ECLIPSE data on effects of Otsuka's investigational novel treatment,...( PRINCETON N.J. Sept. 19 2007 -- A sin...),Health

PRINCETON, N.J., Sept. 19, 2007 -- A single dose of Otsukas investigational oral medication tolvaptan, a vasopressin receptor antagonist, resulted in favorable changes in hemodynamics associated with a significant increase in urine output in patients with advanced heart failure (ADHF) who participated in the international trial the EffeCt of ToLvaptan on HemodynamIc Parameters in Subjects with HEart failure (ECLIPSE), presented at the late breaking trials symposium of the Heart Failure Society of Americas Annual Scientific Meeting (HFSA).

These ECLIPSE data are the first to clarify the hemodynamic effects of orally dosed tolvaptan in patients with advanced heart failure due to systolic dysfunction. Such details of the mechanism of action of tolvaptan help us further understand its clinical effects, said investigator James Udelson M.D., associate chief of the Division of Cardiology at the Tufts-New England Medical Center and associate professor of medicine at Tufts University School of Medicine.

In the ECLIPSE study, 180 patients with symptomatic heart failure (New York Heart Association class III and IV) were randomized to double-blind treatment with tolvaptan at a single oral dose of 15, 30, 60 mg or placebo. All three doses of tolvaptan examined in ECLIPSE significantly changed the primary outcome variable, pulmonary capillary wedge pressure (PCWP), compared to placebo treatment (tolvaptan 15 mg -6.38 0.62 mmHg, tolvaptan 30 mg- 5.67 0.70 mmHg, tolvaptan 60 mg -5.71 0.65 mmHg, placebo -4.16 0.67 mmHg; p vs. placebo less than 0.05 for each tolvaptan group). The primary statistical analysis comparing the effects across the placebo group and two higher doses of tolvaptan approach statistical significance (p=0.0563). PCWP provides information about two aspects of lung and heart function: an estimate of the lung capillary pressure, which is the fluid pressure that plays a role in pulmonary edema, and an estimate of the filling pressure
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