Efficacy and Safety of Itraconazole 400 mg/day Pulse Therapy for Onychomycosis-Based on the Results of Post-marketing Surveillance-

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  • 爪白癬に対するイトラコナゾール１日４００ｍｇパルス療法の有効性ならびに安全性―市販後調査結果より―
  • 治療 爪白癬に対するイトラコナゾール1日400mgパルス療法の有効性ならびに安全性--市販後調査結果より
  • チリョウ ツメ ハクセン ニ タイスル イトラコナゾール 1ニチ 400mg パルス リョウホウ ノ ユウコウセイ ナラビニ アンゼンセイ シハン ゴ チョウサ ケッカ ヨリ
  • —Based on the Results of Post-marketing Surveillance—
  • ―市販後調査結果より―

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Itraconazole (Itrizole® Capsule 50) is a triazole antifungal agent that is synthesized by the Belgian company, Janssen Pharmaceutica. In February 2004, itraconazole pulse therapy was approved for the treatment of onychomycosis in Japan. Itraconazole pulse therapy consists of a cycle of 400 mg/day for 1 week, followed by a three-week cessation period, and the cycle is repeated three times. A post-marketing surveillance study of patients with onychomycosis was conducted to assess the efficacy and safety of itraconazole pulse therapy. The overall efficacy rate in 1,051 patients included in the efficacy analysis was 84.3%. An efficacy rate of 80% or more was shown in infected site, primary/recurrent infection, thickness, opacity ratio, etc., regardless of the condition or severity of onychomycosis. Among the 2,394 patients included in an analysis of the completion of therapy rate, 93.0% of the patients completed three cycles of itraconazole administration. Among 2,532 patients included in the safety analysis, adverse drug reactions were reported in 288 cases (11.4%), but most adverse drug reactions were expected mild abnormalities in laboratory test values. Based on these results, we confirmed the favorable efficacy and safety of pulse therapy with Itrizole® Capsule 50 for the treatment of onychomycosis.

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