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Serum sodium concentration

The effect of Vaprisol on serum sodium was demonstrated in a double-blind, placebo-controlled, randomized, multicenter study in patients with euvolemic or hypervolemic hyponatremia (serum sodium 115-130 mEq/L), the primary efficacy endpoint of which 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.1,2

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In clinical studies of patients with hyponatremia (serum sodium <130 mEq/L), Vaprisol significantly increased the baseline-adjusted serum sodium area during a 4-day treatment period1

  • A 6.5 mEq/L mean change from baseline in serum sodium concentration was achieved at the end of Vaprisol treatment (day 4) compared with 1.5 mEq/L for placebo
  • 69% of patients receiving Vaprisol 40 mg/day IV achieved a ≥6 mEq/L increase in serum sodium concentration or normal serum sodium concentration by the end of treatment (day 4) compared with 21% of patients receiving placebo1*
    • By day 2, 41% of patients receiving Vaprisol achieved a ≥6 mEq/L increase in serum sodium concentration or normal serum sodium concentration compared with 0% of patients receiving placebo1
  • In controlled clinical trials, about 9% of patients who received Vaprisol in doses of 20-40 mg/day IV had rises of serum sodium >12 mEq/L/24 hours, but none of these patients had evidence of osmotic demyelination or permanent neurologic sequelae1

*The effect of Vaprisol on maintenance of serum sodium concentration is not known.



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.