The University of Michigan and STATinMED Research, Ann Arbor, MI 48104, USA.
J Med Econ. 2011;14(5):576-83. doi: 10.3111/13696998.2011.596873. Epub 2011 Jul 6.
To compare adherence, healthcare costs and utilization of valsartan/amlodipine single-pill combination (SPC) and angiotensin-receptor blocker/calcium-channel blocker multiple-pill free-combination (ARB + CCB FC) therapy using real-world data.
A retrospective study (January 1, 2007 to April 30, 2009) was conducted using US commercial healthcare insurance claims. Patients were assigned to two cohorts: 'valsartan/amlodipine SPC cohort' and 'ARB + CCB FC therapy cohort'. The primary endpoints were adherence and persistence. The secondary endpoints were 1-year healthcare costs and utilization.
Out of 12,628 eligible patients 3259 (26%) were included in the valsartan/amlodipine SPC cohort and 9369 (%74) in the ARB + CCB FC cohort. Risk-adjusted adherence rates were higher for valsartan/amlodipine SPC patients [OR: 1.38, 95% CI: (1.24, 1.53)]. The Cox proportional hazard model showed that valsartan/amlodipine SPC cohort patients were less likely to discontinue medication (HR: 0.87, p < 0.001). Comparison between the groups also yielded that total healthcare costs of valsartan/amlodipine SPC patients were 16-20% lower than ARB + CCB FC therapy patients (p < 0.0001).
Since claims data are collected for payment purposes rather than research purposes, the study is bound by limitations for the retrospective analysis. For example, the presence of a claim for a filled prescription does not indicate that the medication was consumed or taken as prescribed. Data on health behaviors and patient lifestyle were not available. Over-the-counter medications and clinical disease severity were not available in the dataset. Incorrect coding is also a possibility. However, we have used previously validated datasets where these effects are minimal. Heterogeneity of the sample may create bias in our estimates, however, we have used advanced statistical methods to control for observed and unobserved bias.
The real-world use of valsartan/amlodipine SPC was associated with better adherence and persistence relative to ARB + CCB FC therapy among patients with hypertension. Moreover, patients taking single-pill combination therapy had lower healthcare costs and utilization.
利用真实世界数据比较缬沙坦/氨氯地平单片复方制剂(SPC)与血管紧张素受体阻滞剂/钙通道阻滞剂多片自由联合(ARB+CCB FC)治疗的依从性、医疗成本和利用情况。
本回顾性研究(2007 年 1 月 1 日至 2009 年 4 月 30 日)使用美国商业医疗保险理赔数据进行。患者被分为两个队列:“缬沙坦/氨氯地平 SPC 队列”和“ARB+CCB FC 治疗队列”。主要终点为依从性和持久性。次要终点为 1 年医疗成本和利用情况。
在 12628 名符合条件的患者中,3259 名(26%)被纳入缬沙坦/氨氯地平 SPC 队列,9369 名(74%)被纳入 ARB+CCB FC 队列。缬沙坦/氨氯地平 SPC 患者的风险调整后依从率更高[比值比:1.38,95%置信区间:(1.24,1.53)]。Cox 比例风险模型显示,缬沙坦/氨氯地平 SPC 队列患者停药的可能性较低(HR:0.87,p<0.001)。两组比较还表明,缬沙坦/氨氯地平 SPC 患者的总医疗成本比 ARB+CCB FC 治疗患者低 16-20%(p<0.0001)。
由于理赔数据是为支付目的而不是为研究目的而收集的,因此该研究受到回顾性分析的限制。例如,有已填写处方的理赔并不表示药物已被消耗或按规定服用。健康行为和患者生活方式的数据不可用。在数据集里也没有非处方药和临床疾病严重程度的数据。编码错误也是一种可能性。但是,我们已经使用了经过验证的数据集,这些影响是最小的。样本的异质性可能会导致我们的估计产生偏差,但是,我们已经使用了先进的统计方法来控制观察到和未观察到的偏差。
在高血压患者中,与 ARB+CCB FC 治疗相比,使用缬沙坦/氨氯地平 SPC 的真实世界数据与更好的依从性和持久性相关。此外,服用单片联合治疗的患者的医疗成本和利用率较低。