An open-label, multicenter study of the combination of amorolfine nail lacquer and oral itraconazole compared with oral itraconazole alone in the treatment of severe toenail onychomycosis

Abstract

Background: Data indicate that combination therapy may provide enhanced clinical and economic benefits over monotherapy in the treatment of onychomycosis. Objective: The aim of this study was to compare the efficacy of 2 topical amorolfine/oral itraconazole combination regimens with oral itraconazole alone in the treatment of severe toenail onychomycosis. Cost implications of all treatments were assessed in a pilot pharmacoeconomic analysis. Methods: In this multicenter, open-label, 24-week study, patients were randomized to 3 parallel treatment groups: 5% solution of amorolfine nail lacquer applied once weekly for 24 weeks plus itraconazole 200 mg once daily for either 6 weeks (group AI-6) or 12 weeks (group AI-12), or itraconazole alone for 12 weeks (group I-12). Results: Mycologic cure at week 12 was achieved in 93% of patients in group AI-6, 83% in group AI-12, and 41% in group I-12. Combination therapies were significantly more effective than itraconazole monotherapy ( P < 0.001). Global assessment (combined measure of mycologic and clinical cure rates) at 24 weeks demonstrated cure rates of 84% for patients in group AI-6, 94% in group AI-12, and 69% in group I-12. The difference between the AI-12 group and the I-12 group was statistically significant ( P < 0.05). There were no serious adverse events during the study, and the distribution of adverse events was not significantly different between groups. Pharmacoeconomic assessment demonstrated that both durations of combination therapy were more cost-effective than monotherapy. Conclusions: Our results show that topical amorolfine combined with oral itraconazole was more effective in treating severe toenail onychomycosis than was itraconazole monotherapy. Combination with a short course of oral therapy had a marked pharmacoeconomic advantage over the other regimen, suggesting that switching from the current 12-week itraconazole monotherapy to the 6-week combination therapy would cure more patients for a lower cost.