TY - JOUR
T1 - Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis
T2 - A randomized, double-blind trial
AU - Galgiani, J. N.
AU - Catanzaro, A.
AU - Cloud, G. A.
AU - Johnson, R. H.
AU - Williams, P. L.
AU - Mirels, L. F.
AU - Nassar, F.
AU - Lutz, J. E.
AU - Stevens, D. A.
AU - Sharkey, P. K.
AU - Singh, V. R.
AU - Larsen, R. A.
AU - Delgado, K. L.
AU - Flanigan, C.
AU - Rinaldi, M. G.
PY - 2000/11/7
Y1 - 2000/11/7
N2 - Background: In previous open-label noncomparative clinical trials, both fluconazole and itraconazole were effective therapy for progressive forms of coccidioidomycosis. Objective: To determine whether fluconazole or itraconazole is superior for treatment of nonmeningeal progressive coccidioidal infections. Design: Randomized, double-blind, placebo-controlled trial. Setting: 7 treatment centers in California, Arizona, and Texas. Patients: 198 patients with chronic pulmonary, soft tissue, or skeletal coccidioidal infections. Intervention: Oral fluconazole, 400 mg/d, or itraconazole, 200 mg twice daily. Measurements: After 4, 8, and 12 months, a predefined scoring system was used to assess severity of infection. Findings were compared with those at baseline. Results: 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. Conclusions: 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.
AB - Background: In previous open-label noncomparative clinical trials, both fluconazole and itraconazole were effective therapy for progressive forms of coccidioidomycosis. Objective: To determine whether fluconazole or itraconazole is superior for treatment of nonmeningeal progressive coccidioidal infections. Design: Randomized, double-blind, placebo-controlled trial. Setting: 7 treatment centers in California, Arizona, and Texas. Patients: 198 patients with chronic pulmonary, soft tissue, or skeletal coccidioidal infections. Intervention: Oral fluconazole, 400 mg/d, or itraconazole, 200 mg twice daily. Measurements: After 4, 8, and 12 months, a predefined scoring system was used to assess severity of infection. Findings were compared with those at baseline. Results: 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. Conclusions: 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.
UR - http://www.scopus.com/inward/record.url?scp=0034619472&partnerID=8YFLogxK
U2 - 10.7326/0003-4819-133-9-200011070-00009
DO - 10.7326/0003-4819-133-9-200011070-00009
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C2 - 11074900
AN - SCOPUS:0034619472
SN - 0003-4819
VL - 133
SP - 676
EP - 686
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 9
ER -