Evidence map›Paper›PMID 25296623›Full record

Trial reportBMC medicine2014

Combining varenicline and nicotine patches: a randomized controlled trial study in smoking cessation.

Josep M Ramon, Sergio Morchon, Antoni Baena, Cristina Masuet-Aumatell

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01538394 (Randomized Double-blind Trial of Two Parallel Groups Design to Evaluate the Efficacy of Smoking Cessation With Combined), which is not on this map. Cited by 27 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 6 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT01538394 phase4completednot on this map

Randomized Double-blind Trial of Two Parallel Groups Design to Evaluate the Efficacy of Smoking Cessation With Combined (Varenicline Plus Nicotine Patches) Versus Monotherapy (Varenicline Plus Placebo Patches)

TypeinterventionalSponsorJosep Maria Ramon Torrell, PhDRan2012 to 2013Enrolled322ConditionsSmoking CessationArmsVarenicline, Nicotine patches, Placebo (nicotine patches)
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 6 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
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  5. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
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  14. Zonisamide Reduces Withdrawal Symptoms But Does Not Enhance Varenicline-Induced Smoking Cessation.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

Josep M RamonBellvitge Biomedical Research Institute (IDIBELL), Smoking Cessation Clinic, Preventive Medicine Department, Bellvitge University Hospital, Feixa Llarga s/n 08907 Hospitalet de Llobregat, Barcelona, Spain. jmramon@ub.edu.
Sergio Morchon
Antoni Baena
Cristina Masuet-Aumatell
Universitat de Barcelona · ESBellvitge University Hospital · ESInstitut d'Investigació Biomédica de Bellvitge · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSome smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy.

methodsThree hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013. The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours (170) or varenicline plus a placebo patch (171). All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day. Both groups received behavioral support. The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide. Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers.

resultsThe combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks (39.1% versus 31.8%; odds ratio (OR) 1.24; 95% confidence interval (CI) 0.8 to 2.6) and 24 weeks (32.8% versus 28.2%; OR 1.17; 95% CI 0.4 to 1.9). When participants were analyzed by subgroups according to cigarette consumption, the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks (OR 1.39; 95% CI 1.2 to 2.5) and 24 weeks (OR 1.46; 95% CI 1.2 to 2.8) were significantly higher in the combination group. Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences. No differences between the groups for the reported adverse events were observed (χ2 value 0.07; P 0.79).

conclusionsThe combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole, independent of consumption level.

trial registrationThis study is registered at clinicaltrial.gov (NCT01538394).

Indexed as

Smoking CessationAdministration, CutaneousAdolescentAdultBenzazepinesDrug Therapy, CombinationFemaleHumansMaleMiddle AgedNicotineNicotinic AgonistsQuinoxalinesTobacco Use Cessation DevicesTobacco Use DisorderTreatment OutcomeBenzazepinesNicotineNicotinic AgonistsQuinoxalinesVarenicline

Identifiers

PMID25296623
PMCPMC4198796
OpenAlexW2123239058

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.