Pulse versus continuous terbinafine for onychomycosis: A randomized, double-blind, controlled trial

Journal of the American Academy of Dermatology

Volumn 53, Issue 4, 2005, Pages 578-584

  Warshaw, Erin M ^a,b,c   Fett, Debra D ^d   Bloomfield, Hanna E ^a,b,c   Grill, Joseph P ^a,b   Nelson, David B ^a,b   Quintero, Vicente ^d   Carver, Susan M ^b   Zielke, Gary R ^b   Lederle, Frank A ^a,b,c  

^a Center for Chronic Disease Outcomes Research   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^d Dermatology ^*

Author keywords

[No Author keywords available]

Indexed keywords

CLOTRIMAZOLE; MICONAZOLE; TERBINAFINE;

ABDOMINAL PAIN; ACUTE HEPATITIS; ADULT; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVALESCENCE; DERMATOPHYTE; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DETERMINATION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG PULSE THERAPY; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; ERYTHEMA MULTIFORME; FEMALE; FLATULENCE; FUNGUS CULTURE; GASTROINTESTINAL SYMPTOM; HEADACHE; HEARTBURN; HUMAN; INFECTION RISK; MAJOR CLINICAL STUDY; MALE; MASS SCREENING; NAUSEA; OUTCOMES RESEARCH; POPULATION RESEARCH; PRESCRIPTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; REINFECTION; STANDARD; TINEA PEDIS; TOENAIL ONYCHOMYCOSIS; UNIVERSITY HOSPITAL; VETERINARY MEDICINE;

AGED; ANTIFUNGAL AGENTS; DOUBLE-BLIND METHOD; FEMALE; FOOT DERMATOSES; HUMANS; MALE; NAPHTHALENES; ONYCHOMYCOSIS; PULSE THERAPY, DRUG; TABLETS; TREATMENT OUTCOME;

EID: 25844494519     PISSN: 01909622     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jaad.2005.04.055     Document Type: Article

References (58)

1. B.E. Elewski, and M.A. Charif Prevalence of onychomycosis in patients attending a dermatology clinic in northeastern Ohio for other conditions Arch Dermatol 133 1997 1172 1173
2. M.P. English, and R. Atkinson Onychomycosis in elderly chiropody patients Br J Dermatol 91 1974 67 72
3. D.P. Lubeck, D.L. Patrick, P. McNulty, S.K. Fifer, and J. Birnbaum Quality of life in persons with onychomycosis Qual Life Res 2 1993 341 348
4. J.R. Schein, D. Gause, D.M. Stier, D.P. Lubeck, M.M. Bates, and R. Fisk Onychomycosis. Baseline results of an observational study J Am Podiatr Med Assoc 87 1997 512 519
5. B.E. Elewski The effect of toenail onychomycosis on patient quality of life Int J Dermatol 36 1997 754 756
6. Rosenbach M, Schneider JE. The burden of onychomycosis in the Medicare population. Health Economic Research, Inc. Sandoz Pharmaceuticals Corporation.
7. T.R. Einarson, S.R. Arikian, and N.H. Shear Cost-effectiveness analysis for onychomycosis therapy in Canada from a government perspective Br J Dermatol 130 1994 32 34
8. S.R. Arikian, T.R. Einarson, G. Kobelt-Nguyen, and F. Schubert A multinational pharmacoeconomic analysis of oral therapies for onychomycosis. The Onychomycosis Study Group Br J Dermatol 130 1994 35 44
9. A. Marchetti, C.T. Piech, W.F. McGhan, A.I. Neugut, and B.T. Smith Pharacoeconomic analysis of oral therapies for onychomycosis: a US model Clin Ther 18 1996 757 777
10. R. Jansen, W.K. Redekop, and F.F.H. Rutten Cost effectiveness of continuous terbinafine compared with intermittent itraconazole in the treatment of dermatophyte toenail onychomycosis Pharmacoeconomics 19 2001 401 410
11. T.R. Einarson Pharmacoeconomic applications of meta-analysis for single groups using antifungal onychomycosis lacquers as an example Clin Ther 19 1997 559 569
12. A.K. Gupta Pharmacoeconomic analysis of oral antifungal therapies used to treat dermatophyte onychomycosis of the toenails. A US analysis Pharmacoeconomics 13 1998 243 256
13. V.N. Joish, and E.P. Armstrong Which antifungal agent for onychomycosis? A pharmacoeconomic analysis Pharmacoeconomics 19 2001 983 1002
14. D.M. Stier, C. Henke, J. Schein, W.H. Schonfeld, and J. Broering Cost of treatment for onychomycosis. Data from a 9-month observational study Pharmacoeconomics 19 2001 267 279
15. H. Salo, and M. Pekurinen Cost effectiveness of oral terbinafine (Lamisil) compared with oral fluconazole (diflucan) in the treatment of patients with toenail onychomycosis Pharmacoeconomics 20 2002 319 324
16. J.L. Bootman Cost-effectiveness of two new treatments for onychomycosis: an analysis of two comparative clinical trials J Am Acad Dermatol 38 Suppl 1998 S69 S72
17. K.M. Humphrey, M.J. Cork, and A. Haycox A retrospective cost-effectiveness analysis of the treatment of onychomycosis in general practice Br J Dermatol 139 1998 660 664
18. E. Alpsoy, E. Yilmaz, and E. Basaran Intermittent therapy with terbinafine for dermatophyte toe onychomycosis: a new approach J Dermatol 23 1996 259 262
19. A. Tosti, B.M. Piraccini, C. Stinchi, N. Venturo, F. Bardazzi, and M.D. Colombo Treatment of dermatophyte nail infections: an open randomized study comparing intermittent terbinafine with continuous terbinafine treatment and intermittent itraconazole therapy J Am Acad Dermatol 34 1996 595 600
20. A. Tosti, B.M. Piraccini, C. Stinchi, and M.D. Colombo Relapses of onychomycosis after successful treatment with systemic antifungals: a three-year follow-up Dermatology 197 1998 162 166
21. A.K. Gupta, C.W. Lynde, and N. Konnikov Single-blind, randomized, prospective study of sequential itraconazole and terbinafine pulse compared with terbinafine pulse for the treatment of toenail onychomycosis J Am Acad Dermatol 44 2001 485 491
22. P. Fleckman Basic science of the nail unit R.K. Scher C.R. Daniel Nails: Therapy, diagnosis, surgery 1990 Saunders Philadelphia 42 44
23. E.G. Evans, and B. Sigurgeirsson Double blind, randomized study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis. The LION Study Group BMJ 318 1999 1031 1035
24. M. De Backer, C. De Vroey, E. Lesaffre, I. Scheys, and P. De Keyser Twelve weeks of continuous oral therapy for toenail onychomycosis caused by dermatophytes: a double-blind comparative trial of terbinafine 250 mg/day versus itraconazole 200 mg/day J Am Acad Dermatol 38 Suppl 1998 S57 S63
25. P. De Doncker, J. Decroix, G.E. Pierard, D. Roelant, R. Woestenborghs, and P. Jacqmin Antifungal pulse therapy for onychomycosis. A pharmacokinetic and pharmacodynamic investigation of monthly cycles of 1-week pulse therapy with itraconazole Arch Dermatol 132 1996 34 41
26. V. Havu, H. Brandt, H. Heikkila, A. Hollmen, R. Oksman, and T. Rantamen A double-blind, randomized study comparing itraconazole pulse therapy with continuous dosing for the treatment of toe-nail onychymycosis Br J Dermatol 136 1997 230 234
27. R.B. Odom, R. Aly, R.K. Scher, C.R. Daniel II, B. Elewski, and N. Zaias A multicenter, placebo-controlled, double-blind study of intermittent therapy with itraconazole for the treatment of onychomycosis of the fingernail J Am Acad Dermatol 36 1997 231 235
28. R.K. Scher, D. Breneman, P. Rich, R.C. Savin, D.S. Feingold, and N. Konnikov Once-weekly fluconazole (150, 300 or 450 mg) in the treatment of distal subungual onychomycosis of the toenail J Am Acad Dermatol 38 Suppl 1998 S77 S86
29. M. Brautigam Terbinafine versus itraconazole: a controlled clinical comparison in onychomycosis of the toenails J Am Acad Dermatol 38 Suppl 1998 S53 S56
30. H. Hofmann, M. Brautigam, G. Weidinger, and H. Zaun Treatment of toenail onychomycosis. A randomized, double-blind study with terbinafine and griseofulvin Arch Dermatol 131 1995 919 922
31. J. Faergemann, C. Anderson, K. Hersle, E. Hradil, P. Nordin, and T. Kaaman Double-blind, parallel-group comparison of terbinafine and griseofulvin in the treatment of toenail onychomycosis J Am Acad Dermatol 32 1995 750 753
32. B.E. Elewski Diagnostic techniques for confirming onychomycosis J Am Acad Dermatol 35 Suppl 1996 S6 S9
33. A.K. Gupta, P. Fleckman, and R. Baran Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis J Am Acad Dermatol 43 Suppl 2000 S70 S80
34. R.R. Davies, J.D. Everall, and E. Hamilton Mycological and clinical evaluation of griseofulvin for chronic onychomycosis BMJ 3 1967 464 468
35. R.J. Hay, Y.M. Clayton, W.A. Griffiths, and P.M. Dowd A comparative double-blind study of ketoconazole and griseofulvin in dermatophytosis Br J Dermatol 112 1985 691 696
36. M.R. Ling, L.J. Swinyer, M.T. Jarratt, L. Falo, E.W. Monroe, and M. Tharp Once-weekly fluconazole (450 mg) for 4, 6, or 9 months of treatment for distal subungual onychomycosis of the toenail J Am Acad Dermatol 38 Suppl 1998 S95 S102
37. D. Roseeuw, and P. De Doncker New approaches to the treatment of onychomycosis J Am Acad Dermatol 29 Suppl 1993 S45 S50
38. S.W. Smith, D.P. Sealy, E. Schneider, and D. Lackland An evaluation of the safety and efficacy of fluconazole in the treatment of onychomycosis South Med J 88 1995 1217 1220
39. R. Arenas, J. Dominguez-Cherit, and L.M. Fernandez Open randomized comparison of itraconazole versus terbinafine in onychomycosis Int J Dermatol 34 1993 138 143
40. M.J. Goodfield Short-duration therapy with terbinafine for dermatophyte onychomycosis: a multicentre trial Br J Dermatol 126 Suppl 39 1992 33 35
41. J.G. van der Schroeff, P.K. Cirkel, M.B. Crijns, T.J. Van Dijk, F.J. Govaert, and D.A. Groeneweg A randomized treatment duration-finding study of terbinafine in onychomycosis Br J Dermatol 126 Suppl 39 1992 36 39
42. E. Epstein How often does oral treatment of toenail onychomycosis produce a disease-free nail? An analysis of published data Arch Dermatol 134 1998 1551 1554
43. F. Crawford, P. Young, C. Godfrey, S.E. Bell-Syer, R. Hart, and E. Brunt Oral treatments for toenail onychomycosis: a systematic review Arch Dermatol 138 2002 811 816
44. M. Haugh, S. Helou, J.P. Boissel, and B.J. Cribier Terbinafine in fungal infections of the nails: a meta-analysis of randomised clinical trials Br J Dermatol 137 2002 118 121
45. H. Degreef, A. del Palacio, S. Mygind, G. Ginter, A. Pinto Soares, and A. Zuluago de Cadena Randomized double-blind comparison of short-term itraconazole and terbinafine therapy for toenail onychomycosis Acta Derm Venereol 79 1999 221 223
46. L.A. Drake, N.H. Shear, J.P. Arlette, R. Cloutier, F.W. Danby, and B.E. Elewski Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial J Am Acad Dermatol 37 1997 740 745
47. B. Farkas, C. Paul, A. Dobozy, J. Hunyadi, A. Horvath, and G. Fekete Terbinafine (Lamisil) treatment of toenail onychomycosis in patients with insulin-dependent and non-insulin-dependent diabetes mellitus: a multicentre trial Br J Dermatol 146 2002 254 260
48. R. Pollak, and S.A. Billstein Efficacy of terbinafine for toenail onychomycosis. A multicenter trial of various treatment durations J Am Podiatr Med Assoc 91 2001 127 131
49. I. Tausch, M. Brautigam, G. Weidinger, and T.C. Jones Evaluation of 6 weeks treatment of terbinafine in tinea unguium in a double-blind trial comparing 6 and 12 weeks therapy. The Lagos V Study Group Br J Dermatol 136 1997 737 742
50. M. De Backer, P. De Keyser, C. De Vroey, and E. Lesaffre A 12-week treatment for dermatophyte toe onychomycosis: terbinafine 250 mg/day vs itraconazole 200 mg/day - a double-blind comparative trial Br J Dermatol 143 1996 16 17
51. M. Brautigam, S. Nolting, R.E. Schopf, and G. Weidinger German randomized double-blind multicenter comparison of terbinafine and itraconazole for the treatment of toenail tinea infections Br J Dermatol 134 1996 18 21
52. E.L. Svejgaard, F. Brandrup, K. Kragballe, P.O. Larsen, N.K. Veien, and M. Holst Oral terbinafine in toenail dermatophytosis. A double-blind, placebo-controlled multicenter study with 12 months' follow-up Acta Derm Venereol 77 1997 66 69
53. F. Schatz, M. Brautigam, E. Dobrowolski, I. Effendy, H. Haberl, and H. Mensing Nail incorporation kinetics of terbinafine in onychomycosis patients Clin Exp Dermatol 20 1995 377 383
54. N. Zaias, and G. Rebell The successful treatment of Trichophyton rubrum nail bed (distal subungual) onychomycosis with intermittent pulse-dosed terbinafine Arch Dermatol 140 2004 691 695
55. T. Matsumoto, H. Tanuma, S. Kaneko, H. Takasu, and S. Nishiyama Clinical and pharmacokinetic investigations of oral terbinafine in patients with tinea unguium Mycoses 38 1995 135 144
56. B.D. McInnes, and G.L. Dockery Surgical treatment of mycotic toenails J Am Podiatr Med Assoc 87 1997 557 564
57. A.K. Gupta, R. Baran, and R. Summerbell Onychomycosis: strategies to improve efficacy and reduce recurrence J Eur Acad Dermatol Venereol 16 2002 579 586
58. B.E. Elewski, M. El Charif, K.D. Cooper, M. Ghannoum, and J.E. Birnbaum Reactivity to trichophytin antigen in patients with onychomycosis: effect of terbinafine J Am Acad Dermatol 46 2002 371 375