Xigris Looked at Again for Sepsis

Drotrecogin alfa reviewed again in large meta analysis

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Last year a drug designed to treat patients with severe sepsis was yanked from the market after a large study's results showed no benefit. Guess what...a new study shows that no-longer-available drug may, in fact, offer an effective treatment.

Drotrecogin alfa (activated), also called Xigris, was removed from the market on October 25, 2011 by marketer Eli Lilly & Company.

In addition to a major study that suggested the drug wasn't effective at treating severe cases of sepsis, a type of bloodstream infection, doctors also had questions about side effects including a higher risk of serious bleeding.

However, some concerns over the medication may have been unwarranted. A new review study suggests drotrecogin alfa reduces the risk of mortality among patients with severe sepsis.

"Wash your hands frequently to keep infections at bay."

Andre C Kalil, MD, a lead researcher from the Department of Internal Medicine at the University of Nebraska Medical Center, still found that the drug was associated with an increased risk of bleeding.

Though the drug did not benefit all patients while it was on the market and doctors had a tough time pinpointing who would benefit, it was the only approved drug for treating severe sepsis. The departure of drotrecogin alfa from the market left physicians without any approved treatment specifically for sepsis.

During the review study researchers reviewed 10 years worth of studies beginning in 2001, the year that drotrecogin alfa was approved to treat sepsis. Investigators adjusted risk ratios to examine the drug for effectiveness and safety, including bleeding risk. They also assessed the effect of the severity of illness on risk of dying.

Reviewed research included nine controlled trials with 41,401 patients and 16 single-group studies with 5,822 participants to analyze the drug's effectiveness, and an additional 20 studies with 8,245 participants used to determine the medication's safety.

Researchers found that drotrecogin alfa reduced the hospital mortality of patients with severe sepsis by 18 percent. This was similar to the findings of the previous PROWESS trial. The current study also suggested that patients with more severe forms of the bloodstream infection may receive greater benefits.

The single-group study findings suggested a hospital mortality rate of 41 percent, greater than the 31 percent found during the PROWESS trial.

The rate of serious bleeding was determined to be up to 6 percent, higher than the 3.5 percent identified in PROWESS, but similar when examining only PROWESS patients with higher disease severity.

The study was recently published in journal The Lancet Infectious Diseases.

Reviewed by: 
Review Date: 
July 18, 2012
Last Updated:
July 21, 2012