Safety and efficacy of oral terbinafine in the treatment of onychomycosis: Analysis of the elderly subgroup in improving results in ONychomycosis-concomitant lamisil® and debridement (IRON-CLAD), an open-label, randomized trial

American Journal Geriatric Pharmacotherapy

Volumn 4, Issue 1, 2006, Pages 1-13

  Tavakkol, Amir ^a   Fellman, Stephanie ^a   Kianifard, Farid ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

antifungal; efficacy; elderly; onychomycosis; safety; terbinafine; tolerability

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ANGIOTENSIN RECEPTOR ANTAGONIST; ANTIDIABETIC AGENT; ANTIHYPERTENSIVE AGENT; ANTILIPEMIC AGENT; BENZOTHIAZEPINE DERIVATIVE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BIGUANIDE DERIVATIVE; BILE ACID SEQUESTRANT; CHOLESTEROL; DIHYDROPYRIDINE DERIVATIVE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; FIBRIC ACID DERIVATIVE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN; PHENYLALKYLAMINE; POTASSIUM HYDROXIDE; POTASSIUM SPARING DIURETIC AGENT; SULFONAMIDE; TERBINAFINE; THIAZIDE DIURETIC AGENT; UREA DERIVATIVE;

ADULT; AGED; ARTHRALGIA; ARTICLE; CAUCASIAN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEBRIDEMENT; DIABETES MELLITUS; DISEASE SEVERITY; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; ELDERLY CARE; FEMALE; FUNGUS CULTURE; HEADACHE; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; INCIDENCE; INGROWN NAIL; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MEDICAL ASSESSMENT; MICROSCOPY; MULTICENTER STUDY; NAUSEA; PATIENT INFORMATION; PHYSICAL EXAMINATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINUSITIS; TOENAIL ONYCHOMYCOSIS; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGE FACTORS; AGED; ANTIFUNGAL AGENTS; DEBRIDEMENT; FEMALE; FOOT DERMATOSES; HUMANS; MALE; MIDDLE AGED; NAPHTHALENES; ONYCHOMYCOSIS;

EID: 33646815354     PISSN: 15435946     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amjopharm.2005.12.012     Document Type: Article

References (37)

1. Gupta A.K., Jain H.C., Lynde C.W., et al. Prevalence and epidemiology of onychomycosis in patients visiting physicians' offices: A multicenter Canadian survey of 15,000 patients. J Am Acad Dermatol 43 (2000) 244-248
2. Elewski B.E., and Charif M.A. Prevalence of onychomycosis in patients attending a dermatology clinic in northeastern Ohio for other conditions. Arch Dermatol 133 (1997) 1172-1173
3. Ghannoum M.A., Hajjeh R.A., Scher R., et al. A large-scale North American study of fungal isolates from nails: The frequency of onychomycosis, fungal distribution, and antifungal susceptibility patterns. J Am Acad Dermatol 43 (2000) 641-648
4. Gupta A.K., Ryder J.E., Lynch L.E., and Tavakkol A. The use of terbinafine in the treatment of onychomycosis in adults and special populations: A review of the evidence. J Drugs Dermatol 4 (2005) 302-308
5. March. Pollack R., and Tavakkol A. Onychomycosis in diabetic patients: To treat or not to treat?. Podiatry Manag (2005) 111-117
6. Tan J.S., and Joseph W.S. Common fungal infections of the feet in patients with diabetes mellitus. Drugs Aging 21 (2004) 101-112
7. Elewski B.E. Onychomycosis: Pathogenesis, diagnosis, and management. Clin Microbiol Rev 11 (1998) 415-429
8. Scher R.K. Onychomycosis: A significant medical disorder. J Am Acad Dermatol 35 (1996) S2-S5
9. Lamisil (2004), Novartis Pharmaceutical Corporation, East Hanover, NJ
10. Sporanox (2003), Janssen Pharmaceutica Products, Titusville, NJ
11. Penlac nail lacquer (2000), Dermik Laboratories, Berwyn, Pa
12. Rask K.J., Wells K.J., Teitel G.S., et al. Can an algorithm for appropriate prescribing predict adverse drug events?. Am J Manag Care 11 (2005) 145-151
13. Gupta A.K. Onychomycosis in the elderly. Drugs Aging 16 (2004) 397-407
14. Evans E.G., Sigurgeirsson B., and LION Study Group. Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis. BMJ 318 (1999) 1031-1035
15. Heikkila H., and Stubb S. Long-term results in patients with onychomycosis treated with terbinafine or itraconazole. Br J Dermatol 146 (2002) 250-253
16. Sigurgeirsson B., Olafsson J.H., Steinsson J.B., et al. Long-term effectiveness of treatment with terbinafine vs itraconazole in onychomycosis: A 5-year blinded prospective follow-up study. Arch Dermatol 138 (2002) 353-357
17. Gupta A.K., Ryder J.E., and Johnson A.M. Cumulative metaanalysis of systemic antifungal agents for the treatment of onychomycosis. Br J Dermatol 150 (2004) 537-544
18. Singer M.I., Shapiro L.E., and Shear N.H. Cytochrome P-450 3A: Interactions with dermatologic therapies. J Am Acad Dermatol 37 (1997) 765-771
19. Vickers A.E., Sinclair J.R., Zollinger M., et al. Multiple cytochrome P-450s involved in the metabolism of terbinafine suggest a limited potential for drug-drug interactions. Drug Metab Dispos 27 (1999) 1029-1038
20. [published correction appears in J Am Acad Dermatol. 2000;42:148]. Gupta A.K., Katz I., and Shear N.H. Drug interactions with itraconazole, fluconazole, and terbinafine and their management. J Am Acad Dermatol 41 (1999) 237-249
21. Del Rosso J.Q. Oral antifungals: What you should know about drug interactions. Podiatry Today 17 (2004) 61-66
22. Smith E.B., Stein L.P., Fivenson D.P., and Atillasoy E.S. Clinical trial: The safety of terbinafine in patients over the age of 60 years: A multicenter trial in onychomycosis of the feet. Int J Dermatol 39 (2000) 861-884
23. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Good Clinical Practice Guideline: Consolidated Guideline (1997), Health Canada, Therapeutic Products Programme, Ottawa, Ont
24. Available at:. World Medical Association Declaration of Helsinki. Accessed. Ethical Principles for Medical Research Involving Human Subjects (November 30, 2005). http://www.wma.net/e/policy/b3.htm
25. Katz H.I. How should managed care treat onychomycosis?. Am J Manag Care 4 (1998) 1471-1479
26. Lawry M.A., Haneke E., Strobeck K., et al. Methods for diagnosing onychomycosis: A comparative study and review of the literature. Arch Dermatol 136 (2000) 1112-1116
27. Zabawski Jr. E.J., Styles A.R., and Cockerell C.J. Routine periodic acid-Schiff staining of nail plate fragments in fungal cultures for onychomycosis: A method to increase the sensitivity of diagnosis. Cutis 66 (2000) 456-458
28. [published correction appears in Br J Dermatol. 2001;144:448]. Baran R., Feuilhade M., Combernale P., et al. A randomized trial of amorolfine 5% solution nail lacquer combined with oral terbinafine compared with terbinafine alone in the treatment of dermatophytic toenail onychomycoses affecting the matrix region. Br J Dermatol 142 (2000) 1177-1183
29. Zaias N., and Drachman D. A method for the determination of drug effectiveness in onychomycosis. Trials with ketoconazole and griseofulvin ultramicrosize. J Am Acad Dermatol 9 (1983) 912-919
30. Presented at:. Jennings M., Pollak R.A., Harkless L.B., et al. Quantitation of visibly infected nail area in onychomycosis utilizing the Mycotic Nail Involvement Assessment Tool. Boston, Mass. American Podiatric Medical Association meeting. August 21-25 (2004)
31. Drake L.A., Shear N.H., Arlette J.P., et al. Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial. J Am Acad Dermatol 37 (1997) 740-745
32. Hall M., Monka C., Krupp P., and O'Sullivan D. Safety of oral terbinafine: Results of a postmarketing surveillance study in 25,884 patients. Arch Dermatol 133 (1997) 1213-1219
33. Scher R.K., and Baran R. Onychomycosis in clinical practice: Factors contributing to recurrence. Br J Dermatol 149 Suppl 65 (2003) 5-9
34. Sigurgeirsson B., Paul C., Curran D., and Evans E.G. Prognostic factors of mycological cure following treatment of onychomycosis with oral antifungal agents. Br J Dermatol 147 (2002) 1241-1243
35. Hiruma M., Matsushita A., Kobayashi M., and Ogawa H. One week pulse therapy with itraconazole (200 mg day-1) for onychomycosis. Evaluation of treatment results according to patient background. Mycoses 44 (2001) 87-93
36. Arnold B., Kianifard F., and Tavakkol A. A comparison of KOH and culture results from two mycology laboratories for the diagnosis of onychomycosis during a randomized, multicenter clinical trial: A subset study. J Am Podiatr Med Assoc 95 (2005) 421-424
37. Gupta A.K., Konnikov N., and Lynde C.W. Single-blind, randomized, prospective study on terbinafine and itraconazole for treatment of dermatophyte toenail onychomyco sis in the elderly. J Am Acad Dermatol 44 (2001) 479-484