Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial.
BACKGROUND
Onychomycosis is an increasing problem with limited therapeutic options.


OBJECTIVE
We evaluated the safety and efficacy, of oral terbinafine, a new fungicidal antimycotic, in patients with toenail onychomycosis.


METHODS
A North American multicenter, double-blind, placebo-controlled study evaluated the mycologic and clinical efficacy of oral terbinafine 250 mg/day for 12 or 24 weeks in 358 patients with toenail onychomycosis.


RESULTS
A total of 74% of patients treated with 12 or 24 weeks of terbinafine achieved a successful clinical outcome. Approximately 11% of terbinafine responders showed evidence of relapse 18 of 21 months after cessation of treatment. Terbinafine was well tolerated; most adverse events were transient and mild to moderate in severity.


CONCLUSIONS
The results of this study confirm that oral terbinafine is a safe and effective therapy for the treatment of onychomycosis.
Drake
L A
LA
Massachusetts General Hospital, Boston 02114-2698, USA.
Shear
N H
NH
Arlette
J P
JP
Cloutier
R
R
Danby
F W
FW
Elewski
B E
BE
Garnis-Jones
S
S
Giroux
J M
JM
Gratton
D
D
Gulliver
W
W
Hull
P
P
Jones
H E
HE
Journet
M
M
Krol
A L
AL
Leyden
J J
JJ
Maddin
S C
SC
Ross
J B
JB
Savin
R C
RC
Scher
R K
RK
Sibbald
G R
GR
Tawfik
N H
NH
Zaias
N
N
Tolpin
M
M
Evans
S
S
Birnbaum
J E
JE
D015746:Abdominal Pain / Q000139:chemically induced; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000209:etiology; D004821:Epidermophyton / Q000302:isolation & purification; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D014009:Onychomycosis / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D012008:Recurrence; D000077291:Terbinafine; D014034:Toes; D014249:Trichophyton / Q000302:isolation & purification
D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine