Use of Drotrecogin alfa (activated) in Italian intensive care units: the results of a nationwide survey

被引:67
作者
Bertolini, Guido
Rossi, Carlotta
Anghileri, Abramo
Livigni, Sergio
Addis, Antonio
Poole, Daniele
机构
[1] Ist Ric Farmacol Mario Negri, Ctr Ric Clin Malattie Rare Aldo & Cele Dacco, Lab Clin Epidemiol, GIVITI Coordinating Ctr, I-24020 Ranica, Bergamo, Italy
[2] Osped San Giovanni Bosco, Serv Anestesia & Rianimaz BDEA, I-10148 Turin, Italy
[3] AIFA, Minist Salute, I-00144 Rome, Italy
[4] Osped Civile San Martino di Belluno, Serv Anestesia & Rianimaz, I-32100 Belluno, Italy
关键词
intensive care; Drotrecogin alfa activated; drug utilization review; severe sepsis; septic shock;
D O I
10.1007/s00134-007-0554-x
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
Objective: To monitor the use of drotrecogin alfa activated (DrotAA) in Italy and its effects on patients' health. Design: Prospective pharmaco-surveillance program with a parallel non-randomized control group. Setting: The Ministry of Health required all intensive care units (ICUs) using DrotAA to participate in the pharmaco-surveillance program. Our control group was formed of patients eligible for treatment with DrotAA but who had not received it. Patients and participants: The data we collected included basic demographic characteristics, indications, modalities of use, adverse events, and ICU mortality. We identified potentially non-collaborating centres on the basis of data on DrotAA purchasing by hospitals. Measurements and results: From 2003 to 2006, 668 cases of treatment with DrotAA were reported. We estimate that 79.3% of all patients treated in Italy in this period were recruited. Off-label use was common. Delayed start was the main reason for off-label prescription. Bleeding during infusion occurred in 73 patients (10.9%). The ICU mortality was higher in patients with bleeding (57.5 vs. 44.9%; p = 0.041). Crude ICU mortality was lower in patients receiving DrotAA than in controls (46.4 vs. 54.9%; p = 0.0004); however, multivariate analysis, which adjusted for certain relevant differences, showed that DrotAA treatment was associated with higher mortality after scheduled surgery. Conclusions: These results question the way in which the drug is used in everyday clinical practice and its efficacy in a selected subgroup, and reinforce the need for a new, independent, confirmatory trial to reassess the risk-to-benefit ratio of DrotAA.
引用
收藏
页码:426 / 434
页数:9
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