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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

an placebo in increasing baseline-adjusted serum [Na+] AUC during the four-day treatment (P=.0001). In the OLS, the increases in serum [Na+] were sustained at the post-treatment assessments. Mean increases in serum [Na+] above baseline with VAPRISOL on day 11 were 7.1 mEq/L with 20 mg/d and 8.0 mEq/L with 40 mg/d. On day 34, increases were 11.5 and 10.7 mEq/L with 20 and 40 mg/d, respectively.

The most common adverse events included injection-site phlebitis, injection-site reaction and hypokalemia. An overly rapid serum [Na+] increase occurred in 15 patients treated with VAPRISOL, usually manifested by a >12- mEq/L rise within 24 hours. Treatment was discontinued in 12 patients; the dose was lowered in the other three. No adverse events related to a rapid rise in serum [Na+] were reported.

About Hyponatremia

Hyponatremia often results from elevated levels of the hormone arginine vasopressin (AVP), which regulates water and salt balance in the body. It is the most common electrolyte disorder in clinical medicine.

Syndrome of inappropriate antidiuretic hormone (SIADH), advanced kidney failure, hypothyroidism, cancer and chronic high blood pressure are common causes of hyponatremia. Dilutional hyponatremia, which includes euvolemic and hypervolemic hyponatremia, is the most common form of the condition, and occurs when retained water dilutes serum sodium content. Patients with hyponatremia are classified as hypervolemic if swelling of body tissues (edema) is present or euvolemic if there is an increase in total body water content without edema.(1,2)

About VAPRISOL

Discovered and developed by Astellas Pharma Inc. headquartered in Tokyo, Japan, VAPRISOL is a novel drug that blocks the activity of AVP, resulting in increased urine output without loss of valuable electrolytes such as sodium and potassium. This effect, known as "aquaresis," helps to increase serum sodium levels in patients with hyponatremia, a condition of low serum sodiu
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SOURCE Astellas Pharma US, Inc.
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