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Drotrecogin Alfa (Activated) Effective in Severe Sepsis

Last Updated: July 17, 2012.

 

Results of meta-analysis similar to those of original PROWESS trial, but risk of bleeding increased

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For patients with severe sepsis, drotrecogin alfa (activated) is associated with significant reductions in hospital mortality, according to a study published online July 17 in The Lancet Infectious Diseases.

TUESDAY, July 17 (HealthDay News) -- For patients with severe sepsis, drotrecogin alfa (activated) is associated with significant reductions in hospital mortality, according to a study published online July 17 in The Lancet Infectious Diseases.

Andre C. Kalil, M.D., from the University of Nebraska Medical Center in Omaha, and Steven P. LaRosa, M.D., from Beverly Hospital in Massachusetts, conducted a meta-analysis and metaregression to assess the effectiveness and safety of drotrecogin alfa (activated) in the past 10 years. Results were compared with those from the original Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial.

In the effectiveness analyses, the researchers included nine controlled trials (41,401 patients) and 16 single-group studies (5,822 patients); 20 studies involving 8,245 patients were included in the safety analyses. There was an 18 percent reduction in hospital mortality with drotrecogin alfa (activated) versus controls (relative risk [RR], 0.822; I² = 40 percent), which was similar to that noted in the original PROWESS study (RR, 0.851) and smaller than that of patients with high disease severity in PROWESS (RR, 0.708). In propensity-adjusted studies, the mortality reduction was similar with lower heterogeneity (RR, 0.844; I² = 18 percent). Addition of the PROWESS-SHOCK results did not alter these findings. For single-group studies, the hospital mortality rate was 41 percent, significantly higher than that observed in PROWESS (31 percent). The rate of serious bleeding was 5.6 percent, significantly higher than the 3.5 percent observed in PROWESS and similar to that of patients with high disease severity in PROWESS (P = 0.073).

"Real-life use of drotrecogin alfa (activated) was associated with significant reduction in hospital mortality and increased rates of bleeding in patients with severe sepsis," the authors write.

Both authors disclosed financial ties to the pharmaceutical industry.

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Copyright © 2012 HealthDay. All rights reserved.


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