Evidence map›Paper›PMID 21727225›Full record

SynthesisCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2011

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

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

Abstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 93 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 12 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 12 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
    Pooled it
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  11. Guideline
  12. Pooled it
  13. Trial
  14. Trial
  15. A double-blind placebo-controlled randomized trial of varenicline for smokeless tobacco dependence in India.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2014
    Trial
  16. Trial
  17. Trial
  18. Safety of varenicline among smokers enrolled in the lung HIV study.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2013
    Trial
  19. Trial
  20. Article

33 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Sonal SinghDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. ssingh31@jhu.edu
Yoon K Loke
John G Spangler
Curt D Furberg

Funding

Institute for Clinical and Translational Research (KL2)KL2RR025006 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2007 to 2011
$12.9M
NCRR NIH HHS 1KL2RR025006-03NCRR NIH HHS KL2 RR025006
6 · The paper itself

Abstract

backgroundThere 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.

methodsWe 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.

resultsWe 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.

interpretationOur 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.

Indexed as

BenzazepinesCardiovascular DiseasesHumansNicotinic AgonistsProduct Surveillance, PostmarketingQuinoxalinesRandomized Controlled Trials as TopicRiskVareniclineBenzazepinesNicotinic AgonistsQuinoxalinesVarenicline

Identifiers

PMID21727225
PMCPMC3168618

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.