Balu Sanjeev, Simko Robert J, Quimbo Ralph M, Cziraky Mark J
Pharmaceutical Products Group, Abbott Laboratories, 200 Abbott Park Road, Abbott Park, IL 60064, USA.
Curr Med Res Opin. 2009 Nov;25(11):2765-75. doi: 10.1185/03007990903297741.
To compare medication adherence between patients initiating fixed-dose combination versus multi-pill combination dyslipidemia therapies and assess the association between optimal adherence (MPR > or = 80%) and cardiovascular disease (CVD)-associated total healthcare resource utilization (THR) and costs (THC).
The HealthCore Integrated Research Database was used to identify patients > or =18 years newly initiating fixed-dose combination [niacin extended-release (NER) and lovastatin (NERL)] or multi-pill combination therapies [NER and simvastatin (NER/S) or lovastatin (NER/L)] between 1/1/2000 and 6/30/2006 (index date), with minimum 18 months of follow-up. Adherence was measured using medication possession ratio (MPR). Three multivariate models were developed controlling for demographic and clinical characteristics. A logistic model evaluated the association between study cohorts and optimal adherence, while negative binomial and gamma models estimated the association between optimal adherence and CVD-associated THR and THC, respectively.
In all, 6638 NERL, 1687 NER/S, and 663 NER/L patients were identified. Fixed-dose combination patients were younger [mean (SD) ages of 51.9 (10.5) vs. 56.0 (9.4) [NER/S] and 56.1 (10.6) [NER/L]; p < 0.01], had lower comorbidity (Deyo-Charlson Index 0.50 +/- 0.9 vs. 0.7 +/- 1.1 and 0.6 +/- 1.1, p < 0.01 and p < 0.05) and comprised fewer males (73.1 vs. 83.0% and 77.7%; p < 0.01 and p = 0.1). Fixed-dose combination patients had higher average 1-year MPR versus NER/S and NER/L patients (0.54 +/- 0.35 vs. 0.50 +/- 0.35 and 0.47 +/- 0.34, p < 0.01). NER/S and NER/L patients were 31.3% (95% CI: 22.9-39.5%) and 39.1% (95% CI: 26.7-49.4%) less likely to be optimally adherent than fixed-dose combination patients (p < 0.01). Additionally, optimally adherent patients had 8% and 40% decreases in annual CVD-attributable THR [0.920 (95% CI: 0.857-0.989); p = 0.023] and THC [0.601 (95% CI: 0.427-0.845); p = 0.003] versus sub-optimally adherent patients. Key limitations of the study include the limited ability of MPR to analyze the continuity of medication usage, inability to capture data on other key variables including race, income, and clinical characteristics such as smoking history, absence of laboratory values on all study patients, inability to capture over-the-counter fills of niacin, and inability to show causality of results obtained.
Adherence was significantly higher among patients initiating fixed-dose combination versus multi-pill combination dyslipidemia therapies in this managed-care population. Additionally, patients with optimal adherence had a significantly lower CVD-associated THR and THC versus patients with sub-optimal adherence.
比较起始使用固定剂量复方制剂与多片复方制剂治疗血脂异常的患者的用药依从性，并评估最佳依从性（服药时间比例[MPR]≥80%）与心血管疾病（CVD）相关的总医疗资源利用（THR）及费用（THC）之间的关联。
利用HealthCore综合研究数据库，识别2000年1月1日至2006年6月30日（索引日期）期间新起始使用固定剂量复方制剂[烟酸缓释剂（NER）和洛伐他汀（NERL）]或多片复方制剂治疗[NER与辛伐他汀（NER/S）或洛伐他汀（NER/L）]且年龄≥18岁的患者，随访时间至少18个月。采用服药持有率（MPR）来衡量依从性。建立了三个多变量模型，对人口统计学和临床特征进行了控制。一个逻辑模型评估了研究队列与最佳依从性之间的关联，而负二项模型和伽马模型分别估计了最佳依从性与CVD相关的THR和THC之间的关联。
共识别出6638例NERL患者、1687例NER/S患者和663例NER/L患者。固定剂量复方制剂组患者更年轻[平均（标准差）年龄分别为51.9（10.5）岁，而NER/S组为56.0（9.4）岁，NER/L组为56.1（10.6）岁；p<0.01]，合并症更少（Deyo-Charlson指数分别为0.50±0.9、0.7±1.1和0.6±1.1，p<0.01和p<0.05），男性比例更低（分别为73.1%、83.0%和77.7%；p<0.01和p = 0.1）。固定剂量复方制剂组患者的1年平均MPR高于NER/S组和NER/L组患者（分别为0.54±0.35、0.50±0.35和0.47±0.34，p<0.01）。NER/S组和NER/L组患者达到最佳依从性的可能性分别比固定剂量复方制剂组患者低31.3%（95%可信区间：22.9 - 39.5%）和39.1%（95%可信区间：26.7 - 49.4%）（p<0.01）。此外，与依从性欠佳的患者相比，依从性最佳的患者每年CVD归因的THR[0.920（95%可信区间：0.857 - 0.989）；p = 0.023]和THC[0.601（95%可信区间：0.427 - 0.845）；p = 0.003]分别降低了8%和40%。该研究的主要局限性包括MPR分析用药连续性的能力有限，无法获取包括种族、收入以及吸烟史等其他关键变量的数据，所有研究患者均缺乏实验室检查值，无法获取烟酸的非处方配药情况，以及无法证明所获结果的因果关系。
在这个管理式医疗人群中，起始使用固定剂量复方制剂治疗血脂异常的患者依从性显著高于使用多片复方制剂的患者。此外，与依从性欠佳的患者相比，依从性最佳患者的CVD相关THR和THC显著更低。
