Professional Documents
Culture Documents
Challenges and Opportunities in The Management of Onychomycosis PDF
Challenges and Opportunities in The Management of Onychomycosis PDF
Objective: To examine long-term cure and relapse rates microscopy and culture at the end of follow-up and no re-
after treatment with continuous terbinafine and inter- quirement of second intervention treatment. Secondary ef-
mittent itraconazole in onychomycosis. ficacy criteria included clinical cure without second inter-
vention treatment and mycological and clinical relapse rates.
Design: Long-term prospective follow-up study.
Results: Median duration of follow-up was 54 months.
Setting: Three centers in Iceland. At the end of the study, mycological cure without second
intervention treatment was found in 34 (46%) of the 74
Subjects: The study population comprised 151 pa- terbinafine-treated subjects and 10 (13%) of the 77 itra-
tients aged 18 to 75 years with a clinical and mycologi- conazole-treated subjects (P!.001). Mycological and clini-
cal diagnosis of dermatophyte toenail onychomycosis. cal relapse rates were significantly higher in itraconazole-
vs terbinafine-treated patients (53% vs 23% and 48% vs
Interventions: In a double-blind, double-dummy study, 21%, respectively). Of the 72 patients who received sub-
patients were randomized to receive either terbinafine (250 sequent terbinafine treatment, 63 (88%) achieved myco-
mg/d) for 12 or 16 weeks or itraconazole (400 mg/d) for logical cure and 55 (76%) achieved clinical cure.
1 week in every 4 for 12 or 16 weeks (first intervention).
Patients who did not achieve clinical cure at month 18 or Conclusion: In the treatment of onychomycosis, continu-
experienced relapse or reinfection were offered an addi- ous terbinafine provided superior long-term mycological
tional course of terbinafine (second intervention). and clinical efficacy and lower rates of mycological and clini-
cal relapse compared with intermittent itraconazole.
Main Outcome Measures: The primary efficacy crite-
rion was mycological cure, defined as negative results on Arch Dermatol. 2002;138:353-357
O
NYCHOMYCOSIS is a com- multicenter, double-blind, double-dum-
mon disease, and recent my study (the Lamisil vs Itraconazole in
population studies have Onychomycosis [LION] study) that pa-
shown a prevalence of be- tients treated with continuous terbin-
tween 2% and 8%.1-3 This afine achieved significantly superior my-
disease is more common in older age groups cological and clinical cure rates compared
From the Department and in selected populations, such as swim- with patients treated with intermittent itra-
of Dermatology, University
mers and individuals with diabetes melli- conazole.9,10
of Iceland and Landspitali
University Hospital, Reykjavik, tus or psoriasis.4-6 Onychomycosis can be While both itraconazole and terbin-
Iceland (Drs Sigurgeirsson and an infection reservoir for dermatomycoses afine have proven to be effective against ony-
Ólafsson); Húðlæknastöðin, of the adjacent skin, such as interdigital or chomycosis, very little is known about the
Dermatology Center plantar (“moccasin type”) tinea pedis. Stud- long-term maintenance of cure and relapse
(Dr Steinsson); the Department ies have shown that onychomycosis can rates observed with both drugs.11 The ob-
of Dermatology, Mulhouse have severe impact on quality of life,7 and jective of the present study was to exam-
Hospital, Mulhouse, France; this disease should not be trivialized.8 ine long-term mycological and clinical cure
Clinical Research, Novartis For several years treatment of ony- rates after treatment with terbinafine and
Pharma AG, Basel, Switzerland chomycosis was limited to griseofulvin, itraconazole for onychomycosis. Similarly,
(Dr Paul); Clinical Research,
which provided low cure rates and long mycological and clinical relapse rates were
Novartis Pharmaceutical
Corporation, East Hanover, NJ treatment times. Modern antifungal agents, examined. A secondary objective was to
(Dr Billstein); and Mycology such as terbinafine and itraconazole, are evaluate the effect of subsequent treatment
Reference Centre, University of significantly more effective with shorter withterbinafineinpatientswhoexperienced
Leeds and General Infirmary, treatment times. It has previously been relapses or failed the original treatment with
Leeds, England (Dr Evans). demonstrated in a randomized controlled, terbinafine or itraconazole.
}
Continuous) n = 68
Terbinafine Patients Randomized
n = 39 (n = 158)
(16-wk Course,
Continuous)
Itraconazole n = 40
(3-mo Course, Intention-to-Treat Population (n = 151) Excluded (n = 7)
}
Intermittent) n = 76
Terbinafine (n = 74) Insufficient Follow-up (n = 5)
Itraconazole n = 38 Itraconazole (n = 77) Protocol Violation (n = 2)
(4-mo Course,
Intermittent)
Completed 18 mo Intervention (n = 72)
(n = 143) Terbinafine (n = 25)
0 34 12 18 5 Itraconazole (n = 47)
Months Years
Terbinafine Itraconazole
gard to demographics and the extent and duration of nail Group Group Total
disease at baseline (Table 1). Characteristic (n = 74) (n = 77) (N = 151)
Mean age, y 48 48 48
CAUSAL AGENTS Male sex, No. (%) 47 (64) 53 (69) 100 (66)
Mean % of Trichophyton 97 96 97
The dermatophyte species isolated at screening were rubrum
Trichophyton rubrum alone (146 patients [97%]), Mean weight, kg 81 81 81
Mean No. of infected toenails 5.4 5.6 5.5
T rubrum plus a nondermatophyte mold (4 patients
Mean duration of 12.8 11.8 12.3
[3%]), and Trichophyton mentagrophytes alone (1 onychomycosis, y
patient [1%]). Mean % of nail involvement 77 76 76
40
clinical cure
No. (%) of patients achieving 18 (72) 34 (72) 52 (72)
complete cure
20