THIS INFORMATION IS INTENDED FOR US HEALTHCARE PROFESSIONALS
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Efficacy

The effect on serum sodium of Vaprisol was demonstrated in a double-blind, placebo-controlled, randomized, multicenter study conducted in 84 patients with euvolemic (N=56) or hypervolemic (N=28) hyponatremia (serum sodium 115-130 mEq/L) from a variety of underlying causes (malignant or nonmalignant diseases of the central nervous system, lung, or abdomen; congestive heart failure; hypertension; myocardial infarction; diabetes; osteoarthritis; or idiopathic).1 The primary efficacy endpoint of the study was change from baseline in serum sodium during the course of treatment, measured by the baseline-adjusted area under the sodium-time curve (AUC) from the beginning through the end of treatment. Fluid restricted to ≤2.0 L/day in all patients. The mean baseline serum sodium concentrations in patients treated with Vaprisol or placebo were 123.3 mEq/L or 124.3 mEq/L, respectively.2

The effect on serum sodium of Vaprisol (administered as a 20 or 40 mg/day IV continuous infusion for 4 days following a 30-minute IV infusion of a 20 mg loading dose on the first treatment day) was also evaluated in an open-label study of 251 patients with euvolemic or hypervolemic hyponatremia.1 The primary efficacy endpoint of the study was baseline-adjusted serum sodium AUC over the duration of treatment (mEq·hr/L).3



REFERENCES: 1. Vaprisol Prescribing Information. Cumberland Pharmaceuticals Inc. 2. Zeltser D, Rosansky S, van Rensburg H, Verbalis JG, Smith N. Assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia. Am J Nephrol. 2007;27:447-457. 3. Data on file. Cumberland Pharmaceuticals.