Heart Centre, University Hospital Ghent, Ghent, Belgium.
Curr Med Res Opin. 2011 Apr;27(4):769-75. doi: 10.1185/03007995.2011.557718. Epub 2011 Feb 4.
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.
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 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.
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.
酒石酸伐仑克林，一种α4β2 烟碱型乙酰胆碱受体的选择性部分激动剂，在多项随机对照试验中被证实为一种有效的戒烟辅助药物，具有可接受的安全性。CHOICES（戒烟观察性研究）研究的目的是在真实临床实践中评估伐仑克林的有效性和安全性。
CHOICES 研究是一项为期 12 周的前瞻性、观察性、非对照研究，在四个欧洲国家（比利时、希腊、匈牙利和斯洛文尼亚）进行，时间为 2007 年 11 月 21 日至 2009 年 8 月 3 日。参与者根据欧洲药品说明书（SmPC）的建议处方伐仑克林。根据尼古丁使用清单，通过口头报告确定第 11 至 12 周期间的 7 天内的戒烟率。还评估了伐仑克林的安全性概况。
在这项研究中，566 名参与者中有 551 名接受了伐仑克林治疗，并对其有效性和安全性进行了评估。在基线时，总体研究人群的平均年龄为 45.5 岁；平均吸烟史为 27.0 年；尼古丁依赖测试（FTND）平均得分为 6.1。总体而言，在治疗阶段结束时（第 12 周），64.6%（95%CI，60.1%，68.3%）的参与者成功戒烟。最常见的治疗中出现的（所有因果关系）不良事件是恶心（8.9%）、失眠（2.9%）和睡眠障碍（2.2%），大多为轻度或中度。由于与治疗相关的不良事件，有 3.4%的参与者退出了研究。
由于这不是欧洲国家普遍使用的做法，因此未通过一氧化碳测量来验证戒烟率。
CHOICES 研究表明，在临床试验环境之外的真实临床实践环境中，伐仑克林是一种有效的戒烟辅助药物，具有可接受的安全性。
