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Terbinafine (Lamisil) More Effective than Itraconazole (Sporanox) for Onychomycosis in Older Patients: Presented at AAD

By Bruce Sylvester

SAN FRANCISCO, CA -- March 7, 2006 -- Treatment of onychomycosis, the most common nail disease, in older patients is significantly more effective with terbinafine (Lamisil) 250 mg/day than with intermittent itraconazole (Sporanox).

Researchers reported this finding here on March 5^th in a poster presentation at the 64^th Annual Meeting of the American Academy of Dermatology (AAD).

Onychomycosis is an infection that causes fingers or toenails to become thickened, discolored, disfigured, and/or split.

Terbinafine is an antifungal agent that is FDA-approved to treat fungal infections of the toenail and fingernail. It is taken as a tablet, usually once a day for 6 weeks for fingernail fungus and once a day for 12 weeks for toenail fungus.

Itraconazole is a triazole antifungal that is FDA-approved to treat fungal infections of the fingernails and/or toenails as well as other fungal infections. It works by slowing the growth of fungi that cause infection. When used to treat fungal infections of the fingernails it is taken by capsule twice a day for 1 week, not taken at all for 3 weeks, and then taken twice a day for an additional week.

The research presented at the AAD meeting was a 72-week, double-blind, multicenter, parallel-group study that compared daily terbinafine with intermittent (1 week every 4 weeks) itraconazole. The investigators randomized 496 subjects, aged 18 to 75 years, with toenail onychomycosis to one of four treatment groups: terbinafine 250 mg/day for 12 or 16 weeks, or itraconazole 400 mg/day for 1 week every 4 weeks for 12 or 16 weeks.

For this sub-analysis, investigators combined data by treatment group without regard to treatment duration.

The primary endpoint was mycological cure at week 72. Secondary variables were clinical cure based on global patient and investigator assessments and complete cure (mycological-plus-clinical cure), and were assessed at weeks 12, 24, 48 and 72.

The investigators reported that efficacy in patients who were 50 years or older was similar to the overall study population. They also reported a statistically significant difference favoring terbinafine in mycological, clinical and complete cure at weeks 48 and 72.

At week 48, 76.1% of older patients taking terbinafine achieved mycological cure compared to 39.6% with itraconazole (P <.0001). Mycological cure rates at week 72 were 78.3% for terbinafine and 40.2% for itraconazole (P <.0001). Complete cure at week 48 was 36.3% for terbinafine and 17.0% for itraconazole (P =.0017) and 48.7% and 14.7%, respectively at week 72 (P <.0001).

At week 72, in the under-50 subgroup, the researchers observed complete cure in 52.2% of patients treated with terbinafine and in 33.6% of patients treated with itraconazole (P =.0099).

"Terbinafine exhibited good tolerability in the older subgroup," the authors noted. "Incidence of adverse events was low, generally mild to moderate, and similar to that previously reported in the pivotal trials."

The authors concluded that terbinafine 250 mg/day is significantly more effective than intermittent intraconazole for treatment of toenail onychomycosis in older patients.

The study was supported by Novartis Pharmaceuticals.


[Presentation title: Efficacy and Safety of Oral Terbinafine in an Elderly Population: Subanalysis of the L.I.ON Study. Abstract P1617]

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