Servicio de Nefrología, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Servicio de Nefrología, Hospital Universitario de La Princesa, Madrid, Spain.
Nefrologia (Engl Ed). 2022 May-Jun;42(3):301-310. doi: 10.1016/j.nefroe.2022.05.005. Epub 2022 Jun 7.
To describe the clinical characteristics, the reasons for initiating therapy and the effects of treatment in the initial phase of evolocumab availability in the Nephrology Units of Spain.
Retrospective, observational and multicentric study that included patients initiating treatment with evolocumab (from February 2016 to August 2018), in 15 Nephrology Units in Spain. The demographic and clinical characteristics of the patients, the lipid lowering treatment and the evolution of the lipid profiles between 24 weeks pre-initiation and 12±4 weeks post-initiation of evolocumab were reviewed.
60 patients were enrolled: 53.3% women; mean (SD) age, 56.9 (12.8) years, 45.0% with familial hypercholesterolemia (FH) (5.0% homozygous and 40.0% heterozygous) and 65.0% with atherosclerotic cardiovascular disease. The mean (SD) eGFR was 62.6 (30.0) ml/min/1.73m (51.7% of patients had eGFR <60ml/min/1.73m [CKD stage>2]), 50.0% had proteinuria (>300mg/g) and 10.0% had nephrotic syndrome. Other CV risk factors were hypertension (75.0%), diabetes (25.0%), and smoking (21.7%). A 40.0% of patients were statin intolerant. At evolocumab initiation, 41.7% of patients were on a high intensity statin, 18.3% on moderate intensity statin and 50.0% were receiving ezetimibe. Mean (SD) LDL-c at evolocumab initiation was 179.7 (62.9) mg/dL (53.4% of patients with LDL-c ≥160mg/dL and 29.3% ≥190mg/dL). After 12 weeks, evolocumab resulted in LDL-c reductions of 60.1%. At week 12, 90.0% of patients reached LDL-c levels <100mg/dL, 70.0% <70mg/dL, and 55.0% <55mg/dL, while mean eGFR levels and statin use remained stable.
In Nephrology Units of Spain, evolocumab was predominantly prescribed in patients with FH, chronic renal disease (CRD>2) and secondary prevention, with LDL-c levels above those recommended by the guidelines. Evolocumab used in clinical practice significantly reduced the LDL-c levels in all patients included in the study.
描述在西班牙肾病科中,依洛尤单抗(Evolocumab)开始供应后的初始阶段的临床特征、起始治疗的原因和治疗效果。
这是一项回顾性、观察性和多中心研究,纳入了自 2016 年 2 月至 2018 年 8 月期间在西班牙 15 个肾病科开始接受依洛尤单抗治疗的患者。研究回顾了患者的人口统计学和临床特征、降脂治疗以及起始依洛尤单抗治疗前 24 周和治疗后 12±4 周的血脂谱变化。
共纳入 60 例患者:女性占 53.3%;平均(标准差)年龄为 56.9(12.8)岁,45.0%患有家族性高胆固醇血症(FH)(5.0%为纯合子,40.0%为杂合子),65.0%患有动脉粥样硬化性心血管疾病。平均(标准差)肾小球滤过率(eGFR)为 62.6(30.0)ml/min/1.73m(51.7%的患者 eGFR<60ml/min/1.73m[CKD 分期>2]),50.0%有蛋白尿(>300mg/g),10.0%有肾病综合征。其他心血管风险因素包括高血压(75.0%)、糖尿病(25.0%)和吸烟(21.7%)。40.0%的患者对他汀类药物不耐受。在起始依洛尤单抗治疗时,41.7%的患者使用高强度他汀类药物,18.3%使用中强度他汀类药物,50.0%使用依折麦布。起始依洛尤单抗时,平均(标准差)LDL-c 为 179.7(62.9)mg/dL(53.4%的患者 LDL-c≥160mg/dL,29.3%≥190mg/dL)。12 周后,依洛尤单抗使 LDL-c 降低了 60.1%。在第 12 周时,90.0%的患者达到 LDL-c<100mg/dL,70.0%达到 LDL-c<70mg/dL,55.0%达到 LDL-c<55mg/dL,而平均 eGFR 水平和他汀类药物的使用保持稳定。
在西班牙的肾病科中,依洛尤单抗主要用于 FH、慢性肾脏病(CKD>2)和二级预防的患者,其 LDL-c 水平高于指南推荐的水平。在临床实践中使用依洛尤单抗可显著降低研究中所有患者的 LDL-c 水平。