Efficacy, safety and toleration of fluconazole suppositories in the treatment of oral candidosis

An open multicentre, non-comparative study was conducted in three countries to investigate the efficacy, safety and tolerance of fluconazole suppositories in the treatment of oropharyngeal candidosis. Patients received fluconazole 100 mg day -1 in the form of suppositories or capsules. Minimum duration of total treatment was 7 days, maximum total treatment duration was 14 days, and median duration of total treatment was 9.5 (7-14) days. After having received suppository-based treatment for at least 5 days, patients could be switched to oral treatment. Eighty-two male and 19 female patients with a mean age of 43 years were enrolled in the study. The median duration of suppository treatment was 8.9 (5-14) days. Patients were evaluated clinically and mycologically at regular intervals during and at the end of treatment. Seventy-nine of 101 patients enrolled in the study were considered efficacy-evaluable. Clinical cure was achieved in 75 of 79 (95%) patients and improvement was seen in four of 79 (5%) at the end of therapy. At follow-up after 1 month, clinical cure was observed in 48 of 63 (76%) patients. The results of this study demonstrates that the fluconazole suppository formulation is effective, safe and well tolerated.