Randomized double-blind comparison of short-term itraconazole and terbinafine therapy for toenail onychomycosis.
Previous studies evaluating short-term itraconazole and terbinafine therapy for onychomycosis have varied in protocol and size; this double-blind study enabled a large-scale, standardized, direct comparison. Patients with toenail onychomycosis were randomized to itraconazole 200 mg daily (n = 146) or terbinafine 250 mg daily (n = 146) for 12 weeks, with a 36-week follow-up. Mycological cure rates at the follow-up end-point were significantly equivalent (61% with itraconazole vs. 67% with terbinafine). A similar proportion of patients in each group experienced adverse events during treatment (itraconazole, 22%; terbinafine, 23%). More patients receiving terbinafine stopped treatment permanently because of treatment-related adverse events (8% vs. 1%).
Degreef
H
H
Department of Dermatology, Catholic University of Leuven, Belgium.
del Palacio
A
A
Mygind
S
S
Ginter
G
G
Pinto Soares
A
A
Zuluaga de Cadena
A
A
D015746:Abdominal Pain / Q000139:chemically induced; D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004415:Dyspepsia / Q000139:chemically induced; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy / Q000382:microbiology; D006261:Headache / Q000139:chemically induced; D006801:Humans; D017964:Itraconazole / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced; D014009:Onychomycosis / Q000188:drug therapy*; D013651:Taste Disorders / Q000139:chemically induced; D000077291:Terbinafine; D016896:Treatment Outcome; D014249:Trichophyton / Q000187:drug effects / Q000302:isolation & purification; D014777:Virus Diseases / Q000139:chemically induced
D000935:Antifungal Agents; D009281:Naphthalenes; D017964:Itraconazole; D000077291:Terbinafine