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Vasopressin V2 Receptor Blockade With Tolvaptan Versus Fluid Restriction
in the Treatment of Hyponatremia

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.

[ Last edited by ?? on 2012-10-9 at 11:29 ]

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