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动脉粥样硬化疾病患者采用前蛋白转化酶枯草溶菌素 9(PCSK9)抑制剂。

Adoption of PCSK9 Inhibitors Among Patients With Atherosclerotic Disease.

机构信息

Division of Cardiovascular Medicine Hospital of the University of Pennsylvania Philadelphia PA.

Department of Medicine Hospital of the University of Pennsylvania Philadelphia PA.

出版信息

J Am Heart Assoc. 2021 May 4;10(9):e019331. doi: 10.1161/JAHA.120.019331. Epub 2021 Apr 27.

Abstract

Background PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors represent a promising class of lipid-lowering therapy, although their use has been limited by cost concerns. Methods and Results A retrospective cohort study was conducted using a nationwide commercial claims database comprising patients with atherosclerotic cardiovascular disease (ASCVD), aged 18 to 64 years. We identified the number of patients with ASCVD started on a PCSK9 inhibitor from the dates of US Food and Drug Administration approval in quarter 3 2015 through quarter 2 2019. Secondary objectives identified the proportions of patients started on a PCSK9 inhibitor in various ASCVD risk groups based on statin use and baseline low-density lipoprotein cholesterol. We identified 126 419 patients with ASCVD on either PCSK9 inhibitor or statin therapy. Among these patients, 1168 (0.9%) filled a prescription for a PCSK9 inhibitor. The number of patients initiating a PCSK9 inhibitor increased from 2 patients in quarter 3 2015 to 119 patients in quarter 2 2019, corresponding to an increase from 0.05% to 2.5% of patients with ASCVD already on statins who started PCSK9 inhibitor therapy. Of patients with ASCVD with high adherence to a high-intensity statin, 13 643 had low-density lipoprotein cholesterol ≥70 mg/dL, and in this subgroup, 119 (0.9%) patients initiated a PCSK9 inhibitor. Conclusions Few patients started PCSK9 inhibitors from 2015 through mid-2019, despite increasing trial evidence of efficacy, guidelines recommending PCSK9 inhibitors in high-risk patients with ASCVD, and price reductions during this period. The magnitude of price reductions may not yet be sufficient to influence use management strategies aimed to limit PCSK9 inhibitor use.

摘要

背景 PCSK9(脯氨酸羧肽酶/枯草杆菌蛋白酶 Kexin 9 型)抑制剂是一类很有前途的降脂治疗药物,但其应用受到成本问题的限制。

方法和结果 采用全国商业索赔数据库进行回顾性队列研究,该数据库包含年龄在 18 至 64 岁之间的动脉粥样硬化性心血管疾病(ASCVD)患者。我们从美国食品药品监督管理局(FDA)于 2015 年第 3 季度批准的日期到 2019 年第 2 季度,确定了开始使用 PCSK9 抑制剂的 ASCVD 患者数量。次要目标根据他汀类药物的使用情况和基线低密度脂蛋白胆固醇(LDL-C),确定了不同 ASCVD 风险组中开始使用 PCSK9 抑制剂的患者比例。我们确定了 126419 例接受 PCSK9 抑制剂或他汀类药物治疗的 ASCVD 患者。在这些患者中,有 1168 例(0.9%)患者开具了 PCSK9 抑制剂处方。开始使用 PCSK9 抑制剂的患者数量从 2015 年第 3 季度的 2 例增加到 2019 年第 2 季度的 119 例,这相当于已接受他汀类药物治疗的 ASCVD 患者中开始接受 PCSK9 抑制剂治疗的患者比例从 0.05%增加到 2.5%。在高强度他汀类药物高依从性的 ASCVD 患者中,有 13643 例患者 LDL-C≥70mg/dL,在此亚组中,有 119 例(0.9%)患者开始使用 PCSK9 抑制剂。

结论 尽管不断有临床试验证据显示其疗效、指南推荐将 PCSK9 抑制剂用于 ASCVD 高危患者,以及在此期间价格降低,但 2015 年至 2019 年期间开始使用 PCSK9 抑制剂的患者仍然很少。价格降低的幅度可能还不足以影响旨在限制 PCSK9 抑制剂使用的用药管理策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/864b/8200752/9dfb7fc93341/JAH3-10-e019331-g001.jpg

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