Elis Avishay, Melzer Cohen Cheli, Chodick Gabriel
Department of Internal Medicine "C", Beilinson Hospital, Rabin Medical Center, Petah-Tikva 4941492, Israel.
Sackler School of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.
J Clin Med. 2023 Jan 30;12(3):1084. doi: 10.3390/jcm12031084.
With the emerging use of anti-PCSK9 monoclonal antibodies for lowering low-density lipoprotein cholesterol (LDL-C) levels, real-world evidence (RWE) is needed to evaluate drug effectiveness. This study aimed to characterize new users of alirocumab and evaluate its effectiveness in achieving LDL-C target levels. Included were patients initiating treatment with alirocumab from 1 August 2016 to 1 May 2020, with blood lipids evaluations during baseline (180 days prior to therapy initiation) and after 120 (±60) days of follow-up. Patients with treatment intensification during the follow-up period were excluded. LDL-C change from baseline and reaching LDL-C target levels, according to 2019 ESC/EAS guidelines, were evaluated. Among 623 included patients, 50.2% were men, the mean age was 65 years (±9 y), 62% were classified as very-high risk, and 76% had statin intolerance. During the follow-up, 65% (n = 407) were treated only with alirocumab. In 90% the initiation dose was 75 mg, and 21% were up-titrated. Alirocumab was associated with a 31.7% reduction in LDL-C, with 20.5% of patients reaching target levels. In this RWE study, alirocumab was used primarily as a single agent for eligible patients. Suboptimal use and adherence to therapy may have led to a lower LDL-C reduction compared to previous RCTs and most reported real-world studies.
随着抗前蛋白转化酶枯草溶菌素9（PCSK9）单克隆抗体在降低低密度脂蛋白胆固醇（LDL-C）水平方面的应用不断涌现，需要真实世界证据（RWE）来评估药物疗效。本研究旨在描述阿利西尤单抗新使用者的特征，并评估其在实现LDL-C目标水平方面的有效性。纳入的患者为2016年8月1日至2020年5月1日开始接受阿利西尤单抗治疗的患者，在基线期（治疗开始前180天）和随访120（±60）天后进行血脂评估。排除随访期间强化治疗的患者。根据2019年欧洲心脏病学会/欧洲动脉粥样硬化学会（ESC/EAS）指南，评估LDL-C相对于基线的变化以及达到LDL-C目标水平的情况。在纳入的623例患者中，50.2%为男性，平均年龄为65岁（±9岁），62%被归类为极高风险，76%有他汀类药物不耐受。在随访期间，65%（n = 407）仅接受阿利西尤单抗治疗。90%的起始剂量为75 mg，21%进行了剂量上调。阿利西尤单抗使LDL-C降低了31.7%，20.5%的患者达到目标水平。在这项RWE研究中，阿利西尤单抗主要作为单一药物用于符合条件的患者。与之前的随机对照试验（RCT）和大多数报道的真实世界研究相比，使用不充分和治疗依从性差可能导致LDL-C降低幅度较小。
