RICHMOND, Va. – Recognition of severe septic shock early and starting a patient on an effective antibiotic treatment immediately is critical to saving lives, according to an editorial by two Virginia Commonwealth University physicians published in the May 31 issue of the New England Journal of Medicine.
In the editorial, Richard P. Wenzel, M.D., professor in the Department of Internal Medicine in the VCU School of Medicine, and Michael B. Edmond, M.D., M.P.H., chair of the Division of Infectious Diseases, noted that approximately 20 adjuvant drugs, apart from antibiotics, have failed in trials of sepsis in the last two decades. They concluded that new therapies will emerge only from a “more crystalline view of the biology of sepsis.”
Wenzel and Edmond based their observations on a multi-institutional study of a controversial drug for sepsis known as drotrecogin alfa. According to Wenzel and Edmond, the weight of evidence now should “end any further pursuit of a niche for Human Activated Protein C in sepsis.”
According to Wenzel, an initial study in 2001 of the drug showed modest success in treating sepsis. However, the favorable outcome of slightly reduced mortality could not be replicated in lower risk adult patients or in children with sepsis. The international team testing the new drug proceeded to enroll a large number of patients with the most severe stage of sepsis – septic shock – and waited for at least four hours of shock to enroll them. The drug had no effect on mortality different from the placebo. However, both study groups received antibiotic therapy.
Based on their analysis, Wenzel and Edmond noted that in studying mortality from an acute infection like sepsis, investigators fail to consider the component of death from infection separate from the component from underlying diseases.
“In other words, some people die with sepsis but not from it, and they die because they have serious underlying diseases like lung or heart disorders or cancer,” said Wenzel.
The VCU team showed that failing to consider each component leads to errors in calculating the necessary number of subjects in a clinical trial. However, Wenzel and Edmond also said that the trends in the recent trial were slightly in favor of placebo being safer that the drug.
EDITOR’S NOTE: A copy of the editorial is available to reporters in PDF format by email request from firstname.lastname@example.org.
- About VCU and the VCU Medical Center
Virginia Commonwealth University is a major, urban public research university with national and international rankings in sponsored research. Located on two downtown campuses in Richmond, VCU enrolls more than 31,000 students in 222 certificate and degree programs in the arts, sciences and humanities. Sixty-six of the programs are unique in Virginia, many of them crossing the disciplines of VCU’s 13 schools and one college. MCV Hospitals and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the nation’s leading academic medical centers. For more, see www.vcu.edu.
Sathya Achia Abraham
VCU Communications and Public Relations