Short-term Clinical Effects of Tolvaptan, an Oral Vasopressin Antagonist, in Patients Hospitalized for Heart Failure

Abstract ContextHeart failure causes more than 1 million US hospitalizations yearly, mostly related to congestion. Tolvaptan, an oral, nonpeptide, selective vasopressin V2-receptor antagonist, shows promise in this condition.ObjectiveTo evaluate short-term effects of tolvaptan when added to standard therapy in patients hospitalized with heart failure.Design, Setting, and PatientsTwo identical prospective, randomized, double-blind, placebo-controlled trials at 359 sites in North America, South America, and Europe were conducted during the inpatient period of the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) between October 7, 2003, and February 3, 2006. A total of 2048 (trial A) and 2085 (trial B) patients hospitalized with heart failure and congestion were studied.InterventionPatients were randomized to receive either tolvaptan (30 mg/d) or matching placebo, within 48 hours of admission.Main Outcome MeasuresPrimary end point was a composite...