Gupta Milan, Wani Rajvi J, Al Faraidy Khalid, Bergeron Jean, Contreras Eduardo, Peña Angel Alberto Garcia, Mancini G B John, Padilla Francisco, Lopez Abel Alberto Pavia, Philip Kiran, Wu Johnny, Mackinnon Erin S
Department of Medicine, University of Toronto and the Canadian Collaborative Research Network, 3 Conestoga Dr., Suite 200, Brampton, ON, L6Z 4N5, Canada.
Amgen Canada Inc., 6775 Financial Dr., Suite 300, Mississauga, ON, L5N 0A4, Canada.
Cardiol Ther. 2023 Dec;12(4):703-722. doi: 10.1007/s40119-023-00334-5. Epub 2023 Oct 7.
This study characterizes patients receiving evolocumab in clinical practice and assesses treatment effectiveness, safety and persistence outcomes across five countries.
This retrospective and prospective observational study enrolled patients initiated on evolocumab during August 2017 to July 2019 at 49 sites across Canada, Mexico, Colombia, Saudi Arabia and Kuwait. Medical records data were extracted within 6 months prior to (baseline) and every 3 months for 12 months post evolocumab initiation and reported as available.
A total of 578 patients were enrolled (40.1% female, median age 60 [interquartile range (IQR) 51-68] years); 83.7% had atherosclerotic cardiovascular disease and/or familial hypercholesterolemia. Median low-density lipoprotein cholesterol (LDL-C) at baseline was 3.4 (IQR 2.7-4.2) mmol/L (131.5 [IQR 104.4-162.4] mg/dL), with 75.6% of patients receiving a statin (59.2% high intensity). Compared to baseline, the median lowest LDL-C was reduced by 70.2% and remained stable over 12 months of treatment. Guideline-recommended LDL-C thresholds < 1.8, < 1.4 and < 1.0 mmol/L (< 70, < 55 and < 40 mg/dL) were achieved by 75.3%, 63.6% and 47.4% of patients. LDL-C outcomes were consistent across high- and very high-risk patients. Background lipid-lowering therapy remained relatively stable. No serious treatment-emergent adverse events were reported, and persistence to evolocumab was 90.2% at 12 months.
These findings provide real-world evidence that evolocumab use is in accordance with its international guideline-recommended place in dyslipidemia therapy, as well as confirmation of its effectiveness and safety in a heterogeneous population. Evolocumab can address a healthcare gap in the management of dyslipidemia by increasing the proportion of patients achieving LDL-C goals recommended to lower cardiovascular risk.
本研究对临床实践中接受依洛尤单抗治疗的患者进行了特征描述，并评估了五个国家的治疗效果、安全性和持续性结果。
这项回顾性和前瞻性观察性研究纳入了2017年8月至2019年7月期间在加拿大、墨西哥、哥伦比亚、沙特阿拉伯和科威特的49个地点开始接受依洛尤单抗治疗的患者。在依洛尤单抗开始治疗前6个月（基线）内以及开始治疗后12个月内每3个月提取一次医疗记录数据，并按可用情况报告。
共纳入578例患者（女性占40.1%，中位年龄60岁[四分位间距（IQR）51 - 68岁]）；83.7%患有动脉粥样硬化性心血管疾病和/或家族性高胆固醇血症。基线时低密度脂蛋白胆固醇（LDL-C）的中位数为3.4（IQR 2.7 - 4.2）mmol/L（131.5[IQR 104.4 - 162.4]mg/dL），75.6%的患者接受他汀类药物治疗（59.2%为高强度）。与基线相比，最低LDL-C中位数降低了70.2%，并在12个月的治疗期间保持稳定。75.3%、63.6%和47.4%的患者达到了指南推荐的LDL-C阈值<1.8、<1.4和<1.0 mmol/L（<70、<55和<40 mg/dL）。高危和极高危患者的LDL-C结果一致。背景降脂治疗保持相对稳定。未报告严重的治疗中出现的不良事件，12个月时依洛尤单抗的持续性为90.2%。
这些发现提供了真实世界的证据，表明依洛尤单抗的使用符合其在血脂异常治疗中国际指南推荐的地位，并证实了其在异质性人群中的有效性和安全性。依洛尤单抗可以通过增加达到推荐的降低心血管风险的LDL-C目标的患者比例，解决血脂异常管理中的医疗差距。
