Itraconazole versus terbinafine (LAMISIL®): which is better for the treatment of onychomycosis?

Objectives To compare the efficacy, safely and tolerability of oral terbinafine with itraconazole in patients with toenail onychomycosis treated for 4 months. Setting Departments of dermatology of six universities and one private clinic. Design Double-blind double-dummy, multicentric, multinational, parallel-group therapeutic trial, involving 179 patients with toenail onychomycosis. Patients were randomly treated with either 200 mg/day oral itraconazole or 250 mg/day terbinafine for 4 months. After the 4th month both treatment groups received oral placebo for another 8 months. The total duration of the study was therefore 12 months. After the 12th month a final evaluation of efficacy was performed in 167 patients (85 on itraconazole and 82 on terbinafine) and a final evaluation of tolerability was performed in 175 patient. Results The dermatophytes identified at the initial visit were Trichophyton rubrum (82.1%), Trichophyton mentagrophytes (14%) and others (3.9%), The mycological cure rates at the end of the 4th and 12th months were 54.9% and 95.3% in the terbinafine group and 51.8% and 84.31% in the itraconazole group (the difference between the groups was. statistically significant at the 12th month, P 0,05). A complete mycological cure associated with clinical improvement over 50%. was observed at the 4th month in 50% of the patients treated with terbinafine and 49.4% of the patients treated with itraconazole which was not statistically significant (NS). At the 12th month the rates increased to 95.4% with terbinafine and 75.7% with itraconazole (statistically significant. P < 0.001). Seven patients of the terbinafine group and 9 patients of the itraconazole group presented drug-related side effects (NS). Six patients (6.3%) discontinued the study due to adverse events in the itraconazole group hut no patient discontinued in the terbinafine group. At entry into the study all subjects in both groups presented normal values in liver function tests which remained unchanged throughout the study in the patients of the terbinafine group. One patient of the itraconazole group presented small increases in SGOT and SGPT associated with abdominal pain and nausea.