Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial - 11/09/11

Doi : 10.1016/S0190-9622(97)70111-7

Lynn A. Drake, MD^a, Neil H. Shear, MD^b, Jon P. Arlette, MD^c, Richard Cloutier, MD^d, Frederick W. Danby^e, Boni E. Elewski, MD^f, Sylvia Garnis-Jones, MD^g, Jean-Mario Giroux, MD^h, David Gratton, MDⁱ, Wayne Gulliver, MD^j, Peter Hull, MD^k, H.Earl Jones, MD^l, Michel Journet, MD^h, Alfons L. Krol, MD^m, James J. Leyden, MDⁿ, Stuart C. Maddin, MD^o, J.Barrie Ross, MD^p, Ronald C. Savin, MD^q, Richard K. Scher, MD^r, Gary R. Sibbald, MD^s, Naji H. Tawfik, MD^t, Nardo Zaias, MD^u, Mark Tolpin, MD^v, Sandra Evans, PhD^v, Christian Marsolais, PhD^v, Thomas Chin^v, Tsuang-Hua Lin, PhD^v, Thomas Maher, MS^v, Jay E. Birnbaum, PhD^v
Boston, Massachusetts; Toronto, Kingston, Ottawa, and Mississauga, Ontario; Calgary and Edmonton, Alberta; Laval and Montréal Quebec; Cleveland, Ohio; St. Johns, Newfoundland; Saskatoon, Saskatchewan; Fairhope, Alaska; Philadelphia, Pennsylvania; Vancouver, British Columbia; Halifax, Nova Scotia; New Haven, Connecticut; New York, New York; Winnipeg, Manitoba; Miami Beach, Florida; and East Hanover, New Jersey
From Massachusetts General Hospital, Boston^a; University of Toronto, Ontario^b; University of Calgary, Alberta^c; University of Laval, Quebec^d; Queen's University, Kingston, Ontario^e; University Hospitals of Cleveland, Ohio^f; University of Ottawa, Ontario^g; Université de Montréal^h and Centre Hospitalier Cote-des-Neiges,ⁱ Montréal, Quebec; Memorial University of Newfoundland, St. Johns^j; University of Saskatchewan, Saskatoon^k; Thomas Hospital, Fairhope, Alaska^l; University of Alberta, Edmonton^m; Hospital of the University of Pennsylvania, Philadelphiaⁿ; University of British Columbia, Vancouver^o; Dalhousie University, Halifax, Nova Scotia^p; Yale-New Haven Hospital, Connecticut^q; Columbia Presbyterian Hospital, New York^r; University of Toronto, Mississauga, Ontario^s; University of Manitoba, Winnipeg^t; Mt. Sinai Medical Center, Miami Beach^u; and Novartis Pharmaceuticals Corporation, East Hanover.^v

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 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.)

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Long-term outcomes/relapse in follow-up population

Safety

DISCUSSION

	Supported by Novartis Pharmaceuticals Corporation, East Hanover, N.J.
	Reprint requests: Lynn A. Drake, MD, Massachusetts General Hospital, Dermatology-BAR 604, 40 Blossom St., Boston, MA 02114-2698.
	0190-9622/97/$5.00 + 0 16/1/84863

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Vol 37 - N° 5

P. 740-745 - novembre 1997 Retour au numéro

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Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial - 11/09/11

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