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| |  Tolvaptan Helps Patients With Worsening Heart Failure: Presented at HFSA By Jill Stein TORONTO -- September 24, 2008 -- Tolvaptan, when added to standard therapy, may help relieve congestion in heart failure patients who are hospitalised with renal impairment and low systolic blood pressure, according to data presented at the Heart Failure Society of America (HFSA) 12th Annual Scientific Meeting. Peter Pang, MD, Northwestern University, Chicago, Illinois, and colleagues determined the short- and long-term effects of the investigational oral vasopressin antagonist tolvaptan in patients with hypotension and renal impairment. For their investigation, they conducted a retrospective subanalysis of the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST). Dr. Pang presented the findings on September 23. The prospective, multicentre, randomised, double-blind, placebo-controlled EVEREST study evaluated the short- and long-term efficacy and safety of tolvaptan when added to standard therapy in 4,133 adults hospitalised for worsening heart failure and a left ventricular ejection fraction <=40%. Patients in the study were randomised to standard therapy alone or to standard therapy with tolvaptan 30 mg/day or matching placebo and were followed for 9.9 months. "Although congestion is the number-1 reason for hospital admissions for acute heart failure syndromes, patients with a low systolic blood pressure (<=105 mm Hg) and high blood urea nitrogen levels (>20 mg/dL) often do not respond adequately to traditional diuretic therapy," Dr. Pang pointed out. "Effective and safe relief of congestion in this high-risk subgroup is needed." The EVEREST trial included 759 patients with renal impairment and low systolic pressure. Patients in this subgroup who had been randomised to tolvaptan experienced a decrease in the signs and symptoms of congestion that was associated with weight loss as early as the first day of treatment. Mean weight loss in the tolvaptan and placebo groups was 1.63 and 0.76 kg, respectively, at day 1 (P < .0001). At day 7 or discharge (whichever came first), weight loss was 3.23 kg with tolvaptan and 2.10 kg with placebo (P < .0001). As in the overall EVEREST cohort, the positive benefits observed in this "difficult-to-treat population" were achieved without any negative effect on heart rate, blood pressure, or serum electrolytes, Dr. Pang noted. Funding for the study was provided by the Otsuka Research Institute.
[Presentation title: Effects of Tolvaptan in Patients Hospitalized With Heart Failure and Renal Impairment and Hypotension in the EVEREST Trial. Abstract 222]
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