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ECLIPSE Data on Effects of Otsuka's Investigational Novel Treatment, Tolvaptan, on Advanced Heart Failure Patients' Hemodynamics and Urine Output Featured in Heart Failure Society of America's Late Breaking Trials
Date:9/19/2007

onary edema, and an estimate of the filling pressures of the left side of the heart.

Compared with placebo, each dose of tolvaptan significantly increased urine volume at 3 hours after dose was given (p<0.0001). Also, during the three to eight hour interval after tolvaptan administration, mean reductions of the pressure in the pulmonary artery that carries venous blood from the right ventricle of the heart to the lungs, a secondary endpoint, were observed and were statistically greater (p<0.05) in all tolvaptan groups than in the placebo group. Over the same time period, mean reductions in pressure within the heart's right atrium were also observed, and those were statistically greater in the tolvaptan 15 mg and 30 mg groups than in the placebo group. None of the other secondary outcome measures, including cardiac output (the amount of blood the heart's left ventricle ejects into the circulation in one minute), cardiac index (cardiac output indexed to a patient's body size), systemic vascular resistance (the resistance to blood flow by all of the blood vessels, excluding those in the lungs), heart rate, and blood pressure, showed significantly different changes in the tolvaptan and placebo groups.

Overall, 77 (42.5%) subjects experienced at least one treatment-emergent adverse event during the trial. The incidence of these events was highest in the tolvaptan 60 mg group (54.3%) and lowest in the placebo group (33.3%). Most common adverse events (greater than 3% and more frequent than placebo) associated with tolvaptan were dry mouth, thirst, back pain, headache, anxiety, and haematuria. No treatment-emergent adverse event occurred in more than 10% of the patients in any of the groups. No deaths occurred during study drug administration. Two patients died during the 7-day follow-up period (originally assigned to tolvaptan 30 mg and 60 mg, respectively). Both of those patients died from complications resulting from worsening of underlying disease.

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SOURCE Otsuka America Pharmaceutical, Inc.
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