Center for Primary Care and Public Health, University of Lausanne, Lausanne, Switzerland.
Division of Cardiology, Department of Medicine, Geneva University Hospital, Geneva, Switzerland.
Adv Ther. 2022 Jan;39(1):504-517. doi: 10.1007/s12325-021-01962-w. Epub 2021 Nov 18.
The aims of this study were to describe patient characteristics, lipid parameters, lipid-lowering drug use, and safety of patients receiving evolocumab in a real-world clinical setting.
We conducted a 1-year multicenter observational study of adults using evolocumab with confirmed atherosclerotic cardiovascular disease (CVD) or at high cardiovascular risk, and elevated LDL-C despite maximally tolerated statin doses. An e-health application optionally supported patient management. The primary outcome was change in lipid parameters over time. The secondary outcomes included evolocumab safety.
Of 100 participants, 81% had pre-existing CVD, 71% self-reported statin-related muscle symptoms, 44% received statins. All patients received evolocumab, 65% were PCSK9i pre-treated at baseline. PCSK9i-naïve patients achieved a mean LDL-C reduction of 60% within 3 months of evolocumab treatment, which was maintained thereafter; 74% achieved LDL-C < 1.8 mmol/L at least once during observation, 69% attained < 1.4 mmol/L. In PCSK9i pre-treated patients, LDL-C remained stable throughout; 79% and 74% attained < 1.8 mmol/L and < 1.4 mmol/L, respectively, at least once. Goal attainment was higher with any combination of evolocumab, statin, and/or ezetimibe. Overall, 89% self-reported full evolocumab adherence. Treatment-emergent adverse events (TEAE) were reported in 30% of patients, two serious TEAEs occurred in one patient; three patients discontinued evolocumab because of TEAEs.
In real-world clinical practice, evolocumab was mainly used in patients with statin intolerance and pre-existing CVD. In this population, adherence to evolocumab and low LDL-C levels were maintained over 1 year, with better LDL-C goal achievement in patients using evolocumab in combination with other lipid-lowering drugs. Safety of evolocumab was similar to that documented in randomized controlled trials.
本研究旨在描述接受依洛尤单抗治疗的患者的临床特征、血脂参数、降脂药物使用情况及安全性，该研究为真实世界临床环境下的研究。
我们进行了一项为期 1 年的多中心观察性研究，纳入使用依洛尤单抗治疗的患有动脉粥样硬化性心血管疾病（CVD）或心血管疾病风险高、最大耐受剂量他汀类药物治疗后 LDL-C 仍升高的成年患者。可选电子健康应用程序支持患者管理。主要结局是随时间变化的血脂参数变化。次要结局包括依洛尤单抗的安全性。
在 100 名参与者中，81%有既往 CVD，71%自述他汀类药物相关肌肉症状，44%接受他汀类药物治疗。所有患者均接受依洛尤单抗治疗，65%患者基线时为 PCSK9i 预处理。PCSK9i 初治患者在依洛尤单抗治疗 3 个月内 LDL-C 降低 60%，此后保持稳定；74%患者在观察期间至少有一次 LDL-C<1.8mmol/L，69%患者 LDL-C<1.4mmol/L。在 PCSK9i 预处理患者中，LDL-C 始终保持稳定；79%和 74%患者至少有一次 LDL-C<1.8mmol/L 和<1.4mmol/L。依洛尤单抗、他汀类药物和/或依折麦布联合使用时，达标率更高。总体而言，89%患者报告了依洛尤单抗的完全依从性。30%的患者报告了治疗中出现的不良事件（TEAE），1 名患者发生 2 例严重 TEAE；3 名患者因 TEAE 停止使用依洛尤单抗。
在真实世界临床实践中，依洛尤单抗主要用于他汀类药物不耐受和既往 CVD 的患者。在该人群中，依洛尤单抗的依从性和 LDL-C 水平在 1 年内保持稳定，与单独使用降脂药物相比，联合使用依洛尤单抗和其他降脂药物可更好地实现 LDL-C 目标。依洛尤单抗的安全性与随机对照试验中记录的安全性相似。
