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01 March 2006

Results of severe sepsis treatment program using recombinant human activated protein C in Poland.

Andrzej Kübler, Ewa Mayzner-Zawadzka, Grażyna Durek, Wojciech Gaszyński, Ewa Karpel, Małgorzata Mikaszewska-Sokolewicz, Paweł Majak

Med Sci Monit 2006; 12(3): CR107-112 :: ID: 447107

Abstract

Background: Recombinant human activated protein C (drotrecogin alfa [activated]- DAA) demonstrated in Phase III controlled clinical studies significant reduction of mortality in patientswith severe sepsis and high risk of death. The aim of the study was to assess the therapeutic efficacyof DAA in patients included in the National Severe Sepsis Register in Poland. Material/Methods: The analysisincluded 3233 cases of severe sepsis reported between 04.2003 and 11.2005. 302 patients (9.3%) were treatedwith DAA. The clinical course of the disease in DAA and non-DAA treatment groups was compared. Logisticregression models for the effects of independent variables on the risk of death (dependent variable)were developed. Results: In the patients treated with DAA, the relative risk of death was lower by 31%than in those who were not treated. In a multivariate logistic regression model, the use of DAA was,independently of the patient's age, severity of the clinical condition and type of organ dysfunction,the most significant mortality-reducing factor in severe sepsis. Conclusions: The use of DAA in the treatmentof severe sepsis proved to be a very effective method of mortality reduction. Controlled nationwide surveillanceprogram contributed to its effective utilization. The National Severe Sepsis Register proved to be avery useful instrument for assessment of the course of the disease and treatment efficacy.

Keywords: Sepsis - mortality, Registries, Recombinant Proteins - therapeutic use, Protein C - therapeutic use, Population Surveillance, Poland - epidemiology, Multivariate Analysis, Anti-Infective Agents - therapeutic use, Logistic Models, Intensive Care Units - statistics & numerical data, Hemorrhage - chemically induced, Evaluation Studies as Topic, APACHE

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