Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease.
Identifieur interne : 001565 ( Ncbi/Merge ); précédent : 001564; suivant : 001566Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease.
Auteurs : Rajesh Pahwa [États-Unis] ; Kelly E. Lyons [États-Unis] ; Robert A. Hauser [États-Unis] ; Stanley Fahn [États-Unis] ; Joseph Jankovic [États-Unis] ; Emmanuelle Pourcher [Canada] ; Ann Hsu [États-Unis] ; Martin O'Connell [États-Unis] ; Sherron Kell [États-Unis] ; Suneel Gupta [États-Unis]Source :
- Parkinsonism & related disorders [ 1873-5126 ] ; 2014.
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Carbidopa (administration & dosage), Carbidopa (adverse effects), Dose-Response Relationship, Drug, Double-Blind Method, Drug Combinations, Female, Humans, Levodopa (administration & dosage), Levodopa (adverse effects), Levodopa (metabolism), Male, Middle Aged, Parkinson Disease (drug therapy), Parkinson Disease (metabolism), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Carbidopa, Levodopa.
- chemical , adverse effects : Antiparkinson Agents, Carbidopa, Levodopa.
- chemical , metabolism : Levodopa.
- drug therapy : Parkinson Disease.
- metabolism : Parkinson Disease.
- Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
IPX066 is an extended release carbidopa/levodopa formulation designed to rapidly attain and maintain therapeutic plasma concentrations for a prolonged duration, allowing dosing intervals of approximately 6 h. The objective was to assess the efficacy, safety, and impact on quality of life of IPX066 in the treatment of levodopa-naive Parkinson's disease (PD) patients.
DOI: 10.1016/j.parkreldis.2013.08.017
PubMed: 24055014
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Electronic address: rpahwa@kumc.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Kansas Medical Center, Kansas City, KS</wicri:regionArea><placeName><region type="state">Kansas</region></placeName></affiliation></author><author><name sortKey="Lyons, Kelly E" sort="Lyons, Kelly E" uniqKey="Lyons K" first="Kelly E" last="Lyons">Kelly E. Lyons</name><affiliation wicri:level="2"><nlm:affiliation>University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: kelly.lyons@att.net.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Kansas Medical Center, Kansas City, KS</wicri:regionArea><placeName><region type="state">Kansas</region></placeName></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><nlm:affiliation>University of South Florida, Tampa, FL, USA. Electronic address: rhauser@health.usf.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of South Florida, Tampa, FL</wicri:regionArea><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name><affiliation wicri:level="4"><nlm:affiliation>Columbia University, New York, NY, USA. 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Electronic address: psa@riq.qc.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Quebec Memory and Motor Skills Disorders Research Clinic, Quebec City</wicri:regionArea><wicri:noRegion>Quebec City</wicri:noRegion></affiliation></author><author><name sortKey="Hsu, Ann" sort="Hsu, Ann" uniqKey="Hsu A" first="Ann" last="Hsu">Ann Hsu</name><affiliation wicri:level="2"><nlm:affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: annhsu@impaxlabs.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Impax Pharmaceuticals, Hayward, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="O Connell, Martin" sort="O Connell, Martin" uniqKey="O Connell M" first="Martin" last="O'Connell">Martin O'Connell</name><affiliation wicri:level="2"><nlm:affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: moconnell@impaxlabs.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Impax Pharmaceuticals, Hayward, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Kell, Sherron" sort="Kell, Sherron" uniqKey="Kell S" first="Sherron" last="Kell">Sherron Kell</name><affiliation wicri:level="2"><nlm:affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: skell@impaxlabs.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Impax Pharmaceuticals, Hayward, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Gupta, Suneel" sort="Gupta, Suneel" uniqKey="Gupta S" first="Suneel" last="Gupta">Suneel Gupta</name><affiliation wicri:level="2"><nlm:affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: sgupta@impaxlabs.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Impax Pharmaceuticals, Hayward, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author></analytic><series><title level="j">Parkinsonism & related disorders</title><idno type="eISSN">1873-5126</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Antiparkinson Agents (administration & dosage)</term><term>Antiparkinson Agents (adverse effects)</term><term>Carbidopa (administration & dosage)</term><term>Carbidopa (adverse effects)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Combinations</term><term>Female</term><term>Humans</term><term>Levodopa (administration & dosage)</term><term>Levodopa (adverse effects)</term><term>Levodopa (metabolism)</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (metabolism)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Levodopa</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Dose-Response Relationship, Drug</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">IPX066 is an extended release carbidopa/levodopa formulation designed to rapidly attain and maintain therapeutic plasma concentrations for a prolonged duration, allowing dosing intervals of approximately 6 h. The objective was to assess the efficacy, safety, and impact on quality of life of IPX066 in the treatment of levodopa-naive Parkinson's disease (PD) patients.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24055014</PMID><DateCreated><Year>2014</Year><Month>02</Month><Day>03</Day></DateCreated><DateCompleted><Year>2014</Year><Month>09</Month><Day>24</Day></DateCompleted><DateRevised><Year>2014</Year><Month>02</Month><Day>03</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-5126</ISSN><JournalIssue CitedMedium="Internet"><Volume>20</Volume><Issue>2</Issue><PubDate><Year>2014</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Parkinsonism & related disorders</Title><ISOAbbreviation>Parkinsonism Relat. Disord.</ISOAbbreviation></Journal><ArticleTitle>Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease.</ArticleTitle><Pagination><MedlinePgn>142-8</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.parkreldis.2013.08.017</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1353-8020(13)00311-8</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">IPX066 is an extended release carbidopa/levodopa formulation designed to rapidly attain and maintain therapeutic plasma concentrations for a prolonged duration, allowing dosing intervals of approximately 6 h. The objective was to assess the efficacy, safety, and impact on quality of life of IPX066 in the treatment of levodopa-naive Parkinson's disease (PD) patients.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This was a randomized, double-blind, placebo-controlled, 30-week study of 381 levodopa-naïve patients assigned to placebo or IPX066 containing 145, 245 or 390 mg of levodopa administered three times daily (TID). The primary efficacy measure was change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) activities of daily living (Part II) + motor scores (Part III), at 30 weeks. Secondary outcome measures included UPDRS total and subscores, patient and clinician global impressions (PGI-I, CGI-I), and the Parkinson's Disease Questionnaire (PDQ-39).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">All IPX066 dosages were superior to placebo throughout the study and at 30 weeks (P < 0.0001). The mean improvement in UPDRS Parts II + III at 30 weeks compared to baseline was 11.7, 12.9, and 14.9 points for the three dosages and 0.6 points for placebo (P < 0.0001, all dosages). PDQ-39 total scores improved with IPX066 (P ≤ 0.034, all dosages). The most commonly reported adverse events with IPX066 included nausea, dizziness, and headache. No unexpected drug-related serious adverse events were reported.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">IPX066 provided significant clinical benefits at the three dosages tested compared to placebo and was well tolerated in levodopa-naive PD patients. Of the dosages tested, IPX066 145 mg TID appeared to provide the best overall balance between efficacy and safety.</AbstractText><CopyrightInformation>Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Pahwa</LastName><ForeName>Rajesh</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: rpahwa@kumc.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lyons</LastName><ForeName>Kelly E</ForeName><Initials>KE</Initials><AffiliationInfo><Affiliation>University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: kelly.lyons@att.net.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>University of South Florida, Tampa, FL, USA. Electronic address: rhauser@health.usf.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fahn</LastName><ForeName>Stanley</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Columbia University, New York, NY, USA. Electronic address: sf1@columbia.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jankovic</LastName><ForeName>Joseph</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Baylor College of Medicine, Houston, TX, USA. Electronic address: josephj@bcm.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pourcher</LastName><ForeName>Emmanuelle</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Quebec Memory and Motor Skills Disorders Research Clinic, Quebec City, Canada. Electronic address: psa@riq.qc.ca.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hsu</LastName><ForeName>Ann</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: annhsu@impaxlabs.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>O'Connell</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: moconnell@impaxlabs.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kell</LastName><ForeName>Sherron</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: skell@impaxlabs.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gupta</LastName><ForeName>Suneel</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: sgupta@impaxlabs.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>APEX-PD Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>09</Month><Day>05</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Parkinsonism Relat Disord</MedlineTA><NlmUniqueID>9513583</NlmUniqueID><ISSNLinking>1353-8020</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="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 UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000978" MajorTopicYN="N">Antiparkinson Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002230" MajorTopicYN="N">Carbidopa</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004305" MajorTopicYN="N">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007980" MajorTopicYN="N">Levodopa</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010300" MajorTopicYN="N">Parkinson Disease</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Carbidopa/levodopa</Keyword><Keyword MajorTopicYN="N">Clinical trial</Keyword><Keyword MajorTopicYN="N">Parkinson's disease</Keyword><Keyword MajorTopicYN="N">Randomized controlled trial</Keyword></KeywordList><InvestigatorList><Investigator ValidYN="Y"><LastName>Cohen</LastName><ForeName>Steven</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ellenbogen</LastName><ForeName>Aaron</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Elmer</LastName><ForeName>Lawrence</ForeName><Initials>L</Initials></Investigator><Investigator ValidYN="Y"><LastName>Gil</LastName><ForeName>Ramon</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ginsberg</LastName><ForeName>Paul</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Gitt</LastName><ForeName>Jeffrey</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Jabbari</LastName><ForeName>Bahman</ForeName><Initials>B</Initials></Investigator><Investigator 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ValidYN="Y"><LastName>Statinova</LastName><ForeName>Olena</ForeName><Initials>O</Initials></Investigator></InvestigatorList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2013</Year><Month>05</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2013</Year><Month>08</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2013</Year><Month>08</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2013</Year><Month>9</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2013</Year><Month>9</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>9</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24055014</ArticleId><ArticleId IdType="pii">S1353-8020(13)00311-8</ArticleId><ArticleId IdType="doi">10.1016/j.parkreldis.2013.08.017</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Canada</li><li>États-Unis</li></country><region><li>Californie</li><li>Floride</li><li>Kansas</li><li>Texas</li><li>État de New York</li></region><settlement><li>Houston</li><li>New York</li><li>Tampa</li></settlement><orgName><li>Baylor College of Medicine</li><li>Université Columbia</li><li>Université de Floride du Sud</li></orgName></list><tree><country name="États-Unis"><region name="Kansas"><name sortKey="Pahwa, Rajesh" sort="Pahwa, Rajesh" uniqKey="Pahwa R" first="Rajesh" last="Pahwa">Rajesh Pahwa</name></region><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name><name sortKey="Gupta, Suneel" sort="Gupta, Suneel" uniqKey="Gupta S" first="Suneel" last="Gupta">Suneel Gupta</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><name sortKey="Hsu, Ann" sort="Hsu, Ann" uniqKey="Hsu A" first="Ann" last="Hsu">Ann Hsu</name><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><name sortKey="Kell, Sherron" sort="Kell, Sherron" uniqKey="Kell S" first="Sherron" last="Kell">Sherron Kell</name><name sortKey="Lyons, Kelly E" sort="Lyons, Kelly E" uniqKey="Lyons K" first="Kelly E" last="Lyons">Kelly E. Lyons</name><name sortKey="O Connell, Martin" sort="O Connell, Martin" uniqKey="O Connell M" first="Martin" last="O'Connell">Martin O'Connell</name></country><country name="Canada"><noRegion><name sortKey="Pourcher, Emmanuelle" sort="Pourcher, Emmanuelle" uniqKey="Pourcher E" first="Emmanuelle" last="Pourcher">Emmanuelle Pourcher</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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