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FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
Date:5/21/2009

e daily, 7 percent of SAMSCA-treated subjects with a serum sodium less than 130 mEq/L had an increase in serum sodium greater than 8 mEq/L at approximately 8 hours and 2 percent had an increase greater than 12 mEq/L at 24 hours. Approximately 1 percent of placebo-treated subjects with a serum sodium less than 130 mEq/L had a rise greater than 8 mEq/L at 8 hours and no patient had a rise greater than 12 mEq/L/24 hours. None of the patients in these studies had evidence of osmotic demyelination syndrome or related neurological sequelae, but such complications have been reported following too-rapid correction of serum sodium.

Study Information

In two double-blind, placebo-controlled, multi-center studies (SALT-1 and SALT-2), a total of 424 patients with euvolemic or hypervolemic hyponatremia (serum sodium less than 135 mEq/L) resulting from a variety of underlying causes (congestive heart failure [CHF], liver cirrhosis, syndrome of inappropriate anti-diuretic hormone [SIADH], and others) were treated for 30 days with SAMSCA or placebo, then followed for an additional 7 days after withdrawal.

The primary endpoint of these studies was the average daily area under the curve (AUC) for change in serum sodium from baseline to Day 4 and baseline to Day 30 in patients with a serum sodium less than 135 mEq/L. Compared to placebo, SAMSCA caused a statistically greater increase in serum sodium (p less than 0.0001) during both periods in both studies. For patients with a serum sodium of less than 130 mEq/L or less than 125 mEq/L, the effects at Day 4 and Day 30 remained significant. This effect was also seen across all disease etiology subsets (e.g., CHF, cirrhosis, SIADH/other). Seven days after withdrawal of SAMSCA, serum sodium levels of patients decreased to levels approximately equivalent to those of patients treated with placebo.

In addition, serum sodium concentrations increased to a significantly grea
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SOURCE Otsuka Pharmaceutical Co., Ltd.; Otsuka America Pharmaceutical, Inc.; Otsuka Pharmaceutical Development & Commercialization, Inc.
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