Drotrecogin alfa (activated) - A new approach to treating sepsis

Drotrecogin alfa (activated), a recombinantly produced preparation of human activated protein C, reduces the inflammatory, procoagulant, and antifibri nolytic host response to infection. At press time, an FDA advisory committe e was split over whether to recommend it for approval for treating severe s epsis. An FDA decision on approval was expected at the end of October. The large PROWESS trial demonstrated a 6.1% absolute reduction In the risk of d eath in adults with severe sepsis treated with drotrecogin alfa as opposed to placebo (p = 0.005). At the same time, there was a trend toward an incre ased incidence of serious bleeding with drotrecogin alfa compared with plac ebo. Clinical efficacy has not been demonstrated in pediatric patients with sepsis and must at this point be extrapolated from the PROWESS trial. The cost of the drotrecogin alfa is unknown at press time but is expected to be considerable. Pharmacoeconomic analysis is needed to further define the ag ent's role in patients with severe sepsis, Treatment benefit is not proven in patients who do not meet predefined inclusion criteria; therefore, poten tial candidates for drotrecogin alfa therapy should be carefully screened a nd stringent institutional protocols developed for optimal use.