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Study Shows Vasopressin Receptor Antagonist VAPRISOL(R) (Conivaptan Hydrochloride Injection) Significantly Increased Serum Sodium Concentration in Patients with Euvolemic & Hypervolemic Hyponatremia
Date:9/20/2007

- Phase III data published in the American Journal of Nephrology -

DEERFIELD, Ill., Sept. 20 /PRNewswire-FirstCall/ -- Astellas Pharma US, Inc. today announced that its Phase III data on VAPRISOL was published in the September issue of the American Journal of Nephrology. In this study, VAPRISOL showed a significant increase in serum sodium concentrations in patients with hyponatremia -- a potentially life-threatening condition that occurs when the body's sodium level falls below normal.

"This study demonstrated that VAPRISOL 40 mg/day significantly increased serum [Na+] in patients with euvolemic or hypervolemic hyponatremia," said Joseph G. Verbalis, M.D., at the Georgetown University Hospital. "VAPRISOL will likely address an important clinical need for euvolemic or hypervolemic hyponatremia in hospitalized patients."

VAPRISOL is the first in a new class of arginine vasopressin (AVP) receptor antagonists. VAPRISOL blocks both V1a and V2 vasopressin receptors, resulting in increased urine output without increased sodium loss. This effect, known as "aquaresis," increases serum sodium levels and helps to restore salt and water balance in patients with hyponatremia due to increased body water (dilutional hyponatremia).

VAPRISOL is approved by the U.S. Food and Drug Administration as a treatment for euvolemic and hypervolemic hyponatremia in hospitalized patients. VAPRISOL is not indicated for the treatment of congestive heart failure. It should only be used for the treatment of hyponatremia in patients with underlying heart failure when the expected benefit of raising serum sodium outweighs the increased risk of adverse events. The approved doses for VAPRISOL include 20 mg/day and 40 mg/day. The 80 mg/day dose used in this study is not an approved dose.

In the double-blind, multicenter study, 84 patients with serum sodium levels of 115 to <130 mEq/L were randomized to receive placebo or a 20-mg intravenous bolus of conivaptan, fo
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SOURCE Astellas Pharma US, Inc.
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