Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy
Identifieur interne : 001531 ( Istex/Corpus ); précédent : 001530; suivant : 001532Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy
Auteurs : Rey ; Bulteau ; Motte ; Tran ; Sturm ; D'Souza ; Markabi ; Pons ; DulacSource :
- The Journal of Clinical Pharmacology [ 0091-2700 ] ; 2004-11.
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Abstract
This two‐part, open‐label study evaluated the pharmacokinetics, safety, and tolerability of oxcarbazepine as combination therapy in 112 children 2 to 12 years old with inadequately controlled epilepsy. Part I was a pharmacokinetic study in children stratified by age (2–5 years and 6–12 years) and randomized to receive a single oxcarbazepine dose of 5 mg/kg or 15 mg/kg. Mean specific AUC and t1/2 values of the active metabolite (MHD) were approximately 30% lower in younger children compared with older children, regardless of dose. Part II was a 4‐month safety, tolerability, and pharmacokinetic study in which children received oxcarbazepine doses of 11 to 68 mg/kg/day. The mean specific oxcarbazepine daily dose was 38% higher in younger children compared with older children. Similarly, mean trough plasma MHD concentrations were 34% lower in younger children. Six (5%) children discontinued due to adverse events. Oxcarbazepine was safe and well tolerated. Younger children require higher oxcarbazepine doses because of rapid clearance.
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DOI: 10.1177/0091270004266617
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ISTEX:0F319887FB34D93881854D4C0EC67FD5D7EC173ELe document en format XML
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Part I was a pharmacokinetic study in children stratified by age (2–5 years and 6–12 years) and randomized to receive a single oxcarbazepine dose of 5 mg/kg or 15 mg/kg. Mean specific AUC and t1/2 values of the active metabolite (MHD) were approximately 30% lower in younger children compared with older children, regardless of dose. Part II was a 4‐month safety, tolerability, and pharmacokinetic study in which children received oxcarbazepine doses of 11 to 68 mg/kg/day. The mean specific oxcarbazepine daily dose was 38% higher in younger children compared with older children. Similarly, mean trough plasma MHD concentrations were 34% lower in younger children. Six (5%) children discontinued due to adverse events. Oxcarbazepine was safe and well tolerated. 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revised version accepted April 20, 2004</unparsedEditorialHistory><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="5"></count><count type="formulaTotal" number="0"></count><count type="referenceTotal" number="28"></count><count type="linksCrossRef" number="49"></count></countGroup><titleGroup><title type="main">Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy</title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1" corresponding="yes"><personName><honorifics>Dr</honorifics><givenNames>Elisabeth</givenNames><familyName>Rey</familyName><degrees>PharmD</degrees></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a1"><personName><honorifics>Dr</honorifics><givenNames>Christine</givenNames><familyName>Bulteau</familyName><degrees>MD</degrees></personName></creator><creator creatorRole="author" xml:id="cr3" affiliationRef="#a2"><personName><honorifics>Dr</honorifics><givenNames>Jacques</givenNames><familyName>Motte</familyName><degrees>MD</degrees></personName></creator><creator creatorRole="author" xml:id="cr4" affiliationRef="#a1"><personName><honorifics>Dr</honorifics><givenNames>Agnes</givenNames><familyName>Tran</familyName><degrees>PharmD, PhD</degrees></personName></creator><creator creatorRole="author" xml:id="cr5" affiliationRef="#a3"><personName><honorifics>Dr</honorifics><givenNames>Yvonne</givenNames><familyName>Sturm</familyName><degrees>PhD</degrees></personName></creator><creator creatorRole="author" xml:id="cr6" affiliationRef="#a4"><personName><honorifics>Dr</honorifics><givenNames>Joseph</givenNames><familyName>D'Souza</familyName><degrees>PhD</degrees></personName></creator><creator creatorRole="author" xml:id="cr7" affiliationRef="#a4"><personName><honorifics>Dr</honorifics><givenNames>Sabri</givenNames><familyName>Markabi</familyName><degrees>MD</degrees></personName></creator><creator creatorRole="author" xml:id="cr8" affiliationRef="#a1"><personName><honorifics>Dr</honorifics><givenNames>Gérard</givenNames><familyName>Pons</familyName><degrees>MD, PhD</degrees></personName></creator><creator creatorRole="author" xml:id="cr9" affiliationRef="#a1"><personName><honorifics>Dr</honorifics><givenNames>Olivier</givenNames><familyName>Dulac</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="FR"><unparsedAffiliation>Hǒpital St. Vincent de Paul, Paris, France</unparsedAffiliation></affiliation><affiliation xml:id="a2" countryCode="FR"><unparsedAffiliation>Hǒpital Americain, Reims, France</unparsedAffiliation></affiliation><affiliation xml:id="a3" countryCode="CH"><unparsedAffiliation>Novartis Pharma AG, Basel, Switzerland</unparsedAffiliation></affiliation><affiliation xml:id="a4" countryCode="US"><unparsedAffiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en"><keyword xml:id="k1">Oxcarbazepine</keyword><keyword xml:id="k2">pharmacokinetics</keyword><keyword xml:id="k3">safety</keyword><keyword xml:id="k4">tolerability</keyword><keyword xml:id="k5">inadequately controlled epilepsy</keyword><keyword xml:id="k6">pediatrics</keyword><keyword xml:id="k7">antiepileptic drugs</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><p>This two‐part, open‐label study evaluated the pharmacokinetics, safety, and tolerability of oxcarbazepine as combination therapy in 112 children 2 to 12 years old with inadequately controlled epilepsy. Part I was a pharmacokinetic study in children stratified by age (2–5 years and 6–12 years) and randomized to receive a single oxcarbazepine dose of 5 mg/kg or 15 mg/kg. Mean specific AUC and t<sub>1/2</sub> values of the active metabolite (MHD) were approximately 30% lower in younger children compared with older children, regardless of dose. Part II was a 4‐month safety, tolerability, and pharmacokinetic study in which children received oxcarbazepine doses of 11 to 68 mg/kg/day. The mean specific oxcarbazepine daily dose was 38% higher in younger children compared with older children. Similarly, mean trough plasma MHD concentrations were 34% lower in younger children. Six (5%) children discontinued due to adverse events. Oxcarbazepine was safe and well tolerated. Younger children require higher oxcarbazepine doses because of rapid clearance.</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="n-fnt-1"><p>Source of financial support: Novartis Pharmaceuticals Corp, East Hanover, New Jersey</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy</title></titleInfo><name type="personal"><namePart type="termsOfAddress">Dr</namePart><namePart type="family">Rey</namePart><namePart type="termsOfAddress">PharmD</namePart><affiliation>Hǒpital St. Vincent de Paul, Paris, France</affiliation><description>Correspondence: Address for reprints: Elisabeth Rey, PharmD, Hǒpital St. Vincent de Paul, 74, Avenue Denfert‐Rochereau, 75 674 Paris Cedex 14, France.</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="termsOfAddress">Dr</namePart><namePart type="family">Bulteau</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Hǒpital St. Vincent de Paul, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="termsOfAddress">Dr</namePart><namePart type="family">Motte</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Hǒpital Americain, Reims, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="termsOfAddress">Dr</namePart><namePart type="family">Tran</namePart><namePart type="termsOfAddress">PharmD, PhD</namePart><affiliation>Hǒpital St. Vincent de Paul, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="termsOfAddress">Dr</namePart><namePart type="family">Sturm</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Novartis Pharma AG, Basel, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="termsOfAddress">Dr</namePart><namePart type="family">D'Souza</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="termsOfAddress">Dr</namePart><namePart type="family">Markabi</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="termsOfAddress">Dr</namePart><namePart type="family">Pons</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Hǒpital St. Vincent de Paul, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="termsOfAddress">Dr</namePart><namePart type="family">Dulac</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Hǒpital St. Vincent de Paul, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><place><placeTerm type="text">Oxford, UK</placeTerm></place><dateIssued encoding="w3cdtf">2004-11</dateIssued><edition>Submitted for publication July 7, 2003; revised version accepted April 20, 2004</edition><copyrightDate encoding="w3cdtf">2004</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">2</extent><extent unit="tables">5</extent><extent unit="references">28</extent></physicalDescription><abstract lang="en">This two‐part, open‐label study evaluated the pharmacokinetics, safety, and tolerability of oxcarbazepine as combination therapy in 112 children 2 to 12 years old with inadequately controlled epilepsy. Part I was a pharmacokinetic study in children stratified by age (2–5 years and 6–12 years) and randomized to receive a single oxcarbazepine dose of 5 mg/kg or 15 mg/kg. Mean specific AUC and t1/2 values of the active metabolite (MHD) were approximately 30% lower in younger children compared with older children, regardless of dose. Part II was a 4‐month safety, tolerability, and pharmacokinetic study in which children received oxcarbazepine doses of 11 to 68 mg/kg/day. The mean specific oxcarbazepine daily dose was 38% higher in younger children compared with older children. Similarly, mean trough plasma MHD concentrations were 34% lower in younger children. Six (5%) children discontinued due to adverse events. Oxcarbazepine was safe and well tolerated. Younger children require higher oxcarbazepine doses because of rapid clearance.</abstract><subject lang="en"><genre>keywords</genre><topic>Oxcarbazepine</topic><topic>pharmacokinetics</topic><topic>safety</topic><topic>tolerability</topic><topic>inadequately controlled epilepsy</topic><topic>pediatrics</topic><topic>antiepileptic drugs</topic></subject><relatedItem type="host"><titleInfo><title>The Journal of Clinical Pharmacology</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0091-2700</identifier><identifier type="eISSN">1552-4604</identifier><identifier type="DOI">10.1002/(ISSN)1552-4604</identifier><identifier type="PublisherID">JCPH</identifier><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>44</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>1290</start><end>1300</end><total>11</total></extent></part></relatedItem><identifier type="istex">0F319887FB34D93881854D4C0EC67FD5D7EC173E</identifier><identifier type="DOI">10.1177/0091270004266617</identifier><identifier type="ArticleID">JCPH988</identifier><accessCondition type="use and reproduction" contentType="copyright">2004 American College of Clinical Pharmacology</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Blackwell Publishing Ltd</recordOrigin></recordInfo></mods></metadata><enrichments><json:item><type>multicat</type><uri>https://api.istex.fr/document/0F319887FB34D93881854D4C0EC67FD5D7EC173E/enrichments/multicat</uri></json:item></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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