Document Detail

An open-label comparative pilot study of oral voriconazole and itraconazole for long-term treatment of paracoccidioidomycosis.
MedLine Citation:
PMID:  17990229     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: In previous studies, itraconazole was revealed to be an effective therapy and was considered to be the gold standard treatment for mild-to-moderate acute and chronic clinical forms of paracoccidioidomycosis. A pilot study was conducted to investigate the efficacy, safety, and tolerability of voriconazole for the long-term treatment of acute or chronic paracoccidioidomycosis, with itraconazole as the control treatment. METHODS: A randomized, open-label study was conducted at 3 Brazilian tertiary care hospitals. Patients were randomized (at a 2 : 1 ratio) to receive oral therapy with voriconazole or itraconazole for 6 months. Patients receiving >or=1 dose of study drug were evaluated for safety; patients with confirmed paracoccidioidomycosis who completed >or=6 months of therapy (treatment-evaluable patients) were evaluated for treatment efficacy. Satisfactory global response was assessed at the end of treatment. RESULTS: Fifty-three patients were evaluated for treatment safety (35 received voriconazole, and 18 received itraconazole). Both drugs were well tolerated. The most common treatment-related adverse events in the voriconazole group included abnormal vision, chromatopsia, rash, and headache; the most common treatment-related adverse events in the itraconazole group included bradycardia, diarrhea, and headache. Liver function test values were slightly higher in patients receiving voriconazole than in those receiving itraconazole; 2 patients in the voriconazole group were withdrawn from treatment because of increased liver function test values. In the intent-to-treat populations, the satisfactory response rate (i.e., complete or partial global response) was 88.6% among the voriconazole group and 94.4% among the itraconazole group. The response rate among treatment-evaluable patients was 100% for both treatment groups; no relapses were observed after 8 weeks of follow-up. CONCLUSIONS: This is, to our knowledge, the first study to demonstrate that voriconazole is as well tolerated and effective as itraconazole for the long-term treatment of paracoccidioidomycosis.
Flavio Queiroz-Telles; Luciano Z Goldani; Haran T Schlamm; James M Goodrich; Ana Espinel-Ingroff; Maria A Shikanai-Yasuda
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial     Date:  2007-10-22
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  45     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2007 Dec 
Date Detail:
Created Date:  2007-11-08     Completed Date:  2007-12-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1462-9     Citation Subset:  IM    
Department of Community Health, Hospital de Clinicas de Curitiba Universidade Federal do Paraná, Curitiba, Paraná, Brazil
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MeSH Terms
Administration, Oral
Aged, 80 and over
Antifungal Agents / administration & dosage,  therapeutic use
Drug Administration Schedule
Itraconazole / administration & dosage*,  therapeutic use*
Middle Aged
Paracoccidioidomycosis / drug therapy*
Pilot Projects
Pyrimidines / administration & dosage*,  therapeutic use*
Triazoles / administration & dosage*,  therapeutic use*
Reg. No./Substance:
0/Antifungal Agents; 0/Pyrimidines; 0/Triazoles; 0/voriconazole; 84625-61-6/Itraconazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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