Vasopressin V2 receptor blockade with Tolvaptan versus fluid restriction in the treatment of hyponatremia

Mihai Gheorghiade*, Stephen S. Gottlieb, James E. Udelson, Marvin A. Konstam, Frank Czerwiec, John Ouyang, Cesare Orlandi

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

127 Scopus citations


Hyponatremia is common and is associated with a poor prognosis. Traditional management with fluid restriction is difficult to maintain, and it is often ineffective. The objective of this study was to determine the effect of tolvaptan versus fluid restriction on serum sodium concentration. The study was a prospective, multicenter, randomized, active-controlled, open-label trial. Twenty-eight hospitalized subjects with serum sodium <135 mmol/L were enrolled in the study. After a 2-day run-in period, subjects were randomized 2:1 to tolvaptan alone (n = 17) or fluid restriction (1,200 ml/day) plus placebo (n = 11). Oral tolvaptan was started at 10 mg/day and increased to 60 mg/day as needed. Treatment was continued for up to 27 days, and follow-up continued for up to 65 days. The primary end point was the normalization of serum sodium, defined as >135 mmol/L or a <10% increase from baseline. At the last inpatient visit, serum sodium had increased by 5.7 ± 3.2 mmol/L in the tolvaptan group and 1.0 ± 4.7 mmol/L in the fluid restriction group (p = 0.0065). No differences in adverse events were observed between the groups. In conclusion, tolvaptan appears to be more effective than fluid restriction at correcting hyponatremia in hospitalized subjects, without an increase in adverse events.

Original languageEnglish (US)
Pages (from-to)1064-1067
Number of pages4
JournalAmerican Journal of Cardiology
Issue number7
StatePublished - Apr 1 2006

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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