Recombinant Human Activated Protein C

O1 Recombinant human activated protein C (drotrecogin alfa) is recommended for patients at a high risk of death (APACHE II score greater than or equal to 25, multiple-organ failure, septic shock, or ARDS) and no absolute contraindications related to bleeding.41 Drotrecogin alfa has antithrombotic, anti-inflammatory, and profibrinolyt-ic properties. The Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial evaluated the effects of a 96-hour continuous infusion of drotrecogin alfa. Drotrecogin alfa decreased 28-day mortality compared to placebo (30.8% versus 24.7%). A higher incidence of serious bleeding occurred during the 28-day period in the drotrecogin alfa group (3.5%) than in the placebo group (2.0%). An analysis of secondary endpoints suggested that the incidence of multiple-organ dysfunction was lower in patients treated with drotrecogin alfa, and that therapy was associated with more rapid recovery of cardiac and pulmonary function. A second study of patients with severe sepsis, Extended Evaluation of Recombinant Human Activated Protein C (ENHANCE) trial noted that 28-day all cause mortality for patients treated with drotrecogin alfa was similar to that observed in PROWESS. ENHANCE also found that patients treated within the first 24 hours of their first sepsis-induced organ dysfunction had significantly lower mortality than those treated after 24 hours (22.9-27.4%). Cost-effectiveness models have found that for septic patients with a APACHE II score greater than or equal to 25, the cost per year of life saved with drotrecogin alfa is $24,000 to $27,000, suggesting that this is a cost-effective therapy in patients with severe sepsis and septic shock. The effect of drotrecogin alfa on long-term survival was evaluated in a retrospective analysis of patients in PROWESS. The mortality benefit of drotrecogin alfa persisted up to hospital discharge; however, there were no mortality differences between drotrecogin alfa and

placebo thereafter.

Drotrecogin alfa is not recommended for severe sepsis patients at low risk for death. The Administration of Drotrecogin Alpha in Early Stage Severe Sepsis (ADDRESS) trial evaluated the effects of a 96-hour continuous infusion of drotrecogin alfa. There were no statistically significant differences between drotrecogin alfa and placebo in 28-day mortality (18.5% versus 17.0%)43 The rate of serious bleeding was higher for drotrecogin alfa during the 96-hour infusion and the 28-day study period.

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