Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trials.

Background

To evaluate the efficacy and safety of cytisinicline versus placebo for cessation among smokers with and without COPD.

评估细胞尼辛对有无COPD的吸烟者戒烟的疗效和安全性，与安慰剂进行比较。

Methods

This post hoc analysis used combined data from the phase 3 ORCA-2 (Ongoing Research of Cytisinicline for Addiction) and ORCA-3 double-blind, placebo-controlledtrials.

本次事后分析使用了第3阶段ORCA-2（持续进行的关于戒瘾的细胞尼辛研究）和ORCA-3双盲、安慰剂对照试验的合并数据。

Participants received 6 or 12 weeks of cytisinicline or placebo.

参与者接受了6周或12周的细胞尼辛或安慰剂治疗。

Of 1602 participants, 145 (9.3%) self-reported COPD.

在1602名参与者中，有145人（9.3%）自我报告患有慢性阻塞性肺疾病（COPD）。

Participants received 3 mg of cytisinicline three times daily (6 weeks: n=532; 12 weeks: n=534) or placebo (12 weeks: n=536), plus behavioural support.

参与者每天三次接受3毫克的西替尼酸（6周：n=532；12周：n=534）或安慰剂（12周：n=536），并辅以行为支持。

outcome

Biochemically verified continuous smoking abstinence during the last 4 treatment weeks.

在治疗的最后4周内，通过生化验证了持续的吸烟戒断。

Results

COPD participants were older, smoked longer and had greater nicotine dependence.

COPD参与者年龄较大，吸烟时间更长，对尼古丁的依赖性更强。

Cytisinicline was associated with significantly higher smoking abstinence compared with placebo in both COPD and non-COPD subgroups.

Cytisinicline与安慰剂相比，在COPD和非COPD亚组中均显示出显著更高的吸烟戒断率。

There was no statistical evidence of heterogeneity in treatment effect between arms.

在治疗效果上，两组之间没有统计学证据表明存在异质性。

In the 6-week arm, quit estimates were 17.3% versus 2.1% (OR 9.7, p=0.03) for COPD and 19.3% versus 5.5% (OR 4.1, p<0.0001) for non-COPD.

在6周组中，戒烟估计值为慢性阻塞性肺疾病（COPD）患者17.3%对比2.1%（比值比OR 9.7，p=0.03），非COPD患者19.3%对比5.5%（比值比OR 4.1，p<0.0001）。

In the 12-week arm, quit estimates were 19.1% versus 4.3% (OR 5.3, p=0.04) for COPD and 32.6% versus 8.6% (OR 5.2, p<0.0001) for non-COPD.

在12周组中，戒烟估计值为慢性阻塞性肺疾病（COPD）患者19.1%对比4.3%（比值比OR 5.3，p=0.04），非COPD患者32.6%对比8.6%（比值比OR 5.2，p<0.0001）。

Cytisinicline was well tolerated with no serious treatment-related events.

Cytisinicline 耐受性良好，未出现与治疗相关的严重事件。

Conclusions

Cytisinicline significantly increased quitting for smokers with and without COPD and was well tolerated.

Cytisinicline 显著提高了有和没有COPD的吸烟者的戒烟率，并且耐受性良好。

The findings support cytisinicline as a viable treatment for smokers with COPD who want to quit.

研究结果支持将赛替尼可作为慢性阻塞性肺疾病（COPD）吸烟者戒烟的有效治疗方案。

trial_registration_number

ORCA-2 (NCT04576949) and ORCA-3 (NCT05206370).

ORCA-2（NCT04576949）和ORCA-3（NCT05206370）研究。