Center for Tobacco Research and Intervention, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI.
Division of General Internal Medicine, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI.
Nicotine Tob Res. 2019 Oct 26;21(11):1488-1495. doi: 10.1093/ntr/nty157.
Nonadherence to pharmacotherapies complicates studies of comparative pharmacotherapy effectiveness. Modeling adherence and abstinence simultaneously may facilitate analysis of both treatment acceptability and effectiveness.
Secondary analyses of a three-arm randomized comparative trial of nicotine patch, varenicline, and combination nicotine patch and lozenge among adult daily smokers (N = 1086) were conducted. Adherence rates collected via interactive voice response systems during the first 27 days of quitting were compared across treatment conditions. Repeated measures latent class analyses of adherence and abstinence in 3-day parcels through 27 days of a quit attempt were conducted with treatment, demographic, and smoking history covariates.
Adherence varied across treatments and was lowest for nicotine lozenge use in combination nicotine replacement therapy (NRT). Five latent classes that differed significantly in 6-month abstinence rates were retained, including three subgroups of adherent participants varying in treatment response and two nonadherent groups varying in abstinence probabilities. Nonadherence was more likely among those receiving varenicline and combination NRT, relative to patch monotherapy. Varenicline and combination NRT did not promote abstinence among adherent latent classes but did promote abstinence among those partially adherent, relative to patch alone. Combination therapy attenuated increased risk of treatment disengagement with more years smoking. Minority smokers, those high in dependence, and those with shorter past abstinence were at increased risk for low-adherence and low-abstinence latent classes.
Varenicline and combination nicotine patch and lozenge are less likely to be used as directed and may not increase first-month abstinence better than patch alone when taken adherently.
This secondary analysis of adherence and abstinence in a comparative effectiveness trial shows that adherence is highest for the nicotine patch, next highest for varenicline, and lowest for combination nicotine patch and lozenge therapy due to low lozenge use. Distinct latent classes were found that varied in both first-month abstinence and adherence. Varenicline and combination NRT may not enhance abstinence over patch alone among smokers who take medication adherently. Adherent use of medication especially benefits those who are low in dependence and have positive quitting histories; it is less beneficial to at-risk smokers and members of racial minorities.
药物治疗依从性会使比较药物治疗效果的研究变得复杂。同时对依从性和戒断进行建模可能有助于分析治疗的可接受性和有效性。
对尼古丁贴片、伐伦克林和尼古丁贴片与含片联合治疗成年每日吸烟者的三臂随机对照试验(N=1086)进行二次分析。通过交互式语音应答系统在戒烟的前 27 天内收集依从率,并在治疗条件下进行比较。在戒烟尝试的 27 天内,通过 3 天的包裹进行重复测量潜在类别分析,将治疗、人口统计学和吸烟史协变量纳入其中。
不同治疗组的依从性存在差异,尼古丁含片联合尼古丁替代疗法(NRT)的依从性最低。保留了 5 个在 6 个月戒烟率上差异显著的潜在类别,包括在治疗反应上存在差异的三个依从性参与者亚组和两个在戒烟概率上存在差异的非依从性组。与单独使用贴片治疗相比,接受伐伦克林和联合 NRT 治疗的患者更有可能不依从。伐伦克林和联合 NRT 并未促进依从性较好的潜在类别戒烟,但促进了部分依从性的潜在类别戒烟,而单独使用贴片治疗则没有。与单独使用贴片治疗相比,组合疗法减少了因吸烟时间较长而导致的治疗中断的风险。少数民族吸烟者、依赖性高的吸烟者和过去戒烟时间较短的吸烟者,更有可能出现低依从性和低戒烟率的潜在类别。
与单独使用贴片治疗相比,伐伦克林和尼古丁贴片与含片联合治疗不太可能按照规定使用,而且当患者依从性较高时,也不太可能增加第一个月的戒烟率。
本研究对一项比较疗效试验中的依从性和戒烟情况进行了二次分析,结果表明,由于尼古丁含片使用量低,尼古丁贴片的依从性最高,伐伦克林次之,尼古丁贴片与含片联合治疗的依从性最低。发现了不同的潜在类别,这些潜在类别在第一个月的戒烟率和依从性上都存在差异。对于依从性较高的吸烟者,伐伦克林和联合 NRT 可能不会比单独使用贴片治疗更能增强戒烟效果。药物的依从性使用尤其有益于依赖性低和有积极戒烟史的吸烟者;对有风险的吸烟者和少数民族成员的益处较小。