Double-blind study of the actively transported levodopa prodrug XP21279 in Parkinson's disease.
Identifieur interne : 000613 ( PubMed/Checkpoint ); précédent : 000612; suivant : 000614Double-blind study of the actively transported levodopa prodrug XP21279 in Parkinson's disease.
Auteurs : Peter A. Lewitt [États-Unis] ; F Jacob Huff ; Robert A. Hauser ; Dan Chen ; Dmitri Lissin ; Katie Zomorodi ; Kenneth C. CundySource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2014.
English descriptors
- KwdEn :
- Antiparkinson Agents (adverse effects), Antiparkinson Agents (pharmacokinetics), Antiparkinson Agents (therapeutic use), Carbidopa (adverse effects), Carbidopa (pharmacokinetics), Carbidopa (therapeutic use), Cross-Over Studies, Double-Blind Method, Drug Combinations, Female, Humans, Levodopa (adverse effects), Levodopa (pharmacokinetics), Levodopa (therapeutic use), Male, Middle Aged, Parkinson Disease (drug therapy), Prodrugs (adverse effects), Prodrugs (pharmacokinetics), Prodrugs (therapeutic use), Treatment Outcome.
- MESH :
- chemical , adverse effects : Antiparkinson Agents, Carbidopa, Levodopa, Prodrugs.
- chemical , pharmacokinetics : Antiparkinson Agents, Carbidopa, Levodopa, Prodrugs.
- chemical , therapeutic use : Antiparkinson Agents, Carbidopa, Levodopa, Prodrugs.
- drug therapy : Parkinson Disease.
- Cross-Over Studies, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
The objective of this study was to assess the efficacy, safety, and pharmacokinetics of XP21279-carbidopa in patients with Parkinson's disease who experience motor fluctuations compared with immediate-release carbidopa-levodopa tablets. XP21279 is a levodopa prodrug that is actively absorbed by high-capacity nutrient transporters expressed throughout the gastrointestinal tract and then rapidly converted to levodopa by carboxylesterases. XP21279-carbidopa sustained-release bilayer tablets were developed to overcome pharmacokinetic limitations of levodopa by providing more continuous exposure. Patients with motor fluctuations who required carbidopa-levodopa four or five times daily were optimized for 2 weeks each on carbidopa-levodopa four or five times daily and XP21279-carbidopa three times daily in a randomized sequence. Next, they received each optimized treatment for 2 weeks in a double-blind/double-dummy, randomized sequence. The primary outcome measure was change from baseline in daily off time at the end of each double-blind treatment period. All patients at 2 sites underwent pharmacokinetic analyses. Twenty-eight of 35 enrolled patients completed both double-blind treatments. The mean total daily off time was reduced from baseline by a mean (± standard error) of 2.7 hours (± 0.48 hours) for immediate-release carbidopa-levodopa and 3.0 hours (± 0.57 hours) for XP21279-carbidopa (P = 0.49). Among 11 patients who completed pharmacokinetic sampling on each optimized treatment, the percentage deviation from the mean levodopa concentration was lower (P < 0.05) for XP21279-carbidopa than carbidopa-levodopa. Both treatments had a similar incidence of new or worsening dyskinesias. XP21279-carbidopa administered three times daily produced a reduction in off time similar to that of carbidopa-levodopa administered four or five times daily, and the difference was not statistically significant. XP21279-carbidopa significantly reduced variability in levodopa concentrations compared with carbidopa-levodopa.
DOI: 10.1002/mds.25742
PubMed: 24339234
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Double-blind study of the actively transported levodopa prodrug XP21279 in Parkinson's disease.</title><author><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter A" last="Lewitt">Peter A. Lewitt</name><affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, Henry Ford Hospital, West Bloomfield, Michigan, USA; Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Henry Ford Hospital, West Bloomfield, Michigan, USA; Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Huff, F Jacob" sort="Huff, F Jacob" uniqKey="Huff F" first="F Jacob" last="Huff">F Jacob Huff</name></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name></author><author><name sortKey="Chen, Dan" sort="Chen, Dan" uniqKey="Chen D" first="Dan" last="Chen">Dan Chen</name></author><author><name sortKey="Lissin, Dmitri" sort="Lissin, Dmitri" uniqKey="Lissin D" first="Dmitri" last="Lissin">Dmitri Lissin</name></author><author><name sortKey="Zomorodi, Katie" sort="Zomorodi, Katie" uniqKey="Zomorodi K" first="Katie" last="Zomorodi">Katie Zomorodi</name></author><author><name sortKey="Cundy, Kenneth C" sort="Cundy, Kenneth C" uniqKey="Cundy K" first="Kenneth C" last="Cundy">Kenneth C. Cundy</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:24339234</idno><idno type="pmid">24339234</idno><idno type="doi">10.1002/mds.25742</idno><idno type="wicri:Area/PubMed/Corpus">000654</idno><idno type="wicri:Area/PubMed/Curation">000654</idno><idno type="wicri:Area/PubMed/Checkpoint">000613</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Double-blind study of the actively transported levodopa prodrug XP21279 in Parkinson's disease.</title><author><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter A" last="Lewitt">Peter A. Lewitt</name><affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, Henry Ford Hospital, West Bloomfield, Michigan, USA; Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Henry Ford Hospital, West Bloomfield, Michigan, USA; Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Huff, F Jacob" sort="Huff, F Jacob" uniqKey="Huff F" first="F Jacob" last="Huff">F Jacob Huff</name></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name></author><author><name sortKey="Chen, Dan" sort="Chen, Dan" uniqKey="Chen D" first="Dan" last="Chen">Dan Chen</name></author><author><name sortKey="Lissin, Dmitri" sort="Lissin, Dmitri" uniqKey="Lissin D" first="Dmitri" last="Lissin">Dmitri Lissin</name></author><author><name sortKey="Zomorodi, Katie" sort="Zomorodi, Katie" uniqKey="Zomorodi K" first="Katie" last="Zomorodi">Katie Zomorodi</name></author><author><name sortKey="Cundy, Kenneth C" sort="Cundy, Kenneth C" uniqKey="Cundy K" first="Kenneth C" last="Cundy">Kenneth C. Cundy</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiparkinson Agents (adverse effects)</term><term>Antiparkinson Agents (pharmacokinetics)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Carbidopa (adverse effects)</term><term>Carbidopa (pharmacokinetics)</term><term>Carbidopa (therapeutic use)</term><term>Cross-Over Studies</term><term>Double-Blind Method</term><term>Drug Combinations</term><term>Female</term><term>Humans</term><term>Levodopa (adverse effects)</term><term>Levodopa (pharmacokinetics)</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Prodrugs (adverse effects)</term><term>Prodrugs (pharmacokinetics)</term><term>Prodrugs (therapeutic use)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Levodopa</term><term>Prodrugs</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Levodopa</term><term>Prodrugs</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Levodopa</term><term>Prodrugs</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Cross-Over Studies</term><term>Double-Blind Method</term><term>Drug Combinations</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to assess the efficacy, safety, and pharmacokinetics of XP21279-carbidopa in patients with Parkinson's disease who experience motor fluctuations compared with immediate-release carbidopa-levodopa tablets. XP21279 is a levodopa prodrug that is actively absorbed by high-capacity nutrient transporters expressed throughout the gastrointestinal tract and then rapidly converted to levodopa by carboxylesterases. XP21279-carbidopa sustained-release bilayer tablets were developed to overcome pharmacokinetic limitations of levodopa by providing more continuous exposure. Patients with motor fluctuations who required carbidopa-levodopa four or five times daily were optimized for 2 weeks each on carbidopa-levodopa four or five times daily and XP21279-carbidopa three times daily in a randomized sequence. Next, they received each optimized treatment for 2 weeks in a double-blind/double-dummy, randomized sequence. The primary outcome measure was change from baseline in daily off time at the end of each double-blind treatment period. All patients at 2 sites underwent pharmacokinetic analyses. Twenty-eight of 35 enrolled patients completed both double-blind treatments. The mean total daily off time was reduced from baseline by a mean (± standard error) of 2.7 hours (± 0.48 hours) for immediate-release carbidopa-levodopa and 3.0 hours (± 0.57 hours) for XP21279-carbidopa (P = 0.49). Among 11 patients who completed pharmacokinetic sampling on each optimized treatment, the percentage deviation from the mean levodopa concentration was lower (P < 0.05) for XP21279-carbidopa than carbidopa-levodopa. Both treatments had a similar incidence of new or worsening dyskinesias. XP21279-carbidopa administered three times daily produced a reduction in off time similar to that of carbidopa-levodopa administered four or five times daily, and the difference was not statistically significant. XP21279-carbidopa significantly reduced variability in levodopa concentrations compared with carbidopa-levodopa.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">24339234</PMID><DateCreated><Year>2014</Year><Month>01</Month><Day>24</Day></DateCreated><DateCompleted><Year>2014</Year><Month>09</Month><Day>19</Day></DateCompleted><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>29</Volume><Issue>1</Issue><PubDate><Year>2014</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Double-blind study of the actively transported levodopa prodrug XP21279 in Parkinson's disease.</ArticleTitle><Pagination><MedlinePgn>75-82</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.25742</ELocationID><Abstract><AbstractText>The objective of this study was to assess the efficacy, safety, and pharmacokinetics of XP21279-carbidopa in patients with Parkinson's disease who experience motor fluctuations compared with immediate-release carbidopa-levodopa tablets. XP21279 is a levodopa prodrug that is actively absorbed by high-capacity nutrient transporters expressed throughout the gastrointestinal tract and then rapidly converted to levodopa by carboxylesterases. XP21279-carbidopa sustained-release bilayer tablets were developed to overcome pharmacokinetic limitations of levodopa by providing more continuous exposure. Patients with motor fluctuations who required carbidopa-levodopa four or five times daily were optimized for 2 weeks each on carbidopa-levodopa four or five times daily and XP21279-carbidopa three times daily in a randomized sequence. Next, they received each optimized treatment for 2 weeks in a double-blind/double-dummy, randomized sequence. The primary outcome measure was change from baseline in daily off time at the end of each double-blind treatment period. All patients at 2 sites underwent pharmacokinetic analyses. Twenty-eight of 35 enrolled patients completed both double-blind treatments. The mean total daily off time was reduced from baseline by a mean (± standard error) of 2.7 hours (± 0.48 hours) for immediate-release carbidopa-levodopa and 3.0 hours (± 0.57 hours) for XP21279-carbidopa (P = 0.49). Among 11 patients who completed pharmacokinetic sampling on each optimized treatment, the percentage deviation from the mean levodopa concentration was lower (P < 0.05) for XP21279-carbidopa than carbidopa-levodopa. Both treatments had a similar incidence of new or worsening dyskinesias. XP21279-carbidopa administered three times daily produced a reduction in off time similar to that of carbidopa-levodopa administered four or five times daily, and the difference was not statistically significant. XP21279-carbidopa significantly reduced variability in levodopa concentrations compared with carbidopa-levodopa.</AbstractText><CopyrightInformation>Copyright © 2013 Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>LeWitt</LastName><ForeName>Peter A</ForeName><Initials>PA</Initials><AffiliationInfo><Affiliation>Department of Neurology, Henry Ford Hospital, West Bloomfield, Michigan, USA; Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huff</LastName><ForeName>F Jacob</ForeName><Initials>FJ</Initials></Author><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Dan</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Lissin</LastName><ForeName>Dmitri</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Zomorodi</LastName><ForeName>Katie</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Cundy</LastName><ForeName>Kenneth C</ForeName><Initials>KC</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>12</Month><Day>13</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011355">Prodrugs</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C009265">carbidopa, levodopa drug combination</NameOfSubstance></Chemical><Chemical><RegistryNumber>46627O600J</RegistryNumber><NameOfSubstance UI="D007980">Levodopa</NameOfSubstance></Chemical><Chemical><RegistryNumber>MNX7R8C5VO</RegistryNumber><NameOfSubstance UI="D002230">Carbidopa</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000978">Antiparkinson Agents</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000493">pharmacokinetics</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D002230">Carbidopa</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000493">pharmacokinetics</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018592">Cross-Over Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004338">Drug Combinations</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007980">Levodopa</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000493">pharmacokinetics</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011355">Prodrugs</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000493">pharmacokinetics</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Parkinson's disease</Keyword><Keyword MajorTopicYN="N">XP21279</Keyword><Keyword MajorTopicYN="N">dyskinesias</Keyword><Keyword MajorTopicYN="N">levodopa</Keyword><Keyword MajorTopicYN="N">motor fluctuations</Keyword><Keyword MajorTopicYN="N">pharmacokinetics</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2013</Year><Month>5</Month><Day>1</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2013</Year><Month>9</Month><Day>25</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2013</Year><Month>10</Month><Day>1</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2013</Year><Month>12</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2013</Year><Month>12</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2013</Year><Month>12</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>9</Month><Day>23</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24339234</ArticleId><ArticleId IdType="doi">10.1002/mds.25742</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Michigan</li></region></list><tree><noCountry><name sortKey="Chen, Dan" sort="Chen, Dan" uniqKey="Chen D" first="Dan" last="Chen">Dan Chen</name><name sortKey="Cundy, Kenneth C" sort="Cundy, Kenneth C" uniqKey="Cundy K" first="Kenneth C" last="Cundy">Kenneth C. Cundy</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><name sortKey="Huff, F Jacob" sort="Huff, F Jacob" uniqKey="Huff F" first="F Jacob" last="Huff">F Jacob Huff</name><name sortKey="Lissin, Dmitri" sort="Lissin, Dmitri" uniqKey="Lissin D" first="Dmitri" last="Lissin">Dmitri Lissin</name><name sortKey="Zomorodi, Katie" sort="Zomorodi, Katie" uniqKey="Zomorodi K" first="Katie" last="Zomorodi">Katie Zomorodi</name></noCountry><country name="États-Unis"><region name="Michigan"><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter A" last="Lewitt">Peter A. Lewitt</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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