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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

sults 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. The pooled analysis evaluated the frequency of overly rapid [Na+] increases during Vaprisol clinical trials. Note: Overly rapid [Na+] increase can lead to serious neurologic sequelae associated osmotic demyelinization syndrome. This study defined overly rapid increase of serum [Na+] as an increase in serum [Na+] > 12 mEq/L in 24 hours.

In both studies, baseline characteristics were largely similar between those who had an overly rapid increase in [Na+] and those who did not. Among patients who received Vaprisol in the RCT, the mean change in [Na+] was significantly higher compared to the placebo group throughout the 4-day course of treatment. In the OLS, both doses of Vaprisol produced prompt increases that were sustained throughout the 4-day study. The median time to a

confirmed greater than or equal to 4 mEq/L increase in [Na+] was approximately 24 hours in all Vaprisol groups in both studies.

Overall, these two clinical studies demonstrated an overly rapid [Na+] increase in about 5 percent of patients who received Vaprisol for the treatment of hyponatremia. In the RCT, 2 (7 percent) of the 29 patients treated with Vaprisol 40 mg/d, 2 (8 percent) of the 26 treated with Vaprisol 80 mg/d, and 0 of the 29 treated with placebo met the protocol-defined criteria for excessive or overly rapid increase of [Na+]. In the OLS, 1 (3 percent) of 37 patients treated with Vaprisol 20 mg/d and 10 (5 percent) of 214 treated with 40 mg/d met the protocol-defined criteria for excessive or overly rapid increase of [Na+].

None of these patients in either the RCT or the OLS experienced adverse events (AEs) associated with the overly rapid increa
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SOURCE Astellas Pharma US
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