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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

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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