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Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study

Hedwig Boudrez UGent, Christina Gratziou, Michael Messig and Michael Metcalfe (2011) CURRENT MEDICAL RESEARCH AND OPINION. 27(4). p.769-775
abstract
Varenicline tartrate, a selective partial agonist of the alpha alpha 4 beta beta 2 nicotinic receptor, has been shown to be an effective smoking cessation aid with an acceptable safety profile in a number of randomized, controlled trials. The aim of the CHOICES (Champix Observational Investigation in the Cessation of Smoking) study was to investigate the effectiveness and safety of varenicline in real-world clinical practice. The CHOICES study was a 12-week, prospective, observational, non-comparative study of varenicline conducted in four European countries (Belgium, Greece, Hungary, and Slovenia) between November 21, 2007 and August 3, 2009. Participants were prescribed varenicline according to the recommendations on the European Summary of Product Characteristics (SmPC). Smoking abstinence rates in the 7 days between week 11 and 12 were determined based on verbal reporting using a nicotine use inventory. The safety profile of varenicline was also assessed. Of 566 participants enrolled in this study, 551 received varenicline and were evaluated for effectiveness and safety. At baseline, the overall study population had a mean age of 45.5 years; a mean history of smoking of 27.0 years; and a mean score on the Fagerstroom Test of Nicotine Dependence (FTND) of 6.1. Overall, 64.6%% (95%% CI 60.1, 68.3) of participants successfully quit smoking by the end of the treatment phase at week 12. The most frequent treatment-emergent (all causality) adverse events were nausea (8.9%%), insomnia (2.9%%), and sleep disorder (2.2%%) of mostly mild or moderate intensity. Discontinuations from the study due to treatment-related adverse events occurred in 3.4%% of participants. Abstinence rates were not validated by carbon monoxide measurements, as this is not a practice uniformly used in European countries. The CHOICES study shows that in a real-world clinical practice setting outside a clinical trial environment, varenicline is an effective smoking cessation aid with an acceptable safety profile. ClinicalTrials.gov identifier: NCT00669240.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
Varenicline, Observational study, RECEPTOR PARTIAL AGONIST, RANDOMIZED CONTROLLED-TRIAL, SUSTAINED-RELEASE BUPROPION, TOBACCO DEPENDENCE, FOLLOW-UP, PLACEBO, SMOKERS, SAFETY, ABSTINENCE, EFFICACY, Smoking cessation
journal title
CURRENT MEDICAL RESEARCH AND OPINION
Curr. Med. Res. Opin.
volume
27
issue
4
pages
769 - 775
Web of Science type
Article
Web of Science id
000288380900008
JCR category
MEDICINE, GENERAL & INTERNAL
JCR impact factor
2.38 (2011)
JCR rank
32/153 (2011)
JCR quartile
1 (2011)
ISSN
0300-7995
DOI
10.1185/03007995.2011.557718
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1141371
handle
http://hdl.handle.net/1854/LU-1141371
date created
2011-02-07 14:50:47
date last changed
2016-12-19 15:46:03
@article{1141371,
  abstract     = {Varenicline tartrate, a selective partial agonist of the alpha alpha 4 beta beta 2 nicotinic receptor, has been shown to be an effective smoking cessation aid with an acceptable safety profile in a number of randomized, controlled trials. The aim of the CHOICES (Champix Observational Investigation in the Cessation of Smoking) study was to investigate the effectiveness and safety of varenicline in real-world clinical practice.
The CHOICES study was a 12-week, prospective, observational, non-comparative study of varenicline conducted in four European countries (Belgium, Greece, Hungary, and Slovenia) between November 21, 2007 and August 3, 2009. Participants were prescribed varenicline according to the recommendations on the European Summary of Product Characteristics (SmPC). Smoking abstinence rates in the 7 days between week 11 and 12 were determined based on verbal reporting using a nicotine use inventory. The safety profile of varenicline was also assessed.
Of 566 participants enrolled in this study, 551 received varenicline and were evaluated for effectiveness and safety. At baseline, the overall study population had a mean age of 45.5 years; a mean history of smoking of 27.0 years; and a mean score on the Fagerstroom Test of Nicotine Dependence (FTND) of 6.1. Overall, 64.6\%\% (95\%\% CI 60.1, 68.3) of participants successfully quit smoking by the end of the treatment phase at week 12. The most frequent treatment-emergent (all causality) adverse events were nausea (8.9\%\%), insomnia (2.9\%\%), and sleep disorder (2.2\%\%) of mostly mild or moderate intensity. Discontinuations from the study due to treatment-related adverse events occurred in 3.4\%\% of participants.
Abstinence rates were not validated by carbon monoxide measurements, as this is not a practice uniformly used in European countries.
The CHOICES study shows that in a real-world clinical practice setting outside a clinical trial environment, varenicline is an effective smoking cessation aid with an acceptable safety profile.
ClinicalTrials.gov identifier: NCT00669240.},
  author       = {Boudrez, Hedwig and Gratziou, Christina and Messig, Michael and Metcalfe, Michael},
  issn         = {0300-7995},
  journal      = {CURRENT MEDICAL RESEARCH AND OPINION},
  keyword      = {Varenicline,Observational study,RECEPTOR PARTIAL AGONIST,RANDOMIZED CONTROLLED-TRIAL,SUSTAINED-RELEASE BUPROPION,TOBACCO DEPENDENCE,FOLLOW-UP,PLACEBO,SMOKERS,SAFETY,ABSTINENCE,EFFICACY,Smoking cessation},
  language     = {eng},
  number       = {4},
  pages        = {769--775},
  title        = {Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study},
  url          = {http://dx.doi.org/10.1185/03007995.2011.557718},
  volume       = {27},
  year         = {2011},
}

Chicago
Boudrez, Hedwig, Christina Gratziou, Michael Messig, and Michael Metcalfe. 2011. “Effectiveness of Varenicline as an Aid to Smoking Cessation: Results of an inter-European Observational Study.” Current Medical Research and Opinion 27 (4): 769–775.
APA
Boudrez, H., Gratziou, C., Messig, M., & Metcalfe, M. (2011). Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. CURRENT MEDICAL RESEARCH AND OPINION, 27(4), 769–775.
Vancouver
1.
Boudrez H, Gratziou C, Messig M, Metcalfe M. Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. CURRENT MEDICAL RESEARCH AND OPINION. 2011;27(4):769–75.
MLA
Boudrez, Hedwig, Christina Gratziou, Michael Messig, et al. “Effectiveness of Varenicline as an Aid to Smoking Cessation: Results of an inter-European Observational Study.” CURRENT MEDICAL RESEARCH AND OPINION 27.4 (2011): 769–775. Print.