Wu Jia-Rong, Moser Debra K, De Jong Marla J, Rayens Mary Kay, Chung Misook L, Riegel Barbara, Lennie Terry A
University of Kentucky, College of Nursing, Lexington, 40536-0232, USA.
Am Heart J. 2009 Feb;157(2):285-91. doi: 10.1016/j.ahj.2008.10.001. Epub 2008 Dec 24.
Despite the importance of medication adherence in heart failure, clinically relevant cutpoints for distinguishing the level of adherence associated with outcomes are unknown.
The purpose of this study is to determine the cutpoint above which there is a positive relationship between level of medication adherence and event-free survival.
This was a longitudinal study of 135 patients with heart failure. Medication adherence was measured using a valid and objective measure, the Medication Event Monitoring System. Two indicators of adherence were assessed by the Medication Event Monitoring System (AARDEX, Union City, CA): (1) dose count, percentage of prescribed doses taken, and (2) dose days, percentage of days the correct number of doses was taken. Patients were followed up to 3.5 years to collect data on outcomes. A series of Kaplan-Meier plots with log-rank tests, Cox survival analyses, and receiver operating characteristic curves were assessed comparing event-free survival in patients divided at one-point incremental cutpoints.
Event-free survival was significantly better when the prescribed number of doses taken (dose count) or the correct dose (dose day) was > or =88%. This level was confirmed in a Cox regression model controlling for age, gender, ejection fraction, New York Heart Association, comorbidity, angiotensin-converting enzyme inhibitor use, and beta-blocker use. Receiver operating characteristic curves showed that adherence rates above 88% produced the optimal combination of sensitivity and specificity with respect to predicting better event-free survival. With 88% as the adherence cutpoint, the hazard ratio for time to first event for the nonadherent group was 2.2 by dose count (P = .021) and 3.2 by dose day (P = .002).
The results of this study provide clinicians and researchers with an evidence-based recommendation about the level of adherence needed to achieve optimal clinical outcomes.
尽管药物依从性在心力衰竭治疗中至关重要,但用于区分与预后相关的依从性水平的临床相关切点尚不清楚。
本研究旨在确定一个切点,高于该切点时药物依从性水平与无事件生存率之间存在正相关关系。
这是一项对135例心力衰竭患者的纵向研究。使用有效的客观测量方法——药物事件监测系统来测量药物依从性。药物事件监测系统(AARDEX,加利福尼亚州联合市)评估了两个依从性指标:(1)剂量计数,即服用的规定剂量的百分比;(2)剂量天数,即正确服用剂量的天数的百分比。对患者进行长达3.5年的随访以收集预后数据。通过一系列带有对数秩检验的Kaplan-Meier曲线、Cox生存分析和受试者工作特征曲线,比较了以1个百分点递增的切点划分的患者的无事件生存率。
当服用的规定剂量数(剂量计数)或正确剂量(剂量天数)≥88%时,无事件生存率显著更好。在控制年龄、性别、射血分数、纽约心脏协会分级、合并症、血管紧张素转换酶抑制剂使用情况和β受体阻滞剂使用情况的Cox回归模型中证实了这一水平。受试者工作特征曲线表明,就预测更好的无事件生存率而言,依从率高于88%可产生敏感性和特异性的最佳组合。以88%作为依从性切点,非依从组首次事件发生时间的风险比按剂量计数为2.2(P = 0.021),按剂量天数为3.2(P = 0.002)。
本研究结果为临床医生和研究人员提供了关于实现最佳临床结局所需依从性水平的循证推荐。