A randomized, double-blind comparison of itraconazole oral solution and fluconazole tablets in the treatment of esophageal candidiasis.

This multicenter, randomized, double-blind study compared the efficacy and safety of itraconazole oral solution and fluconazole tablets in the treatment of esophageal candidiasis. One hundred twenty-six immunocompromised patients with esophageal candidiasis were treated with itraconazole oral solution or fluconazole tablets (both at 100-200 mg) once daily for 3-8 weeks, for 2 weeks beyond the resolution of symptoms, and were then followed for 4 more weeks. Severity of symptoms was assessed weekly during treatment and every 2 weeks during follow-up. Patients treated with itraconazole oral solution had a rate of clinical response (cured or improved) comparable to that of patients treated with fluconazole (94% vs. 91%). The mycologic eradication rate was 92% for itraconazole and 78% for fluconazole. Both treatments were well tolerated. Results from treatment with once-daily itraconazole oral solution was clinically comparable to those with fluconazole and is an alternative for the treatment of esophageal candidiasis in immunocompromised patients.

Itraconazole oral solution versus clotrimazole troches for the treatment of oropharyngeal candidiasis in immunocompromised patients.

This multicenter, open-label, third-party-masked trial compared the efficacy and safety of itraconazole oral solution (200 mg once daily) and clotrimazole troches (10 mg five times daily) in a population of immunocompromised subjects composed primarily of patients with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). Patients were treated for 14 days; patients who exhibited a clinical response were followed up for an additional month to document the occurrence of relapse. Efficacy was judged by changes from baseline in symptoms of oropharyngeal candidiasis (erythema, soreness/burning), extent of oral lesions, and the presence/absence of Candida species on fungal culture. A total of 162 patients were randomized, and 149 were evaluated for efficacy. The percentage of patients with negative cultures at the end of treatment was significantly greater in the itraconazole group than in the clotrimazole group (60% vs 32%, respectively). Negative culture plus clinical response was achieved in significantly more itraconazole-treated patients (53%) than clotrimazole-treated patients (30%); results were similar in the subgroup of patients with HIV/AIDS. Both drugs were well tolerated, with the most frequently reported adverse events for both agents involving the gastrointestinal system. In conclusion, systemic therapy with intraconazole oral solution is efficacious and well tolerated in immunocompromised patients, including those with HIV/AIDS, when administered once daily for 14 days for the treatment of oral candidiasis.