Evidence map›Paper›PMID 33735416›Full record

ArticleInternal and emergency medicine2021

A double blind randomized controlled trial investigating efficacy and safety of varenicline for smoking cessation in patients with type 2 diabetes: study protocol.

C Russo, P Caponnetto, F Cibella, M Maglia, A Alamo, D Campagna, L Frittitta, M Di Mauro, C Leotta, E Mondati and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Internal and emergency medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01387425 (Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 39% 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.

NCT01387425 nacompletednot on this map

Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: A Double-Blind, Placebo-Controlled, Randomized, Trial

TypeinterventionalSponsorUniversity of CataniaRan2011Enrolled300ConditionsSmoking Cessation, DiabetesArmsvarenicline, placebo tablet is made of lactose
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Trial
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

13 authors at 5 institutions in 2 countries.

C RussoAmbulatorio Di Diabetologia, UOC Medicina Interna E D'Urgenza, Policlinico Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy.
P CaponnettoCentro Per La Prevenzione E Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria "Policlinico-V.Emanuele" Dell'Università Di Catania, Via S. Sofia 78, 95123, Catania, Italy.
F CibellaInstitute for Biomedical Research and Innovation, National Research Council of Italy, Palermo, Italy.
M MagliaCentro Per La Prevenzione E Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria "Policlinico-V.Emanuele" Dell'Università Di Catania, Via S. Sofia 78, 95123, Catania, Italy.
A AlamoCentro Diabetologico - UOC Andrologia Ed Endocrinologia, Policlinico Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy.
D CampagnaAmbulatorio Di Diabetologia, UOC Medicina Interna E D'Urgenza, Policlinico Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy.
L FrittittaCentro Per Il Diabete E L'Obesità - UOC Endocrinologia, Ospedale Garibaldi Nesima, ARNAS Garibaldi, Catania, Italy.
M Di MauroCenter of Excellence for the Acceleration of HArm Reduction (CoEHAR), Dipartimento Di Medicina Clinica E Sperimentale, Università Di Catania, Catania, Italy.
C LeottaAmbulatorio Di Diabetologia - UOC Geriatria, Ospedale Cannizzaro, Catania, Italy.
E MondatiCenter of Excellence for the Acceleration of HArm Reduction (CoEHAR), Dipartimento Di Medicina Clinica E Sperimentale, Università Di Catania, Catania, Italy.
A KrysińskiMossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.
E FranekMossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.
R PolosaAmbulatorio Di Diabetologia, UOC Medicina Interna E D'Urgenza, Policlinico Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy. polosa@unict.it.ORCID http://orcid.org/0000-0002-8450-5721
University of Catania · ITPoliclinico Universitario di Catania · ITCentral Clinical Hospital · PLInstitute for Biomedical Research and Innovation · ITOspedale Cannizzaro · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Reducing exposure to cigarette smoke is an imperative for public health and for diabetic patients. Patients with diabetes who continue to smoke face challenges at quitting and the delivery of effective smoking cessation interventions is a major unmet need. The high-affinity α4β2 nicotinic acetylcholine receptor partial agonist varenicline in combination with counseling is effective for smoking cessation, but evidence in patients with diabetes is limited. A clinical trial of varenicline targeted specifically at smokers with T2DM is warranted. This randomized, double blind, placebo-controlled trial will be the first study to test efficacy and safety of varenicline in smokers with type 2 diabetes mellitus (T2DM) over the course of 52 weeks. We hypothesize that varenicline treatment (1 mg BID, administered for 12 weeks) would increase quit rates, maintain smoking abstinence up to 1 year after treatment, and be well-tolerated in T2DM smokers intending to quit. Efficacy end points will include carbon monoxide-confirmed continuous abstinence rate (CAR) and 7-day point prevalence of abstinence. The results of this RCT will help inform medical/health authorities and physicians worldwide whether an optimally varenicline-treated cohort of T2DM patients who smoke will experience significant success rates, without significant side effects.Trial registration NCT01387425 ( https://clinicaltrials.gov/ct2/show/NCT01387425 ).

Indexed as

Smoking CessationAdultAgedDiabetes Mellitus, Type 2Double-Blind MethodFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicSmoking Cessation AgentsTobacco Use DisorderTreatment OutcomeVareniclineYoung AdultSmoking Cessation AgentsVareniclineDiabetes mellitusRandomized controlled trialSmoking cessationVarenicline

Identifiers

PMID33735416
PMCPMC8502165
OpenAlexW3136955274

What OpenQuestion holds

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LicenceCC BY
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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.