12 WEEKS OF CONTINUOUS ORAL-THERAPY FOR TOENAIL ONYCHOMYCOSIS CAUSED BY DERMATOPHYTES - A DOUBLE-BLIND COMPARATIVE TRIAL OF TERBINAFINE 250MG DAY VERSUS ITRACONAZOLE 200 MG/DAY/

Background: Dermatophyte infections of the toenail have been difficult to treat, requiring long courses of therapy and having high recurrenc e rates. New oral antifungal agents with better outcomes and minimal a dverse events are needed. Objective: The purpose of this study was to compare two newer antifungal compounds, terbinafine and itraconazole, for efficacy and safety in toenail onychomycosis caused by dermatophyt es. Methods: The study was randomized and double-blind. It compared 12 weeks of continuous oral treatment with terbinafine 250 mg/day or itr aconazole 200 mg/day for confirmed toenail dermatophyte onychomycosis. Clinical symptoms and mycologic outcome were assessed at weeks 4, 8, 12, 24, 36, and 48. A total of 372 patients (186 in each group) with d ermatophyte infection confirmed by microscopy and culture were include d in the intent-to-treat analysis. Results: At week 48, a statisticall y significantly greater percentage of the terbinafine group than itrac onazole group showed negative mycology (73% [119 of 163] vs 45.8% [77 of 168];p < 0.0001) (difference = 27.2%; 95% CI = [17.0%, 37.3%]). The difference was also confirmed clinically (p = 0.001) in the patients who were clinically cured or had only minimal symptoms at the end of t he study (76.2% [125 of 164] vs 58.1% [100 of 172]) (difference = 18.1 %; 95% CI = [8.24%, 27.9%]). The geometric mean length of healthy nail of the big toe was significantly greater in the terbinafine than itra conazole group (8.1 vs 6.4 mm; p = 0.026). Tolerability was good to ve ry good in almost 90% of patients in both groups, and all reported adv erse events were known for these compounds. Conclusion: Terbinafine pr oduced higher rates of clinical and mycologic cure at follow-up than d id itraconazole.