Lamisil tablets (terbinafine hydrochloride tablets) provide a long-term cure for toenail fungal infection (onychomycosis) with low relapse rates, according to five-year data reported in this month`s issue of Archives of Dermatology.

Almost half of all patients treated with Lamisil remain mycologically cured (based on negative results on both microscopy and culture samples taken from the target toenail) after 5 years without any additional treatment.

"These findings offer patients and physicians evidence that toenail fungus can be effectively treated with 12 weeks of treatment with Lamisil," said Bardur Sigurgeirsson, MD, lead author of the study and assistant professor of dermatology at the University of Iceland and Landspitali University Hospital in Reykjavik, Iceland. "For patients, this means that they are likely to be able to avoid having an infection relapse and to remain cured into the foreseeable future."

The L.I.ON. I.E.S. (Lamisil versus Itraconazole in Onychomycosis Icelandic Extension Study) study represents the longest follow-up study of patients treated for toenail fungal infection (onychomycosis). The study was an actively controlled follow-up that included 74 Lamisil-treated patients from 3 centers in Iceland who participated in the original L.I.ON. study. These patients were tracked at 6-month intervals for anaverage of 54 months. Patients who did not achieve cure in the original L.I.ON. study were given a second course of treatment with Lamisil, as were those who did achieve cure during the original L.I.ON. study but relapsed or were reinfected during the follow-up period. The original L.I.ON. study covered 18 months. The L.I.ON. Icelandic Extension Study followed patients out to 5 years.

During the original L.I.ON. study, published in April 1999 in the British Medical Journal (BMJ), 76 percent of Lamisil-treated patients (n=57) achieved mycological cure at the end of the 18-month follow-up. The L.I.ON. Extension Study confirms that Lamisil Tablets provide low rates of relapse for up to 5 years 77 percent (44/57) remained mycologically cured for the entire 54-month follow-up period; defined as negative results on both microscopy and culture samples taken from the target toenail 79 percent (31/39) remained clinically cured for the entire 54-months follow-up period; defined as 100 percent normal appearing nail 26 patients achieved complete cure at the end of the 54 months; defined as both mycologically and clinically cured

"More than 19 million patients worldwide have benefited from the use of Lamisil to treat onychomycosis. These results confirm that Lamisil is an effective treatment for this infection," said Thomas Ebeling, CEO of Novartis Pharma. "We believe this long-term follow up study will enable physicians to make better decisions in the treatment of toenail fungal infections."