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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

llowed by continuous infusion of conivaptan 40 mg/day (n=29) or 80 mg/day (n=26) for four days.

The primary endpoint of the study was the change from baseline in serum sodium levels over the entire course of treatment (expressed as the "area under the curve," or AUC). Secondary endpoints included: time to reach a >/= 4 mEq/L increase in serum sodium levels; total time during which patients had a >/= 4 mEq/L increase in serum sodium levels; change in serum sodium levels at day four; and number of patients who achieved a >/= 6 mEq/L increase in serum sodium levels or a normal serum sodium concentration (>/= 135 mEq/L) over the course of the study.

Both doses of VAPRISOL significantly improved serum sodium levels relative to placebo, with a mean change in AUC of 490.9 (mEq/L)hr in the VAPRISOL 40 mg/day group, 716.6 (mEq/L)hr in the VAPRISOL 80 mg/day group, and 12.9 (mEq/L)hr in the placebo group (p=0.001). On average, VAPRISOL 40 mg/day and 80 mg/day produced a >/= 4 mEq/L increase in serum sodium levels within 23.7 hours and 23.4 hours, respectively. Over the course of the study, patients receiving VAPRISOL 40 mg/day, 80 mg/day, or placebo experienced increases in serum sodium of >/= 4 mEq/L for 53.2 hrs, 72.7 hrs, and 14.2 hrs, respectively (p<.001). At study's end, the mean change in serum sodium concentration was 6.3 mEq/L in patients who received VAPRISOL 40 mg/day and 9.4 mEq/L in those who received VAPRISOL 80 mg/day, compared with 0.8 mEq/L in patients who were given placebo (p<.001). Sixty-nine percent of VAPRISOL 40 mg/day patients (p<.001) and 88.5 percent of VAPRISOL 80 mg/day patients (p<.001) achieved a >/= 6 mEq/L increase in serum sodium levels or a normal serum sodium concentration (>/= 135 mEq/L) over the treatment period, compared with 20.7 percent of patients receiving placebo.

Several treatment-emergent adverse events were more common in VAPRISOL patients than in placebo patients, including injection site phlebitis, hypotension
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SOURCE Astellas Pharma US, Inc.
Copyright©2007 PR Newswire.
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