Evidence map›Paper›PMID 18263663›Full record

Trial reportThorax2008

Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial.

H-J Aubin, A Bobak, J R Britton, C Oncken, C B Billing, J Gong, K E Williams, K R Reeves

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

Trial report in Thorax, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 135 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
135citing papers in PubMed, 10 pooled it
20.4field-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.

NCT00143325 phase3completednot on this map

An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation

TypeinterventionalSponsorPfizerRan2005 to 2006Enrolled730ConditionsSmoking CessationArmsvarenicline (CP-526,555)
NCT00709696 nacompletednot on this map

Human Laboratory Study Of Varenicline in Smokers

TypeinterventionalSponsorUniversity of MinnesotaRan2008 to 2009Enrolled7ConditionsNicotine DependenceArmsPlacebo, Varenicline
NCT00959972 phase4completednot on this mapstarted 2009, after this paper: background citation

Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease: a Pilot Randomized Trial

TypeinterventionalSponsorOttawa Heart Institute Research CorporationRan2009 to 2010Enrolled50ConditionsCoronary Heart DiseaseArmsVarenicline, Transdermal Nicotine Patch
NCT01623505 phase4completednot on this mapstarted 2010, after this paper: background citation

Interventions for Cardiovascular Disease: "Real-World" Effectiveness of Combined Pharmacotherapy and Behavioural Counseling for Smoking Cessation

TypeinterventionalSponsorOttawa Heart Institute Research CorporationRan2010 to 2014Enrolled738ConditionsSmoking Cessation, Psychiatric IllnessArmsChampix, Transdermal Nicoderm patch combined with gum or inhaler, Transdermal Nicoderm patch
3 · Its place in the literature

Who cites it

135 citing papers in PubMed, 10 syntheses or guidelines pooled it, 346 citations in OpenAlex.

  1. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
  3. Interventions for preventing weight gain after smoking cessation.The Cochrane database of systematic reviews · 2021
    Pooled it
  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
    Pooled it
  8. 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
  9. Pooled it
  10. Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2011
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75 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

H-J AubinHôpital Emile Roux, Assistance Publique-Hopitaux de Paris, Limeil-Brévannes, Paris, France. henri-jean.aubin@erx.aphp.fr
A Bobak
J R Britton
C Oncken
C B Billing
J Gong
K E Williams
K R Reeves
Pfizer (United States) · USHôpital Émile-Roux · FRUConn Health · USUniversity of Nottingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVarenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). A study was undertaken to compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal nicotine replacement therapy (NRT) for smoking cessation.

methodsIn this 52-week, open-label, randomised, multicentre, phase 3 trial conducted in Belgium, France, The Netherlands, UK and USA, participants were randomly assigned (1:1) to receive varenicline uptitrated to 1 mg twice daily for 12 weeks or transdermal NRT (21 mg/day reducing to 7 mg/day) for 10 weeks. Non-treatment follow-up continued to week 52. The primary outcome was the biochemically confirmed (exhaled carbon monoxide < or = 10 ppm) self-reported continuous abstinence rate (CAR) for the last 4 weeks of the treatment period in participants who had taken at least one dose of treatment. Secondary outcomes included CAR from the last 4 weeks of treatment through weeks 24 and 52, and measures of craving, withdrawal and smoking satisfaction.

resultsA total of 376 and 370 participants assigned to varenicline and NRT, respectively, were eligible for analysis. The CAR for the last 4 weeks of treatment was significantly greater for varenicline (55.9%) than NRT (43.2%; OR 1.70, 95% CI 1.26 to 2.28, p<0.001). The week 52 CAR (NRT, weeks 8-52; varenicline, weeks 9-52) was 26.1% for varenicline and 20.3% for NRT (OR 1.40, 95% CI 0.99 to 1.99, p = 0.056). Varenicline significantly reduced craving (p<0.001), withdrawal symptoms (p<0.001) and smoking satisfaction (p<0.001) compared with NRT. The most frequent adverse event was nausea (varenicline, 37.2%; NRT, 9.7%).

conclusionsThe outcomes of this trial established that abstinence from smoking was greater and craving, withdrawal symptoms and smoking satisfaction were less at the end of treatment with varenicline than with transdermal NRT. TRIAL REGISTRATION NUMBER: NCT00143325.

Indexed as

Smoking PreventionAdministration, CutaneousAdolescentAdultAgedBenzazepinesFemaleHumansMaleMiddle AgedNicotineNicotinic AgonistsPatient ComplianceQuinoxalinesReinforcement, PsychologySmoking CessationBenzazepinesNicotineNicotinic AgonistsQuinoxalinesVarenicline

Identifiers

PMID18263663
PMCPMC2569194
OpenAlexW2129372385

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.