Lungenfachklinik Immenhausen, Krs. Kassel and Universitätsmedizin Göttingen, Göttingen, Germany.
Eur Addict Res. 2013;19(1):47-54. doi: 10.1159/000341638. Epub 2012 Sep 14.
Although varenicline is commonly prescribed in primary care, information on smoking-related comorbidities and the effectiveness of varenicline in this context in Germany is scarce. This study assessed the efficacy and safety of varenicline in a large sample of patients seeking smoking cessation treatment through their general practitioners. The frequency of comorbidities was also evaluated.
This was a 12-week, prospective, observational, non-comparative phase IV trial conducted in Germany. Abstinence rates at week 12 were evaluated by verbal reporting using the nicotine use inventory.
Overall, 1,391 subjects were enrolled; 1,177 received study medication and were evaluated for effectiveness and safety. At the end of the study, 71.1% (95% confidence interval 68.5-73.7) of subjects were abstinent. There were a total of 205 all-causality adverse events; 2.2% were classified as serious or severe. There were no fatal adverse events. At inclusion, 66.7% of participants had at least 1 concurrent comorbidity, with chronic obstructive pulmonary disease (35.5%), hypertension (29.6%) and depression (10.4%) being the most commonly reported.
These real-world data indicate that varenicline is an effective and well-tolerated smoking cessation treatment when used in the primary care setting including patients with smoking-related comorbidities.
尽管伐伦克林在初级保健中常被开处方，但德国关于与吸烟相关的合并症的信息以及在这种情况下伐伦克林的疗效有限。本研究评估了伐伦克林在通过其全科医生寻求戒烟治疗的大量患者中的疗效和安全性。还评估了合并症的频率。
这是一项在德国进行的为期 12 周的前瞻性、观察性、非对照 IV 期研究。使用尼古丁使用清单通过口头报告评估第 12 周的戒烟率。
总体而言，共有 1391 名受试者入组；1177 名受试者接受了研究药物治疗，并对其有效性和安全性进行了评估。研究结束时，71.1%（95%置信区间 68.5-73.7）的受试者戒烟。共有 205 例全因不良事件；2.2%被归类为严重或严重。没有致命的不良事件。纳入时，66.7%的参与者至少有 1 种合并症，最常见的报告为慢性阻塞性肺疾病（35.5%）、高血压（29.6%）和抑郁症（10.4%）。
这些真实世界的数据表明，伐伦克林在包括与吸烟相关的合并症在内的初级保健环境中是一种有效且耐受良好的戒烟治疗方法。
