Servicio de Medicina Interna, Hospital Universitario Sant Joan, IISPV, CIBERDEM, Reus, Tarragona, España.
Servicio de Medicina Interna, Hospital Universitario Reina Sofía, IMIBIC, Universidad de Córdoba, CIBEROBN, Córdoba, España.
Clin Investig Arterioscler. 2020 Sep-Oct;32(5):183-192. doi: 10.1016/j.arteri.2020.02.003. Epub 2020 Apr 18.
To describe the clinical characteristics, the reasons for initiating therapy, and the effects of treatment in the initial phase of evolocumab availability in lipid/internal medicine units in Spain.
Retrospective, observational study, based on the medical records of consecutive patients initiating treatment with evolocumab (from February 2016 to July 2017) in 20 internal medicine units in Spain. A review was made of the demographic and clinical characteristics of the patients, the lipid lowering treatment, and the evolution of the lipid profiles between 12weeks pre-initiation and 12±4weeks post-initiation of evolocumab.
A total of 136 patients were analysed, of whom 64.0% were men, and the mean age (standard deviation, SD) was 56.6 (11.5) years. The large majority (75%) had familial hypercholesterolaemia (4 homozygous), and 51.0% of them had suffered at least one cardiovascular event. Atherosclerotic cardiovascular disease (ASCVD) was present in 61% of all patients. At initiation of evolocumab, 61.0% of the patients were taking high-intensity statins, and 60.3% were receiving ezetimibe. The mean (and SD) of LDL-C levels at initiation of evolocumab was 169.1 (56.6) mg/dL. The LDL-C was greater than 160mg/dL in 46.4% of patients, and ≥190mg/dL in 26.5%. During the observation period, evolocumab produced significant reductions in LDL-C of 55.7% (P<.0001), achieving mean values of 74.3mg/dL. At week12, more than half (53.8%) of patients achieved LDL-C levels <70mg/dL, and 26.9% <50mg/dL.
In the lipid/internal medicine units, evolocumab was mainly prescribed in patients with familial hypercholesterolaemia, with or without ASCVD. The initial use of evolocumab was in accordance with the guidelines of the Spanish Society of Arteriosclerosis (SEA) of 2016, with LDL-C levels being well above the recommended thresholds for treatment initiation. Evolocumab treatment in clinical practice reduced LDL-C levels by about 55%, a similar reduction to that reported in clinical trials. Most patients achieved LDL-C goals.
描述在西班牙的脂类/内科单位中，依洛尤单抗可及性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、观察性研究，基于 2016 年 2 月至 2017 年 7 月期间西班牙 20 个内科单位中连续起始依洛尤单抗治疗的患者的病历。对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前 12 周和起始后 12±4 周期间血脂谱的变化进行了回顾。
共分析了 136 例患者，其中 64.0%为男性，平均（标准差）年龄为 56.6（11.5）岁。绝大多数（75%）患者有家族性高胆固醇血症（4 例纯合子），51.0%的患者至少发生过一次心血管事件。所有患者中有 61%存在动脉粥样硬化性心血管疾病（ASCVD）。起始依洛尤单抗治疗时，61.0%的患者正在服用高强度他汀类药物，60.3%的患者正在服用依折麦布。起始依洛尤单抗时 LDL-C 的平均值（标准差）为 169.1（56.6）mg/dL。46.4%的患者 LDL-C 大于 160mg/dL，26.5%的患者 LDL-C 大于 190mg/dL。在观察期间，依洛尤单抗使 LDL-C 显著降低了 55.7%（P<.0001），达到 74.3mg/dL 的平均水平。在第 12 周时，超过一半（53.8%）的患者 LDL-C 水平<70mg/dL，26.9%<50mg/dL。
在脂类/内科单位中，依洛尤单抗主要用于有或无 ASCVD 的家族性高胆固醇血症患者。依洛尤单抗的初始使用符合 2016 年西班牙动脉粥样硬化学会（SEA）指南，LDL-C 水平远高于治疗起始的推荐阈值。依洛尤单抗在临床实践中的治疗降低了约 55%的 LDL-C 水平，与临床试验报告的结果相似。大多数患者达到了 LDL-C 目标。
