title: Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial.
abstract: 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.
authors.affiliation: Massachusetts General Hospital, Boston 02114-2698, USA.
authors.forename: L A
authors.initials: LA
authors.lastname: Drake
authors.forename: N H
authors.initials: NH
authors.lastname: Shear
authors.forename: J P
authors.initials: JP
authors.lastname: Arlette
authors.forename: R
authors.initials: R
authors.lastname: Cloutier
authors.forename: F W
authors.initials: FW
authors.lastname: Danby
authors.forename: B E
authors.initials: BE
authors.lastname: Elewski
authors.forename: S
authors.initials: S
authors.lastname: Garnis-Jones
authors.forename: J M
authors.initials: JM
authors.lastname: Giroux
authors.forename: D
authors.initials: D
authors.lastname: Gratton
authors.forename: W
authors.initials: W
authors.lastname: Gulliver
authors.forename: P
authors.initials: P
authors.lastname: Hull
authors.forename: H E
authors.initials: HE
authors.lastname: Jones
authors.forename: M
authors.initials: M
authors.lastname: Journet
authors.forename: A L
authors.initials: AL
authors.lastname: Krol
authors.forename: J J
authors.initials: JJ
authors.lastname: Leyden
authors.forename: S C
authors.initials: SC
authors.lastname: Maddin
authors.forename: J B
authors.initials: JB
authors.lastname: Ross
authors.forename: R C
authors.initials: RC
authors.lastname: Savin
authors.forename: R K
authors.initials: RK
authors.lastname: Scher
authors.forename: G R
authors.initials: GR
authors.lastname: Sibbald
authors.forename: N H
authors.initials: NH
authors.lastname: Tawfik
authors.forename: N
authors.initials: N
authors.lastname: Zaias
authors.forename: M
authors.initials: M
authors.lastname: Tolpin
authors.forename: S
authors.initials: S
authors.lastname: Evans
authors.forename: J E
authors.initials: JE
authors.lastname: Birnbaum
mesh_terms: 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
chemical_list: D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine