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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

 Seong Hyun Jeong  ;  Dae Young Kim  ;  Jun Ho Jang  ;  Yeung-Chul Mun  ;  Chul Won Choi  ;  Sung-Hyun Kim  ;  Jin Seok Kim  ;  Joon Seong Park 
 ANNALS OF HEMATOLOGY, Vol.95(2) : 337-344, 2016 
Journal Title
Issue Date
Administration, Intravenous ; Adult ; Aged ; Aged, 80 and over ; Antifungal Agents/administration & dosage* ; Antifungal Agents/adverse effects ; Echinocandins/administration & dosage* ; Echinocandins/adverse effects ; Empirical Research ; Febrile Neutropenia/diagnosis ; Febrile Neutropenia/drug therapy* ; Febrile Neutropenia/epidemiology ; Female ; Hematologic Neoplasms/diagnosis ; Hematologic Neoplasms/drug therapy* ; Hematologic Neoplasms/epidemiology ; Humans ; Itraconazole/administration & dosage* ; Itraconazole/adverse effects ; Length of Stay/trends ; Lipopeptides/administration & dosage* ; Lipopeptides/adverse effects ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome ; Young Adult
Empirical ; Febrile neutropenia ; Micafungin
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jin Seok(김진석) ORCID logo https://orcid.org/0000-0001-8986-8436
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