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

L. A. Drake; N. H. Shear; J. P. Arlette; R. Cloutier; F. W. Danby; B. E. Elewski; S. Garnis-Jones; J. M. Giroux; D. Gratton; W. Gulliver; P. Hull; H. E. Jones; M. Journet; A. L. Krol; J. J. Leyden; S. C. Maddin; J. B. Ross; R. C. Savin; R. K. Scher; G. R. Sibbald; N. H. Tawfik; N. Zaias; M. Tolpin; S. Evans; C. Marsolais; T. Chin; T. H. Lin; T. Maher; J. E. Birnbaum

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

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

L. A. Drake, N. H. Shear, J. P. Arlette, R. Cloutier, F. W. Danby, B. E. Elewski, S. Garnis-Jones, J. M. Giroux, D. Gratton, W. Gulliver, P. Hull, H. E. Jones, M. Journet, A. L. Krol, J. J. Leyden, S. C. Maddin, J. B. Ross, R. C. Savin, R. K. Scher, G. R. SibbaldN. H. Tawfik, N. Zaias, M. Tolpin, S. Evans, C. Marsolais, T. Chin, T. H. Lin, T. Maher, J. E. Birnbaum

Research output: Contribution to journal › Article › peer-review

104 Scopus citations

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.

Original language	English (US)
Pages (from-to)	740-745
Number of pages	6
Journal	Journal of the American Academy of Dermatology
Volume	37
Issue number	5 I
DOIs	https://doi.org/10.1016/S0190-9622(97)70111-7
State	Published - 1997
Externally published	Yes

ASJC Scopus subject areas

Dermatology

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Drake, L. A., Shear, N. H., Arlette, J. P., Cloutier, R., Danby, F. W., Elewski, B. E., Garnis-Jones, S., Giroux, J. M., Gratton, D., Gulliver, W., Hull, P., Jones, H. E., Journet, M., Krol, A. L., Leyden, J. J., Maddin, S. C., Ross, J. B., Savin, R. C., Scher, R. K., ... Birnbaum, J. E. (1997). Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial. Journal of the American Academy of Dermatology, 37(5 I), 740-745. https://doi.org/10.1016/S0190-9622(97)70111-7

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, Marsolais, C, Chin, T, Lin, TH, Maher, T & Birnbaum, JE 1997, 'Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial', Journal of the American Academy of Dermatology, vol. 37, no. 5 I, pp. 740-745. https://doi.org/10.1016/S0190-9622(97)70111-7

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title = "Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial",

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.",

author = "Drake, {L. A.} and Shear, {N. H.} and Arlette, {J. P.} and R. Cloutier and Danby, {F. W.} and Elewski, {B. E.} and S. Garnis-Jones and Giroux, {J. M.} and D. Gratton and W. Gulliver and P. Hull and Jones, {H. E.} and M. Journet and Krol, {A. L.} and Leyden, {J. J.} and Maddin, {S. C.} and Ross, {J. B.} and Savin, {R. C.} and Scher, {R. K.} and Sibbald, {G. R.} and Tawfik, {N. H.} and N. Zaias and M. Tolpin and S. Evans and C. Marsolais and T. Chin and Lin, {T. H.} and T. Maher and Birnbaum, {J. E.}",

note = "Funding Information: Supported by Novartis Pharmaceuticals Corporation, East Hanover, N.J. ",

year = "1997",

doi = "10.1016/S0190-9622(97)70111-7",

language = "English (US)",

volume = "37",

pages = "740--745",

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TY - JOUR

T1 - Oral terbinafine in the treatment of toenail onychomycosis

T2 - North American multicenter trial

AU - Drake, L. A.

AU - Shear, N. H.

AU - Arlette, J. P.

AU - Cloutier, R.

AU - Danby, F. W.

AU - Elewski, B. E.

AU - Garnis-Jones, S.

AU - Giroux, J. M.

AU - Gratton, D.

AU - Gulliver, W.

AU - Hull, P.

AU - Jones, H. E.

AU - Journet, M.

AU - Krol, A. L.

AU - Leyden, J. J.

AU - Maddin, S. C.

AU - Ross, J. B.

AU - Savin, R. C.

AU - Scher, R. K.

AU - Sibbald, G. R.

AU - Tawfik, N. H.

AU - Zaias, N.

AU - Tolpin, M.

AU - Evans, S.

AU - Marsolais, C.

AU - Chin, T.

AU - Lin, T. H.

AU - Maher, T.

AU - Birnbaum, J. E.

N1 - Funding Information: Supported by Novartis Pharmaceuticals Corporation, East Hanover, N.J.

PY - 1997

Y1 - 1997

N2 - 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.

AB - 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.

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AN - SCOPUS:0030666538

SN - 0190-9622

VL - 37

SP - 740

EP - 745

JO - Journal of the American Academy of Dermatology

JF - Journal of the American Academy of Dermatology

IS - 5 I

ER -

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

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