[Identification of surgical patients for therapy with activated Drotrecogin alfa].

There is uncertainty whether surgical patients with severe sepsis have a benefit from therapy with Drotrecogin alfa (activated). In the PROWESS and ENHANCE studies 4,068 patients were included and 3,228 were treated with Drotrecogin alfa (activated). Approximately 28% of the PROWESS patients and 41% of the ENHANCE patients were surgical patients. The subgroup of surgical patients showed the same benefit from therapy with Drotrecogin alfa (activated) as the overall cohort. The relative risk was 0.9 (95% CI 0.7-1.25, absolute risk reduction 3.2%). Patients with intraabdominal infections have a special benefit and here the relative risk was 0.7 (95% CI 0.5-1.0, absolute risk reduction 9.1%). Serious bleeding was more frequent in patients treated with Drotrecogin alfa (activated): 2.4-3.6% vs. 1.0% in the placebo group. In surgical patients bleeding was not more frequent than in non-surgical patients (3.1% vs. 2.1%, difference not significant). Surgical patients with severe sepsis, especially with peritonitis, should receive therapy with Drotrecogin alfa (activated), if severely ill.

RCT Entities:   Population Interventions Outcomes