Journal article
Lixivaptan safely and effectively corrects serum sodium concentrations in hospitalized patients with euvolemic hyponatremia
Kidney international, v 82(11), pp 1223-1230
01 Dec 2012
PMID: 22932119
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Hyponatremia is a common electrolyte disorder associated with increased morbidity and mortality, particularly in the elderly. Lixivaptan, a new selective vasopressin V2-receptor antagonist, safely corrected serum sodium concentrations in phase II studies of patients with euvolemic hyponatremia. Here our multinational, double-blind, placebo-controlled, phase III study assessed the effect of lixivaptan on serum sodium concentrations in 106 initially hospitalized patients with euvolemic hyponatremia (serum sodium less than 130mmol/l). Of them, 52 were randomized to receive placebo and 54 received 50mg lixivaptan once daily and were then titrated to receive 25–100mg once daily depending on serum sodium concentration. Fluid restriction was at the investigator's discretion. Initial titration occurred in a monitored inpatient setting; patients were then treated as outpatients for a total of 30 days. The primary end point was the change in serum sodium concentration from baseline to day 7. Lixivaptan significantly increased the serum sodium concentration from baseline to day 7 (the primary end point) by 6.7mmol/l compared with placebo (4.5mmol/l; P=0.034). Importantly, the serum sodium concentration was normalized safely and more rapidly in patients receiving lixivaptan than placebo (P=0.004) and was well tolerated. After drug discontinuation, serum sodium concentrations decreased to near-baseline levels within 7 days. Thus, lixivaptan safely and effectively corrects serum sodium concentrations in patients with euvolemic hyponatremia.
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Details
- Title
- Lixivaptan safely and effectively corrects serum sodium concentrations in hospitalized patients with euvolemic hyponatremia
- Creators
- William T. Abraham - The Ohio State UniversityJohannes Hensen - KRH Klinikum NordstadtPeter A. Gross - Medizinische Klinik III, Universitätsklinikum C.G. Carus, Dresden, GermanyDaniel G. Bichet - Hôpital du Sacré-Cœur de MontréalRichard C. Josiassen - Drexel UniversityDeoDatta S. Chafekar - Department of Nephrology, Shri Samarth Hospital, Nasik, IndiaCesare Orlandi - Cardiokine Biopharma, Philadelphia, Pennsylvania, USAfor the LIBRA Study Group
- Publication Details
- Kidney international, v 82(11), pp 1223-1230
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Psychiatry
- Web of Science ID
- WOS:000311156300012
- Scopus ID
- 2-s2.0-84869235804
- Other Identifier
- 991019167986804721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Urology & Nephrology