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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

hospitalized heart failure patients,"(1) said Cesare Orlandi, M.D., vice president of Clinical Development at Otsuka Pharmaceutical Development & Commercialization, Inc.

Safety Data

Common adverse events associated with tolvaptan were dry mouth and thirst, which are consistent with the pharmacologic effects of the drug.(1,2) In the EVEREST trial, adverse events resulting in study drug discontinuation occurred in 6.5 percent of tolvaptan patients and 5.5 percent of placebo patients. Among these, only thirst occurred significantly more frequently with tolvaptan (n equal to 7) vs. placebo (n equal to 0); (p equal to 0.02). Dry mouth resulted in discontinuation in 4 tolvaptan patients vs. 0 placebo patients (p equal to 0.12).

Hypernatremia occurred in 1.7 percent of tolvaptan patients, compared to 0.5 percent of placebo patients. The incidence of kidney failure and low blood pressure were comparable in the two groups. Tolvaptan-treated patients showed no differences from placebo-treated patients with regards to heart rate and blood pressure. In addition, tolvaptan demonstrated no deleterious effects on renal function relative to placebo in these patients.(2)

About EVEREST

EVEREST is a landmark, prospective, international, multicenter, randomized, double-blind, placebo-controlled trial conducted at 432 sites in North America, South America and Europe between 2003 and 2006. EVEREST investigators randomized patients with worsening congestive heart failure and who had a left ventricular ejection fraction (LVEF) of 40 percent or less within 48 hours of their hospitalization to receive either 30 milligrams (mg) tolvaptan once-daily or a placebo until the end of the long-term outcome trial. Additionally, treating physicians could choose conventional therapies for their patients, including diuretics, digoxin, ACE inhibitors, angiotensin II receptor blockers, aldosterone blockers, beta-blockers, nitrates, nesiritide and/or hydralazine.(1)<
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