Experimental drug fails to reduce deaths from sepsis infection

Wednesday, July 9, 2003

CHICAGO -- An experimental drug has failed to live up to expectations that it could treat a life-threatening bloodstream infection called sepsis that affects more than a half-million Americans a year.

The intravenous drug tifacogin, developed by Chiron Corp., did not reduce deaths from severe sepsis in a study of 1,754 patients in 17 countries. In fact, the drug was linked with an increased risk of bleeding.

When the study was designed, researchers were racing to develop the first drug to directly treat the underlying process in sepsis, which causes inflammation and blood clots that damage vital organs.

Shortly after the study ended in September 2001, a similar drug, Eli Lilly's Xigris, won federal approval as the first such medication.

The tifacogin findings appear in today's Journal of the American Medical Association. The research was led by Dr. Edward Abraham of the University of Colorado Health Sciences Center and was funded by Chiron and Pharmacia Corp., which would have marketed the drug had it been successful,

About 700,000 Americans develop sepsis each year. Many are already sick with ailments caused by various organisms that overcome the bloodstream, including bacterial pneumonia.

In the tifacogin study, sepsis patients were given the drug or a placebo for 96 hours. In the seven weeks afterward, there were 301 deaths in the tifacogin group and 296 in the placebo patients, about 34 percent each.

Bleeding complications occurred in 138 patients in the drug group, or 23 percent, compared with 114, or 19 percent, in the placebo group.

Tifacogin might have been ineffective because patients were generally sicker and had more organ damage than those in the Xigris research, said Emory University's Dr. Greg Martin, who participated in a Xigris study.

He said tifacogin would have been hailed as a "wonder drug" if it had proved its effectiveness before Xigris.

Chiron spokesman John Gallagher said the company has not given up on the drug.

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JAMA: http://jama.ama-assn.org

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