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Sodium Zirconium Cyclosilicate: A Review in Hyperkalaemia

机译:硅酸锆锆钠:高钾血症的回顾

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摘要

Sodium zirconium cyclosilicate (Lokelma™) [hereafter referred to as SZC] is a non-absorbed, non-polymer zirconium silicate compound that preferentially exchanges hydrogen and sodium for potassium and ammonium ions in the gastrointestinal tract (GIT), thereby increasing faecal potassium excretion and lowering serum potassium levels. It is available as a powder for oral suspension (in water) and is approved in the EU and the USA for the treatment of hyperkalaemia in adults. In two multinational, phase III studies in adults with hyperkalaemia, SZC 10 g three times daily lowered serum potassium levels to within the normal range (3.5–5.0 mmol/L) during the first 48 h of treatment, and SZC 5 and 10 g once daily maintained normokalaemia over ≤ 28 days’ therapy. These beneficial effects were consistent across all patient subgroups (e.g. chronic kidney disease, diabetes, heart failure, concomitant use of RAAS inhibitor therapy), and appeared to be maintained over the longer term (≤ 12 months). SZC was generally well tolerated in adults with hyperkalaemia. Its tolerability profile was generally similar to that seen with placebo over ≤ 28 day, and its safety profile appeared to remain consistent over the longer term (≤ 12 months). Moreover, the incidence of hypokalemia was low. Current evidence indicates that SZC is a promising therapy for the management of hyperkalaemia in adults.
机译:环硅酸锆钠(Lokelma™)[以下简称SZC]是一种非吸收性的,非聚合的硅酸锆化合物,可优先将氢和钠交换为胃肠道(GIT)中的钾和铵离子,从而增加粪便中钾的排泄量。并降低血清钾水平。它以口服混悬剂(在水中)的粉末形式提供,并已在欧盟和美国批准用于成人高钾血症的治疗。在两项针对高钾血症成人的多国III期研究中,在治疗的前48小时内,每日3次SZC 10 g将血清钾水平降低至正常范围(3.5-5.0 mmol / L),一次SZC 5和10 g治疗后28天内每日维持正常血钾水平。这些有益作用在所有患者亚组中都是一致的(例如,慢性肾脏疾病,糖尿病,心力衰竭,同时使用RAAS抑制剂治疗),并且似乎可以长期维持(≤12个月)。成人高血钾症患者普遍对SZC耐受良好。它的耐受性一般与安慰剂超过≤28天时所观察到的相似,并且其安全性在长期(≤12个月)中似乎保持一致。此外,低血钾的发生率很低。目前的证据表明,SZC是治疗成人高钾血症的有前途的疗法。

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