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Everest Data on Short- and Long-Term Use of Otsuka's,Investigational Novel Treatment, Tolvaptan, Published in Journal of,the American Medical Association and Featured in ACC's Late,Breaking Clinical Trials

PRINCETON, N.J., March 25, 2007 /PRNewswire/ -- Once-daily dosing with Otsuka's investigational oral medication tolvaptan, a vasopressin receptor antagonist, was associated with improvements in signs and symptoms of acutely decompensated heart failure (ADHF) in hospitalized patients receiving conventional care, without an adverse effect on their long-term survival versus placebo.(1) These data are from the short- and long-term analyses of the international landmark trial Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) published in the March 28 issue of the Journal of the American Medical Association (JAMA). These data were presented at the of Cardiology's 56th Annual Scientific Sessions (ACC).

The phase 3 EVEREST trial, involving a total of 4,133 ADHF patients, represents three studies: a long-term outcomes trial evaluating patients after their discharge for a minimum of 60 days of treatment, and two identical, embedded short-term pivotal studies that examined tolvaptan compared to placebo over seven days of inpatient care or discharge, whichever came first.(1,2)

Data from the two short-term studies documented that tolvaptan treatment yielded significantly greater improvements than placebo based on the primary endpoint (study A: p less than 0.001 and study B: p less than 0.001), which was the composite score of changes in patient-assessed global clinical status and changes in body weight at day seven or discharge.(1) Long-term tolvaptan use did not differ from placebo on either of the study's two primary endpoints: deaths from all causes (p equal to 0.68) or from the combined endpoint of cardiovascular (CV) deaths or subsequent hospitalization for worsening HF (p equal to 0.55).(2)

"Tolvaptan exhibited short-term symptomatic benefits in patients hospitalized with worsening heart failure,"(2) said investigator Marvin A. Konstam, M.D., chief of the D
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