Itraconazole versus terbinafine (LAMISIL (R)): which is better for the treatment of onychomycosis?
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1997-12-01
Autores
Honeyman, J. F.
Talarico, S.
Arruda, LHF
Pereira, A. C.
Santamaria, JR
Souza, E. M.
Woscoff, A.
Amorim, R.
De la Parra, C. R.
Enokihara, M. Y.
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Objectives To compare the efficacy, safety 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 patients.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,stoup and 51.8% and 84.3% in the itraconazole group (the difference between the groups was statistically significant at the 12th month, P < 0.04). Clinical cure was achieved by 8.5% and 9.4% of the patients in the terbinafine and itraconazole groups at the 4th month (not significant, NS) and these rates increased to 57.8% and 62.9%, respectively, at the 12th month (difference between groups NS, 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 but 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 SOOT and SGPT associated with abdominal pain and nausea.Conclusion Although both itraconazole and terbinafine were effective, well tolerated and safe, terbinafine demonstrated a higher rate of efficacy in the long run after treatment was stopped. (C) 1997 Elsevier Science B.V.
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Journal of the European Academy of Dermatology and Venereology. Amsterdam: Elsevier B.V., v. 9, n. 3, p. 215-221, 1997.