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
ivision of Cardiology at theTufts-New England Medical Center and pro...Tolvaptan is a novel investigational small molecule designed tobe an...Short-Term Studies: Pre-Specified Secondary Endpoints ...In the two short-term studies reductions in average body weightat da...
ivision of Cardiology at the
Tufts-New England Medical Center, and professor of Medicine at
Tufts University School of Medicine, Boston, Mass. Konstam
presented the short- and long-term EVEREST data analyses during a
late-breaker session Sunday, March 25 at the ACC. "In the long-term
trial, tolvaptan neither statistically improved nor worsened
survival relative to placebo. The EVEREST data suggest that
tolvaptan may be a potential therapy for patients with heart
failure."
Tolvaptan is a novel, investigational small molecule designed to
be an antagonist of the vasopressin V2 receptor, which plays a role
in the kidney's regulation of fluid excretion. The majority of
patients hospitalized for ADHF, the worsening of chronic HF that
affects 1 million U.S. residents annually,(3) have edema or excess
body fluid, which is treated with diuretics to excrete the fluid.
In contrast to diuretics, tolvaptan is designed to promote
aquaresis, the excretion of electrolyte-free water.(1) Otsuka
Pharmaceutical Co., Ltd. (Japan) and Otsuka Pharmaceutical
Development & Commercialization, Inc., are developing
tolvaptan, which has the potential to be the first available oral
vasopressin receptor antagonist.(4,5)
Short-Term Studies: Pre-Specified Secondary Endpoints
In the two short-term studies, reductions in average body weight
at day seven or discharge were statistically significantly
different between the tolvaptan group versus the placebo group,
3.35 kilograms (kg) and 2.73 kg, respectively, in study A (p less
than 0.001) and 3.77 kg and 2.79 kg, respectively, in study B (p
less than 0.001). In addition, the use of tolvaptan significantly
reduced patients' body weight as early as on the first day of
treatment in both short-term studies (p less than 0.001).(1) There
was no significant difference between the treatment groups in
improvement in patient-assessed global clinical status at day 7 or
discharge, if earlier; however the changes were numerically in
favor
'"/>
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