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In a meta-analysis assessing recombinant human activated protein C and including the PROWESS and ADDRESS studies, the heterogeneity of the results (efficacy in the PROWESS study, failure in the ADDRESS study) was observed even when considering patients with APACHE II score ≥ 25 [25].
These data suggest that a potential sequence effect was present in the ADDRESS study as was observed in PROWESS.
At the time of termination, 2,640 patients had been enrolled in the ADDRESS study at 516 centers in 34 countries.
Among the RCTs identified, the PROWESS reported 30 (3.5%) 28-day serious bleeding events with drotrecogin alfa and 17 (2%) with placebo (p = 0.06), in the ADDRESS study there were 51 (3.9%) and 28 (2.2%) such events respectively (p = 0.01) [ 14].
In a meta-analysis assessing recombinant human activated protein C and including the PROWESS and ADDRESS studies, the heterogeneity of the results (efficacy in the PROWESS study, failure in the ADDRESS study) was observed even when considering patients with APACHE II score ≥ 25 [ 25].
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