达格列净III期DAPA-CKD试验达到所有主要终点和次要终点

2020-07-30 MedSci原创 MedSci原创

声明:这些药品的用法和相关适应症在中国尚未获批,阿斯利康不推荐任何未被批准的药品使用。

2020年7月28日英国——达格列净(安达唐®)III期DAPA-CKD研究的高水平结果显示,在慢性肾脏病患者中,肾功能恶化或死亡风险的主要复合终点(定义为估算的肾小球滤过率eGFR持续下降≥50%,进展为终末期肾脏病血管疾病/肾脏疾病死亡的复合终点)有统计学意义和临床意义效果的降低。研究还在伴或不伴2型糖尿病的慢性肾脏病患者中达到所有次要终点,使达格列净成为第一个显著降低这类患者全因死亡的药物。

慢性肾脏病是一种严重的进行性疾病,定义为肾功能下降,影响全球近7亿人口1,2,其包括很多未被诊断的患者3,4。目前,针对这类患者的治疗手段有限5。慢性肾脏病与患者显著的发病率,以及心血管事件风险的增加息息相关6,例如心力衰竭和过早死亡7

研究的执行委员会联合主席,伦敦大学学院的David Wheeler教授和格罗宁根大学医学中心的Hiddo L. Heerspink教授指出:“DAPA-CKD研究显示了达格列净的潜力,它可能是大家期待已久的慢性肾病患者治疗新选择。这些数据将为这类患者(的治疗)带来革命性的影响。”

研发部执行副总裁Mene Pangalos说:“DAPA-CKD试验是第一个证明(达格列净)在伴或不伴2型糖尿病的慢性肾脏病患者中,具有包括提高生存率在内的相关疗效。我们期待与全世界的科学组织和卫生当局分享这些令人兴奋的结果。”

达格列净的安全性和耐受性与已在临床使用的成熟药物安全性一致。

DAPA-CKD该试验的完整结果将在最近期的一个医学大会进行公布。

2020年3月,阿斯利康宣布:根据独立数据监测委员会(DMC)的建议,基于达格列净对慢性肾脏病患者明确的压倒性疗效,达格列净预防慢性肾脏病患者肾脏不良结局(DAPA-CKD)III期试验已提前终止。

References

1. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney International Supplement 2013; (3):1–150.

2. GBD 2017 Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: asystematic analysis for the Global Burden of Disease Study 2017 Lancet 2018; 392:1789–858.

3. National Kidney Foundation. Kidney Disease: The Basics [cited 07.08.20]. Available from: URL: https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics.

4. Hirst JA et al. Prevalence of chronic kidney disease in the community using data from OxRen: A UK population-based cohort study. Br J Gen Pract 2020; 70(693):e285-e293.

5. Ward F et al. Drug therapies to delay the progression of chronic kidney disease. Clin Med (Lond) 2015; 15(6):550–7

6. Bikbov, Boris, et al. “Global, Regional, and National Burden of Chronic Kidney Disease, 1990–2017: a Systematic Analysis for the Global Burden of Disease Study 2017.” The Lancet, vol. 395, no. 10225, 13 Feb. 2020, pp. 709–733., doi:10.1016/s0140-6736(20)30045-3.

7. Segall L et al. Heart failure in patients with chronic kidney disease: A systematic integrative review. Biomed Res Int 2014; 2014:937398.

8. National Kidney Foundation. Kidney Disease: Causes, 2017; [cited 2020 Jun 25]. Available from URL: https://www.kidney.org/atoz/content/kidneydiscauses

9. Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2019 [cited 01.05.20]. Available from URL: https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html.

10. Briasoulis A, Bakris GL. Chronic Kidney Disease as a Coronary Artery Disease Risk Equivalent. Cur Cardiol Rep 2013; 15(3):340.

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