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Data Show Vaprisol(R) Is Effective & Safe in Promptly Increasing Serum Sodium Levels in Patients With Euvolemic or Hypervolemic Hyponatremia
Date:10/10/2007

DEERFIELD, Ill., Oct. 10 /PRNewswire/ -- Astellas Pharma US, Inc. today announced results of an analysis showing that Vaprisol (conivaptan hydrochloride injection) produced a prompt and sustained (over the 4-day treatment period) increase in serum sodium concentration [Na+] among hospitalized patients with euvolemic and hypervolemic hyponatremia with a low risk of overly rapid [Na+] correction. The study results were presented during the annual meeting of the American College of Emergency Physicians in Seattle.

"Acute hyponatremia is a serious condition that requires immediate medical attention," said Lynne E. Wagoner, MD, Director of Heart Failure, Greater Cincinnati Cardiovascular Consultants. "These data demonstrated that Vaprisol promptly and safely increased [Na+] in patients with euvolemic and hypervolemic hyponatremia."

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 treatment regimen for Vaprisol starts with a 20 mg loading dose followed by a continuous infusion of 20 mg/day, which may be titrated to 40 mg/day if necessary. The 80 mg/day dose included in this analysis is not an approved dose.

Study Findings

The post-hoc pooled analysis is based on re
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SOURCE Astellas Pharma US
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