Itraconazole pulse therapy for onychomycosis

NewsBot · Jun 28, 2006

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Two novel itraconazole pulse therapies for onychomycosis: a 2-year follow-up.
J Dermatolog Treat. 2006;17(2):117-20

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.
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Admin2 · Jun 29, 2006

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NewsBot · Sep 26, 2008

Fatal hepatitis after long-term pulse itraconazole treatment for onychomycosis.
Tuccori M, Bresci F, Guidi B, Blandizzi C, Del Tacca M, Di Paolo M.
Ann Pharmacother. 2008 Jul;42(7):1112-7.

OBJECTIVE: To report the occurrence of acute cytolytic hepatitis in a patient exposed to pulse itraconazole therapy for 24 weeks and provide a concise review of the literature on cases of itraconazole-induced hepatitis.

CASE SUMMARY: A 61-year-old woman with no apparent risk factors for liver injury developed acute hepatitis one week after the final dose of a long-term course of pulse itraconazole therapy (200 mg orally twice daily, 1 wk on, 3 wk off, for 24 wk) for onychomycosis. Monitoring of liver enzymes was not performed during the treatment period. Serologic evaluations on presentation ruled out infectious diseases or other etiological factors. Liver function tests showed alanine aminotransferase 3330 U/L, aspartate aminotransferase 3250 U/L, and bilirubin 21 mg/dL. Liver function continued to deteriorate, and the patient underwent liver transplantation 17 days after admission. Her liver displayed reduced volume and there was a mild accumulation of ascitic fluid in the retroperitoneal cavity. Histologic evaluation showed massive panlobular necrosis. Complications occurred after transplantation and a rejection crisis worsened the clinical picture until the patient died about 4 months later. Use of the Naranjo probability scale showed the relationship of itraconazole therapy and the occurrence of acute hepatitis as probable.

DISCUSSION: Itraconazole pulse therapy for onychomycosis appears to be at least as effective as and safer than a continuous treatment regimen, particularly from the perspective of potential liver damage. Only one case of severe symptomatic hepatitis occurring after pulse therapy with itraconazole for onychomycosis and requiring transplantation has been reported previously. In that case, as well as the one reported here, hepatitis symptoms occurred after completion of long-term treatment in patients who were asymptomatic both before and during therapy.

CONCLUSIONS: Prolonged exposure to itraconazole, administered either continuously or intermittently, may precipitate severe and irreversible hepatotoxic events. Accordingly, careful monitoring of liver function parameters should be performed both during and after treatment when onychomycosis requires prolonged itraconazole administration, even in asymptomatic patients lacking apparent risk factors of hepatic injury
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Itraconazole for onychomycosis

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