Two novel itraconazole pulse therapies for onychomycosis: a 2-year follow-up.

BACKGROUND

Itraconazole given in pulse therapy has become popular for onychomycosis treatment since it results in less plasma exposure to the drug while maintaining an effective drug concentration in the nail plate and also increasing patient compliance.

OBJECTIVE

The current study aims to evaluate two different regimens of itraconazole for toenail onychomycosis, looking at both the immediate post-therapy cure rate and the relapse rate after 2 years.

METHODS

Two groups of 52 patients each were given either 'standard' oral itraconazole pulse therapy for 3 months (200 mg x 2/day for 1 week/month) followed by an additional single course (200 mg/day for 7 days) after 3 months (regimen A) or 'modified' (6-week interval) itraconazole pulse therapy x3 followed by an additional single course (200 mg x 2/day for 7 days) after 3 months. All patients were followed-up for 24 months from the beginning of treatment.

RESULTS

Regimen A: 37 patients were available for examination after 24 months, of whom 22 patients (59.5%) had total cure and two patients (5.5%) had marked improvement. Regimen B: 38 patients were available for examination after 24 months, of whom 29 patients (76.3%) had total cure and three patients (7.9%) had marked improvement. There were no statistical differences in cure rates between the two groups at the end of treatment, after 12 months and after 24 months. None of the patients (in both treatment groups) who had total cure at the end of the treatment period had onychomycosis recurrence after 12 or 24 months.

CONCLUSION

The results at the end of the 24-month period are encouraging, where 64.9% (regimen A) and 84.2% (regimen B) of the patients had total cure or marked improvement in their toenail condition. Therefore, those two regimens are acceptable alternatives to the current treatment regimen.