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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

of tolvaptan.

In each short-term study, significantly more patients in the tolvaptan groups reported improvements in dyspnea (difficult breathing) on the first inpatient day compared with the placebo groups (p less than 0.001 in both study A and study B). Significantly more patients in the tolvaptan group had improvements in investigator-assessed pedal edema at inpatient day seven or discharge in study B (p equal to 0.020), while the difference between groups in study A did not reach statistical significance (p equal to 0.070).(1)

Long-Term Trial: Pre-Specified Secondary Endpoints

The secondary endpoints of the composite of cardiovascular death or cardiovascular hospitalization, the incidence of cardiovascular mortality, and the incidence of clinical worsening of heart failure did not differ between the two treatment groups. A larger number of cardiovascular hospitalizations were adjudicated as due to myocardial infarction in the placebo group (n equal to 42) than in the tolvaptan group (n equal to 25) and a larger number were adjudicated as due to stroke in the tolvaptan group (n equal to 45) than in the placebo group (n equal to 24).(2)

The long-term tolvaptan data were consistent with those reported in the short-term clinical studies. Specifically, long-term tolvaptan treatment significantly reduced participants' body weight at day one (p less than 0.001) compared to placebo and the difference in body weight numerically favored tolvaptan through week 56. The long-term trial also documented that tolvaptan patients who enrolled with hyponatremia (serum sodium less than 134 mEq/L) exhibited significantly greater corrections in serum sodium at day seven or discharge, if earlier, (p less than 0.001) and the effect was maintained through 40 weeks of treatment.(2)

"The EVEREST data suggest that the mechanism of action of tolvaptan may represent a new therapeutic strategy that could provide symptomatic improvement for short-term care of
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