tags更新基于iii期b期DIALIZE试验的数据
The Committee for Medicinal Products for Human Use (CHMP) of the European 药物 Agency (EMA) has adopted a positive opinion on a dosing and administration label update for 澳门在线赌城娱乐’s Lokelma (sodium zirconium cyclosilicate) to include patients with hyperkalaemia on stable haemodialysis.
The recommendation was based on data from the Phase IIIb DIALIZE trial, which showed a significant reduction in potassium levels pre-dialysis for patients receiving Lokelma，与安慰剂相比.1
Mene Pangalos，澳门第一赌城在线娱乐R的执行副总裁&D, 他说:“尽管我在做透析, 许多肾脏疾病患者仍然有高钾水平, 如果不及时治疗，可能会危及生命. 这一建议强调了临床价值 Lokelma could provide to physicians and patients who are looking to normalise potassium levels between dialysis sessions.”
在DIALIZE, 41%的患者接受 Lokelma maintained pre-dialysis potassium levels on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy. 这个和1比较.0%的患者接受安慰剂, making it a statistically significant and clinically meaningful improvement. 的安全概况 Lokelma 在DIALIZE中观察到的结果与之前的试验一致.1
Lokelma 是高度选择性的, 目前在美国被批准的口服除钾剂, EU, 加拿大, 中国, 俄罗斯和日本用于治疗高钾血症.
高钾血症
高钾血症 is characterised by high levels of potassium in the blood, 一般分类为大于5mmol/l.2 Many people living with chronic kidney disease (CKD) have hyperkalaemia despite being on haemodialysis and often experience fluctuations in their potassium levels.3,4 Patients with high variability in potassium levels between dialysis sessions are at significant risk of arrhythmias which can lead to cardiac arrest.3 高钾血症 occurs in 23% to 47% of patients with CKD and/or heart failure with an estimated 700 million and 64 million people, 分别, 生活在世界各地.5,6
DIALIZE
DIALIZE是第一个随机试验, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis. The Phase IIIb, multicentre, double-blinded trial investigated the efficacy of Lokelma versus placebo in 196 patients on haemodialysis with hyperkalaemia. 患者随机接受治疗 Lokelma or placebo once daily on non-dialysis days for a treatment period of eight weeks. This included a four-week dose adjustment phase (starting at 5g and titrated weekly in 5g increments up to a maximum of 15g) and a four-week evaluation phase on stable dose.
The full results of the DIALIZE trial were published in September 2019 in the 美国肾脏病学会杂志.
Lokelma
Lokelma 是不可溶的, 不吸收的硅酸锆钠, 配制成粉末用于口服悬浮液, 这是一种高选择性的除钾药物. It is administered orally, is odourless, tasteless and stable at room temperature. 它已经在三个双盲实验中进行了研究, placebo-controlled trials and in one 12-month open label clinical trial in patients with hyperkalaemia.
澳门在线赌城娱乐在crvrm
心血管，肾脏和代谢 (CVRM) together forms one of 澳门在线赌城娱乐’s three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, 肾脏和胰腺, 澳门在线赌城娱乐 is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, 减少风险和处理合并症. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
澳门在线赌城娱乐
澳门在线赌城娱乐(LSE/STO/NYSE: AZN)是一家全球性制药公司, science-led biopharmaceutical company that focuses on the discovery, 处方药的开发和商业化, primarily for the treatment of diseases in three therapy areas - 肿瘤学, 心血管，肾脏和代谢, 和呼吸. 总部设在剑桥, UK, 澳门在线赌城娱乐 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在推特上关注公司 @澳门在线赌城娱乐.
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参考文献
1. Fishbane S等人. A期3b, 随机, 双盲, Placebo-Controlled Study of Sodium Zirconium Cyclosilicate for Reducing the Incidence of Predialysis Hyperkalemia. 我是Soc Nephrol 2019.
2. Kovesdy CP. 慢性肾病患者高钾血症的处理. Nat Rev Nephrol. Nov 2014; 10:653-662.
3. Kovesdy CP. 等. Serum and Dialysate Potassium Concentrations and Survival in Hemodialysis Patients. 临床J . Soc . Nephrol. 2007:2:999-1007.
4. Evans KJ, Greenberg A. 高钾血症:综述. J重症监护医学. 2005;20:272-290.
5. Vos T等. 全球, 区域, 全国发病率, 患病率, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the 全球 Burden of Disease Study 2016. 《澳门在线赌城娱乐》 2017; 390(10100):1211–59.
6. James SL等. 全球, 区域, 全国发病率, 患病率, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: A systematic analysis for the 全球 Burden of Disease Study 2017. 《澳门在线赌城娱乐》 2018; 392(10159):1789–858.