Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
J Clin Lipidol. 2018 Mar-Apr;12(2):277-291.e3. doi: 10.1016/j.jacl.2018.01.004. Epub 2018 Jan 12.
Monoclonal antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) have been shown to significantly reduce low-density lipoprotein cholesterol (LDL-C) levels.
The purpose of this study was to assess the long-term efficacy and safety of PCSK9 antibodies.
PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov were searched for relevant studies.
A total of 11 studies including 38,235 participants who were treated for at least 48 weeks were included in this meta-analysis. The results suggested that PCSK9 antibody treatment significantly decreased LDL-C levels (mean difference, -50.23% [95% confidence interval {CI}, -56.65% to -43.82%]) compared with no PCSK9 antibody treatment and also decreased other atherogenic lipid fractions. PCSK9 antibody treatment also elicited a significant reduction in cardiovascular event rates compared with no antibody treatment (relative risk [RR], 0.86 [95% CI, 0.81-0.92]). This reduction consisted of separate significant reductions in the rates of myocardial infarction (RR, 0.73 [95% CI, 0.65-0.82]), coronary revascularization (RR, 0.79 [95% CI, 0.73-0.87]), and stroke (RR, 0.81 [95% CI, 0.68-0.96]). There were no clear differences in the incidences of treatment-emergent adverse events (TEAEs), serious TEAEs, or TEAEs of interest between the 2 groups; moreover, no differences between the 2 groups were found for other laboratory parameters.
PCSK9 antibodies have significant effects on reducing LDL-C levels and improve cardiovascular outcomes. These antibodies have a satisfactory safety profile, which suggests that they are suitable for use as a long-term treatment.
靶向前蛋白转化酶枯草溶菌素 9（PCSK9）的单克隆抗体已被证实可显著降低低密度脂蛋白胆固醇（LDL-C）水平。
本研究旨在评估 PCSK9 抗体的长期疗效和安全性。
检索了 PubMed、EMBASE、Cochrane 图书馆和 ClinicalTrials.gov 以获取相关研究。
本荟萃分析共纳入了 11 项研究，共 38235 名参与者接受了至少 48 周的治疗。结果表明，与未接受 PCSK9 抗体治疗相比，PCSK9 抗体治疗可显著降低 LDL-C 水平（平均差值，-50.23%[95%置信区间（CI），-56.65%至-43.82%]），并降低其他致动脉粥样硬化的脂质分数。与未接受抗体治疗相比，PCSK9 抗体治疗还显著降低了心血管事件发生率（相对风险[RR]，0.86[95%CI，0.81-0.92]）。这一降低由心肌梗死（RR，0.73[95%CI，0.65-0.82]）、冠状动脉血运重建（RR，0.79[95%CI，0.73-0.87]）和卒中（RR，0.81[95%CI，0.68-0.96]）发生率的单独显著降低组成。两组之间治疗相关不良事件（TEAEs）、严重 TEAEs 或感兴趣的 TEAEs 的发生率无明显差异；此外，两组之间其他实验室参数也无差异。
PCSK9 抗体可显著降低 LDL-C 水平，改善心血管结局。这些抗体具有良好的安全性，表明它们适合作为长期治疗药物。
