The safety of terbinafine in patients over the age of 60 years: a multicenter trial in onychomycosis of the feet

Thirty patients completed this open-label, multicenter prospective study pe rformed to evaluate the efficacy and safety of terbinafine treatment of ony chomycosis of the feet in elderly patients. Inclusion criteria included an age of 60 years or older, a diagnosis of onychomycosis confirmed by positiv e potassium hydroxide (KOH) preparation at baseline, and toenails capable o f regrowth. Patients were excluded from the study if they had received any systemic antifungal therapy within the previous 3 months or topical antifun gal therapy within 1 week prior to the start of the study; had psoriasis; h ad toenail abnormalities interfering with normal toenail appearance; were i mmunosuppressed or immunodeficient; or had serum hepatic enzyme (serum glut amic-oxaloacetic transaminase, SGOT; serum glutamic-pyruvic transaminase, S GPT) values greater than 1.5 times the upper limit of normal at baseline. Following baseline evaluations, eligible patients received a 12-week supply of oral terbinafine (250 mg/day) for self-administration. Compliance was a ssessed by tablet counts at each visit and defined as the use of at least 8 0% of the medication prescribed at the first two visits. Follow-up evaluati ons were conducted for the next 60 weeks, for a total study period of 72 we eks. These visits occurred at weeks 6, 12, 24, 36, 48, and 72. All follow-u p visits included: (i) the reporting of adverse effects; (ii) assessment of efficacy by KOH preparation, mycologic culture, and investigator evaluatio n; and (iii) physician and patient global assessments of various quality of life parameters (except for the visit at week 36). Safety and tolerance were assessed by physical examination at baseline and week 12, by laboratory evaluations (hematology, blood chemistry, and urinal ysis) at baseline, week 6 and week 12, and by reporting and evaluation of a dverse events throughout the entire study. Investigators assessed the exten t of involvement of the target toenail and recorded global assessments of t herapeutic efficacy at all visits. Mycologic evaluation was conducted by KO H preparation and a mycologic culture of the target toenail. Because of dis crepancies in KOH results between the investigator sites and the central la boratory in early analyses, we chose to use the mycologic culture results t o evaluate efficacy. Because all 30 subjects were treated with terbinafine, the entire group was considered for safety evaluation.