Intravenous Itraconazole vs. Amphotericin B Deoxycholate for Empirical Antifungal Therapy in Patients with Persistent Neutropenic Fever.
10.3904/kjim.2006.21.3.165
- Author:
Sun Hee PARK
1
;
Su Mi CHOI
;
Dong Gun LEE
;
Jung Hyun CHOI
;
Jin Hong YOO
;
Woo Sung MIN
;
Wan Shik SHIN
Author Information
1. Department of Internal Medicine, The Catholic Hematopoietic Stem Cell Transplantation Center, The Catholic University of Korea College of Medicine, Seoul, Korea. zenithbr@catholic.ac.kr
- Publication Type:Original Article ; Clinical Trial ; Comparative Study
- Keywords:
Itraconazole;
Amphotericin B deoxycholate;
Empirical antifungal therapy;
Persistent febrile neutropenia
- MeSH:
Neutropenia/drug therapy/*physiopathology;
Male;
Itraconazole/*administration & dosage/therapeutic use;
Infusions, Intravenous;
Humans;
Hematologic Neoplasms/*drug therapy/physiopathology;
Fever/drug therapy/*physiopathology;
Female;
Chronic Disease;
Case-Control Studies;
Antifungal Agents/*administration & dosage/therapeutic use;
Amphotericin B/*administration & dosage/therapeutic use;
Adult
- From:The Korean Journal of Internal Medicine
2006;21(3):165-172
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND: Amphotericin B dexoycholate is currently the standard empirical antifungal therapy for neutropenic patients with hematologic malignancies and who also have persistent fever that does not respond to antibacterial therapy. The antifungal triazoles offer a potentially safer and effective treatment alternative to Amphotericin B dexoycholate. METHODS: We assessed the efficacy and safety of intravenous itraconazole, as compared with the efficacy and safety of amphotericin B deoxycholate, as an empirical antifungal therapeutic agent in a matched case-control clinical trial from June 2004 to August 2005. RESULTS: Efficacy was evaluated in 96 patients (48 received itraconazole and 48 received amphotericin B deoxycholate) and all the patients who received the study drugs were evaluated for safety. The baseline demographic characteristics were well matched. The overall success rates were 47.9% for itraconazole and 43.8% for amphotericin B deoxycholate (% difference: 4.1 % [95% confidence interval for the difference: -15.8 to 24]), which fulfilled the statistical criteria for the non-inferiority of itraconazole. The proportions of patients who survived for at least seven days after discontinuation of therapy or who were prematurely discontinued from the study were not significantly different between the two groups. The rates of breakthrough fungal infections and resolution of fever during neutropenia were similar in both groups. More patients who received amphotericin B deoxycholate developed nephrotoxicity, hypokalemia or infusion-related events than did those patients who received itraconazole (nephrotoxicity: 16.7% vs. 1.8%, hypokalemia: 66.7% vs. 24.6%, and infusion-related events: 41.7% vs. 3.5%, respectively). CONCLUSIONS: Intravenous itraconazole is as effective as amphotericin B deoxycholate and it is generally better tolerated than amphotericin B deoxycholate when it is given as empirical antifungal therapy for Korean patients with persistent neutropenic fever.
