ITRACONAZOLE IN THE TREATMENT OF ONYCHOMYCOSIS - A DOUBLE-BLIND COMPARISON WITH MICONAZOLE

Background: In recent years, itraconazole pulse therapy for onychomyco sis has been developed [three 1-week pulses with itraconazole 400 (2x2 00) mg daily every month]. This has proved an effective and safe regim en which requires only 50% of the medication used for continuous dosin g schedules, Parallel to the development of the new dosage schedule, a dditional studies were conducted to further document the safety and ef ficacy of itraconazole 200 mg once daily for 3 months to treat onychom ycosis. Objective: To compare the safety of itraconazole 200 mg once d aily for 3 months, with or without itraconazole 200 mg once weekly for a further 3 months, with that of miconazole cream twice daily for 6 m onths, in the treatment of onychomycosis. Treatment efficacy was compa red as a secondary objective. Methods: In this multicenter, double-bli nd study, patients were randomized to receive itraconazole 200 mg once daily for 3 months followed by either itraconazole 200 mg once weekly for 3 months (ITR-ITR group, n=599) or oral placebo once weekly for 3 months (ITR-PLAC group, n=613), or to receive miconazole cream twice daily for 6 months (MIC-MIC group, n=396). The primary variable was el evation of alanine aminotransferase (ALT) concentration above 50 U/l. Results: Overall incidence of elevation of ALT concentration above 50 U/l, adverse events and rate of withdrawal because of adverse events w ere low and similar in the three treatment groups. Efficacy was signif icantly greater in the ITR groups than the MIC-MIC group. Conclusion: Itraconazole and miconazole were well tolerated and had no significant effect on liver function, but itraconazole was significantly more eff ective.