Software for Dosage Individualization of Voriconazole: a Prospective Clinical Study
Voriconazole is a first-line antifungal agent. Therapeutic drug monitoring is a standard of care. The best way to adjust dosages to achieve desired drug exposure endpoints is unclear due to nonlinear and variable pharmacokinetics. Previously described software was used to prospectively adjust vorico...
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| Veröffentlicht in: | Antimicrobial agents and chemotherapy 2019-04, Vol.63 (4) |
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| creator | Hope, William Johnstone, Gary Cicconi, Silvia Felton, Timothy Goodwin, Joanne Whalley, Sarah Santoyo-Castelazo, Anahi Ramos-Martin, Virginia Lestner, Jodi Credidio, Leah Dane, Aaron Carr, Daniel F Pirmohamed, Munir Salim, Rahim Neely, Michael |
| description | Voriconazole is a first-line antifungal agent. Therapeutic drug monitoring is a standard of care. The best way to adjust dosages to achieve desired drug exposure endpoints is unclear due to nonlinear and variable pharmacokinetics. Previously described software was used to prospectively adjust voriconazole dosages. The
,
, and
genotypes were determined. The primary endpoint was the proportion of patients with a
at 120 h in the range 1 to 3 mg/liter using software to adjust voriconazole dosages. A total of 19 patients were enrolled, and 14 were evaluable. Of these, 12/14 (85.7%; 95% confidence interval = 57.2 to 98.2%) had a
at 120 h posttreatment initiation of 1 to 3 mg/liter, which was higher than the
expected proportion of 33%. There was no association of
genotype-derived metabolizer phenotype with voriconazole AUC. Software can be used to adjust the dosages of voriconazole to achieve drug exposures that are safe and effective. (The clinical trial discussed in this paper has been registered in the European Clinical Trials Database under EudraCT no. 2013-0025878-34 and in the ISRCTN registry under no. ISRCTN83902726.). |
| doi_str_mv | 10.1128/AAC.02353-18 |
| format | Article |
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,
, and
genotypes were determined. The primary endpoint was the proportion of patients with a
at 120 h in the range 1 to 3 mg/liter using software to adjust voriconazole dosages. A total of 19 patients were enrolled, and 14 were evaluable. Of these, 12/14 (85.7%; 95% confidence interval = 57.2 to 98.2%) had a
at 120 h posttreatment initiation of 1 to 3 mg/liter, which was higher than the
expected proportion of 33%. There was no association of
genotype-derived metabolizer phenotype with voriconazole AUC. Software can be used to adjust the dosages of voriconazole to achieve drug exposures that are safe and effective. (The clinical trial discussed in this paper has been registered in the European Clinical Trials Database under EudraCT no. 2013-0025878-34 and in the ISRCTN registry under no. ISRCTN83902726.).</description><identifier>ISSN: 0066-4804</identifier><identifier>EISSN: 1098-6596</identifier><identifier>DOI: 10.1128/AAC.02353-18</identifier><identifier>PMID: 30670416</identifier><language>eng</language><publisher>United States: American Society for Microbiology</publisher><subject>Antifungal Agents ; Antifungal Agents - administration & dosage ; Antifungal Agents - pharmacokinetics ; Clinical Therapeutics ; Clinical Trials as Topic ; Cytochrome P-450 Enzyme System - metabolism ; Female ; Genotype ; Humans ; Male ; Middle Aged ; Prospective Studies ; Software ; Voriconazole ; Voriconazole - administration & dosage ; Voriconazole - pharmacokinetics</subject><ispartof>Antimicrobial agents and chemotherapy, 2019-04, Vol.63 (4)</ispartof><rights>Copyright © 2019 Hope et al.</rights><rights>Copyright © 2019 Hope et al. 2019 Hope et al.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a484t-dbe0a7c0d7705baff88b494e7f52628f2b65c6007466ae8be971c798858e7d133</citedby><cites>FETCH-LOGICAL-a484t-dbe0a7c0d7705baff88b494e7f52628f2b65c6007466ae8be971c798858e7d133</cites><orcidid>0000-0001-6187-878X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6496160/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6496160/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30670416$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hope, William</creatorcontrib><creatorcontrib>Johnstone, Gary</creatorcontrib><creatorcontrib>Cicconi, Silvia</creatorcontrib><creatorcontrib>Felton, Timothy</creatorcontrib><creatorcontrib>Goodwin, Joanne</creatorcontrib><creatorcontrib>Whalley, Sarah</creatorcontrib><creatorcontrib>Santoyo-Castelazo, Anahi</creatorcontrib><creatorcontrib>Ramos-Martin, Virginia</creatorcontrib><creatorcontrib>Lestner, Jodi</creatorcontrib><creatorcontrib>Credidio, Leah</creatorcontrib><creatorcontrib>Dane, Aaron</creatorcontrib><creatorcontrib>Carr, Daniel F</creatorcontrib><creatorcontrib>Pirmohamed, Munir</creatorcontrib><creatorcontrib>Salim, Rahim</creatorcontrib><creatorcontrib>Neely, Michael</creatorcontrib><title>Software for Dosage Individualization of Voriconazole: a Prospective Clinical Study</title><title>Antimicrobial agents and chemotherapy</title><addtitle>Antimicrob Agents Chemother</addtitle><addtitle>Antimicrob Agents Chemother</addtitle><description>Voriconazole is a first-line antifungal agent. Therapeutic drug monitoring is a standard of care. The best way to adjust dosages to achieve desired drug exposure endpoints is unclear due to nonlinear and variable pharmacokinetics. Previously described software was used to prospectively adjust voriconazole dosages. The
,
, and
genotypes were determined. The primary endpoint was the proportion of patients with a
at 120 h in the range 1 to 3 mg/liter using software to adjust voriconazole dosages. A total of 19 patients were enrolled, and 14 were evaluable. Of these, 12/14 (85.7%; 95% confidence interval = 57.2 to 98.2%) had a
at 120 h posttreatment initiation of 1 to 3 mg/liter, which was higher than the
expected proportion of 33%. There was no association of
genotype-derived metabolizer phenotype with voriconazole AUC. Software can be used to adjust the dosages of voriconazole to achieve drug exposures that are safe and effective. (The clinical trial discussed in this paper has been registered in the European Clinical Trials Database under EudraCT no. 2013-0025878-34 and in the ISRCTN registry under no. ISRCTN83902726.).</description><subject>Antifungal Agents</subject><subject>Antifungal Agents - administration & dosage</subject><subject>Antifungal Agents - pharmacokinetics</subject><subject>Clinical Therapeutics</subject><subject>Clinical Trials as Topic</subject><subject>Cytochrome P-450 Enzyme System - metabolism</subject><subject>Female</subject><subject>Genotype</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Software</subject><subject>Voriconazole</subject><subject>Voriconazole - administration & dosage</subject><subject>Voriconazole - pharmacokinetics</subject><issn>0066-4804</issn><issn>1098-6596</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kN9LwzAQx4Mobk7ffJa8CnZe2jRJfRBG_TUYKEx9DWmbzIyuGWk72f56q9OhDz4dx33vw90HoVMCQ0JCcTkapUMIozgKiNhDfQKJCFicsH3UB2AsoAJoDx3V9Ry6Pk7gEPUiYBwoYX00nTrTvCuvsXEe37hazTQeV4Vd2aJVpd2oxroKO4Nfnbe5q9TGlfoKK_zkXb3UeWNXGqelrWyuSjxt2mJ9jA6MKmt98l0H6OXu9jl9CCaP9-N0NAkUFbQJikyD4jkUnEOcKWOEyGhCNTdxyEJhwozFOQPglDGlRaYTTnKeCBELzQsSRQN0veUu22yhi1xXjVelXHq7UH4tnbLy76Syb3LmVpLRhBEGHeBiC8i7X2qvzW6XgPyUKzu58kuuJKKLn2_jql6Ecu5aX3Xv_Zc9-33bDvxjPvoAolqDHw</recordid><startdate>20190401</startdate><enddate>20190401</enddate><creator>Hope, William</creator><creator>Johnstone, Gary</creator><creator>Cicconi, Silvia</creator><creator>Felton, Timothy</creator><creator>Goodwin, Joanne</creator><creator>Whalley, Sarah</creator><creator>Santoyo-Castelazo, Anahi</creator><creator>Ramos-Martin, Virginia</creator><creator>Lestner, Jodi</creator><creator>Credidio, Leah</creator><creator>Dane, Aaron</creator><creator>Carr, Daniel F</creator><creator>Pirmohamed, Munir</creator><creator>Salim, Rahim</creator><creator>Neely, Michael</creator><general>American Society for Microbiology</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6187-878X</orcidid></search><sort><creationdate>20190401</creationdate><title>Software for Dosage Individualization of Voriconazole: a Prospective Clinical Study</title><author>Hope, William ; Johnstone, Gary ; Cicconi, Silvia ; Felton, Timothy ; Goodwin, Joanne ; Whalley, Sarah ; Santoyo-Castelazo, Anahi ; Ramos-Martin, Virginia ; Lestner, Jodi ; Credidio, Leah ; Dane, Aaron ; Carr, Daniel F ; Pirmohamed, Munir ; Salim, Rahim ; Neely, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a484t-dbe0a7c0d7705baff88b494e7f52628f2b65c6007466ae8be971c798858e7d133</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Antifungal Agents</topic><topic>Antifungal Agents - administration & dosage</topic><topic>Antifungal Agents - pharmacokinetics</topic><topic>Clinical Therapeutics</topic><topic>Clinical Trials as Topic</topic><topic>Cytochrome P-450 Enzyme System - metabolism</topic><topic>Female</topic><topic>Genotype</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Software</topic><topic>Voriconazole</topic><topic>Voriconazole - administration & dosage</topic><topic>Voriconazole - pharmacokinetics</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hope, William</creatorcontrib><creatorcontrib>Johnstone, Gary</creatorcontrib><creatorcontrib>Cicconi, Silvia</creatorcontrib><creatorcontrib>Felton, Timothy</creatorcontrib><creatorcontrib>Goodwin, Joanne</creatorcontrib><creatorcontrib>Whalley, Sarah</creatorcontrib><creatorcontrib>Santoyo-Castelazo, Anahi</creatorcontrib><creatorcontrib>Ramos-Martin, Virginia</creatorcontrib><creatorcontrib>Lestner, Jodi</creatorcontrib><creatorcontrib>Credidio, Leah</creatorcontrib><creatorcontrib>Dane, Aaron</creatorcontrib><creatorcontrib>Carr, Daniel F</creatorcontrib><creatorcontrib>Pirmohamed, Munir</creatorcontrib><creatorcontrib>Salim, Rahim</creatorcontrib><creatorcontrib>Neely, Michael</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Antimicrobial agents and chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hope, William</au><au>Johnstone, Gary</au><au>Cicconi, Silvia</au><au>Felton, Timothy</au><au>Goodwin, Joanne</au><au>Whalley, Sarah</au><au>Santoyo-Castelazo, Anahi</au><au>Ramos-Martin, Virginia</au><au>Lestner, Jodi</au><au>Credidio, Leah</au><au>Dane, Aaron</au><au>Carr, Daniel F</au><au>Pirmohamed, Munir</au><au>Salim, Rahim</au><au>Neely, Michael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Software for Dosage Individualization of Voriconazole: a Prospective Clinical Study</atitle><jtitle>Antimicrobial agents and chemotherapy</jtitle><stitle>Antimicrob Agents Chemother</stitle><addtitle>Antimicrob Agents Chemother</addtitle><date>2019-04-01</date><risdate>2019</risdate><volume>63</volume><issue>4</issue><issn>0066-4804</issn><eissn>1098-6596</eissn><abstract>Voriconazole is a first-line antifungal agent. Therapeutic drug monitoring is a standard of care. The best way to adjust dosages to achieve desired drug exposure endpoints is unclear due to nonlinear and variable pharmacokinetics. Previously described software was used to prospectively adjust voriconazole dosages. The
,
, and
genotypes were determined. The primary endpoint was the proportion of patients with a
at 120 h in the range 1 to 3 mg/liter using software to adjust voriconazole dosages. A total of 19 patients were enrolled, and 14 were evaluable. Of these, 12/14 (85.7%; 95% confidence interval = 57.2 to 98.2%) had a
at 120 h posttreatment initiation of 1 to 3 mg/liter, which was higher than the
expected proportion of 33%. There was no association of
genotype-derived metabolizer phenotype with voriconazole AUC. Software can be used to adjust the dosages of voriconazole to achieve drug exposures that are safe and effective. (The clinical trial discussed in this paper has been registered in the European Clinical Trials Database under EudraCT no. 2013-0025878-34 and in the ISRCTN registry under no. ISRCTN83902726.).</abstract><cop>United States</cop><pub>American Society for Microbiology</pub><pmid>30670416</pmid><doi>10.1128/AAC.02353-18</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-6187-878X</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Antimicrobial agents and chemotherapy, 2019-04, Vol.63 (4) |
| issn | 0066-4804 1098-6596 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6496160 |
| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Antifungal Agents Antifungal Agents - administration & dosage Antifungal Agents - pharmacokinetics Clinical Therapeutics Clinical Trials as Topic Cytochrome P-450 Enzyme System - metabolism Female Genotype Humans Male Middle Aged Prospective Studies Software Voriconazole Voriconazole - administration & dosage Voriconazole - pharmacokinetics |
| title | Software for Dosage Individualization of Voriconazole: a Prospective Clinical Study |
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