A comparison of fluconazole oral suspension and amphotericin B oral suspension in older patients with oropharyngeal candidosis. Multicentre Study Group.

Abstract

the optimum treatment for oropharyngeal candidosis, particularly in older patients, has not been established. Local treatment with nystatin and amphotericin B can be problematic. The oral suspension formulation of fluconazole may offer a good alternative to these conventional agents. to compare the safety and efficacy of fluconazole oral suspension with amphotericin B oral suspension in the treatment of older patients with oropharyngeal candidosis. randomized open-label study. three hundred and five patients, aged 62 or older, with at least one sign or symptom of oropharyngeal candidosis. we evaluated patients for the signs and symptoms of candidosis before receiving the study drug and on days 4, 7 and 14. We assessed patients who were cured or improved after 7-14 days of treatment 2 weeks after the end of treatment (follow-up). We obtained specimens from buccal lesions for microscopic examination (baseline only) and culture at baseline and on days 7 and 14. Patients were evaluated for adverse events on days 4, 7 and 14. one hundred and fifty patients received fluconazole and 155 received amphotericin B. There were no statistically significant differences in clinical or mycological response between fluconazole and amphotericin B at the end of treatment or at follow-up. At the end of treatment, 122 (81%) of 150 fluconazole-treated and 135 (87%) of 155 amphotericin B-treated patients were clinically cured or improved. Mycological cure rates were 35% and 46% for fluconazole and amphotericin B, respectively. The symptoms of burning sensation and buccal pain resolved significantly sooner (P < 0.05) in fluconazole-treated patients. The presence of dentures did not affect the response to antifungal therapy. The incidence of adverse events was 46% in the fluconazole group and 50% in the amphotericin B group (not statistically significant). fluconazole oral suspension is a good therapeutic alternative to amphotericin B oral suspension in the treatment of older patients with oropharyngeal candidosis.