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 t he treatment of esophageal candidiasis. One hundred twenty-six immunoc ompromised patients with esophageal candidiasis were treated with itra conazole oral solution or fluconazole tablets (both at 100-200 mg) onc e 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 asse ssed weekly during treatment and every 2 weeks during follow-up. Patie nts treated with itraconazole oral solution had a rate of clinical res ponse (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 tolera ted. Results from treatment with once-daily itraconazole oral solution was clinically comparable to those with fluconazole and is an alterna tive for the treatment of esophageal candidiasis in immunocompromised patients.