Xu Leyu, Lei Ming, Li Liren, Li Yilei, Gu Chunping, Zheng Ping
Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Clinical Pharmacy Center, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Front Pharmacol. 2025 Jun 24;16:1555508. doi: 10.3389/fphar.2025.1555508. eCollection 2025.
Alirocumab and evolocumab are proprotein convertase subtilisin/kexin type 9 inhibitors that significantly reduce the relative risk of cardiovascular events. However, the relative efficacy and safety of alirocumab and evolocumab in different patient groups still warrant further indirect comparison. This systematic review and network meta-analysis indirectly compared the efficacy and safety of alirocumab and evolocumab on major cardiovascular events.
PUBMED, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were comprehensively searched to extract randomized controlled trials (RCTs) regarding alirocumab and evolocumab published from inception to 17 August 2024. The meta-analysis was performed using Software Review Manager 5.4 and R 4.1.0 software.
This network meta-analysis included 26 RCTs with 64,921 patients. Among these, 13 RCTs included patients receiving alirocumab or placebo (n = 13,365) and 13 RCTs included patients receiving evolocumab or placebo (n = 22,048). Compared with the placebo, treatment with alirocumab and evolocumab significantly reduced the relative risk of major adverse cardiovascular and cerebrovascular events (MACCE), myocardial infarction, stroke, and coronary revascularization. Furthermore, alirocumab and evolocumab groups did not show significant differences in MACCE [relative risk (RR): 0.99, 95% confidence interval (CI): 0.88-1.11], cardiovascular death (RR: 0.83, 95% CI: 0.65-1.06), myocardial infarction (RR: 0.87, 95% CI: 0.74-1.03), stroke (RR: 0.96, 95% CI: 0.71-1.29), coronary revascularization (RR: 0.88, 95% CI: 0.77-1.01), and any adverse event (RR: 0.91, 95% CI: 0.76-1.09). Moreover, the all-cause mortality rates were lower for patients treated with alirocumab compared to those treated with evolocumab (RR: 0.84, 95% CI: 0.70-1.00), but the difference was not statistically significant.
Alirocumab and evolocumab demonstrated comparable efficacy in reducing the relative risk of major cardiovascular events. The all-cause mortality rates were lower in patients treated with alirocumab compared to those treated with evolocumab but the differences were not statistically significant, probably due to heterogeneity in the sample size and follow-up duration between different studies. Both drugs exhibited comparable safety profiles.
https://www.crd.york.ac.uk/PROSPERO/myprospero, identifier CRD42024505327.
阿利西尤单抗和依洛尤单抗是前蛋白转化酶枯草溶菌素/克新9型抑制剂，可显著降低心血管事件的相对风险。然而，阿利西尤单抗和依洛尤单抗在不同患者群体中的相对疗效和安全性仍有待进一步间接比较。本系统评价和网状Meta分析间接比较了阿利西尤单抗和依洛尤单抗对主要心血管事件的疗效和安全性。
全面检索了PUBMED、EMBASE、科学网和Cochrane对照试验中央注册库（CENTRAL）数据库，以提取从开始到2024年8月17日发表的关于阿利西尤单抗和依洛尤单抗的随机对照试验（RCT）。使用Review Manager 5.4软件和R 4.1.0软件进行Meta分析。
该网状Meta分析纳入了26项RCT，共64921例患者。其中，13项RCT纳入了接受阿利西尤单抗或安慰剂治疗的患者（n = 13365），13项RCT纳入了接受依洛尤单抗或安慰剂治疗的患者（n = 22048）。与安慰剂相比，阿利西尤单抗和依洛尤单抗治疗显著降低了主要不良心血管和脑血管事件（MACCE）、心肌梗死、中风和冠状动脉血运重建的相对风险。此外，阿利西尤单抗组和依洛尤单抗组在MACCE（相对风险[RR]：0.99，95%置信区间[CI]：0.88 - 1.11）、心血管死亡（RR：0.83，95% CI：0.65 - 1.06）、心肌梗死（RR：0.87，95% CI：0.74 - 1.03）、中风（RR：0.96，95% CI：0.71 - 1.29）、冠状动脉血运重建（RR：0.88，95% CI：0.77 - 1.01）和任何不良事件（RR：0.91，95% CI：0.76 - 1.09）方面均未显示出显著差异。此外，与接受依洛尤单抗治疗的患者相比，接受阿利西尤单抗治疗的患者全因死亡率较低（RR：0.84，95% CI：0.70 - 1.00），但差异无统计学意义。
阿利西尤单抗和依洛尤单抗在降低主要心血管事件相对风险方面显示出相当的疗效。与接受依洛尤单抗治疗的患者相比，接受阿利西尤单抗治疗的患者全因死亡率较低，但差异无统计学意义，可能是由于不同研究之间样本量和随访时间的异质性所致。两种药物的安全性相当。
https://www.crd.york.ac.uk/PROSPERO/myprospero，标识符CRD42024505327。
