Terbinafine vs. itraconazole for onychomycosis – adapted from the British Medical Journal 1995;311:919-22 – Tips from Other Journals
Fungal nail infections are estimated to occur in at least 2 percent of the population. Both local and systemic treatments have been disappointing, resulting in low rates of cure and the risk of significant side effects during the required long treatment periods. New antifungal drugs offer higher rates of cure, with a reduced risk of side effects. Brautigam and colleagues compared the efficacy and tolerability of two of the newer agents, terbinafine and itraconazole.
A total of 195 patients with clinical evidence of onychomycosis and positive culture for dermatophytes were included in the study. More than 60 percent of the toe-nail nail was affected in most of the patients, and 102 of the patients had been treated previously with antimycotic drugs. The patients were randomly allocated to receive either 250 mg of terbinafine or 200 mg of itraconazole daily for 12 weeks. Following treatment, patients were assessed at two, four, eight and 12 weeks and then every eight weeks, for a total follow-up of the weeks. Nail clippings were taken at each visit for microscopy and culture.
Results were available for 86 patients treated with terbinafine and 84 patients treated with itraconazole. Mycologic cure as defined by microscopy and culture was achieved in 81 percent of the patients treated with terbinafine and a percent of the patients treated with itraconazole. The mean time until negative culture was achieved was 8.5 weeks for terbinafine and 11.6 weeks for itraconazole.
Adverse effects occurred in 6 percent of the terbinafine group and in So percent of the itraconazole group. The most commonly reported adverse effects were headache, dyspepsia, diarrhea, taste disorders and constipation. Seven patients discontinued treatment because of adverse effects, two of whom were withdrawn because of an increase in liver enzyme levels.
The authors conclude that both drugs were effective and well-tolerated but that terbinafine was significantly more successful in eradication of fungal pathogens. Neither drug showed significant hepatotoxicity. An interesting additional observation was that serum cholesterol levels decreased in 81 percent of the patients receiving itraconazole. (Brautigam M, et al. Randomized double blind comparison of terbinafine and itraconazole for treatment of toenail tinea infection. BMJ 1995;311;919-22.)
COPYRIGHT 1996 American Academy of Family Physicians
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