Department of Family Medicine and Community Medicine, E-Da Hospital, I-Shou University, Kaohsiung City 824, Taiwan.
College of Medicine, I-Shou University, Kaohsiung City 824, Taiwan.
Eur Heart J Cardiovasc Pharmacother. 2024 Oct 4;10(6):505-514. doi: 10.1093/ehjcvp/pvae056.
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective in reducing cardiovascular events, but their impact on all-cause mortality and medical utilization compared to statins is unclear. This study investigated PCSK9 inhibitor use and its impact on mortality and medical utilization vs. statins, using TriNetX database data with up to 9 years of follow-up.
This retrospective cohort study analysed TriNetX data spanning 1 July 2015, to 31 December 2023, including 79 194 PCSK9 inhibitor users (alirocumab, evolocumab, inclisiran) and 5 437 513 statin users with hyperlipidaemia. The primary outcomes were all-cause mortality and medical utilization, including hospital inpatient services, emergency department visits, critical care, and mechanical ventilation. Propensity score matching showed that PCSK9 inhibitor use was associated with a 28.3% lower risk of all-cause mortality [adjusted hazard ratio (aHR) 0.717, 95% confidence interval (CI): 0.673-0.763] and significant reductions in medical utilization (hospital inpatient services usage: aHR 0.692, 95% CI: 0.664-0.721; emergency department services: aHR 0.756, 95% CI: 0.726-0.788; critical care services: aHR 0.619, 95% CI: 0.578-0.664; and mechanical ventilation: aHR 0.537, 95% CI: 0.484-0.596) compared to statins. These findings were consistent across various demographics and clinical subgroups. The sensitivity analyses supported the robustness of the findings.
PCSK9 inhibitors significantly reduced all-cause mortality and medical utilization compared to statins, suggesting their important role in dyslipidaemia management, particularly for statin-naïve or intolerant patients. Further research, including randomized controlled trials, is needed to confirm these findings and explore the underlying mechanisms.
前蛋白转化酶枯草溶菌素 9（PCSK9）抑制剂在降低心血管事件方面具有显著疗效，但相较于他汀类药物，其对全因死亡率和医疗利用率的影响尚不明确。本研究使用 TriNetX 数据库数据（随访时间最长可达 9 年），旨在探究 PCSK9 抑制剂的应用及其与他汀类药物相比在死亡率和医疗利用率方面的影响。
本回顾性队列研究分析了 2015 年 7 月 1 日至 2023 年 12 月 31 日期间的 TriNetX 数据，共纳入 79194 名使用 PCSK9 抑制剂（阿利西尤单抗、依洛尤单抗、依洛西仑）和 5437513 名患有高脂血症但使用他汀类药物的患者。主要结局为全因死亡率和医疗利用率，包括住院服务、急诊就诊、重症监护和机械通气。倾向评分匹配显示，与使用他汀类药物相比，使用 PCSK9 抑制剂可使全因死亡率降低 28.3%[校正风险比（aHR）0.717，95%置信区间（CI）：0.673-0.763]，且显著降低医疗利用率（住院服务使用率：aHR 0.692，95%CI：0.664-0.721；急诊服务使用率：aHR 0.756，95%CI：0.726-0.788；重症监护服务使用率：aHR 0.619，95%CI：0.578-0.664；机械通气使用率：aHR 0.537，95%CI：0.484-0.596）。这些发现与各种人群和临床亚组一致。敏感性分析支持了研究结果的稳健性。
与他汀类药物相比，PCSK9 抑制剂可显著降低全因死亡率和医疗利用率，表明其在血脂异常管理方面具有重要作用，尤其适用于他汀类药物不耐受或初始治疗失败的患者。需要进一步的研究，包括随机对照试验，以证实这些发现并探索潜在机制。
