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. Oropharyngeal and esophageal candidiasis are common op- histoplasmosis, aspergillosis, and onychomycosis. Like other azoles, itraconazole acts through selective inhibition of fungalportunistic infections in immunocompromised patients, includ-ing persons with human immunodeficiency virus (HIV) infec- cytochrome P450 enzymes involved in the synthesis of ergos-terol. It is a broad-spectrum antifungal agent with potent intion and AIDS and those with underlying malignancie