EFFICACY AND SAFETY OF ITRACONAZOLE PULSE THERAPY - BRAZILIAN MULTICENTRIC STUDY ON TOENAIL ONYCHOMYCOSIS CAUSED BY DERMATOPHYTES

Background Itraconazole is a large spectrum triazole with known effica cy in both continuous and pulse therapy for various mycoses. Objective s Evaluate the efficacy and tolerability of itraconazole pulse therapy for onychomycosis of the toenails due to dermatophytes, in a prospect ive, open, non-comparative and multicentric investigation. Patients an d methods The trial was completed by 72 patients of an initial total o f 89. Treatment consisted of four cycles of itraconazole, 200 mg twice a day, for seven consecutive days each month. Patients were evaluated clinically, mycologically and biochemically before, during and at the end of the investigation, and were divided into two groups according to the measure of normal portion of the most affected nail (target nai l), as follows: Group 1. 0-5.9 mm; and Group 2: more than 6 mm. Result s Improvement was satisfactory and progressive. Results were statistic ally significant, when comparing the three moments of the study: pre-t reatment, end of therapy (fourth month) and follow-up (ninth month) in both groups. Conclusions Itraconazole pulse therapy was efficient and safe for the treatment of onychomycosis caused by dermatophytes, alth ough a much higher daily dosage than the known continuous administrati on was used. Group 1, with nails initially more extensively affected, had a more evident improvement, by the mean variation in millimeters o f normal portion of the target nail. This group showed a very satisfac tory response, although not reaching total cure, thus demonstrating th e great importance of early treatment of this disease. A residual ther apeutic effect is maintained even after suspension of the drug. Group 2 obtained better total cure rates, and four pulses were, in general, sufficient, whereas more cycles would have been beneficial for the Gro up 1 patients with more extensive involvement. (C) 1998 Elsevier Scien ce B.V. All rights reserved.