Conivaptan Is Useful for Hyponatraemia in Heart Failure Patients: Presented at HFSA

To print: Select File and then Print from your browser's menu
---------------------------------------------------------------------------------------
Title: Conivaptan Is Useful for Hyponatraemia in Heart Failure Patients: Presented at HFSA
URL: http://www.pslgroup.com/dg/22D53E.htm
Doctor's Guide
September 23, 2008

By Jill Stein

TORONTO -- September 23, 2008 -- Conivaptan is effective and well tolerated in hyponataremic patients with or without underlying heart failure, researchers reported at the Heart Failure Society of America (HFSA) 12th Annual Scientific Meeting.

Jalal Ghali, MD, Wayne State University, Detroit, Michigan, presented results in patients treated with conivapatan who were enrolled in 1 double-blind, randomised, placebo-controlled trial and 1 open-label trial.

Overall, 98 subjects had underlying heart failure and 237 did not.

"Arginine vasopressin (AVP) is often increased in heart failure patients," Dr. Ghali's group wrote in their poster, presented on September 23. "Reduced cardiac output in heart failure patients triggers the baroreceptor-mediated release of AVP, which promotes free-water reabsorption and the development of dilutional hyponatraemia."

Hyponatraemia and elevated plasma concentrations of AVP are independent predictors of adverse outcomes in heart failure patients, the researchers noted.

The efficacy and safety endpoints were identical in the 2 trials. The primary efficacy endpoint was the change from baseline in serum sodium concentration (Na+) measured by the area under the serum sodium (Na+) concentration time curve (AUC). The safety endpoint was the incidence of adverse events and changes in physical examination findings, vital signs, and clinical laboratory values.

Patients received an IV loading dose of conivaptan 20 mg (or placebo in the randomised, controlled trial only) followed by a continuous 4-day infusion of placebo or conivaptan 40 or 80 mg/day in the randomised, controlled trial, and conivaptan 20 or 40 mg/d in the open-label trial.

Results show that patients both with and without heart failure had increased serum Na+ and improvement in all efficacy measures with all conivaptan doses, although the time to a 4-mEq/L or greater increase in serum Na+ was longer in heart failure patients.

Median time to a confirmed increase of 4 mEq/L or greater with conivaptan ranged from 23.9 to 30 hours in heart failure patients and from 8.4 to 24.0 hours in those without heart failure, but it could not be estimated in the placebo group because too few patients achieved such an increase.

Most patients treated with conivaptan, regardless of heart failure status, achieved an increase of 6 mEq/L or greater in serum Na+ or a normal serum Na+ of 135 mEq/L or greater.

Conivaptan was well tolerated, with a similar number of discontinuations due to adverse events in patients with and without heart failure, the researchers said.

Overall, the data demonstrate that conivaptan safely and effectively corrects hyponatraemia in patients with and without heart failure, the author concluded.

Conivaptan hydrochloride injection is approved for the intravenous treatment of euvolemic and hypervolemic hyponatraemia in hospitalised patients.

Funding for the study was provided by Astellas Pharma US, Inc.

[Presentation title: Conivaptan, a Vasopressin-Receptor Antagonist, for the Treatment of Hyponatremia in Patients With and Without Underlying Heart Failure. Abstract 231]

http://www.docguide.com

Return to News Story Page

webmaster@pslgroup.com