Internal Medicine Department, University Hospital October 12, i+12 Institute, Madrid, Spain; Department of Medicine, Complutense University of Madrid, Madrid, Spain.
Internal Medicine Department, Prince of Asturias University Hospital, Madrid, Spain.
Clin Investig Arterioscler. 2023 Nov-Dec;35(6):263-271. doi: 10.1016/j.arteri.2023.04.004. Epub 2023 May 24.
AIMS: Limited data exist on low-density lipoprotein-cholesterol (LDL-C) level variability or long-term persistence with the monoclonal antibody evolocumab in routine clinical practice. HEYMANS (NCT02770131) is the first multi-country, multicenter, observational study of European patients initiating evolocumab as part of their routine clinical management, based on local reimbursement criteria (overall data recently published). The aim of this analysis is to describe clinical characteristics, baseline and changes in LDL-C levels, treatment patterns and persistence to evolocumab over 30 months in the Spanish cohort using data from the HEYMANS Registry. METHODS: HEYMANS was a prospective study of adult patients (≥18 years) who received at least one dose of evolocumab. A total of 1951 patients were enrolled from 12 countries and were followed up for 30 months after evolocumab initiation. Data were collected for 6 months before evolocumab initiation and up to 30 months thereafter. The Spanish cohort included patients who started evolocumab in routine clinical practice from March 2016 to September 2019. Demographic and clinical characteristics, lipid-lowering therapies (LLT), and lipid levels were collected. RESULTS: In total, 201 patients were included in the Spanish cohort. Median follow-up (Q1-Q3) was 30.0 (12-30) months. A total of 61.7% of patients were men and the mean (standard deviation) age was 59.5 (10.8) years. Most patients (68.7%) had experienced a prior cardiovascular event, 45.3% had coronary artery disease or stable angina, and 60.2% had a diagnosis of familial hypercholesterolemia. Overall, 57.7% of patients were receiving treatment with statins, most of them with high-intensity statins (85.3%); 45.8% of patients were intolerant to statins, and 26.4% of patients did not receive any LLT. At baseline, median (Q1-Q3) LDL-C levels were 151 (123-197) mg/dL. After 3 months of treatment, baseline LDL-C decreased by 66% to a median of 50 (30-83) mg/dL and these levels were maintained over time, with a median LDL-C of 55 (40-99) mg/dL at 30 months. At months 10-12 of treatment, LDL-C levels<55mg/dL were achieved by 56.3% of patients. LDL-C levels<70mg/dL were achieved by 70.1% of patients, and a lowering of LDL-C levels ≥50% was achieved by 76.8% of patients. The percentage of patients on evolocumab treatment was 95% at 12 months and 93% at 30 months. CONCLUSIONS: In the Spanish cohort in routine clinical practice, evolocumab therapy provided a reduction in LDL-C levels consistent with that reported in previous clinical trials, which was sustained during 30 months of follow-up. Treatment with evolocumab was started at LDL-C levels 50% higher than those recommended by The Spanish Society of Arteriosclerosis and the Therapeutic Positioning Report. The probability of achieving the 2019 ESC/EAS LDL-C goals would improve with combination therapy and also with a lower LDL-C threshold when starting evolocumab. Persistence to evolocumab remained high during follow-up, with a very low percentage of discontinuation (5% at 12 months; 7% at 30 months).
目的：在常规临床实践中，关于低密度脂蛋白胆固醇（LDL-C）水平变化或长期持续存在的单克隆抗体依洛尤单抗的数据有限。HEYMANS（NCT02770131）是第一项针对接受依洛尤单抗作为常规临床管理一部分的欧洲患者的多国、多中心观察性研究，该研究基于当地报销标准（最近发表的总体数据）。本分析的目的是使用 HEYMANS 登记处的数据描述西班牙队列的临床特征、基线和 LDL-C 水平变化、治疗模式以及依洛尤单抗治疗的持久性，随访时间为 30 个月。
方法：HEYMANS 是一项针对至少接受一剂依洛尤单抗的成年患者（≥18 岁）的前瞻性研究。共纳入来自 12 个国家的 1951 例患者，在依洛尤单抗起始后随访 30 个月。在开始依洛尤单抗治疗前收集 6 个月的数据，并在之后随访 30 个月。西班牙队列包括 2016 年 3 月至 2019 年 9 月在常规临床实践中开始接受依洛尤单抗治疗的患者。收集人口统计学和临床特征、降脂治疗（LLT）和血脂水平的数据。
结果：西班牙队列共纳入 201 例患者。中位（Q1-Q3）随访时间为 30.0（12-30）个月。61.7%的患者为男性，平均（标准差）年龄为 59.5（10.8）岁。大多数患者（68.7%）有既往心血管事件，45.3%有冠状动脉疾病或稳定型心绞痛，60.2%有家族性高胆固醇血症的诊断。总体而言，57.7%的患者接受他汀类药物治疗，其中大多数为高强度他汀类药物（85.3%）；45.8%的患者不耐受他汀类药物，26.4%的患者未接受任何 LLT。基线时，中位（Q1-Q3）LDL-C 水平为 151（123-197）mg/dL。治疗 3 个月后，LDL-C 降低 66%，中位数为 50（30-83）mg/dL，并且随着时间的推移保持稳定，30 个月时中位数 LDL-C 为 55（40-99）mg/dL。在治疗的第 10-12 个月，56.3%的患者 LDL-C 水平<55mg/dL。70.1%的患者 LDL-C 水平<70mg/dL，76.8%的患者 LDL-C 水平降低≥50%。治疗 12 个月时，依洛尤单抗治疗患者的百分比为 95%，30 个月时为 93%。
结论：在常规临床实践中的西班牙队列中，依洛尤单抗治疗可降低 LDL-C 水平，与之前临床试验报告的结果一致，且在 30 个月的随访期间保持稳定。依洛尤单抗治疗开始时的 LDL-C 水平比动脉粥样硬化学会和治疗定位报告建议的水平高 50%。与单独使用依洛尤单抗相比，联合治疗和降低开始依洛尤单抗的 LDL-C 阈值可提高 2019 年 ESC/EAS LDL-C 目标的达标率。在随访期间，依洛尤单抗的治疗持续率保持较高水平，停药率非常低（治疗 12 个月时为 5%；治疗 30 个月时为 7%）。
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