J Taillandier1, Y Esnault, M Alemanni. 1. Service de Gerontologie, Hópital Paul Brousse, Villejuif, France. jean.taillandier@pbr-hop.paris.fr
Abstract
BACKGROUND: 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. OBJECTIVE: to compare the safety and efficacy of fluconazole oral suspension with amphotericin B oral suspension in the treatment of older patients with oropharyngeal candidosis. DESIGN: randomized open-label study. PATIENTS: three hundred and five patients, aged 62 or older, with at least one sign or symptom of oropharyngeal candidosis. METHODS: 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. RESULTS:one hundred and fifty patients receivedfluconazole 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). CONCLUSION:fluconazole oral suspension is a good therapeutic alternative to amphotericin B oral suspension in the treatment of older patients with oropharyngeal candidosis.
RCT Entities:
BACKGROUND: 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. OBJECTIVE: to compare the safety and efficacy of fluconazole oral suspension with amphotericin B oral suspension in the treatment of older patients with oropharyngeal candidosis. DESIGN: randomized open-label study. PATIENTS: three hundred and five patients, aged 62 or older, with at least one sign or symptom of oropharyngeal candidosis. METHODS: 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. RESULTS: 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). CONCLUSION:fluconazole oral suspension is a good therapeutic alternative to amphotericin B oral suspension in the treatment of older patients with oropharyngeal candidosis.
Authors: Joel B Epstein; Edmond L Truelove; Kimberly Hanson-Huggins; Lloyd A Mancl; Alice Chen; Oliver W Press; Stephen H Petersdorf; Thomas R Fritsche; Joshua D Epstein Journal: Support Care Cancer Date: 2004-04-24 Impact factor: 3.603