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L.I.ON. Study: efficacy and tolerability of continuous terbinafine (Lamisil ® ) compared to intermittent itraconazole in the treatment of toenail onychomycosis
Author(s) -
Bárður Sigurgeirsson,
Stephan Billstein,
Tapio Rantanen,
Thomas Ruzicka,
E. Di Fonzo,
B.J. Vermeer,
M. J. D. Goodfield,
E. G. V. Evans
Publication year - 1999
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1046/j.1365-2133.1999.00008.x
Subject(s) - terbinafine , tolerability , itraconazole , medicine , dermatophyte , adverse effect , clinical trial , surgery , gastroenterology , dermatology , antifungal
We undertook a prospective, randomised, double‐blind, double‐dummy, multicentre, parallel‐group study to compare the efficacy and tolerability of continuous terbinafine (Lamisil ® ) with intermittent itraconazole (Sporanox ® ) in the treatment of toenail onychomycosis. A total of 496 patients (age range 18–75 years) with a clinical diagnosis of dermatophyte toenail onychomycosis, confirmed by positive mycological culture and microscopy (KOH), were recruited from 35 centres in six European countries. They were randomly divided into four parallel groups to receive either terbinafine 250 mg/day for 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 80.8% (80/99) in the T 16 group, compared with 38.3% (41/107) in the I 3 group and 49.1% (53/108) in the I 4 group. All comparisons (T 12 vs. I 3 , T 12 vs. 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. Both treatments were well tolerated, with no significant differences in the number or type of adverse events reported. We conclude that continuous terbinafine is significantly more effective than intermittent itraconazole in the treatment of toenail dermatophyte onychomycosis.