Itraconazole prevents invasive fungal infections in neutropenic patients treated for hematologic malignancies: evidence from a meta-analysis of 3,597 patients.
Author:
Glasmacher A, Prentice A, Gorschluter M, Engelhart S, Hahn C, Djulbegovic B, Schmidt-Wolf IG.
Date: 22 December 2003
Abstract:
Purpose: Efficacy of antifungal prophylaxis has not yetbeen convincingly proven in numerous trials of variousantifungals. New evidence and the anti-Aspergillus efficacyof itraconazole prompted a new look at the data for theprevention of invasive fungal infections.Patients and Methods: Randomized, controlled studieswith itraconazole for antifungal prophylaxis in neutropenicpatients with hematologic malignancies were identifiedfrom electronic databases and hand searching.Results: Thirteen randomized trials included 3,597 patientswho were assessable for invasive fungal infections.Itraconazole reduced the incidence of invasive fungal infection(mean relative risk reduction, 40% 13%; P .002),the incidence of invasive yeast infections (mean, 53% 19%; P .004) and the mortality from invasive fungalinfections (mean, 35% 17%; P .04) significantly. Theincidence of invasive Aspergillus infections was only reducedin trials using the itraconazole cyclodextrine solution(mean, 48% 21%; P .02) and not itraconazole capsules(mean, 75% 73% increase; P .3). The overall mortalitywas not changed. Adverse effects were rare, hypokalemiawas noted in three studies, and a higher rate of drugdiscontinuation was found in trials that compared itraconazolecyclodextrine solution to a control without cyclodextrine.The effect of prophylaxis was clearly associated witha higher bioavailable dose of itraconazole.Conclusion: Antifungal prophylaxis with itraconazole effectivelyprevents proven invasive fungal infections and—shown for the first time for antifungal prophylaxis—reducesmortality from these infections and the rate of invasiveAspergillus infections in neutropenic patients with hematologicmalignancies. Adequate doses of the oral cyclodextrinesolution (at least 400 mg/d) or IV formulations (200mg/d) of itraconazole are necessary for these effects.J Clin Oncol 21:4615-4626. © 2003 by AmericanSociety of Clinical Oncology.
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