An open-label comparative pilot study of oral voriconazole and itraconazole for long-term treatment of paracoccidioidomycosis.

Abstract

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in patients receiving voriconazole than in those receiving itraconazole; 2 patients in the voriconazole group were withdrawn from treatment because of increased liver function test values.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.

• Authors: Flavio Queiroz-Telles, Luciano Z Goldani, Haran T Schlamm, James M Goodrich, Ana Espinel-Ingroff, Maria A Shikanai-Yasuda
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 45 Issue 11 Pg. 1462-9 (Dec 01 2007) ISSN: 1537-6591 [Electronic] United States
• PMID: 17990229 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Antifungal Agents
• Pyrimidines
• Triazoles
• Itraconazole
• Voriconazole

Topics

• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Antifungal Agents (administration & dosage, therapeutic use)
• Drug Administration Schedule
• Female
• Humans
• Itraconazole (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Paracoccidioidomycosis (drug therapy)
• Pilot Projects
• Pyrimidines (administration & dosage, therapeutic use)
• Triazoles (administration & dosage, therapeutic use)
• Voriconazole