Clinical Pharmacology Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain; Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Bellaterra, Spain; Clinical Pharmacology Research Group, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain.
Clinical Pharmacology Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain; Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Bellaterra, Spain; Clinical Pharmacology Research Group, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain.
Med Clin (Barc). 2024 Oct 18;163(7):317-322. doi: 10.1016/j.medcli.2024.05.004. Epub 2024 Jul 14.
The criteria for the use of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) more restrictive than those approved were established in Catalonia by the Health System (CatSalut) to improve their efficiency, with different LDL-C values from which to start treatment according to risk factors. The aim of the study is to analyse adherence to these criteria and results.
A retrospective study of patients treated with PCSK9i at Vall d'Hebron University Hospital between 2016 and 2021 was performed using data from the Registry of Patients and Treatments and medical records. The degree of agreement with the CatSalut criteria, LDL-C-responders (decrease ≥30%), cardiovascular events and discontinuations were analysed.
A total of 193 patients treated with PCSK9i were followed for a median of 27 months (IQR 23). The median age was 61 (IQR 15); 62.7% were men. Seventy percent of the patients had non-familial hypercholesterolemia. Treatment was for secondary prevention of cardiovascular disease in 82.4% of cases. The median LDL-C decreased from 139 (IQR 52) to 59 (IQR 45) mg/dL. The percentage of LDL-C reduction was 61.0% (IQR 30). In 72.5% of patients, all CatSalut criteria for starting treatment were met. The rate of responders was 85.4%. During follow-up, 19 patients (9.8%) had a cardiovascular event, and 15 (7.7%) discontinued treatment, in two cases due to toxicity.
PCSK9i were used according to CatSalut criteria in three out of four cases. In this high-risk population, incidence of cardiovascular events was similar to that in clinical trials.
为了提高其效率，加泰罗尼亚卫生系统（CatSalut）制定了比已批准标准更严格的前蛋白转化酶枯草溶菌素/克那霉 9 抑制剂（PCSK9i）使用标准，根据危险因素，不同的 LDL-C 值用于开始治疗。本研究旨在分析这些标准的遵守情况和结果。
采用患者登记和治疗记录以及病历资料，对 2016 年至 2021 年在 Vall d'Hebron 大学医院接受 PCSK9i 治疗的患者进行了回顾性研究。分析了与 CatSalut 标准的符合程度、LDL-C 应答者（降低≥30%）、心血管事件和停药情况。
共对 193 例接受 PCSK9i 治疗的患者进行了随访，中位随访时间为 27 个月（IQR 23）。中位年龄为 61 岁（IQR 15）；62.7%为男性。70%的患者患有非家族性高胆固醇血症。82.4%的病例治疗用于心血管疾病的二级预防。LDL-C 中位数从 139（IQR 52）mg/dL 降至 59（IQR 45）mg/dL。LDL-C 降低率为 61.0%（IQR 30）。在 72.5%的患者中，所有开始治疗的 CatSalut 标准均得到满足。应答率为 85.4%。在随访期间，19 例（9.8%）患者发生心血管事件，15 例（7.7%）患者停药，有两例因毒性而停药。
在四种情况下，有三种情况是根据 CatSalut 标准使用 PCSK9i 的。在这一高危人群中，心血管事件的发生率与临床试验相似。
