LION-Study: efficacy and tolerability of continuous terbinafine (Lamisil (R)) compared to intermittent itraconazole in the treatment of toenail onychomycosis

We undertook a prospective, randomised, double-blind, double-dummy, multice ntre, parallel-group study to compare the efficacy and tolerability of cont inuous terbinafine (Lamisil(R)) with intermittent itraconazole (Sporanox(R) ) in the treatment of toenail onychomycosis. A total of 496 patients (age r ange 18-75 years) with a clinical diagnosis of dermatophyte toenail onychom ycosis, confirmed by positive mycological culture and microscopy (KOH), wer e recruited from 35 centres in six European countries. They were randomly d ivided into four parallel groups to receive either terbinafine 250 mg/day f or 12 or 16 weeks (groups T-12 and T-16), Or itraconazole 400 mg/day for 1 week. in every 4 weeks for 12 or 16 weeks (groups I-3 and I-4) The primary efficacy measurement at week. 72 was mycological cure, defined as negative microscopy and negative culture of samples from the target toenail. At week 72, the mycological cure rates were 75.5% (81/107) in the T-12 group and 8 0.8% (80/99) in the T16 group, compared with 38.3% (41/107) in the 13 group and 49.1% (53/108) in the I-4 group. All comparisons (T-12 vs. I-3, T-12 v s. I-4, T-16 vs I-3, T-16 vs I-4) showed significantly higher cure rates in the terbinafine groups (all P<0.0001). In addition, all secondary clinical outcome measures were significantly in favour of terbinafine at week 72. B oth treatments were well tolerated, with no significant differences in the number or type of adverse events reported. We conclude that continuous terb inafine is significantly more effective than intermittent itraconazole in t he treatment of toenail dermatophyte onychomycosis.