3rd Department of Internal Medicine - Metabolic Care and Gerontology, University Hospital Hradec Kralove and Charles University, Hradec Kralove, Czech Republic.
Department of General Cardiology, Middle Slovak Institute of Cardiovascular Diseases, Banska Bystrica, Slovakia.
J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231172847. doi: 10.1177/10742484231172847.
We examined clinical characteristics and low-density lipoprotein cholesterol (LDL-C) lowering in patients initiating evolocumab in real-world practice in a Central and Eastern European (CEE) cohort from the pan-European HEYMANS study. Patients from Bulgaria, Czech Republic, and Slovakia were enrolled at initiation of evolocumab (baseline) as per local reimbursement criteria. Demographic/clinical characteristics, lipid-lowering therapy (LLT) and lipid values were collected from medical records for ≤6 months before baseline and ≤30 months after evolocumab initiation. Overall, 333 patients were followed over a mean (SD) duration of 25.1 (7.5) months. At initiation of evolocumab, LDL-C levels were markedly elevated in all three countries, with a median (Q1, Q3) LDL-C of 5.2 (4.0, 6.6) mmol/L in Bulgaria, 4.5 (3.8, 5.8) mmol/L in the Czech Republic, and 4.7 (4.0, 5.6) mmol/L in Slovakia. Within the first three months of evolocumab treatment, LDL-C levels were reduced by a median of 61% in Bulgaria, 64% in the Czech Republic, and 53% in Slovakia. LDL-C levels remained low throughout the remaining period of observation. The 2019 ESC/EAS guideline-recommended risk-based LDL-C goals were attained by 46% of patients in Bulgaria, 59% in the Czech Republic, and 43% of patients in Slovakia. LDL-C goal attainment was higher in patients receiving a statin ± ezetimibe-based background therapy (Bulgaria: 55%, Czech Republic: 71%, Slovakia: 51%) compared to those receiving evolocumab alone (Bulgaria: 19%, Czech Republic: 49%, Slovakia: 34%). In the HEYMANS CEE cohort, patients initiated on evolocumab had baseline LDL-C levels approximately three-fold higher than guideline-recommended thresholds for PCSK9i initiation. Risk-based LDL-C goal attainment was highest in patients receiving high-intensity combination therapy. Lowering the LDL-C reimbursement threshold for PCSK9i initiation would allow more patients to receive combination therapy, thus improving LDL-C goal attainment. ClinicalTrials.gov (NCT02770131; registration date: 27 April 2016).
我们在 HEYMANS 研究的中欧和东欧（CEE）队列中，检查了接受依洛尤单抗治疗的患者的临床特征和低密度脂蛋白胆固醇（LDL-C）降低情况，这是在真实世界环境下进行的。 保加利亚、捷克共和国和斯洛伐克的患者根据当地报销标准，在依洛尤单抗起始治疗时（基线）入组。 从基线前≤6 个月和依洛尤单抗起始后≤30 个月收集了病历中的人口统计学/临床特征、降脂治疗（LLT）和血脂值。 总体而言，333 名患者的平均（SD）随访时间为 25.1（7.5）个月。 在依洛尤单抗起始时，所有三个国家的 LDL-C 水平均显著升高，保加利亚的中位（Q1，Q3）LDL-C 为 5.2（4.0，6.6）mmol/L，捷克共和国为 4.5（3.8，5.8）mmol/L，斯洛伐克为 4.7（4.0，5.6）mmol/L。 在依洛尤单抗治疗的头三个月内，保加利亚、捷克共和国和斯洛伐克的 LDL-C 水平分别降低了中位数 61%、64%和 53%。 在观察的剩余时间内，LDL-C 水平保持较低。 2019 年 ESC/EAS 指南推荐的基于风险的 LDL-C 目标在保加利亚的 46%、捷克共和国的 59%和斯洛伐克的 43%的患者中达到。 在接受他汀类药物±依折麦布为基础的背景治疗的患者中（保加利亚：55%，捷克共和国：71%，斯洛伐克：51%），LDL-C 目标的实现高于单独接受依洛尤单抗治疗的患者（保加利亚：19%，捷克共和国：49%，斯洛伐克：34%）。 在 HEYMANS CEE 队列中，起始接受依洛尤单抗治疗的患者的 LDL-C 基线水平比 PCSK9i 起始的指南推荐阈值高约三倍。 在接受高强度联合治疗的患者中，基于风险的 LDL-C 目标的实现率最高。 降低 PCSK9i 起始的 LDL-C 报销阈值将使更多患者接受联合治疗，从而提高 LDL-C 目标的实现率。 ClinicalTrials.gov（NCT02770131；注册日期：2016 年 4 月 27 日）。
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