阿特拉森坦在患有IgA脏病的患者中
Hiddo J L Heerspink1, Meg Jardine2, Donald E Kohan3
1Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
The New England journal of medicine
|October 26, 2024
概括
阿特拉森坦显著降低了IgA脏病患者的蛋白尿症,为严重脏疾病提供了有前途的治疗方法. 这一发现表明一种潜在的新疗法,可以减缓受影响个体功能衰竭的进展.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 临床药理学 临床药理学
- 免疫学 免疫学 免疫学
背景情况:
- 患有严重蛋白尿症的IgA脏病 (IgAN) 患者面临衰竭的高风险.
- 作为内甲素A型受体对抗剂的阿特拉森坦在降低IgAN蛋白尿的有效性和安全性尚未完全确定.
研究的目的:
- 评估阿特拉森坦在减少成年蛋白尿症中的疗效和安全性,在活检证明的IgA脏病患者中.
- 评估与安慰剂相比,在接受阿特拉森坦治疗的患者中,从基线到第36周的24小时尿蛋白与肌素比率的变化.
主要方法:
- 第三阶段,多国,双盲,随机,受控试验.
- 患有Igan,蛋白尿 ≥1g/天和eGFR ≥30ml/min/1.73m2的成年人接受了atrazentan (0.75mg/天) 或安慰剂,持续了132周.
- 主要结局:通过对270名患者的临时分析分析,在第36周改变了24小时尿蛋白与肌素的比率.
主要成果:
- 与安慰剂相比,阿特拉森坦显示蛋白尿的显著减少 (-38.1% vs -3.1%,P<0.001).
- 经历不良事件的患者的百分比在不同组之间是相似的.
- 在阿特拉森坦组 (11.2%) 留液量略高,但没有导致试验中止;没有发生心力衰竭或严重.
结论:
- 阿特拉森坦在IgA脏病患者中显著且具有临床意义的减少蛋白尿症.
- 这项临时分析支持阿特拉森坦作为一种潜在的治疗选择,用于管理IGAN中的蛋白尿症.
- 这项研究由诺华公司资助,并以ClinicalTrials.gov号NCT04573478.gov注册.
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