Ray Kausik K, Dhalwani Nafeesa, Sibartie Mahendra, Bridges Ian, Ebenbichler Christoph, Perrone-Filardi Pasquale, Villa Guillermo, Vogt Anja, Bruckert Eric
Imperial Centre for Cardiovascular Disease Prevention and Imperial Clinical Trials Unit, Imperial College London, Stadium House, 68 Wood Lane, London W12 7RH, UK.
Center for Observational Research, Amgen Ltd, Uxbridge UB8 1DH, UK.
Eur Heart J Qual Care Clin Outcomes. 2022 Jun 6;8(4):447-460. doi: 10.1093/ehjqcco/qcac009.
To describe the characteristics of patients receiving evolocumab in clinical practice across 12 European countries and simulate the association between low-density lipoprotein cholesterol (LDL-C) reduction and cardiovascular (CV) risk reduction.
The characteristics of hyperlipidaemic patients at initiation of evolocumab and treatment patterns study-HEYMANS (n = 1952) is a prospective registry of patients ≥18 years old who initiated evolocumab from 1 August 2015 onwards. Mean (standard deviation) age was 60 (10.8), 85% had a prior CV event, 45% were diagnosed with familial hypercholesterolaemia (FH), and 60% had statin intolerance. At evolocumab initiation, 43% were receiving any statin, 16% were receiving ezetimibe without statin, and 41% received no background lipid-lowering therapy (LLT), with LDL-C levels reflecting local proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) reimbursement criteria. Median LDL-C decreased from 3.98 to 1.63 mmol/L within 3 months of evolocumab initiation and was maintained over 24 months. Overall, 58% achieved risk-based 2019 European Society of Cardiology/European Atherosclerosis Society LDL-C goals but that proportion was higher (68%) in patients receiving background LLT compared with those not receiving background LLT (44%). In patients with atherosclerotic cardiovascular disease without FH, the simulated relative CV risk reduction associated with evolocumab treatment was 34% (25-44%).
Across Europe, LDL-C levels at evolocumab initiation were three times higher than recommended thresholds for PCSK9i initiation, reflecting disparities between implementation and guidelines. More patients attained risk-based LDL-C goals when receiving evolocumab in combination with LLT vs. those not receiving combination therapy. Population health could be improved and LDL-C goals better attained if LDL-C thresholds for PCSK9i reimbursement were lowered, enabling more patients to receive combination therapy when needed.
描述在12个欧洲国家的临床实践中接受依洛尤单抗治疗的患者特征，并模拟低密度脂蛋白胆固醇（LDL-C）降低与心血管（CV）风险降低之间的关联。
依洛尤单抗起始治疗时高脂血症患者的特征及治疗模式研究-海曼斯研究（HEYMANS，n = 1952）是一项前瞻性登记研究，纳入了自2015年8月1日起开始使用依洛尤单抗的18岁及以上患者。平均（标准差）年龄为60（10.8）岁，85%曾发生过心血管事件，45%被诊断为家族性高胆固醇血症（FH），60%对他汀类药物不耐受。在开始使用依洛尤单抗时，43%的患者正在接受任何他汀类药物治疗，16%的患者在未使用他汀类药物的情况下接受依折麦布治疗，41%的患者未接受背景降脂治疗（LLT），其LDL-C水平反映了当地前蛋白转化酶枯草溶菌素/kexin 9型抑制剂（PCSK9i）的报销标准。依洛尤单抗起始治疗后3个月内，LDL-C中位数从3.98 mmol/L降至1.63 mmol/L，并在24个月内维持该水平。总体而言，58%的患者达到了基于风险的2019年欧洲心脏病学会/欧洲动脉粥样硬化学会LDL-C目标，但接受背景LLT的患者这一比例更高（68%），而未接受背景LLT的患者比例为44%。在无FH的动脉粥样硬化性心血管疾病患者中，依洛尤单抗治疗相关的模拟相对CV风险降低为34%（25%-44%）。
在欧洲范围内，开始使用依洛尤单抗时的LDL-C水平比PCSK9i起始治疗的推荐阈值高3倍，这反映了实施情况与指南之间的差异。与未接受联合治疗的患者相比，接受依洛尤单抗联合LLT治疗的患者更多地达到了基于风险的LDL-C目标。如果降低PCSK9i报销的LDL-C阈值，使更多患者在需要时能够接受联合治疗，那么人群健康状况可能会得到改善，LDL-C目标也能更好地实现。
