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Efficacy and safety of micafungin versus intravenous itraconazole as empirical antifungal therapy for febrile neutropenic patients with hematological malignancies: a randomized, controlled, prospective, multicenter study

Title
Efficacy and safety of micafungin versus intravenous itraconazole as empirical antifungal therapy for febrile neutropenic patients with hematological malignancies: a randomized, controlled, prospective, multicenter study
Authors
Jeong, Seong HyunKim, Dae YoungJang, Jun HoMun, Yeung-ChulChoi, Chul WonKim, Sung-HyunKim, Jin SeokPark, Joon Seong
Ewha Authors
문영철
SCOPUS Author ID
문영철scopus
Issue Date
2016
Journal Title
ANNALS OF HEMATOLOGY
ISSN
0939-5555JCR Link1432-0584JCR Link
Citation
vol. 95, no. 2, pp. 337 - 344
Keywords
MicafunginEmpiricalFebrile neutropenia
Publisher
SPRINGER
Indexed
SCI; SCIE; SCOPUS WOS scopus
Abstract
Micafungin, a clinically important echinocandin antifungal drug, needs to be investigated as empirical therapy in febrile neutropenia in comparison with azole compounds. A prospective randomized study was conducted to compare clinical outcomes between micafungin and intravenous itraconazole as an empirical therapy for febrile neutropenia in hematological malignancies. The antifungal drug (micafungin 100 mg or itraconazole 200 mg IV once daily) was given for high fever that was sustained despite the administration of appropriate antibiotics. Treatment success was determined by composite end points based on breakthrough invasive fungal infection (IFI), survival, premature discontinuation, defervescence, and treatment of baseline fungal infection. Duration of fever, hospital stay, and overall survival (OS) were studied. A total of 153 patients were randomized to receive micafungin or itraconazole. The overall success rate was 7.1 % point higher in the micafungin group (64.4 vs. 57.3%, p=0.404), satisfying the statistical criteria for the non-inferiority of micafungin. The duration of fever and hospital stay were significantly shorter in the micafungin group (6 vs. 7 days, p=0.014; 22 vs. 27 days, p=0.033, respectively). Grade 3 adverse events including hyperbilirubinemia (2 vs. 7), elevation of transaminase levels (2 vs. 4), electrolyte imbalance (1 vs. 2), atrial fibrillation (1 vs. 0), and anaphylaxis (1 vs. 0) occurred in 7 and 13 patients in the micafungin (10.4 %) and itraconazole (18.8 %) groups, respectively. Micafungin, when compared with itraconazole, had favorably comparable success rate and toxicity profiles on febrile neutropenia in patients with hematological malignancies. In addition, it showed superior effect on shortening the hospital stay.
DOI
10.1007/s00277-015-2545-2
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의과대학 > 의학과 > Journal papers
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