New Drug Reduces Death Rate from Sepsis

A worldwide phase III clinical study has shown that recombinant human activated protein C can reduce the relative risk of death from severe sepsis. The study is to be published in the March 8 issue of The New England Journal of Medicine, but was posted early on the journal's website on February 9 because of the potential benefit to patients. Sepsis is the leading cause of death worldwide in the noncoronary intensive care units.

The randomized multicenter study involved 1,690 patients with systemic inflammation and organ failure due to acute infection, of whom 840 were in the placebo group and 850 in the protein C group. Those in the latter group received an intravenous infusion of recombinant human activated protein C for 96 hours. The mortality rate was 30.8% in the placebo group and 24.7% in the protein C group, for a reduction of 19.4% in the relative risk of death. Treatment with protein C may be associated with an increased risk of bleeding, according to the researchers. The recombinant drug used in the study, to be marketed under the name Zovant, is the product of Eli Lilly & Co.(Indianapolis, IN, USA).

"If Zovant turns out to be a successful treatment for this problem we would be able to see a substantial improvement in mortality and this would be a dramatic advance for critical care,” said lead investigator of the trial, Gordon Bernard, M.D., associate director of the division of allergy, pulmonary, and critical care medicine, Vanderbilt University (Nashville, TN, USA).