在患有慢性病的患者中使用Inclisiran:对三项第三期试验的后期聚合分析
Ulf Landmesser1, Kausik K Ray2, Frederick J Raal3
1Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité; Charité-Universitätsmedizin Berlin; Berlin Institute of Health, DZHK, Partner Site Berlin, Friede Springer Cardiovascular Prevention Center at Charité, Berlin, Germany.
Journal of the American Society of Nephrology : JASN
|January 28, 2026
概括
在患有动脉样硬化心血管疾病和慢性病的患者中,Inclisiran有效降低了LDL胆固醇. 这种治疗在所有估计的淋巴细胞过率 (eGFR) 水平上显示了持续的疗效和有利的安全性.
科学领域:
- 心血管医学 心血管医学
- 腎臟病學 (nephrology) 是一種醫學專業.
- 药理学 药理学是指药理学的学科.
背景情况:
- 降低低密度脂蛋白胆固醇 (LDL胆固醇) 对于降低慢性脏病 (CKD) 患者动脉样硬化心血管疾病 (ASCVD) 风险至关重要.
- 在患有和没有慢性病的患者中,通过对三项第三期试验的后期分析,评估了inclisiran的疗效和安全性.
研究的目的:
- 研究inclisiran在降低不同程度功能患者的LDL胆固醇中的有效性和安全性.
- 为了评估inclisiran在不同基线估计膜过率 (eGFR) 层中的有效性.
主要方法:
- 对三项第三期试验 (ORION-9, -10, -11) 的综合分析,这些试验涉及异构性家族性高胆固醇血症或ASCVD风险的患者.
- 患者接受了皮下安克利西兰或安慰剂,根据基线EGFR (≥90,60-89,45-59和15-44毫升/分钟/1.73米2) 的分层.
- 同主终点包括在510日LDL胆固醇的百分比变化和从90日到540日的时间调整百分比变化;安全性也被评估.
主要成果:
- 在510日 (范围:-44.7%至-54.7%) 和90日至540日 (范围:-48.4%至-55.6%) 的所有EGFR组中,Inclisiran显示出显著的安慰剂校正的LDL胆固醇降低.
- 在所有EGFR组中观察到总胆固醇,阿波利波蛋白B,非高密度脂蛋白胆固醇和脂蛋白 (a) 的显著降低.
- 英克利西兰耐受性良好,在整个研究群体中没有发现新的安全问题.
结论:
- 在患有ASCVD风险的患者中,Inclisiran可持续有效地降低LDL胆固醇,无论其基线功能如何,包括那些低至15mL/min/1.73m2.2的eGFR患者.
- 在所有评估的eGFR水平上,inclisiran的安全概况保持一致,支持其在患有CKD的患者中使用.
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