US Health Economics & Outcomes Research, IMS Health, Falls Church, VA, USA.
BMC Cardiovasc Disord. 2010 Jun 17;10:29. doi: 10.1186/1471-2261-10-29.
Prior studies have found that patients taking single-pill amlodipine/atorvastatin (SPAA) have greater likelihood of adherence at 6 months than those taking 2-pill calcium-channel blocker and statin combinations (CCB/statin). This study examines whether this adherence benefit results in fewer cardiovascular (CV) events.
A retrospective cohort study was conducted using administrative claims data from the IMS LifeLink: US Health Plan Claims database, identifying adults already taking CCB or statin (but not both) who had an index event of either initiating treatment with SPAA or adding CCB to statin (or vice versa) between April 1, 2004 to August 31, 2005. Inclusion criteria included age 18+ years, continuously enrolled for minimum of 6 months prior and 18 months following treatment initiation, >1 diagnosis of hypertension, and no prescription claims for SPAA or added CCB or statin for 6 months prior. Exclusion criteria included >1 claim with missing or invalid days supplied, age 65+ years and not enrolled in Medicare Advantage, or history of prior CV events, cancer diagnosis, or chronic renal failure. The primary outcome measure was the rate of CV events (myocardial infarction, heart failure, angina, other ischemic heart disease, stroke, peripheral vascular disease, or revascularization procedure) from 6 to 18 months following index date, analyzed at three levels: 1) all adherent vs. non-adherent patients, 2) SPAA vs. dual-pill patients (regardless of adherence level), and 3) adherent SPAA, adherent dual-pill, and non-adherent SPAA patients vs. non-adherent dual-pill patients.
Of 1,537 SPAA patients, 56.5% were adherent at 6 months, compared with 21.4% of the 17,910 CCB/statin patients (p < 0.001). Logistic regression found SPAA patients more likely to be adherent (OR = 4.7, p < 0.001) than CCB/statin patients. In Cox proportional hazards models, being adherent to either regimen was associated with significantly lower risk of CV event (HR = 0.77, p = 0.003). A similar effect was seen for SPAA vs. CCB/statin patients (HR = 0.68, p = 0.02). In a combined model, the risk of CV events was significantly lower for adherent CCB/statin patients (HR = 0.79, p = 0.01) and adherent SPAA patients (HR = 0.61, p = 0.03) compared to non-adherent CCB/statin patients.
Patients receiving SPAA rather than a 2-pill CCB/statin regimen are more likely to be adherent. In turn, adherence to CCB and statin medications is associated with lower risk of CV events in primary prevention patients.
先前的研究发现，服用单粒氨氯地平/阿托伐他汀（SPAA）的患者在 6 个月时的依从性比服用 2 粒钙通道阻滞剂和他汀类药物组合（CCB/他汀类药物）的患者更高。本研究探讨了这种依从性获益是否会导致心血管（CV）事件减少。
使用 IMS LifeLink：美国健康计划索赔数据库中的行政索赔数据进行回顾性队列研究，确定已经服用 CCB 或他汀类药物（但不是两者都服用）的成年人，他们在 2004 年 4 月 1 日至 2005 年 8 月 31 日之间有一个起始治疗为 SPAA 的索引事件，或者在开始服用 CCB 时添加了他汀类药物（反之亦然）。纳入标准包括年龄 18 岁以上，在治疗开始前至少连续 6 个月和治疗开始后 18 个月内连续入组，至少有 1 次高血压诊断，且在开始治疗前 6 个月内没有 SPAA 或添加的 CCB 或他汀类药物的处方。排除标准包括：1）有缺失或无效天数的索赔超过 1 次；2）年龄在 65 岁以上，且未参加医疗保险优势计划；3）有先前的 CV 事件、癌症诊断或慢性肾功能衰竭史。主要观察指标是从索引日期开始的 6 至 18 个月内 CV 事件（心肌梗死、心力衰竭、心绞痛、其他缺血性心脏病、中风、外周血管疾病或血运重建手术）的发生率，分析了三个水平：1）所有依从性与非依从性患者；2）SPAA 与双丸患者（无论依从性水平如何）；3）依从性 SPAA、依从性双丸和非依从性 SPAA 患者与非依从性双丸患者。
在 1537 名 SPAA 患者中，56.5%的患者在 6 个月时依从性良好，而 17910 名 CCB/他汀类药物患者中只有 21.4%（p < 0.001）。逻辑回归发现 SPAA 患者比 CCB/他汀类药物患者更有可能依从（OR = 4.7，p < 0.001）。在 Cox 比例风险模型中，依从性与 CV 事件风险显著降低相关（HR = 0.77，p = 0.003）。SPAA 与 CCB/他汀类药物患者之间也观察到类似的效果（HR = 0.68，p = 0.02）。在联合模型中，与非依从性 CCB/他汀类药物患者相比，依从性 CCB/他汀类药物患者（HR = 0.79，p = 0.01）和依从性 SPAA 患者（HR = 0.61，p = 0.03）的 CV 事件风险显著降低。
接受 SPAA 治疗而不是 2 粒 CCB/他汀类药物治疗的患者更有可能依从。相反，CCB 和他汀类药物的依从性与初级预防患者的 CV 事件风险降低相关。
