний или психических расстройств рекомендованы беседы и НЗТ; назначение других препаратов, кроме НЗТ, должно быть отло-жено . Мета-анализ 14 рандомизированных клинических исследований, включавший 8216 пациентов, показал незна-чительное, но статистически значимое увеличение риска соредечно-сосудистых событий при использовании варени-клина [262] . В то же время, согласно заключению EMEA (European Medicines Agency) невысокий риск сердечно-сосу-дистых событий при назначении варениклина не превышает его пользу в отказе от курения для тех, кто курит .…”

Section: фармакологические средстваunclassified

A Ten Year Overview of Surgical and Interventional Arrhythmology in Russia. Service Peculiar Features in the Far East

Богачевская¹,

Bogachevskiy²

2017

Soc.Asp.Pop.Hlth

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

Cited by 247 publications

References 30 publications

Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

South African tobacco smoking cessation clinical practice guideline

A Ten Year Overview of Surgical and Interventional Arrhythmology in Russia. Service Peculiar Features in the Far East

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