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

Authors
  • Russo, C1
  • Caponnetto, P2
  • Cibella, F3
  • Maglia, M2
  • Alamo, A4
  • Campagna, D1, 5
  • Frittitta, L6, 7
  • Di Mauro, M7, 8
  • Leotta, C9
  • Mondati, E7, 10
  • Krysiński, A11, 12
  • Franek, E11, 12
  • Polosa, R13, 14, 15
  • 1 Ambulatorio Di Diabetologia, UOC Medicina Interna E D'Urgenza, Policlinico Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy. , (Italy)
  • 2 Centro 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. , (Italy)
  • 3 Institute for Biomedical Research and Innovation, National Research Council of Italy, Palermo, Italy. , (Italy)
  • 4 Centro Diabetologico - UOC Andrologia Ed Endocrinologia, Policlinico Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy. , (Italy)
  • 5 UOC MCAU, University Teaching Hospital "Policlinico-Vittorio Emanuele", University of Catania, Catania, Italy. , (Italy)
  • 6 Centro Per Il Diabete E L'Obesità - UOC Endocrinologia, Ospedale Garibaldi Nesima, ARNAS Garibaldi, Catania, Italy. , (Italy)
  • 7 Center of Excellence for the Acceleration of HArm Reduction (CoEHAR), Dipartimento Di Medicina Clinica E Sperimentale, Università Di Catania, Catania, Italy. , (Italy)
  • 8 Ambulatorio Di Diabetologia, Ospedale V. Emanuele, AOU "Policlinico-V. Emanuele", Catania, Italy. , (Italy)
  • 9 Ambulatorio Di Diabetologia - UOC Geriatria, Ospedale Cannizzaro, Catania, Italy. , (Italy)
  • 10 UOS Sorveglianza Delle Complicanze Delle Malattie Metaboliche, Ospedale S. Marta, AOU "Policlinico-V. Emanuele", Catania, Italy. , (Italy)
  • 11 Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland. , (Poland)
  • 12 Department of Internal Diseases, Endocrinology and Diabetology, Central Clinical Hospital MSWiA, Warsaw, Poland. , (Poland)
  • 13 Ambulatorio Di Diabetologia, UOC Medicina Interna E D'Urgenza, Policlinico Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy. [email protected] , (Italy)
  • 14 Centro 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. [email protected] , (Italy)
  • 15 Center of Excellence for the Acceleration of HArm Reduction (CoEHAR), Dipartimento Di Medicina Clinica E Sperimentale, Università Di Catania, Catania, Italy. [email protected] , (Italy)
Type
Published Article
Journal
Internal and Emergency Medicine
Publisher
Springer-Verlag
Publication Date
Oct 01, 2021
Volume
16
Issue
7
Pages
1823–1839
Identifiers
DOI: 10.1007/s11739-021-02684-1
PMID: 33735416
Source
Medline
Keywords
Language
English
License
Unknown

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 ). © 2021. The Author(s).

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