Sherif B. Mossad, MD
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Mossad SB. Itraconazole versus Fluconazole for Antifungal Prophylaxis. Ann Intern Med. 2004;140:580-581. doi: 10.7326/0003-4819-140-7-200404060-00028
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Published: Ann Intern Med. 2004;140(7):580-581.
TO THE EDITOR:
Winston and colleagues' data and conclusions (1) should remind us of the problems encountered in the design and reporting of trials of antifungal agents (2). First, it is unclear why blinding of the 2 agents studied was “technologically impossible.” Second, even though a multivariable analysis that included graft-versus-host disease showed that itraconazole was still associated with fewer fungal infections than fluconazole, the randomization process could have easily stratified patients by donor type, related versus unrelated, at enrollment. Third, the authors did not mention what percentage of patients in both groups were treated empirically with amphotericin B for suspected fungal infection. Fourth, antifungal prophylactic measures used during the preparative regimens of chemoradiation therapy, such as topical mucosal antifungal agents, were not listed, nor were the prophylactic measures used after day 100 following transplantation. Fifth, the study was designed to show that itraconazole was not inferior to fluconazole but failed to show a significant difference between groups in the incidence of aspergillosis or mortality, including that due to fungal infection, because of the small numbers of patients (3). Sixth, the mean duration of corticosteroid use was not different between groups, but the total cumulative dose of steroids administered was not mentioned.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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