Bashir Bilal, Haslam Shonagh, Ahmad Shaheer, Elnaggar Mohamed N, Allcock Rebecca, Ali Sadaf, Kyi Nyan M, Salazar Lorelei, Gbegbaje Angela, Banerjee Moulinath
Endocrinology, Diabetes and Specialist Weight Management, Royal Bolton Hospital, Bolton, GBR.
Clinical Biochemistry, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, GBR.
Cureus. 2022 Dec 28;14(12):e33044. doi: 10.7759/cureus.33044. eCollection 2022 Dec.
Background and Aims Protein convertase subtilisin/Kexin type 9 monoclonal antibodies (PCSK9mab) are a novel addition to the therapeutic options for managing hyperlipidemia. Various guidelines have advocated the addition of these agents if the target low-density lipoprotein-cholesterol ( LDL-C) is not achieved by maximum lipid-lowering therapy. They have shown a robust and consistent reduction in LDL-C in clinical trials. However, the translation of these results in a real-world setting is limited and confined mainly to tertiary lipid centers. This service evaluation aimed to assess their efficacy in a real-world outpatient setting of secondary care centers. Methods Data was collected retrospectively from four hospitals in the North-West of England. Patients were required to attend a lipid clinic for follow-up investigations to continue with the prescription of PCSK9mab. Results A total of 175 patients were identified. Efficacy outcomes were measured in 169 patients. 6 discontinued the agent within 3 months of initiation and were excluded from the efficacy outcomes. 19.5% (n=33) had confirmed familial hypercholesterolemia. 61% (n=103) of the patients were intolerant to statins. 53.2% (n=90) of the patients have been prescribed Alirocumab. Mean LDL-C reduction was 50.6% at 6-month which was sustained at 48.9% at 12 months. There was no difference in % reduction of LDL-C between Alirocumab and Evolocumab. LDL-C reduction was more significant in patients who were on concomitant statins. 9.1% of patients experienced side effects, and 5.1% discontinued the PCSK9mab during treatment. Conclusion The efficacy of lipid reduction and the side effect profile of PCSK9mab from these secondary care services are similar to randomized clinical trials and real-world observational studies from tertiary lipid centers.
背景与目的 蛋白转化酶枯草杆菌蛋白酶/克新9型单克隆抗体（PCSK9单克隆抗体）是治疗高脂血症的新型药物。各种指南都提倡，如果最大降脂治疗未达到目标低密度脂蛋白胆固醇（LDL-C）水平，则加用这些药物。它们在临床试验中已显示出对LDL-C有显著且持续的降低作用。然而，这些结果在现实环境中的转化应用有限，主要局限于三级脂质中心。本服务评估旨在评估其在二级医疗中心现实门诊环境中的疗效。方法 回顾性收集英格兰西北部四家医院的数据。患者需到脂质门诊进行随访检查，以便继续使用PCSK9单克隆抗体治疗。结果 共确定了175例患者。对169例患者进行了疗效评估。6例在开始治疗的3个月内停用该药物，被排除在疗效评估之外。19.5%（n = 33）确诊为家族性高胆固醇血症。61%（n = 103）的患者对他汀类药物不耐受。53.2%（n = 90）的患者已使用阿利西尤单抗。6个月时LDL-C平均降低50.6%，12个月时维持在48.9%。阿利西尤单抗和依洛尤单抗在LDL-C降低百分比方面无差异。联合使用他汀类药物的患者LDL-C降低更显著。9.1%的患者出现副作用，5.1%的患者在治疗期间停用了PCSK9单克隆抗体。结论 这些二级医疗服务中PCSK9单克隆抗体的降脂疗效和副作用情况与三级脂质中心的随机临床试验及现实观察性研究相似。
