Key result
Treatment with drotrecogin in patients with severe sepsis resulted in a 28-day mortality rate of 27%, comparable to original trial results despite the selection of more critically ill patients.
Why the study?
What are the clinical outcomes and safety of drotrecogin alfa in real-world patients with severe sepsis?
Observational (n=22)
Yes
What are the clinical outcomes and safety of drotrecogin alfa in real-world patients with severe sepsis?
Real-world use of drotrecogin alfa in severe sepsis showed a 28-day mortality rate of 27%, comparable to clinical trial results, though serious bleeding complications occurred.
Supports drotrecogin mortality signals in severe sepsis; case report data leave open safety and efficacy confirmation.
Background Drotrecogin alfa (activated) is a recombinant human activated protein C approved to reduce mortality in patients with severe sepsis. In the PROWESS study, a 28‐day mortality rate of 24.7% was observed in septic patients treated with drotrecogin compared to 30.8% in the placebo group. Aim To compare experience in inpatients with sepsis with the published experience and assess compliance with Queensland Hospitals Drug Advisory Committee prescribing protocol. Method A retrospective review was conducted using data obtained from patients treated with drotrecogin over a 2‐year period at two Brisbane hospitals. Data collection included patient demographics, presenting condition, past medical history, medications, compliance with the prescribing protocol, clinical outcome and safety. Results 22 patients were treated with drotrecogin. The mean age was 48.7 years (range 17–81). All patients complied with the protocol inclusion criteria, had evidence of serious infection, required mechanical ventilation and had 2 or more organ failures. 6 patients (27%) died during the 28‐day post‐administration period. A number of patients had significant co‐morbidities including 4 with cirrhosis and 3 with cancer. Patients often received the drug despite having conditions listed as precautions and relative contraindications. There were 2 confirmed cases of serious bleeding complications. Conclusions Treatment outcomes were comparable to the original trial results, despite the selection of more critically ill patients. All patients met strict inclusion criteria, but consideration of relative contraindications and co‐morbidities could be improved.
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Mackenzie et al. (2006) conducted an observational in severe sepsis (n=22). Drotrecogin alfa (activated) was evaluated on 28-day mortality. Treatment with drotrecogin in patients with severe sepsis resulted in a 28-day mortality rate of 27%, comparable to original trial results despite the selection of more critically ill patients.
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