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Oral lixivaptan effectively increases serum sodium concentrations in outpatients with euvolemic hyponatremia
Journal article   Open access   Peer reviewed

Oral lixivaptan effectively increases serum sodium concentrations in outpatients with euvolemic hyponatremia

William T. Abraham, Guy Decaux, Richard C. Josiassen, Yoram Yagil, Nelson Kopyt, Hemant P. Thacker, Massimo Mannelli, Daniel G. Bichet, Cesare Orlandi, for the HARMONY Study Group, …
Kidney international, v 82(11), pp 1215-1222
01 Dec 2012
PMID: 22932122
url
https://doi.org/10.1038/ki.2012.274View
Published, Version of Record (VoR)Open Access (Publisher-Specific) Open

Abstract

clinical trial hyponatremia vasopressin
Hyponatremia is the most common electrolyte disorder in clinical practice. Its incidence increases with age and it is associated with increased morbidity and mortality. Recently, the vaptans, antagonists of the arginine vasopressin pathway, have shown promise for safe treatment of hyponatremia. Here we evaluated the efficacy, safety, and tolerability of oral lixivaptan, a selective vasopressin V2-receptor antagonist, for treatment of nonhospitalized individuals with euvolemic hyponatremia (sodium less than 135mmol/l) in a multicenter, randomized, double-blind, placebo-controlled, phase III study. About half of the 206 patients were elderly in a chronic care setting. Of these patients, 52 were given a placebo and 154 were given 25–100mg per day lixivaptan, titrated based on the daily serum sodium measurements. Compared with placebo (0.8mmol/l), the serum sodium concentration significantly increased by 3.2mmol/l from baseline to day 7 (primary efficacy endpoint) with lixivaptan treatment. A significantly greater proportion of patients that received lixivaptan achieved normal serum sodium (39.4%) by day 7 relative to placebo (12.2%). Overall, lixivaptan was considered safe and well-tolerated. Thus, oral lixivaptan can be safely initiated in the outpatient setting and effectively increases serum sodium concentrations in outpatients with euvolemic hyponatremia.

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Collaboration types
Domestic collaboration
International collaboration
Web of Science research areas
Urology & Nephrology
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