Itraconazole for the treatment of onychomycosis.

Abstract

The broad spectrum of activity of itraconazole in vitro manifests itself clinically with the drug being effective for the treatment of onychomycosis caused by dermatophytes, Candida and some non-dermatophyte molds. The pharmacokinetics of itraconazole in the nail results in drug remaining at therapeutic levels for 6-9 months after completion of therapy. An overview of studies where continuous or pulse itraconazole therapy has been used in the treatment of fingernail and toenail onychomycosis. Following continuous therapy at 200 mg/day for 3 months for toenail onychomycosis (n = 1741), the rates of clinical cure, clinical response and mycologic cure were: (meta-average +/- 95% standard error (SE)), 52 +/- 9%, 86 +/- 2%, and 74 +/- 3%, respectively, at follow-up 12 months following start of therapy. In fingernail onychomycosis (n = 211), the duration of therapy was 6 weeks and the corresponding efficacy rates at follow-up, 9 months after start of therapy, were meta-average (+/- S.E.) 82 +/- 5%, 90 +/- 2%, and 86 +/- 3%, respectively. In toenail onychomycosis treated with 3 pulses of therapy (n = 1389), the clinical response, clinical cure and mycologic cure were observed in meta-average (+/- S.E.) 58 +/- 10%, 82 +/- 3%, and 77 +/- 5% patients, respectively, at follow-up 12 months after the start of therapy. In fingernail onychomycosis treated with 2 pulses of therapy (n = 210), at follow-up 9 months after the start of therapy, the corresponding efficacy rates were meta-average (+/- S.E.) 78 +/- 10%, 89 +/- 6%, and 87 +/- 8%, respectively. Both the continuous and pulse therapy regimens are safe with few adverse effects. Compared to continuous therapy, the pulse regimen has an improved adverse-effects profile, is more cost-effective, and is preferred by many patients.