An Open-Label Comparative Pilot Study of Oral Voriconazole and Itraconazole for Long-Term Treatment of Paracoccidioidomycosis

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 tolerabilit...

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Bibliographic Details
Published in:Clinical infectious diseases 2007-12, Vol.45 (11), p.1462-1469
Main Authors: Telles, Flavio Queiroz, Goldani, Luciano Z., Schlamm, Haran T., Goodrich, James M., Ingroff, Ana Espinel, Yasuda, Maria A. Shikanai
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Aged
Aged, 80 and over
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antifungal agents
Antifungal Agents - administration & dosage
Antifungal Agents - therapeutic use
Articles and Commentaries
Biological and medical sciences
Blastomycoses and paracoccidioidomycosis
Central nervous system
Comparative analysis
Dosage
Drug Administration Schedule
Drug therapy
Exanthema
Female
Fungal infections
Headache
Human mycoses
Humans
Infections
Infectious diseases
Itraconazole - administration & dosage
Itraconazole - therapeutic use
Lesions
Male
Medical sciences
Middle Aged
Mycoses
Paracoccidioidomycosis
Paracoccidioidomycosis - drug therapy
Pharmacology. Drug treatments
Pilot Projects
Prescription drugs
Pyrimidines - administration & dosage
Pyrimidines - therapeutic use
Radiology
Studies
Symptoms
Triazoles - administration & dosage
Triazoles - therapeutic use
Tropical mycoses
Voriconazole
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Summary: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 ⩾1 dose of study drug were evaluated for safety; patients with confirmed paracoccidioidomycosis who completed ⩾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.
ISSN:1058-4838
1537-6591
DOI:10.1086/522973