Drotrecogin alfa: new preparation. For some cases of severe XXXX ?

@entity1 @entity295 @entity548 @entity3790 @entity204
(1) @entity295 is fatal in 30-50% of cases, despite antibiotic therapy and intensive care. (2) The first specific treatment to be marketed in France was HA-IA monoclonal antibodies, in 1991. However, marketing approval was granted precipitously, on the basis of a single, controversial comparative trial, and the product was withdrawn after a second trial gave negative results. (3) Marketing authorization for drotrecogin alfa (recombinant activated @entity3790 ) was granted in 2002 for this indication. (4) The product was approved after a single comparative double-blind placebo-controlled trial in 1 690 @entity1 . The protocol was modified during the trial, to exclude @entity1 at high risk of @entity204 from causes unrelated to @entity295 . The manufacturing process was also changed, making it difficult to interpret the results of this trial. (5) The trial found that drotrecogin alfa reduced mortality (by 6% in absolute values: 25% versus 31%), but also increased the risk of severe @entity548 , the main adverse effect (3.5% versus 2%). (6) Retrospective subgroup analyses identified @entity1 most likely to benefit from drotrecogin alfa, and also @entity1 who would be needlessly exposed to an additional risk. (7) Drotrecogin alfa is a very expensive drug. (8) In practice, this clinical trial should be considered preliminary. Other, strictly designed and conducted trials are therefore required.
