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Varenicline in smokers with severe or very severe COPD after 24 weeks of treatment. A descriptive analysis: VALUE study

Carlos A. Jiménez-Ruiz, Marcos Garcia Rueda, Manuel A. Martinez Muñiz, Jacobo Sellarés, Maria A. Jiménez-Fuentes, Lourdes Lázaro Asegurado, Esther Rodríguez Gonzalez, Concepción Rodriguez Garcia, Oriol Armengol, Emilia Abad, Teresa Peña, Adolfo Domenech del Rio, Juan A. Riesco Miranda
  • Carlos A. Jiménez-Ruiz
    Tobacco Researching Group of the Spanish Respiratory Society, Smoking Cessation Service, Spain | victorina@ctv.es
  • Marcos Garcia Rueda
    Hospital Carlos Haya, Smoking Unit, Pulmonology Department., Spain
  • Manuel A. Martinez Muñiz
    Hospital San Agustín-Avilés, Smoking Unit, Pulmonology Department, Spain
  • Jacobo Sellarés
    Hospital Clinic Barcelona, Pulmonology Department, Spain
  • Maria A. Jiménez-Fuentes
    Hospital Universitario Valle de Hebron, Spain
  • Lourdes Lázaro Asegurado
    Hospital Universitario Burgos, Pulmonology Department, Spain
  • Esther Rodríguez Gonzalez
    Hospital Vall d'Hebrón, Pulmonology Department, Spain
  • Concepción Rodriguez Garcia
    Hospital San Agustín-Avilés, Smoking Unit, Pulmonology Department, Spain
  • Oriol Armengol
    ABS Poblenou, Spain
  • Emilia Abad
    Hospital Clinic Barcelona, Pulmonology Department, Spain
  • Teresa Peña
    Hospital Universitario Burgos, Pulmonology Department, Spain
  • Adolfo Domenech del Rio
    Hospital Carlos Haya, Smoking Unit, Pulmonology Department, Spain
  • Juan A. Riesco Miranda
    Hospital San Pedro de Alcantara, Smoking Unit, Pulmonology Department, Spain

Abstract

A large number of COPD patients are smokers. The particular characteristics of this group as well as their need to quit usually require psychological counselling and pharmacological treatment to achieve abstinence and, often, intensively. Little information is available about this issue.  The main objective of the study was to evaluate the effectiveness of varenicline after 24 weeks of treatment, with continuous abstinence between weeks 9 and 24.  This study was a post-authorization, open label, observational study of prospective follow-up. Patients included were smokers with severe or very severe COPD criteria who were treated with varenicline for 24 weeks, i.e. with a 12-week extension over the usual treatment.  The outcomes in the population of subjects completing 24 weeks of follow-up were at week 24: continuous abstinence 36.8%, 7 days point prevalence abstinence 65.7%, and continuous smoking 31.5%.The outcomes in the intention-to-treat population included at baseline were: continuous abstinence 17.7% of patients, 7 days point prevalence abstinence 31.6%, continuous smoking 15.1% and not valid/unknown 51.8%.  The mean CAT score at week 24 was 15 and reduction from the baseline was 3.77 (paired T test, p<0.01). The most common adverse events reported were nausea, vivid dreams, stomach ache, insomnia, headache and vomiting.  Patients included in VALUE were active smokers despite all of them had a severe COPD which suggests a very high degree of dependence. Although the study do not allow to infer the results to the global population of smokers with severe COPD, the outcomes have shown that, at 24 weeks follow up 36.8% of the patients were successful in quitting but from 79 patients enrolled initially only 17.7% quit. 

Keywords

COPD; smoking cessation; Varenicline.

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Submitted: 2017-07-03 12:33:35
Published: 2017-12-19 09:45:12
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Copyright (c) 2017 Carlos A. Jiménez-Ruiz, Marcos Garcia Rueda, Manuel A. Martinez Muñiz, Jacobo Sellarés, Maria A. Jiménez-Fuentes, Lourdes Lázaro Asegurado, Esther Rodríguez Gonzalez, Concepción Rodriguez Garcia, Oriol Armengol, Emilia Abad, Teresa Peña, Adolfo Domenech d

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