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Results From Phase II Trial in Critical Care Medicine Showed Eritoran Tetrasodium (E5564) To Be Well Tolerated in Patients with Severe Sepsis
Date:12/22/2009

x days) and 94 patients received eritoran high-dose (105mg given every 12 hours for six days). Seven patients did not receive any trial drug and were not included in the modified intent to treat population for analysis. Eritoran or placebo doses were administered via intravenous infusion within 12 hours of recognition of severe sepsis and repeated every 12 hours for six days.

In this Phase II trial, eritoran was well tolerated, and the following adverse events were found:

Anemia, diarrhea, insomnia, acute renal failure and rash were observed more frequently in the group receiving eritoran compared to the group receiving placebo, although not statistically significant.

Serious adverse events that occurred in greater than 5% of patients in both the eritoran and placebo treated groups included cardiac arrest, multiorgan failure, sepsis, respiratory failure and deep vein thrombosis.

Four patients in the group receiving eritoran experienced a hepatobiliary serious adverse event compared with none in the group receiving placebo. Three of these four subjects had pre-existing liver disease.

A higher incidence of atrial fibrillation seen in the eritoran high-dose group (12.8%) compared to placebo (7.3%) was not statistically significant. Instances were mild or moderate in severity and it was unclear if the increased incidence is related to eritoran administration.

Phlebitis (inflammation of the vein) was observed in 6.7% of patients dosed with eritoran high-dose through a peripheral vein (versus 1.6% through central line); affected subjects recovered. No patient in the group receiving placebo experienced phlebitis.

The occurrence of infectious complications reported as adverse events by trial investigators did not differ notably among the three groups.

The mortality in the placebo, low-dose and high-dose groups was 33.3%, 32% and 26.6% respectively. Although not statistically signific
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SOURCE Eisai
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