Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis

Publisher Website
Google Scholar
Abstract
Objective: To compare the efficacy and safety of continuous terbinafine with intermittent itraconazole in the treatment of toenail onychomycosis. Design: Prospective, randomised, double blind, double dummy, multicentre, parallel group study lasting 72 weeks. Setting:35 centres in six European countries. Subjects: 496 patients aged 18 to 75 years with a clinical and mycological diagnosis of dermatophyte onychomycosis of the toenail. Interventions: Study patients were randomly divided into four parallel groups to receive either terbinafine 250 mg a day for 12 or 16 weeks (groups T12 and T16or itraconazole 400 mg a day for 1 week in every 4 weeks for 12 or 16 weeks (groups I and I). Main outcome measures: Assessment of primary efficacy at week 72 was mycological cure, defined as negative results on microscopy and culture of samples from the target toenail. Results: At week 72 the mycological cure rates were 75.7% (81/107) in the T12 group and 80.8% (80/99) in theT16 group compared with 38.3% (41/107) in theI group and 49.1 % (53/108) in the I4 group.All comparisons (T v I,T12 vI4, T16v I3, T16 vI4) showed significantly higher cure rates in the terbinafine groups (all PConclusion: Continuous terbinafine is significantly more effective than intermittent itraconazole in the treatment of patients with toenail onychomycosis.