Successful Long-Term Treatment of Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion with Satavaptan (SR121463B), an Orally Active Nonpeptide Vasopressin V2-Receptor Antagonist
American Society of Nephrology. Clinical Journal
The effects of satavaptan (SR121463B), a novel long-acting orally active vasopressin V 2 -receptor antagonist, were investigated in patients with the syndrome of inappropriate antidiuretic hormone secretion (SIADH). In the first part of this randomized, double-blind study, 34 patients first were treated with satavaptan (versus placebo) for up to 5 d and then during 23 d of open-label dosage-adjustment period. In the second part of the study, long-term efficacy and safety of satavaptan was
... atavaptan was assessed in an open-label trial during at least 12 mo. Mean (؎SD) serum sodium (SNa) levels before treatment were 127 ؎ 2 mmol/L (placebo, n ؍ 8), 125 ؎ 6 mmol/L (25 mg, n ؍ 14), and 127 ؎ 5 mmol/L (50 mg, n ؍ 12). Responders (patients SNa levels normalized or increased by at least 5 mmol/L from baseline during the double-blind period) were 79% in the 25-mg group (SNa 136 ؎ 3 mmol/L; P ؍ 0.006), 83% in the 50-mg group (SNa 140 ؎ 6 mmol/L; P ؍ 0.005), and 13% in the placebo group (SNa 130 ؎ 5 mmol/L). No drug-related serious adverse events were recorded. During the long-term treatment, 15 of 18 enrolled patients achieved 6 mo and 10 achieved 12 mo of treatment. The SNa response was maintained during this time with a good tolerance. The new oral vasopressin V 2 -receptor antagonist satavaptan adequately corrects mild or moderate hyponatremia in patients with SIADH and has a good safety profile.