An independent comparison of terbinafine and itraconazole in the treatment of toenail onychomycosis.
BACKGROUND
Previously, sponsored publications have shown that either terbinafine or itraconazole (pulse regimen) are effective for patients with toenail onychomycosis. However, independent comparative studies are lacking.


OBJECTIVE
To objectively compare treatment with terbinafine and itraconazole in patients with toenail onychomycosis.


METHODS
The effectiveness of terbinafine (250 mg/day 3 months) versus itraconazole pulse regimen (400 mg/day for the first week of each month, for three cycles) was retrospectively evaluated in patients with toenail onychomycosis using mycological tests and subjective outcome measures. Statistical analyses were performed using one-way analyses of variance (ANOVA) for continuous variables and Fisher exact tests for categorical variables.


RESULTS
Included in the study were 117 patients (74 patients treated by terbinafine and 43 patients treated with itraconazole). Patients were examined at an average period of 20 months after the end of therapy. Mycological cure was observed in 70.6% and 62.8% of the patients who were treated by terbinafine or itraconazole, respectively (not statistically significant). Mean visual analogue scale assessment of treatment outcome was 79.9 mm (SD 24.7 mm) and 65.2 mm (SD 34.6 mm) for patients treated by terbinafine or itraconazole, respectively (p=0.008). When the results were stratified according to age and gender, it was observed that the advantage of terbinafine versus itraconazole retained statistical significance only for patients who were 55 years old and above, or females.


CONCLUSIONS
Mycological cure proportions were not statistically significant between patients treated by terbinafine or itraconazole for toenail onychomycosis. However, better subjective outcome measures indicated an advantage for terbinafine over itraconazole, noticeable in females and patients 55 years old and above.
Cohen
A D
AD
Dermatology Centre, Clalit Health Services (Southern District), Beer-Sheva, Israel. arnonco@clalit.org.il
Medvesovsky
E
E
Shalev
R
R
Biton
A
A
Chetov
T
T
Naimer
S
S
Shai
A
A
Vardy
D A
DA
D000284:Administration, Oral; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000935:Antifungal Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005533:Foot Dermatoses / Q000175:diagnosis / Q000188:drug therapy; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D014009:Onychomycosis / Q000175:diagnosis / Q000188:drug therapy*; D011336:Probability; D020551:Pulse Therapy, Drug; D012189:Retrospective Studies; D012720:Severity of Illness Index; D012737:Sex Factors; D000077291:Terbinafine; D016896:Treatment Outcome
D000935:Antifungal Agents; D009281:Naphthalenes; D017964:Itraconazole; D000077291:Terbinafine