Abstract

This randomized comparative study assessed the efficacy and safety of a 10-mg once-daily topical regimen of miconazole nitrate mucoadhesive buccal tablet (n = 178) versus a 400-mg once-daily systemic regimen of ketoconazole (n = 179) in HIV-positive patients with oropharyngeal candidiasis. A total of 357 patients were treated for 7 or 14 days depending on response after 7 days of treatment. Clinical response was the primary outcome variable, and secondary outcomes included microscopy, time to cure, symptom scores, and safety outcomes. A per-protocol analysis of 332 patients demonstrated that miconazole nitrate was not statistically significantly inferior to ketoconazole treatment. At day 7, the clinical response rate was 135 of 156 (87%) for miconazole nitrate and 137 of 153 (90%) for ketoconazole (90% confidence interval of the treatment difference: [-9%; 3%]). At the end of treatment, dysphagia was 1% in both groups. Microscopic findings paralleled the clinical results. The mucoadhesive tablet was generally well tolerated. A higher incidence of gastrointestinal disorders and drug-related adverse events was seen during ketoconazole treatment. The low-dose 10-mg miconazole mucoadhesive tablet is not inferior to systemic antifungal treatment with ketoconazole in the treatment of AIDS-related oropharyngeal candidiasis with and without dysphagia. It provides the first and only once-daily topical treatment option and should therefore be considered in first-line therapy for this condition, particularly in resource-poor settings, where ease of use can help to guarantee the success of therapy.