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P2Y12 抑制剂共付额降低干预与其他二级预防药物的持续性和依从性的关联:ARTEMIS 集群随机临床试验的事后分析。

Association of a P2Y12 Inhibitor Copayment Reduction Intervention With Persistence and Adherence With Other Secondary Prevention Medications: A Post Hoc Analysis of the ARTEMIS Cluster-Randomized Clinical Trial.

机构信息

Penn Cardiovascular Outcomes, Quality and Evaluative Research Center, University of Pennsylvania, Philadelphia.

Cardiovascular Medicine Division, University of Pennsylvania, Philadelphia.

出版信息

JAMA Cardiol. 2020 Jan 1;5(1):38-46. doi: 10.1001/jamacardio.2019.4408.

Abstract

IMPORTANCE

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) cluster-randomized trial found that copayment reduction for P2Y12 inhibitors improved 1-year patient persistence in taking that medication.

OBJECTIVE

To assess whether providing copayment reduction for P2Y12 inhibitors increases patient persistence in taking other secondary prevention cardiovascular medications.

DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis of the ARTEMIS trial includes data from 287 hospitals that enrolled patients between June 2015 and September 2016. Patients hospitalized with acute myocardial infarction were included. Data analysis occurred from May 2018 through August 2019.

INTERVENTIONS

Hospitals randomized to the intervention provided patients vouchers that waived copayments for P2Y12 inhibitors fills for 1 year. Hospitals randomized to usual care did not provide study vouchers.

MAIN OUTCOMES AND MEASURES

Persistence in taking β-blocker, statin, and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker medications at 1 year, defined as the absence of a gap in medication supply of 30 or more days by pharmacy fill data in the intervention-arm (intent-to-treat) population.

RESULTS

A total of 131 hospitals (with 5109 patients) were randomized to the intervention, and 156 hospitals (with 3264 patients) randomized to the control group. Patients discharged from intervention hospitals had higher persistence in taking statins (2247 [46.1%] vs 1300 [41.9%]; adjusted odds ratio, 1.11 [95% CI, 1.00-1.24]), and β-blockers (2235 [47.6%] vs 1277 [42.5%]; odds ratio, 1.23 [95% CI, 1.10-1.38]), although the association was smaller than that seen for P2Y12 inhibitors (odds ratio, 1.47 [95% CI, 1.29-1.66]). Persistence in taking angiotensin-converting enzyme inhibitors or angiotensin II-receptor blockers were also numerically higher among patients in the intervention arm than in the usual-care arm, but this was not significant after risk adjustment (1520 [43.9%] vs 847 [40.5%]; adjusted odds ratio, 1.10 [95% CI, 0.97-1.24]). Patients in the intervention arm reported greater financial burden associated with medication cost than the patients in the usual-care arm at baseline, but these differences were no longer significant at 1 year.

CONCLUSIONS AND RELEVANCE

Reducing patient copayments for 1 medication class increased persistence not only to that therapy class but may also have modestly increased persistence to other post-myocardial infarction secondary prevention medications. These findings have important implications for the clinical utility and cost-effectiveness of medication cost-assistance programs.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02406677.

摘要

重要性

心肌梗死研究中的负担能力和实际抗血小板治疗效果(ARTEMIS)集群随机试验发现,降低 P2Y12 抑制剂的共付额可提高患者在 1 年内坚持服用该药的比例。

目的

评估为 P2Y12 抑制剂提供共付额减免是否会增加患者坚持服用其他二级预防心血管药物的比例。

设计、地点和参与者:这是 ARTEMIS 试验的一项事后分析,涉及 287 家医院,这些医院在 2015 年 6 月至 2016 年 9 月期间招募了患者。纳入因急性心肌梗死住院的患者。数据分析于 2018 年 5 月至 2019 年 8 月进行。

干预措施

随机分配至干预组的医院为患者提供了为期 1 年的 P2Y12 抑制剂免共付额券,用于支付该药物的处方。随机分配至常规护理组的医院未提供研究券。

主要结局和测量

1 年后β受体阻滞剂、他汀类药物、血管紧张素转换酶抑制剂或血管紧张素 II 受体阻滞剂药物的持续使用情况,定义为通过干预臂(意向治疗)人群的药房配药数据,不存在 30 天或以上的药物供应空白期。

结果

共有 131 家医院(5109 名患者)被随机分配至干预组,156 家医院(3264 名患者)被随机分配至对照组。从干预医院出院的患者坚持服用他汀类药物的比例更高(2247[46.1%]vs 1300[41.9%];调整后的优势比,1.11[95%CI,1.00-1.24])和β受体阻滞剂(2235[47.6%]vs 1277[42.5%];优势比,1.23[95%CI,1.10-1.38]),尽管与 P2Y12 抑制剂的关联较小(优势比,1.47[95%CI,1.29-1.66])。尽管在风险调整后,与常规护理组相比,接受干预的患者服用血管紧张素转换酶抑制剂或血管紧张素 II 受体阻滞剂的比例也呈上升趋势,但差异无统计学意义(1520[43.9%]vs 847[40.5%];调整后的优势比,1.10[95%CI,0.97-1.24])。与常规护理组相比,接受干预的患者在基线时报告的药物费用负担更大,但在 1 年后,这些差异不再具有统计学意义。

结论和相关性

降低 1 类药物的患者共付额不仅提高了对该治疗类别的药物的持续使用比例,而且可能还适度提高了对其他心肌梗死后二级预防药物的持续使用比例。这些发现对药物费用援助计划的临床效用和成本效益具有重要意义。

试验注册

ClinicalTrials.gov 标识符:NCT02406677。

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