Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis. The LION Study Group.
OBJECTIVE
To compare the efficacy and safety of continuous terbinafine with intermittent itraconazole in the treatment of toenail onychomycosis.


METHODS
Prospective, randomised, double blind, double dummy, multicentre, parallel group study lasting 72 weeks.


METHODS
35 centres in six European countries.


METHODS
496 patients aged 18 to 75 years with a clinical and mycological diagnosis of dermatophyte onychomycosis of the toenail.


METHODS
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 T16) or itraconazole 400 mg a day for 1 week in every 4 weeks for 12 or 16 weeks (groups I3 and I4).


METHODS
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 the T16 group compared with 38.3% (41/107) in the I3 group and 49.1 % (53/108) in the I4 group. All comparisons (T12 v I3, T12 v I4, T16 v I3, T16 v I4) showed significantly higher cure rates in the terbinafine groups (all P<0.0001). Also, all secondary clinical outcome measures were significantly in favour of terbinafine at week 72. There were no differences in the number or type of adverse events recorded in the terbinafine or itraconazole groups.


CONCLUSIONS
Continuous terbinafine is significantly more effective than intermittent itraconazole in the treatment of patients with toenail onychomycosis.
Evans
E G
EG
Public Health Laboratory Service (PHLS) Mycology Reference Laboratory, University of Leeds and General Infirmary, Leeds LS2 9JT. E.G.V.Evans@leeds.ac.uk
Sigurgeirsson
B
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005533:Foot Dermatoses / Q000188:drug therapy; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage*; D014009:Onychomycosis / Q000188:drug therapy*; D011446:Prospective Studies; D000077291:Terbinafine; D016896:Treatment Outcome
D000935:Antifungal Agents; D009281:Naphthalenes; D017964:Itraconazole; D000077291:Terbinafine