(HealthDay News) – Eritoran, a synthetic analog of lipid A and a toll-like receptor 4 antagonist, is no better than placebo in reducing mortality in patients with severe sepsis, according to a study published in the March 20 issue of the Journal of the American Medical Association.
As part of a Phase III trial, Steven M. Opal, MD, from the Albert Einstein College of Medicine in Bronx, NY, and colleagues randomly assigned and treated 1,961 patients with severe sepsis with either placebo (657 patients) or 105mg eritoran tetrasodium (1,304 patients) within 12 hours of onset of first organ dysfunction.
The researchers found that the primary end point, 28-day all-cause mortality, was similar in the eritoran and placebo groups (28.1% and 26.9%, respectively; hazard ratio, 1.05). A secondary end point of one-year all-cause mortality was also similar in both groups (44.1% and 43.3%, respectively; hazard ratio, 0.98). Adverse event rates were similar in both groups.
“In summary, in this phase 3 trial eritoran did not significantly improve outcome for patients with severe sepsis and septic shock,” Opal and colleagues conclude. “Eritoran joins a long list of other experimental sepsis treatments that do not improve outcomes in clinical trials in these critically ill patients.”
The study was funded by Eisai, the manufacturer of eritoran; several authors disclosed financial ties to pharmaceutical companies, including Eisai.