Evidence map›Paper›PMID 20048210›Full record

Trial reportCirculation2010

Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial.

Nancy A Rigotti, Andrew L Pipe, Neal L Benowitz, Carmen Arteaga, Dahlia Garza, Serena Tonstad

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 131 papers, 24 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
131citing papers in PubMed, 24 pooled it
26.0field-weighted citation impact, top 1% of its field
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.

NCT00282984 phase3completednot on this map

A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease

TypeinterventionalSponsorPfizerRan2006 to 2008Enrolled714ConditionsSmoking CessationArmsplacebo, Varenicline
NCT01980017 nacompletednot on this mapstarted 2013, after this paper: background citation

A Prospective Cluster-Randomized Trial to Implement the Ottawa Model for Smoking Cessation in Diabetes Education Programs.

TypeinterventionalSponsorOttawa Heart Institute Research CorporationRan2013 to 2017Enrolled313ConditionsPre-diabetic, Diabetic Type II MellitusArmsOttawa Model for Smoking Cessation
3 · Its place in the literature

Who cites it

131 citing papers in PubMed, 24 syntheses or guidelines pooled it, 370 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Guideline
  5. Guideline
  6. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  7. Interventions for preventing weight gain after smoking cessation.The Cochrane database of systematic reviews · 2021
    Pooled it
  8. Pooled it
  9. Smoking-cessation pharmacotherapy for patients with stroke and TIA: Systematic review.Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia · 2020
    Pooled it
  10. Guideline
  11. Guideline
  12. Guideline
  13. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
    Pooled it
  14. Sex Differences in Varenicline Efficacy for Smoking Cessation: A Meta-Analysis.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
    Pooled it
  15. Pooled it
  16. An official American Thoracic Society/European Respiratory Society statement: research questions in COPD.European respiratory review : an official journal of the European Respiratory Society · 2015
    Pooled it
  17. Pooled it
  18. Pooled it
  19. Guideline
  20. Pooled it

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Nancy A RigottiGeneral Medicine Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Tobacco Research and Treatment Center, Boston, Mass 02114, USA. nrigotti@partners.org
Andrew L Pipe
Neal L Benowitz
Carmen Arteaga
Dahlia Garza
Serena Tonstad
Pfizer (United States) · USUniversity of California, San Francisco · USUniversity of Ottawa · CA

Funding

Safety of Nicotine Reduction StrategyR01CA078603 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BENOWITZ, NEAL L · 1999 to 2009
$4.6M
NCI NIH HHS R01 CA078603
6 · The paper itself

Abstract

backgroundSmoking cessation is a key component of secondary cardiovascular disease prevention. Varenicline, a partial alpha4beta2 nicotinic acetylcholine receptor agonist, is effective for smoking cessation in healthy smokers, but its efficacy and safety in smokers with cardiovascular disease are unknown. METHODS AND

resultsA multicenter, randomized, double-blind, placebo-controlled trial compared the efficacy and safety of varenicline with placebo for smoking cessation in 714 smokers with stable cardiovascular disease. Participants received varenicline (1 mg twice daily) or placebo, along with smoking-cessation counseling, for 12 weeks. Follow-up lasted 52 weeks. The primary end point was carbon monoxide-confirmed continuous abstinence rate for weeks 9 through 12 (last 4 weeks of treatment). The continuous abstinence rate was higher for varenicline than placebo during weeks 9 through 12 (47.0% versus 13.9%; odds ratio, 6.11; 95% confidence interval [CI], 4.18 to 8.93) and weeks 9 through 52 (19.2% versus 7.2%; odds ratio, 3.14; 95% CI, 1.93 to 5.11). The varenicline and placebo groups did not differ significantly in cardiovascular mortality (0.3% versus 0.6%; difference, -0.3%; 95% CI, -1.3 to 0.7), all-cause mortality (0.6% versus 1.4%; difference, -0.8%; 95% CI, -2.3 to 0.6), cardiovascular events (7.1% versus 5.7%; difference, 1.4%; 95% CI, -2.3 to 5.0), or serious adverse events (6.5% and 6.0%; difference, 0.5%; 95% CI, -3.1 to 4.1). As a result of adverse events, 9.6% of varenicline and 4.3% of placebo participants discontinued study drug.

conclusionsVarenicline is effective for smoking cessation in smokers with cardiovascular disease. It was well tolerated and did not increase cardiovascular events or mortality; however, trial size and duration limit definitive conclusions about safety. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov/ct2/show/NCT00282984. Unique identifier: NCT00282984.

Indexed as

AgedBenzazepinesCardiovascular DiseasesDirective CounselingDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleMiddle AgedQuinoxalinesSmoking CessationSurvival RateTreatment OutcomeVareniclineBenzazepinesQuinoxalinesVarenicline

Identifiers

PMID20048210
PMCPMC4096941
OpenAlexW2109535127

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.