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

Abstract

Background:

Varenicline tartrate, a selective partial agonist of the α4β2 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.

Methods:

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.

Results:

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 Fagerström 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.

Limitations:

Abstinence rates were not validated by carbon monoxide measurements, as this is not a practice uniformly used in European countries.

Conclusions:

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.

Trial registration: ClinicalTrials.gov identifier: NCT00669240.

Key words::

• Observational study
• Smoking cessation
• Varenicline

Transparency

Declaration of funding

This study was funded by Pfizer Ltd, UK. H.B. and C.G. were participating investigators of the CHOICES study and both reviewed the manuscript at all stages of development. H.B. wrote the Introduction and Discussion sections. M. Messig is an employee of Pfizer Inc, New York, and M. Metcalfe is an employee of Pfizer Ltd, UK.

Declaration of financial relationships

H.B. receives research grants from Pfizer Inc; acts as a consultant for Pfizer Inc and is on the Speakers’ Bureau for Pfizer Inc.

C.G. receives research grants from Novartis, GlaxoSmithKline, and Pfizer Inc.

Acknowledgments

Editorial support was provided by Fiona Nitsche, PhD, a medical writer of UBC Scientific Solutions, and funded by Pfizer Inc.

List of investigators:

Belgium: Prof. Dr Hedwig Boudrez; Dr Erik Ceulemans; Dr Andre Hutsebaut; Dr Luc Swinnen; Dr Marc Meysman; Dr Ludo Christiaen; Dr Alain Gemayel; Dr Nathalie Tilmant; Dr Kristiaan L. P. Nackaerts; Dr Norbert Van Mulders; Dr Francis Vrancken; Dr Philip Thibaut; Dr Pierre Bartsch; Prof. Laurence Galanti; Dr Pierre-Henri Arnould; Dr D. Lousbergh; Dr Jean-Pierre Hoengenaert; Dr Pierre Nys; Dr Robert Gerard; Dr Philippe Rochet; Dr Alfred Wuyard; Dr Bjorn Dieriks; Dr Eric Paquet; Dr Jean Roovers; Dr Veronique Lambert; Dr Guido Vereecken; Greece: Dr Marianna Kakoura; Dr Michael Patentalakis; Dr Stauroula Pataka; Stauroula Mpousmoukilia; Prof. Konstantinos Gourgouliani; Ioanna Mitrouska; Christina Gratziou; Stavros Konstantopoulos; Dimosthenis Mpouros; Michael Toumbis; Hungary: Dr Csaba Bocskei; Dr Zsuzsa Gyori; Dr Balazs Medgyasszay; Dr Zsuzsanna Cseke; Dr Anna Bartha; Dr Veronika Obbagy; Dr Katalin Csicsari; Dr Csilla Szabo; Dr Marta Beke; Dr Katalin Radich; Slovenia: Peter Kecelj; Cvetka Dragos Jancar; Stanislav Kajba; Blanka Bertalanic; Aleksander Stepanovic; Olga Doles; Mira Nikl Kravos.