Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial

• Published in: Journal of the American Academy of Dermatology 1997-11, Vol.37 (5), p.740-745
• Main Authors: Drake, Lynn A., Shear, Neil H., Arlette, Jon P., Cloutier, Richard, Danbye, Frederick W., Elewski, Boni E., Garnis-Jones, Sylvia, Giroux, Jean-Mario, Gratton, David, Gulliver, Wayne, Hull, Peter, Jones, H.Earl, Journet, Michel, Krol, Alfons L., Leyden, James J., Maddin, Stuart C., Ross, J.Barrie, Savin, Ronald C., Scher, Richard K., Sibbald, Gary R., Tawfik, Naji H., Zaias, Nardo, Tolpin, Mark, Evans, Sandra, Marsolais, Christian, Chinv, Thomas, Lin, Tsuang-Hua, Maher, Thomas, Birnbaum, Jay E.
• Format: Article
• Language: English
• Subjects: Abdominal Pain - chemically induced; Administration, Oral; Adult; Aged; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antifungal agents; Antifungal Agents - adverse effects; Antifungal Agents - therapeutic use; Biological and medical sciences; Diarrhea - chemically induced; Double-Blind Method; Drug Eruptions - etiology; Epidermophyton - isolation & purification; Female; Follow-Up Studies; Human mycoses; Humans; Infectious diseases; Male; Medical sciences; Middle Aged; Mycoses; Mycoses of the skin; Naphthalenes - adverse effects; Naphthalenes - therapeutic use; Onychomycosis - diagnosis; Onychomycosis - drug therapy; Onychomycosis - microbiology; Pharmacology. Drug treatments; Recurrence; Terbinafine; Toes; Trichophyton - isolation & purification
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/S0190-9622(97)70111-7

Background: Onychomycosis is an increasing problem with limited therapeutic options. Objective: We evaluated the safety and efficacy of oral terbinafine, a new fungicidal antimycotic, in patients with toenail onychomycosis. Methods: A North American multicenter, double-blind, placebo-controlled study evaluated the mycologic and clinical efficacy of oral terbinafine 250 mg/day for 12 or 24 weeks in 358 patients with toenail onychomycosis. Results: A total of 74% of patients treated with 12 or 24 weeks of terbinafine achieved a successful clinical outcome. Approximately 11% of terbinafine responders showed evidence of relapse 18 to 21 months after cessation of treatment. Terbinafine was well tolerated; most adverse events were transient and mild to moderate in severity. Conclusion: The results of this study confirm that oral terbinafine is a safe and effective therapy for the treatment of onychomycosis. (J Am Acad Dermatol 1997;37:740-5.)