Please use this identifier to cite or link to this item: https://hdl.handle.net/1/134
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dc.contributor.authorPackham, D.en
dc.contributor.authorRasmussen, H.en
dc.contributor.authorLavin, P.en
dc.contributor.authorEl-Shahawy, M.en
dc.contributor.authorRoger, Simon Den
dc.contributor.authorBlock, G.en
dc.contributor.authorQunibi, Wajeh Yen
dc.contributor.authorPergola, P.en
dc.contributor.authorSingh, B.en
dc.date.accessioned2015-03-30T22:41:17Zen
dc.date.available2015-03-30T22:41:17Zen
dc.date.issued2015-01en
dc.identifier.citationVolume 372, Issue 3, pp. 222-231en
dc.identifier.issn1533-4406en
dc.identifier.urihttps://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/handle/1/134en
dc.descriptionOpen Source: http://www.nejm.org/doi/full/10.1056/NEJMoa1411487en
dc.description.abstractBackground Hyperkalemia (serum potassium level, >5.0 mmol per liter) is associated with in- creased mortality among patients with heart failure, chronic kidney disease, or diabetes. We investigated whether sodium zirconium cyclosilicate (ZS-9), a novel selective cation exchanger, could lower serum potassium levels in patients with hyperkalemia. Methods In this multicenter, two-stage, double-blind, phase 3 trial, we randomly assigned 753 patients with hyperkalemia to receive either ZS-9 (at a dose of 1.25 g, 2.5 g, 5 g, or 10 g) or placebo three times daily for 48 hours. Patients with normokalemia (serum potassium level, 3.5 to 4.9 mmol per liter) at 48 hours were randomly assigned to receive either ZS-9 or placebo once daily on days 3 to 14. The primary end point was the exponential rate of change in the mean serum potassium level at 48 hours. Results At 48 hours, the mean serum potassium level had decreased from 5.3 mmol per liter at baseline to 4.9 mmol per liter in the group of patients who received 2.5 g of ZS-9, 4.8 mmol per liter in the 5-g group, and 4.6 mmol per liter in the 10-g group, for mean reductions of 0.5, 0.5, and 0.7 mmol per liter, respectively (P<0.001 for all comparisons) and to 5.1 mmol per liter in the 1.25-g group and the placebo group (mean reduction, 0.3 mmol per liter). In patients who received 5 g of ZS-9 and those who received 10 g of ZS-9, serum potassium levels were maintained at 4.7 mmol per liter and 4.5 mmol per liter, respectively, during days 3 to 15, as compared with a level of more than 5.0 mmol per liter in the placebo group (P<0.01 for all compari- sons). Rates of adverse events were similar in the ZS-9 group and the placebo group (12.9% and 10.8%, respectively, in the initial phase; 25.1% and 24.5%, respectively, in the maintenance phase). Diarrhea was the most common complication in the two study groups. Conclusions Patients with hyperkalemia who received ZS-9, as compared with those who re- ceived placebo, had a significant reduction in potassium levels at 48 hours, with normokalemia maintained during 12 days of maintenance therapy. (Funded by ZS Pharma; ClinicalTrials.gov number, NCT01737697.)en
dc.subjectKidney Diseaseen
dc.subjectHeart Diseaseen
dc.subjectDiabetesen
dc.subjectDrug Therapyen
dc.titleSodium Zirconium Cyclosilicate in Hyperkalemiaen
dc.typeJournal Articleen
dc.identifier.doi10.1056/NEJMoa1411487en
dc.description.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/25415807/en
dc.identifier.journaltitleNew England Journal of Medicineen
dc.type.studyortrialDouble-Blind Methoden
dc.originaltypeTexten
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairetypeJournal Article-
item.cerifentitytypePublications-
Appears in Collections:Renal Medicine
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