Tobacco Induced Diseases | |
Varenicline as a smoking cessation aid in a Greek population: a subanalysis of an observational study | |
Sunil Raju1  Michael Messig3  Georgia D Sykara2  Paraskevi Argyropoulou Pataka4  Konstantinos Gourgoulianis5  Christina Gratziou6  | |
[1] Pfizer Ltd, Tadworth, Surrey, UK;Pfizer, Athens, Greece;Pfizer Inc, New York, New York, USA;Aristotle University of Thessaloniki, Thessaloniki, Greece;Pulmonary Department, Medical School, University of Thessaly, Thessaly, Greece;Evgenidio Hospital, Medical School, University of Athens, Athens, Greece | |
关键词: observational; real world; varenicline; Greece; smoking cessation; | |
Others : 867059 DOI : 10.1186/1617-9625-10-1 |
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received in 2011-09-01, accepted in 2012-02-02, 发布年份 2012 | |
【 摘 要 】
Background
Greece has the highest proportion of smokers in the European Union with 42% of Greeks admitting that they smoke, based on a 2009 survey. This post-hoc analysis of a prospective, observational study evaluated the effectiveness and safety profile of the smoking cessation aid varenicline, as well as potential predictors of quit success in a Greek population.
Methods
Participants were prescribed varenicline according to the recommendations of the European Summary of Product Characteristics (1 mg twice daily). The 7-day point prevalence of abstinence at Week 12 was determined based on verbal reporting using a nicotine use inventory. Abstinence was confirmed by carbon monoxide measurements of exhaled air at the last visit of the study. The safety profile of varenicline was also assessed.
Results
At baseline, the Greek subsample (n = 196) had a mean age of 42.6 years, with 54.6% of them being men. Participants had a smoking history of 23.5 years and a Fagerström Test for Nicotine Dependence total score of 6.6. After 12 weeks of varenicline therapy, 70.4% (95% CI, 64.0-76.7) of all participants had quit smoking. This increased to 86.2% among participants who had taken the study medication for 80% of the planned number of treatment days. Age was a significant predictor of quit success. The most frequently observed treatment-emergent adverse event was nausea, occurring in 13.3% of participants.
Conclusions
In this 'real-world' observational study, 70.4% of Greek smokers successfully quit smoking after 12 weeks of varenicline therapy, providing support that varenicline is an effective smoking cessation medication. Further studies with longer follow-up are warranted.
Trial Registration
ClinicalTrials.gov: NCT00669240
【 授权许可】
2012 Gratziou et al; licensee BioMed Central Ltd.
【 预 览 】
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【 参考文献 】
- [1]The Gallup Organisation, Hungary upon the request of Directorate General Health and Consumers: Eurobarometer Survey on Tobacco - Analytical Report. In Book Eurobarometer Survey on Tobacco - Analytical Report. City; 2009.
- [2]Hughes JR, Keely J, Naud S: Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction 2004, 99:29-38.
- [3]Fiore MC: US public health service clinical practice guideline: treating tobacco use and dependence. Respir Care 2000, 45:1200-1262.
- [4]Cahill K, Stead LF, Lancaster T: Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev 2010, 12:CD006103.
- [5]Nides M, Oncken C, Gonzales D, Rennard S, Watsky EJ, Anziano R, Reeves KR: Smoking cessation with varenicline, a selective alpha4beta2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo- and bupropion-controlled trial with 1-year follow-up. Arch Intern Med 2006, 166:1561-1568.
- [6]Niaura R, Hays JT, Jorenby DE, Leone FT, Pappas JE, Reeves KR, Williams KE, Billing CB Jr: The efficacy and safety of varenicline for smoking cessation using a flexible dosing strategy in adult smokers: a randomized controlled trial. Curr Med Res Opin 2008, 24:1931-1941.
- [7]Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR: Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA 2006, 296:56-63.
- [8]Wang C, Xiao D, Chan KP, Pothirat C, Garza D, Davies S: Varenicline for smoking cessation: a placebo-controlled, randomized study. Respirology 2009, 14:384-392.
- [9]Faessel H, Ravva P, Williams K: Pharmacokinetics, safety, and tolerability of varenicline in healthy adolescent smokers: a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther 2009, 31:177-189.
- [10]Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S: Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation 2010, 121:221-229.
- [11]Eisenberg MJ, Filion KB, Yavin D, Bélisle P, Mottillo S, Joseph L, Gervais A, O'Loughlin J, Paradis G, Rinfret S, Pilote L: Pharmacotherapies for smoking cessation: a meta-analysis of randomized controlled trials. CMAJ 2008, 179:135-144.
- [12]Tonstad S, Davies S, Flammer M, Russ C, Hughes J: Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. Drug Saf 2010, 33:289-301.
- [13]Boudrez H, Gratziou C, Messig M, Metcalfe M: Effectiveness of varenicline as an aid to smoking cessation: Results of an inter-European observational study. Curr Med Res Opin 2011, 27:769-775.
- [14]Vardavas CI, Kafatos AG: Smoking policy and prevalence in Greece: an overview. Eur J Public Health 2007, 17:211-213.
- [15]Reuters: Greece to ban smoking in all indoor public places. In Book Greece to ban smoking in all indoor public places. City; 2010.
- [16]No Smoke Greece [Website in Greek] [http://www.nosmoke.gr/smokingandconsequences/smokingconditions.html] webcite
- [17]Pfizer Ltd: Summary of Product Characteristics (Champix). In Book Summary of Product Characteristics (Champix). City;
- [18]Fagerstrom KO, Schneider NG: Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med 1989, 12:159-182.
- [19]Boudrez H, Hoengenaert J, Nackaerts K, Messig M, Metcalfe M: Predictors of quit success in Belgian participants of a varenicline observational study. Poster presented at the 12th Annual European Conference of the Society for Research on Nicotine and Tobacco; Bath, UK; Sept 06-09 2010.
- [20]Rovina N, Nikoloutsou I, Dima E, Michailidou M, Roussos C, Gratziou C: Smoking cessation treatment in a real-life setting: the Greek experience. Ther Adv Respir Dis 2007, 1:93-104.
- [21]Rovina N, Nikoloutsou I, Katsani G, Dima E, Fransis K, Roussos C, Gratziou C: Effectiveness of pharmacotherapy and behavioral interventions for smoking cessation in actual clinical practice. Ther Adv Respir Dis 2009, 3:279-287.
- [22]Boudrez H, Hoengenaert J, Nackaerts K, Messig M, Metcalfe M: Predictors of quit success in Belgian participants of a varenicline observational study. Respiration 2011.
- [23]Kenford SL, Fiore MC, Jorenby DE, Smith SS, Wetter D, Baker TB: Predicting smoking cessation. Who will quit with and without the nicotine patch. JAMA 1994, 271:589-594.
- [24]Boutou AK, Tsiata EA, Pataka A, Kontou PK, Pitsiou GG, Argyropoulou P: Smoking cessation in clinical practice: predictors of six-month continuous abstinence in a sample of Greek smokers. Prim Care Respir J 2008, 17:32-38.
- [25]Blak BT, Wilson K, Metcalfe M, Maguire A, Hards M: Evaluation of varenicline as an aid to smoking cessation in UK general practice - a THIN database study. Curr Med Res Opin 2010, 26:861-870.
- [26]Andreou G, Gourgoulianis K, Galantomos I: The "language" of the unsuccessful anti-smoking campaign in Greece: examples from Greek newspaper headlines. Prev Med 2010, 51:336-337.