title: Long-term effectiveness of treatment with terbinafine vs itraconazole in onychomycosis: a 5-year blinded prospective follow-up study.
abstract: OBJECTIVE
  To examine long-term cure and relapse rates after treatment with continuous terbinafine and intermittent itraconazole in onychomycosis.
  
  
  METHODS
  Long-term prospective follow-up study.
  
  
  METHODS
  Three centers in Iceland.
  
  
  METHODS
  The study population comprised 151 patients aged 18 to 75 years with a clinical and mycological diagnosis of dermatophyte toenail onychomycosis.
  
  
  METHODS
  In a double-blind, double-dummy study, patients were randomized to receive either terbinafine (250 mg/d) for 12 or 16 weeks or itraconazole (400 mg/d) for 1 week in every 4 for 12 or 16 weeks (first intervention). Patients who did not achieve clinical cure at month 18 or experienced relapse or reinfection were offered an additional course of terbinafine (second intervention).
  
  
  METHODS
  The primary efficacy criterion was mycological cure, defined as negative results on microscopy and culture at the end of follow-up and no requirement of second intervention treatment. Secondary efficacy criteria included clinical cure without second intervention treatment and mycological and clinical relapse rates.
  
  
  RESULTS
  Median duration of follow-up was 54 months. At the end of the study, mycological cure without second intervention treatment was found in 34 (46%) of the 74 terbinafine-treated subjects and 10 (13%) of the 77 itraconazole-treated subjects (P<.001). Mycological and clinical relapse rates were significantly higher in itraconazole vs terbinafine-treated patients (53% vs 23% and 48% vs 21%, respectively). Of the 72 patients who received subsequent terbinafine treatment, 63 (88%) achieved mycological cure and 55 (76%) achieved clinical cure.
  
  
  CONCLUSIONS
  In the treatment of onychomycosis, continuous terbinafine provided superior long-term mycological and clinical efficacy and lower rates of mycological and clinical relapse compared with intermittent itraconazole.
authors.affiliation: Department of Dermatology, University of Iceland, Reykjavik. bsig@isholf.is
authors.forename: Bárour
authors.initials: B
authors.lastname: Sigurgeirsson
authors.forename: Jón H
authors.initials: JH
authors.lastname: Olafsson
authors.forename: Jón B
authors.initials: JB
authors.lastname: Steinsson
authors.forename: Carle
authors.initials: C
authors.lastname: Paul
authors.forename: Stephan
authors.initials: S
authors.lastname: Billstein
authors.forename: E Glyn V
authors.initials: EG
authors.lastname: Evans
mesh_terms: D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D005533:Foot Dermatoses / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D014009:Onychomycosis / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D012008:Recurrence; D019233:Retreatment; D000077291:Terbinafine; D014005:Tinea / Q000150:complications; D016896:Treatment Outcome; D014249:Trichophyton / Q000302:isolation & purification
chemical_list: D000935:Antifungal Agents; D009281:Naphthalenes; D017964:Itraconazole; D000077291:Terbinafine