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  • Title: Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial.
    Author: Drake LA, Shear NH, Arlette JP, Cloutier R, Danby FW, Elewski BE, Garnis-Jones S, Giroux JM, Gratton D, Gulliver W, Hull P, Jones HE, Journet M, Krol AL, Leyden JJ, Maddin SC, Ross JB, Savin RC, Scher RK, Sibbald GR, Tawfik NH, Zaias N, Tolpin M, Evans S, Birnbaum JE.
    Journal: J Am Acad Dermatol; 1997 Nov; 37(5 Pt 1):740-5. PubMed ID: 9366820.
    Abstract:
    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 of 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.
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