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/
M. Debacker et al., 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/, Journal of the American Academy of Dermatology, 38(5), 1998, pp. 57-63
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.