Safety and efficacy of intermittent therapy with itraconazole in finger‐ and toenail onychomycosis: a multicentre trial: Sicherheit und Wirksamkeit der intermittierenden Itraconazol‐Therapie von Onychomykosen der Finger und Zehen. Eine Multizenter‐Studie

Abstract

The efficacy and safety of intermittent itraconazole therapy were investigated in patients with onychomycosis. Patients were divided into two groups according to site and extent of infection. Group A comprised 635 patients with toenail onychomycosis (at least one nail with > or = 20% involvement; n = 560) or fingernail onychomycosis (at least one nail with > 75% involvement; n = 63) or both (n = 12). These patients received itraconazole 400 mg day-1 for 1 week per month for 3 months. Group B comprised 48 patients with fingernail onychomycosis (at least one nail with > or = 20% involvement but no nail with > 75% involvement) who received itraconazole 400 mg day-1 for 1 week per month for 2 months. Patients were followed for a further 18 weeks without treatment, and received another treatment cycle if not cured or markedly improved 6 weeks after the end of the last cycle. An additional cycle was administered to 76 patients with fingernail onychomycosis (group A, n = 43; group B, n = 28) and to 316 patients with toenail onychomycosis. Clinical response rates and mycological cure rates at study end point were 89.0% and 68.4% respectively for toenails, 91.4% and 85.3% respectively for group A fingernails and 84.4% and 77.1% respectively for group B fingernails. Most adverse events occurred infrequently; major changes in liver function tests were not noted. In conclusion, intermittent itraconazole therapy is highly effective and safe in patients with onychomycosis.