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Clinically significant elevations in liver enzymes were reported in 1 placebo patient, 9 of 29 conivaptan 40 mg/day patients, and 13 of 26 conivaptan 80 mg/day patients.
Both doses of conivaptan significantly increased effective water clearance, compared with placebo.
Both conivaptan doses significantly increased serum sodium levels over the 4 days, compared with placebo, with a mean change in AUC of 491 mEq/L per hour in the conivaptan 40 mg/day group, 714 mEq/L per hour in the 80-mg/day group, and 13 mEq/L per hr in the placebo group.
Treatment with conivaptan was well tolerated, with a low rate of drug-related adverse effects and few discontinuations due to adverse effects.
Patients were randomized to receive 20 mg oral conivaptan b.
During the 5 days of treatment, serum sodium levels increased in the conivaptan group in a dose-related manner and to levels that were significantly above those reached in the control group, reported Jala K.
Conivaptan, which was approved in 2005 for euvolemic hyponatremia, received approval in early 2007 for dilutional (hypervolemic) hyponatremia.
The conivaptan study was supported by Astellas Pharma US Inc.
Other investigators assessed conivaptan (Vaprisol, Astellas) and supported its use for euvolemic hyponatremia because the drug increased urine output of mostly free water with little electrolyte loss (J.
Effects of conivaptan, a combined vasopressin V(1a) and V(2) receptor antagonist, on vasopressin-induced cardiac and haemodynamic changes in anaesthetized dogs.
While familiarity with new agents in development including Sanofi's satavaptan, Cardiokine's lixivaptan, and Astellas's oral conivaptan is low, nephrologists report a preference for non-peptide selective vasopressin V2 receptor antagonists over V1A/V2 receptor antagonists.
Two vasopressin antagonists, or "vaptans," have been tested in clinical trials: conivaptan and tolvaptan.