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EAGLES研究中患有吸烟相关疾病参与者的药物辅助戒烟率:一项双盲、随机、安慰剂对照临床试验的事后分析

Medication-assisted quit rates in participants with smoking-related diseases in EAGLES: Post hoc analyses of a double-blind, randomized, placebo-controlled clinical trial.

作者信息

Tønnesen Philip, Lawrence David, Tonstad Serena

机构信息

Pulmonary Medicine, Søernes Privathospital, Frederiksberg, Denmark.

Center for Sleep Medicine, Søernes Privathospital, Frederiksberg, Denmark.

出版信息

Tob Induc Dis. 2022 May 10;20:46. doi: 10.18332/tid/146567. eCollection 2022.

Abstract

INTRODUCTION

Greater understanding is required of how smokers with smoking-related diseases respond to smoking cessation medications. This analysis of EAGLES data compared continuous abstinence rates (CARs) in smokers with/without smoking-related diseases and assessed participant demographic and baseline characteristics that may serve as predictors of continuous abstinence (CA).

METHODS

EAGLES was a 24-week (12-week treatment, 12-week follow-up), double-blind, active- (nicotine replacement therapy; patch) and placebo-controlled study in motivated-to-quit smokers with/without psychiatric disorders. This analysis assessed CARs at weeks 9-12 (CAR9-12) and 9-24 (CAR9-24) in participants with smoking-related diseases [asthma, chronic obstructive pulmonary disease (COPD), diabetes, and/or cardiovascular disease (n=1372)] versus controls without these comorbidities (n=6039). Participants received varenicline 1 mg twice daily, bupropion 150 mg twice daily, nicotine patches 21 mg/day with taper, or placebo for 12 weeks. Stepwise logistic modeling was also performed to analyze odds ratio (OR) for predictors of CA at weeks 9-12 (CA9-12) and 9-24 (CA9-24).

RESULTS

Smokers with smoking-related diseases were older, had a longer smoking history, more quit attempts, and were more likely to have a psychiatric disorder and reside in the US versus smokers without comorbidities. Fagerström Test for Cigarette Dependence scores and treatment adherence were comparable between cohorts. Smokers with smoking-related diseases had lower CARs versus controls (CAR9-12: 20.8% vs 24.0%; CAR9-24: 13.0% vs 16.9%). Use of smoking cessation medication was the strongest predictor of CA after control for demographics, smoking characteristics, and psychiatric disorder. By treatment, OR and CI were: varenicline CA9-12 (OR=3.82; 95% CI: 3.21-4.54) and CA9-24 (OR=2.92; 95% CI: 2.40-3.54); bupropion CA9-12 (OR=2.17; 95% CI: 1.81-2.60) and CA9-24 (OR=1.99; 95% CI: 1.63-2.44); nicotine patches CA9-12 (OR=2.23; 95% CI: 1.87-2.67) and CA9-24 (OR=1.86; 95% CI: 1.52-2.28).

CONCLUSIONS

Smokers with smoking-related diseases had lower quit rates than controls. Of the active treatments compared, varenicline was most effective in smokers with asthma, COPD, diabetes, or cardiovascular disease.

TRIAL REGISTRATION

NCT01456936 (https://clinicaltrials.gov/ct2/show/NCT01456936).

摘要

引言

对于患有吸烟相关疾病的吸烟者如何对戒烟药物做出反应,我们需要有更深入的了解。这项对EAGLES数据的分析比较了患有/未患有吸烟相关疾病的吸烟者的持续戒烟率(CARs),并评估了可能作为持续戒烟(CA)预测指标的参与者人口统计学和基线特征。

方法

EAGLES是一项为期24周(12周治疗期,12周随访期)的双盲、活性药物(尼古丁替代疗法;贴片)和安慰剂对照研究,研究对象为有/无精神疾病的有戒烟意愿的吸烟者。该分析评估了患有吸烟相关疾病(哮喘、慢性阻塞性肺疾病(COPD)、糖尿病和/或心血管疾病,n = 1372)的参与者与无这些合并症的对照组(n = 6039)在第9 - 12周(CAR9 - 12)和第9 - 24周(CAR9 - 24)的CARs。参与者接受1毫克伐尼克兰每日两次、150毫克安非他酮每日两次、21毫克/天的尼古丁贴片并逐渐减量,或安慰剂治疗12周。还进行了逐步逻辑回归建模,以分析第9 - 12周(CA9 - 12)和第9 - 24周(CA9 - 24)持续戒烟预测指标的比值比(OR)。

结果

与无合并症的吸烟者相比,患有吸烟相关疾病的吸烟者年龄更大,吸烟史更长,尝试戒烟次数更多,并且更有可能患有精神疾病且居住在美国。两组之间的香烟依赖程度法格斯特龙测试得分和治疗依从性相当。患有吸烟相关疾病的吸烟者的CARs低于对照组(CAR9 - 12:20.8%对24.0%;CAR9 - 24:13.0%对16.9%)。在对人口统计学、吸烟特征和精神疾病进行控制后,使用戒烟药物是持续戒烟的最强预测指标。按治疗方法,OR和CI分别为:伐尼克兰CA9 - 12(OR = 3.82;95% CI:3.21 - 4.54)和CA9 - 24(OR = 2.92;95% CI:2.40 - 3.54);安非他酮CA9 - 12(OR = 2.17;95% CI:1.81 - 2.60)和CA9 - 24(OR = 1.99;95% CI:(1.63 - 2.44);尼古丁贴片CA9 - 12(OR = 2.23;95% CI:1.87 - 2.67)和CA9 - 24(OR = 1.86;95% CI:1.52 - 2.28)。

结论

患有吸烟相关疾病的吸烟者的戒烟率低于对照组。在比较的活性治疗中,伐尼克兰对患有哮喘、COPD、糖尿病或心血管疾病的吸烟者最有效。

试验注册

NCT01456936(https://clinicaltrials.gov/ct2/show/NCT01456936)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e67e/9086158/1d460249d178/TID-20-46-g001.jpg

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