Safety and efficacy of intermittent therapy with itraconazole in finger- and toenail onychomycosis: a multicentre trial.
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.