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Study Shows VAPRISOL(R) is Effective in Increasing Serum Sodium Levels and Well-Tolerated in Patients With Euvolemic or Hypervolemic Hyponatremia
Date:10/25/2007

DEERFIELD, Ill., Oct. 25 /PRNewswire/ -- Astellas Pharma US, Inc. today announced data demonstrating that VAPRISOL(R) (conivaptan hydrochloride injection) effectively raises serum sodium concentration ([Na+]) and is well-tolerated among hospitalized patients with euvolemic or hypervolemic hyponatremia, a potentially life-threatening condition that occurs when the body's sodium level falls below normal. The efficacy and safety profile of VAPRISOL was comparable under double-blind or open-label conditions. The study results were presented at the American College of Chest Physicians (CHEST) 2007 meeting.

"Hyponatremia is common in patients with congestive heart failure and in patients with the syndrome of inappropriate antidiuretic hormone (SIADH), which is seen in various pulmonary disorders and postsurgical settings," said Joseph G. Verbalis, M.D., at the Georgetown University Hospital. "These data suggest that VAPRISOL can safely and effectively raise serum sodium levels in patients with underlying conditions such as pneumonia, chronic obstructive pulmonary disease and impaired heart function."

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 2
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SOURCE Astellas Pharma US, Inc.
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