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 investiga ted in patients with onychomycosis. Patients were divided into two groups a ccording to site and extent of infection. Group A comprised 635 patients wi th toenail onychomycosis (at least one nail with greater than or equal to 2 0% involvement; n=560) or fingernail onychomycosis (at least one nail with > 75% involvement; n=63) or both (n=12). These patients received itraconazo le 400 mg day(-1) for 1 week per month for 3 months. Group B comprised 48 p atients with fingernail onychomycosis (at least one nail with greater than or equal to 20% involvement but no nail with >75% involvement) who received itraconazole 400 mg day(-1) for 1 week per month for 2 months. Patients we re 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 fi ngernail onychomycosis (group A, n=43; group B, n=28) and to 316 patients w ith toenail onychomycosis. Clinical response rates and mycological cure rat es 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% respect ively for group B fingernails. Most adverse events occurred infrequently; m ajor changes in liver function tests were not noted. In conclusion, intermi ttent itraconazole therapy is highly effective and safe in patients with on ychomycosis.