Lipids and Cardiovascular Risk Service, Department of Cardiology, Imperial College Healthcare NHS Trust, London, UK.
Centre for Bioinformatics, Department of Life Sciences, Imperial College London, London, UK.
Open Heart. 2022 Dec;9(2). doi: 10.1136/openhrt-2022-002184.
The reduction in circulating low-density lipoprotein cholesterol (LDL-c) is the primary aim of lipid-lowering therapies as a method of atherosclerotic cardiovascular disease risk reduction. Inclisiran is a new and potent lipid-lowering drug that is shown to be effective in reducing LDL-c in randomised controlled trials, however, real-world data of its use are not yet known. We sought to analyse the early effects of this drug in a tertiary centre lipid and cardiovascular risk clinic.
We performed a retrospective analysis of the first 80 patients who received a single dose of inclisiran at our lipid clinic between 1 December 2021 and 1 September 2022. Data were collected using electronic healthcare records. Baseline blood tests were taken prior to start of treatment and were repeated at 2 months follow-up. Data on adverse events were also recorded.
At 2 months after treatment initiation, mean baseline LDL-c fell from 3.5±1.1 mmol/L by 48.6% to 1.8±1.0 mmol/L and total cholesterol from 5.7±1.3 mmol/L by 33.3% to 3.8±1.1 mmol/L (both p<0.0001). Mean high-density lipoprotein-c rose by 7.7% to 1.4±0.4 mmol/L (p=0.02) and median triglycerides fell by 31.3% to 1.1 mmol/L (IQR 0.9-2) (p=0.001). Adverse events (injection site reaction, fatigue and headache) were recorded in three patients and all had self-resolved by time of follow-up.
Inclisiran use in line with National Institute for Health and Care Excellence guidelines led to significant lowering of LDL-c at 2 months, with efficacy similar to that reported in trials with good tolerability.
降低循环中的低密度脂蛋白胆固醇(LDL-c)是降脂治疗的主要目标,是降低动脉粥样硬化性心血管疾病风险的方法。依洛尤单抗是一种新型强效降脂药物,随机对照试验显示其可有效降低 LDL-c,但该药的实际应用数据尚不清楚。我们旨在分析该药在一家三级中心血脂和心血管风险门诊的早期效果。
我们对 2021 年 12 月 1 日至 2022 年 9 月 1 日期间在我们的血脂诊所接受单次依洛尤单抗治疗的 80 例患者进行了回顾性分析。数据通过电子医疗记录收集。治疗开始前采集基线血样,在 2 个月随访时重复。还记录了不良事件的数据。
治疗开始后 2 个月,LDL-c 从基线时的 3.5±1.1mmol/L 降低 48.6%至 1.8±1.0mmol/L,总胆固醇从 5.7±1.3mmol/L 降低 33.3%至 3.8±1.1mmol/L(均 p<0.0001)。高密度脂蛋白胆固醇升高 7.7%至 1.4±0.4mmol/L(p=0.02),中位数甘油三酯降低 31.3%至 1.1mmol/L(IQR 0.9-2)(p=0.001)。三名患者出现(注射部位反应、疲劳和头痛)不良事件,所有不良事件在随访时均自行缓解。
依洛尤单抗的使用符合国家卫生与保健卓越研究所指南,在 2 个月时可显著降低 LDL-c,疗效与试验报告结果相似,且具有良好的耐受性。