Efficacy and safety of sodium zirconium cyclosilicate in patients with baseline serum potassium level ≥ 5.5 mmol/L: pooled analysis from two phase 3 trials
| العنوان: | Efficacy and safety of sodium zirconium cyclosilicate in patients with baseline serum potassium level ≥ 5.5 mmol/L: pooled analysis from two phase 3 trials |
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| المؤلفون: | Bhupinder Singh, Alpesh Amin, Jose Menoyo, Christopher S. Kim |
| المصدر: | BMC Nephrology, Vol 20, Iss 1, Pp 1-8 (2019) BMC Nephrology |
| بيانات النشر: | BMC, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Male, medicine.medical_specialty, Hyperkalemia, Efficacy, Potassium, Urology, Administration, Oral, chemistry.chemical_element, lcsh:RC870-923, Double-Blind Method, Internal medicine, Mole, medicine, Humans, In patient, Sodium zirconium cyclosilicate, Adverse effect, Aged, business.industry, Silicates, Middle Aged, lcsh:Diseases of the genitourinary system. Urology, Confidence interval, Treatment Outcome, Pooled analysis, chemistry, Nephrology, Female, Ion Exchange Resins, Drug Monitoring, medicine.symptom, Safety, business, Research Article |
| الوصف: | Background Reliable, timely-onset, oral treatments with an acceptable safety profile for patients with hyperkalemia are needed. We examined the efficacy and safety of sodium zirconium cyclosilicate (SZC; formerly ZS-9) treatment for ≤ 48 h in patients with baseline serum potassium level ≥ 5.5 mmol/L. Methods Data were pooled from two phase 3 studies (ZS-003 and HARMONIZE) among patients receiving SZC 10 g three times daily. Outcomes included mean and absolute change from baseline, median time to potassium level ≤ 5.5 and ≤ 5.0 mmol/L, and proportion achieving potassium level ≤ 5.5 and ≤ 5.0 mmol/L at 4, 24, and 48 h. Outcomes were stratified by baseline potassium. Safety outcomes were evaluated. Results At baseline, 125 of 170 patients (73.5%) had potassium level 5.5– 6.5 mmol/L. Regardless of baseline potassium, mean potassium decreased at 1 h post-initial dose. By 4 and 48 h, 37.5% and 85.0% of patients achieved potassium level ≤ 5.0 mmol/L, respectively. Median (95% confidence interval) times to potassium level ≤ 5.5 and ≤ 5.0 mmol/L were 2.0 (1.1–2.0) and 21.6 (4.1–22.4) h, respectively. Fifteen patients (8.8%) experienced adverse events; none were serious. Conclusions SZC 10 g three times daily achieved serum potassium reduction and normokalemia, with a favorable safety profile. Trial registration ClinicalTrials.gov identifiers: ZS-003: NCT01737697 and HARMONIZE: NCT02088073. |
| اللغة: | English |
| تدمد: | 1471-2369 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::86711259bed02221a593093138bb037a https://doaj.org/article/9c075e8d6007410aa1bf5c98f297d5a2 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....86711259bed02221a593093138bb037a |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 14712369 |
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