Intravenous itraconazole vs. amphotericin B deoxycholate for empirical antifungal therapy in patients with persistent neutropenic fever.
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.
Park
Sun Hee
SH
Department of Internal Medicine, The Catholic Hematopoietic Stem Cell Transplantation Center, The Catholic University of Korea College of Medicine, Seoul, Korea.
Choi
Su-Mi
SM
Lee
Dong-Gun
DG
Choi
Jung-Hyun
JH
Yoo
Jin-Hong
JH
Min
Woo-Sung
WS
Shin
Wan-Shik
WS
D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage* / Q000627:therapeutic use; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D016022:Case-Control Studies; D002908:Chronic Disease; D005260:Female; D005334:Fever / Q000188:drug therapy / Q000503:physiopathology*; D019337:Hematologic Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007262:Infusions, Intravenous; D017964:Itraconazole / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D009503:Neutropenia / Q000188:drug therapy / Q000503:physiopathology*
D000935:Antifungal Agents; D017964:Itraconazole; D000666:Amphotericin B