Efficacy and safety of oral conivaptan, a vasopressin-receptor antagonist, evaluated in a randomized, controlled trial in patients with euvolemic or hypervolemic hyponatremia.

Djillali Annane, Guy Decaux, Neila Smith, Conivaptan Study Group

Department of General Critical Care Medicine/Division of Acute Medicine and Surgery, University of Versailles SQY Raymond Poincaré Hospital, Garches, France. djillali.annane@rpc.aphp.fr

The American journal of the medical sciences 2009 Jan

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In most cases of hyponatremia, arginine vasopressin secretion is inappropriately high. This placebo-controlled, randomized, double-blind multicenter study evaluated the efficacy and safety of oral conivaptan, a V1A/V2-receptor antagonist, in patients with euvolemic or hypervolemic hyponatremia. Eighty-three patients with serum [Na] less than 130 mEq/L were stratified by volume status and randomly assigned to placebo or conivaptan 40 or 80 mg/d for 5 days. Conivaptan increased the baseline-adjusted area under the serum [Na]-time curve significantly more than placebo (P = 0.0001). Patients given either dose of conivaptan demonstrated a serum [Na] of 4 mEq/L or greater above baseline significantly faster than those given placebo (P < 0.001) and maintained that increase for a greater total time (P = 0.0001). The least squares mean change in serum [Na] from baseline to end of treatment was also significantly greater with conivaptan 40 and 80 mg/d (6.8 and 8.8 mEq/L, respectively) (P = 0.0001) than that with placebo (1.2 mEq/L). The percentage of patients who obtained an increase from baseline in serum [Na] of 6 mEq/L or greater or normal serum [Na] was significantly higher among patients given conivaptan 40 and 80 mg/d (67% and 88%, respectively) than among those given placebo (20%; P < 0.001). Conivaptan was well tolerated; the most frequent adverse events were urinary tract infection, anemia, pyrexia, cardiac failure, hypotension, and hypokalemia. Oral conivaptan was effective in increasing serum [Na] in patients with euvolemic or hypervolemic hyponatremia and had a favorable safety profile.

Citation

Djillali Annane, Guy Decaux, Neila Smith, Conivaptan Study Group. Efficacy and safety of oral conivaptan, a vasopressin-receptor antagonist, evaluated in a randomized, controlled trial in patients with euvolemic or hypervolemic hyponatremia. The American journal of the medical sciences. 2009 Jan;337(1):28-36