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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

0 mg/day and 40 mg/day. The 80 mg/day dose used in this study is not an approved dose.

Study Findings

The post-hoc pooled analysis is based on results from a randomized controlled trial (RCT) of 84 patients and an open-label study (OLS) of 251 patients, all with euvolemic or hypervolemic hyponatremia.

After infusion of a 20 mg loading dose or placebo, VAPRISOL was given in a continuous 4-day infusion of 40 or 80 mg/d in the RCT and 20 or 40 mg/d in the OLS. Follow-up time after the 4-day treatment included serum [Na+] assessments at day 11 for both groups as well as day 34 for the OLS group only. The primary endpoint of both studies was the change from baseline in serum [Na+] over the entire course of treatment (expressed as the area under the curve, or AUC). Secondary endpoints included: time to reach a greater than or equal to 4 mEq/L increase in serum [Na+]; total time during which patients had a greater than or equal to 4 mEq/L increase in serum [Na+]; change in serum [Na+] at day four; and number of patients who achieved a greater than or equal to 6 mEq/L increase in serum [Na+] or a normal serum [Na+] (greater than or equal to 135 mEq/L) over the course of the study.

Across both studies, patients receiving VAPRISOL showed significant increases in serum [Na+] starting on day one of treatment, with a sustained increase in serum [Na+] one to four weeks after the completion of the studies. In each VAPRISOL dosing group, mean time to a confirmed greater than or equal to 4-mEq/L increase was ~24 hours and the increase was maintained above baseline for most of the treatment period. By day four, VAPRISOL increased serum [Na+] above baseline (mean) from 6.8 to 9.7 mEq/L across the studies. Most VAPRISOL-treated patients achieved a confirmed greater than or equal to 6-mEq/L increase in serum [Na+] or normal serum [Na+] (69 to 88.5 percent in the RCT and 70.3 to 72 percent in the OLS).

In the RCT, VAPRISOL was significantly more effective th
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SOURCE Astellas Pharma US, Inc.
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