BACKGROUND: Fluconazole could be an alternative to terbinafine and itraconazole for onychomycosis treatment. However, it is difficult to determine the optimal dosing regimen due to the variability in causative agents, dosing regimens and cure rates in clinical trials. By restricting the data to dermatophyte onychomycosis, we aimed to identify an optimal fluconazole dosing regimen. METHODS: We searched the PubMed, EMBASE and CENTRAL databases and the reference sections of published literature for clinical trials on fluconazole monotherapy for culture-proven dermatophyte onychomycosis. Relationships between fluconazole doses, cure rates and duration of therapy were analyzed. RESULTS: Longer treatments, but not higher weekly fluconazole doses, resulted in better cure rates for toenail, and possibly fingernail, onychomycosis. Consequently, mean mycological and clinical cure rates for treatments lasting 6 months or less and more than 6 months were significantly different for toenail onychomycosis. Clinical studies including participants with nondermatophyte mold, Candida species, or negative culture onychomycosis only used fluconazole therapy for 6 months or less. Thus, the relationship between cure rates and duration of treatment could not be confirmed for all causative agents. CONCLUSION: The lowest dose of 150 mg weekly for more than 6 months is recommended for onychomycosis.
BACKGROUND:Fluconazole could be an alternative to terbinafine and itraconazole for onychomycosis treatment. However, it is difficult to determine the optimal dosing regimen due to the variability in causative agents, dosing regimens and cure rates in clinical trials. By restricting the data to dermatophyte onychomycosis, we aimed to identify an optimal fluconazole dosing regimen. METHODS: We searched the PubMed, EMBASE and CENTRAL databases and the reference sections of published literature for clinical trials on fluconazole monotherapy for culture-proven dermatophyte onychomycosis. Relationships between fluconazole doses, cure rates and duration of therapy were analyzed. RESULTS: Longer treatments, but not higher weekly fluconazole doses, resulted in better cure rates for toenail, and possibly fingernail, onychomycosis. Consequently, mean mycological and clinical cure rates for treatments lasting 6 months or less and more than 6 months were significantly different for toenail onychomycosis. Clinical studies including participants with nondermatophyte mold, Candida species, or negative culture onychomycosis only used fluconazole therapy for 6 months or less. Thus, the relationship between cure rates and duration of treatment could not be confirmed for all causative agents. CONCLUSION: The lowest dose of 150 mg weekly for more than 6 months is recommended for onychomycosis.