![]() In fact, in randomized controlled trials of such treatments, the observed clinical benefits have been marginal at best, 8, 9 and concern has been raised about the adverse effect of these treatments on long-term clinical outcomes. To date, no treatment initiated at the time of hospitalization for acute decompensated HF has been found to improve clinical outcomes. Nevertheless, the number of annual hospitalizations for HF continues to rise, and mortality rates among patients hospitalized with HF remain high. Trial Registration Published online Ma(doi:10.1001/jama.2).ĭuring the past 2 decades, there have been substantial advances in drug therapy for chronic heart failure (HF), with much of the improvement in clinical outcomes achieved through pharmacologic inhibition of neurohormonal systems. Trial Registration Identifier: NCT00071331 Tolvaptan caused increased thirst and dry mouth, but frequencies of major adverse events were similar in the 2 groups.Ĭonclusion Tolvaptan initiated for acute treatment of patients hospitalized with heart failure had no effect on long-term mortality or heart failure–related morbidity. ![]() The Kansas City Cardiomyopathy Questionnaire overall summary score was not improved at outpatient week 1, but body weight and serum sodium effects persisted long after discharge. In patients with hyponatremia, serum sodium levels significantly increased. Tolvaptan significantly improved secondary end points of day 1 patient-assessed dyspnea, day 1 body weight, and day 7 edema. Secondary end points of cardiovascular mortality, cardiovascular death or hospitalization, and worsening heart failure were also not different. The composite of cardiovascular death or hospitalization for heart failure occurred in 871 tolvaptan group patients (42.0%) and 829 placebo group patients (40.2% hazard ratio, 1.04 95% CI, 0.95-1.14 P = .55). The upper confidence limit for the mortality difference was within the prespecified noninferiority margin of 1.25 ( P<.001). Results During a median follow-up of 9.9 months, 537 patients (25.9%) in the tolvaptan group and 543 (26.3%) in the placebo group died (hazard ratio, 0.98 95% confidence interval, 0.87-1.11 P = .68). Secondary end points included changes in dyspnea, body weight, and edema. Main Outcome Measures Dual primary end points were all-cause mortality (superiority and noninferiority) and cardiovascular death or hospitalization for heart failure (superiority only). Intervention Within 48 hours of admission, patients were randomly assigned to receive oral tolvaptan, 30 mg once per day (n = 2072), or placebo (n = 2061) for a minimum of 60 days, in addition to standard therapy. The outcome trial comprised 4133 patients within 2 short-term clinical status studies, who were hospitalized with heart failure, randomized at 359 North American, South American, and European sites between October 7, 2003, and February 3, 2006, and followed up during long-term treatment. Objective To investigate the effects of tolvaptan initiated in patients hospitalized with heart failure.ĭesign, Setting, and Participants The Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST), an event-driven, randomized, double-blind, placebo-controlled study. Tolvaptan, a vasopressin V 2 receptor blocker, shows promise for management of heart failure.
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