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-dailydosing with...The phase 3 EVEREST trial involving a total of 4133 ADHFpatients r...Data from the two short-term studies documented that tolvaptantreatme... Tolvaptan exhibited short-term symptomatic benefits in patientshospi...
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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