Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Uppsala Clinical Research Centre, Uppsala, Sweden.
Ups J Med Sci. 2024 Jan 31;129. doi: 10.48101/ujms.v129.9618. eCollection 2024.
BACKGROUND: Treatment with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors reduces low-density lipoprotein cholesterol (LDL-C) levels and decreases the incidence of major ischaemic events in clinical trials. However, less is known about the efficacy of PCSK9 inhibition in clinical practice. This study aimed to describe the change in LDL-C levels over time and LDL-C goal achievement in patients with/without atherosclerotic cardiovascular disease (ASCVD), who were prescribed evolocumab in clinical practice, and to describe adherence to and persistence with treatment. METHODS: Patients in Sweden with at least one evolocumab prescription filled between July 2015 and May 2020 were included. Medical history and lipid-lowering therapy (LLT) were sourced from national registries. LDL-C levels before and after treatment initiation were assessed using medical records. Persistence with and adherence to evolocumab and oral LLT were assessed up to 12 months after treatment initiation using the refill-gap method and proportion of days covered, respectively. RESULTS: Of the 2,360 patients with at least one prescription for evolocumab, 2,341 were included; 1,858 had ASCVD. Persistence with (76%) and adherence to (86%) evolocumab were high throughout the 12 months following initiation. Mean LDL-C levels decreased by 53% (95% confidence interval [CI]: 51-55%) in patients adherent to evolocumab ( = 567) and 59% (95% CI: 55-63%) in patients adherent to evolocumab and oral LLT ( = 186). Similar reductions in LDL-C were observed in patients with/without ASCVD. Reduced LDL-C levels remained stable during follow-up. Amongst patients adherent to evolocumab and those adherent to evolocumab and oral LLT, 23 and 55% achieved the LDL-C goal of <1.4 mmol/L, respectively. CONCLUSIONS: The evolocumab LDL-C-lowering effect observed in clinical trials was confirmed in clinical practice in Sweden, particularly in patients also treated with oral LLT. During follow-up, adherence to and persistence with evolocumab were high, with stable reduced levels of LDL-C during observation.
背景：在临床试验中，使用前蛋白转化酶枯草溶菌素 9（PCSK9）抑制剂治疗可降低低密度脂蛋白胆固醇（LDL-C）水平并降低主要缺血性事件的发生率。然而，对于 PCSK9 抑制在临床实践中的疗效知之甚少。本研究旨在描述在接受依洛尤单抗治疗的有/无动脉粥样硬化性心血管疾病（ASCVD）的患者中，随着时间的推移 LDL-C 水平的变化以及 LDL-C 目标的实现，并描述治疗的依从性和持久性。
方法：纳入 2015 年 7 月至 2020 年 5 月期间至少有一次依洛尤单抗处方的瑞典患者。病史和降脂治疗（LLT）信息来源于国家登记处。使用病历评估治疗前和治疗开始后的 LDL-C 水平。使用再填充缺口法和比例覆盖天数分别评估治疗开始后 12 个月内依洛尤单抗和口服 LLT 的依从性和持久性。
结果：在至少有一次依洛尤单抗处方的 2360 名患者中，有 2341 名患者纳入研究；1858 名患者有 ASCVD。在开始治疗后 12 个月内，依洛尤单抗的依从性（76%）和依洛尤单抗和口服 LLT 的依从性（86%）均很高。在依洛尤单抗依从性良好的患者中（n=567），LDL-C 水平平均降低 53%（95%置信区间 [CI]：51-55%），在依洛尤单抗和口服 LLT 依从性良好的患者中（n=186），LDL-C 水平平均降低 59%（95% CI：55-63%）。在有/无 ASCVD 的患者中观察到类似的 LDL-C 降低。在随访期间，LDL-C 水平保持稳定。在依洛尤单抗依从性良好的患者和依洛尤单抗和口服 LLT 依从性良好的患者中，分别有 23%和 55%达到了 LDL-C 目标<1.4mmol/L。
结论：在瑞典的临床实践中，依洛尤单抗降低 LDL-C 的效果与临床试验一致，特别是在同时接受口服 LLT 治疗的患者中。在随访期间，依洛尤单抗的依从性和持久性较高，观察期间 LDL-C 水平稳定降低。
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