Itraconazole pulse therapy is effective in dermatophyte onychomycosis of the toenail: a double-blind placebo-controlled study
BACKGROUND: Until recently the traditional antifungal agents used to treat onychomycosis of the toenails, griseofulvin and ketoconazole, were generally ineffective and required treatment for a long duration. OBJECTIVE: The objective of the study was to determine the efficacy and safety of itraconazo...
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| Veröffentlicht in: | The Journal of dermatological treatment 2000, Vol.11 (1), p.33-37 |
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| container_title | The Journal of dermatological treatment |
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| creator | Gupta, S Maddin, J Arlette, J-M Giroux, NH Shear, AK |
| description | BACKGROUND: Until recently the traditional antifungal agents used to treat onychomycosis of the toenails, griseofulvin and ketoconazole, were generally ineffective and required treatment for a long duration. OBJECTIVE: The objective of the study was to determine the efficacy and safety of itraconazole (pulse) therapy (200 mg twice daily for 1 week a month for three consecutive months) in onychomycosis of the toenails. METHODS: A randomized, multicenter, placebo-controlled Canadian study was conducted in 200 patients. To allow evaluation for efficacy, the KOH and culture had to be positive at baseline. RESULTS: In the itraconazole (n=78) and placebo (n=74) groups, the mycological cure rates were 61.5% and 28.4%, respectively (p |
| doi_str_mv | 10.1080/09546630050517658 |
| format | Article |
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OBJECTIVE: The objective of the study was to determine the efficacy and safety of itraconazole (pulse) therapy (200 mg twice daily for 1 week a month for three consecutive months) in onychomycosis of the toenails. METHODS: A randomized, multicenter, placebo-controlled Canadian study was conducted in 200 patients. To allow evaluation for efficacy, the KOH and culture had to be positive at baseline. RESULTS: In the itraconazole (n=78) and placebo (n=74) groups, the mycological cure rates were 61.5% and 28.4%, respectively (p<0.0001). The clinical success rates (clinical cure plus marked improvement) in the two groups were 65.4% and 1.4%, respectively (p<0.0001). The numbers of patients experiencing an adverse effect to itraconazole and placebo were 34 (34.7%) of 98 patients and 30 (29.5%) of 102 patients, respectively (attributable risk to itraconazole is 5.2%). The distribution of adverse experiences between the two groups was similar with respect to body system, severity, frequency and action taken. CONCLUSION: Itraconazole (pulse) therapy is effective and safe for the treatment of dermatophyte onychomycosis of the toenails. (J Dermatol Treat (2000) 11:33 37)</description><identifier>ISSN: 0954-6634</identifier><identifier>EISSN: 1471-1753</identifier><identifier>DOI: 10.1080/09546630050517658</identifier><language>eng</language><publisher>Oslo: Informa UK Ltd</publisher><subject>Antibacterial agents ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Biological and medical sciences ; Itraconazole Onychomycosis Pulse Therapy ; Medical sciences ; Pharmacology. Drug treatments</subject><ispartof>The Journal of dermatological treatment, 2000, Vol.11 (1), p.33-37</ispartof><rights>2000 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted 2000</rights><rights>2000 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c377t-3965773ecf50586d2eeebd6651276bca20b5362551c19b8c158a2886eb63cd553</citedby><cites>FETCH-LOGICAL-c377t-3965773ecf50586d2eeebd6651276bca20b5362551c19b8c158a2886eb63cd553</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.tandfonline.com/doi/pdf/10.1080/09546630050517658$$EPDF$$P50$$Ginformahealthcare$$H</linktopdf><linktohtml>$$Uhttps://www.tandfonline.com/doi/full/10.1080/09546630050517658$$EHTML$$P50$$Ginformahealthcare$$H</linktohtml><link.rule.ids>315,781,785,4025,27925,27926,27927,59649,60438,61223,61404</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1308897$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>Gupta, S Maddin, J Arlette, J-M Giroux, NH Shear, AK</creatorcontrib><title>Itraconazole pulse therapy is effective in dermatophyte onychomycosis of the toenail: a double-blind placebo-controlled study</title><title>The Journal of dermatological treatment</title><description>BACKGROUND: Until recently the traditional antifungal agents used to treat onychomycosis of the toenails, griseofulvin and ketoconazole, were generally ineffective and required treatment for a long duration. OBJECTIVE: The objective of the study was to determine the efficacy and safety of itraconazole (pulse) therapy (200 mg twice daily for 1 week a month for three consecutive months) in onychomycosis of the toenails. METHODS: A randomized, multicenter, placebo-controlled Canadian study was conducted in 200 patients. To allow evaluation for efficacy, the KOH and culture had to be positive at baseline. RESULTS: In the itraconazole (n=78) and placebo (n=74) groups, the mycological cure rates were 61.5% and 28.4%, respectively (p<0.0001). The clinical success rates (clinical cure plus marked improvement) in the two groups were 65.4% and 1.4%, respectively (p<0.0001). The numbers of patients experiencing an adverse effect to itraconazole and placebo were 34 (34.7%) of 98 patients and 30 (29.5%) of 102 patients, respectively (attributable risk to itraconazole is 5.2%). The distribution of adverse experiences between the two groups was similar with respect to body system, severity, frequency and action taken. CONCLUSION: Itraconazole (pulse) therapy is effective and safe for the treatment of dermatophyte onychomycosis of the toenails. (J Dermatol Treat (2000) 11:33 37)</description><subject>Antibacterial agents</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Biological and medical sciences</subject><subject>Itraconazole Onychomycosis Pulse Therapy</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><issn>0954-6634</issn><issn>1471-1753</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2000</creationdate><recordtype>article</recordtype><recordid>eNp9kE1r3DAQhkVJoZu0P6A3HXJ1KlmrDze9hJA0gYVc2rMZS2PsRWsZSdvgQP97tWxDCIGc5qDn0TvzEvKVswvODPvGGrlWSjAmmeRaSfOBrPha84prKU7I6vBeFWD9iZymtGWMC8XMivy9zxFsmOApeKTz3iekecAI80LHRLHv0ebxD9Jxog7jDnKYhyUjDdNih7BbbEiFC_3BojngBKP_ToG6sO88Vp0fJ0dnDxa7UJWgHIP36GjKe7d8Jh97KJFf_s8z8vv25tf1XbV5-Hl_fbWprNA6V6JRUmuBti_XGeVqROycUpLXWnUWatZJoWopueVNZyyXBmpjFHZKWCelOCP8-K-NIaWIfTvHcQdxaTlrD_21b_orzvnRmSFZ8H2EyY7pRRTMmEYX7McRG6c-lH4eQ_SuzbD4EJ8d8V7K5St9QPB5sBCx3YZ9nEor7-z4D_dnl4o</recordid><startdate>2000</startdate><enddate>2000</enddate><creator>Gupta, S Maddin, J Arlette, J-M Giroux, NH Shear, AK</creator><general>Informa UK Ltd</general><general>Taylor & Francis</general><scope>IQODW</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>2000</creationdate><title>Itraconazole pulse therapy is effective in dermatophyte onychomycosis of the toenail: a double-blind placebo-controlled study</title><author>Gupta, S Maddin, J Arlette, J-M Giroux, NH Shear, AK</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c377t-3965773ecf50586d2eeebd6651276bca20b5362551c19b8c158a2886eb63cd553</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2000</creationdate><topic>Antibacterial agents</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Biological and medical sciences</topic><topic>Itraconazole Onychomycosis Pulse Therapy</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gupta, S Maddin, J Arlette, J-M Giroux, NH Shear, AK</creatorcontrib><collection>Pascal-Francis</collection><collection>CrossRef</collection><jtitle>The Journal of dermatological treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gupta, S Maddin, J Arlette, J-M Giroux, NH Shear, AK</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Itraconazole pulse therapy is effective in dermatophyte onychomycosis of the toenail: a double-blind placebo-controlled study</atitle><jtitle>The Journal of dermatological treatment</jtitle><date>2000</date><risdate>2000</risdate><volume>11</volume><issue>1</issue><spage>33</spage><epage>37</epage><pages>33-37</pages><issn>0954-6634</issn><eissn>1471-1753</eissn><abstract>BACKGROUND: Until recently the traditional antifungal agents used to treat onychomycosis of the toenails, griseofulvin and ketoconazole, were generally ineffective and required treatment for a long duration. OBJECTIVE: The objective of the study was to determine the efficacy and safety of itraconazole (pulse) therapy (200 mg twice daily for 1 week a month for three consecutive months) in onychomycosis of the toenails. METHODS: A randomized, multicenter, placebo-controlled Canadian study was conducted in 200 patients. To allow evaluation for efficacy, the KOH and culture had to be positive at baseline. RESULTS: In the itraconazole (n=78) and placebo (n=74) groups, the mycological cure rates were 61.5% and 28.4%, respectively (p<0.0001). The clinical success rates (clinical cure plus marked improvement) in the two groups were 65.4% and 1.4%, respectively (p<0.0001). The numbers of patients experiencing an adverse effect to itraconazole and placebo were 34 (34.7%) of 98 patients and 30 (29.5%) of 102 patients, respectively (attributable risk to itraconazole is 5.2%). The distribution of adverse experiences between the two groups was similar with respect to body system, severity, frequency and action taken. CONCLUSION: Itraconazole (pulse) therapy is effective and safe for the treatment of dermatophyte onychomycosis of the toenails. (J Dermatol Treat (2000) 11:33 37)</abstract><cop>Oslo</cop><pub>Informa UK Ltd</pub><doi>10.1080/09546630050517658</doi><tpages>5</tpages></addata></record> |
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| subjects | Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Biological and medical sciences Itraconazole Onychomycosis Pulse Therapy Medical sciences Pharmacology. Drug treatments |
| title | Itraconazole pulse therapy is effective in dermatophyte onychomycosis of the toenail: a double-blind placebo-controlled study |
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