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- Title
Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis. A randomized, double-blind trial. Mycoses Study Group.
- Authors
Galgiani, John N.; Catanzaro, Antonino; Cloud, Gretchen A.; Johnson, Royce H.; Williams, Paul L.; Mirels, Laurence F.; Nassar, Faris; Lutz, Jon E.; Stevens, David A.; Sharkey, P. Kay; Singh, Vipul R.; Larsen, Robert A.; Delgado, Kathy L.; Flanigan, Cynthia; Rinaldi, Michael G.; Galgiani, J N; Catanzaro, A; Cloud, G A; Johnson, R H; Williams, P L
- Abstract
<bold>Background: </bold>In previous open-label noncomparative clinical trials, both fluconazole and itraconazole were effective therapy for progressive forms of coccidioidomycosis.<bold>Objective: </bold>To determine whether fluconazole or itraconazole is superior for treatment of nonmeningeal progressive coccidioidal infections.<bold>Design: </bold>Randomized, double-blind, placebo-controlled trial.<bold>Setting: </bold>7 treatment centers in California, Arizona, and Texas.<bold>Patients: </bold>198 patients with chronic pulmonary, soft tissue, or skeletal coccidioidal infections.<bold>Intervention: </bold>Oral fluconazole, 400 mg/d, or itraconazole, 200 mg twice daily.<bold>Measurements: </bold>After 4, 8, and 12 months, a predefined scoring system was used to assess severity of infection. Findings were compared with those at baseline.<bold>Results: </bold>Overall, 50% of patients (47 of 94) and 63% of patients (61 of 97) responded to 8 months of treatment with fluconazole and itraconazole, respectively (difference, 13 percentage points [95% CI, -2 to 28 percentage points]; P = 0.08). Patients with skeletal infections responded twice as frequently to itraconazole as to fluconazole. By 12 months, 57% of patients had responded to fluconazole and 72% had responded to itraconazole (difference, 15 percentage points [CI, 0.003 to 30 percentage points]; P = 0.05). Soft tissue disease was associated with increased likelihood of response, as in previous studies. Azole drug was detected in serum specimens from all but 3 patients; however, drug concentrations were not helpful in predicting outcome. Relapse rates after discontinuation of therapy did not differ significantly between groups (28% after fluconazole treatment and 18% after itraconazole treatment). Both drugs were well tolerated.<bold>Conclusions: </bold>Neither fluconazole nor itraconazole showed statistically superior efficacy in nonmeningeal coccidioidomycosis, although there is a trend toward slightly greater efficacy with itraconazole at the doses studied.
- Subjects
COCCIDIOIDOMYCOSIS; ANTIFUNGAL agents; THERAPEUTICS
- Publication
Annals of Internal Medicine, 2000, Vol 133, Issue 9, p676
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-133-9-200011070-00009