| 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in patients receiving voriconazole than in those receiving itraconazole; 2 patients in the voriconazole group were withdrawn from treatment because of increased liver function test values.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
(Affiliation: Department of Community Health, Hospital de Clinicas de Curitiba Universidade Federal do Paraná, Curitiba, Paraná, Brazil queiroz.telles at uol.com.br)
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| 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 1 2007)
ISSN: 1537-6591 United States |
| PMID | 17990229
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
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| Chemical References |
- Antifungal Agents
- Pyrimidines
- Triazoles
- voriconazole
- Itraconazole
|
| 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)
|
