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
hospitalizedheart failure patients (1) said Cesare Orlandi M.D. v...Safety Data ...Common adverse events associated with tolvaptan were dry mouthand thi...Hypernatremia occurred in 1.7 percent of tolvaptan patientscompared ...About EVEREST ...
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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