Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson'd Disease: Final 12-Month, Open-Label Results
Identifieur interne : 000A15 ( Main/Exploration ); précédent : 000A14; suivant : 000A16Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson'd Disease: Final 12-Month, Open-Label Results
Auteurs : Hubert H. Fernandez [États-Unis] ; David G. Standaert [États-Unis] ; Robert A. Hauser [États-Unis] ; Anthony E. Lang [Canada] ; Victor Sc Fung [Australie] ; Fabian Klostermann [Allemagne] ; Mark F. Lew [États-Unis] ; Per Odin [Suède] ; Malcolm Steiger [Royaume-Uni] ; Eduard Z. Yakupov [Russie] ; Sylvain Chouinard [Canada] ; Oksana Suchowersky [Canada] ; Jordan Dubow [États-Unis] ; Coleen M. Hall [États-Unis] ; Krai Chatamra [États-Unis] ; Weining Z. Robieson [États-Unis] ; Janet A. Benesh [États-Unis] ; Alberto J. Espay [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2014.
Abstract
Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation.
Url:
DOI: 10.1002/mds.26123
PubMed: 25545465
PubMed Central: 4674978
Affiliations:
- Allemagne, Australie, Canada, Royaume-Uni, Russie, Suède, États-Unis
- Alabama, Californie, Floride, Ohio
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Fernandez</name><affiliation wicri:level="2"><nlm:aff id="au1"><institution>Center for Neurological Restoration, Cleveland Clinic</institution><addr-line>Cleveland, Ohio, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Cleveland, Ohio</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Standaert, David G" sort="Standaert, David G" uniqKey="Standaert D" first="David G" last="Standaert">David G. Standaert</name><affiliation wicri:level="2"><nlm:aff id="au2"><institution>University of Alabama at Birmingham</institution><addr-line>Birmingham, Alabama, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Birmingham, Alabama</wicri:regionArea><placeName><region type="state">Alabama</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="2"><nlm:aff id="au3"><institution>Department of Neurology, University of South Florida</institution><addr-line>Tampa, Florida, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Tampa, Florida</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name><affiliation wicri:level="1"><nlm:aff id="au4"><institution>University of Toronto</institution><addr-line>Toronto, Ontario, Canada</addr-line></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Fung, Victor Sc" sort="Fung, Victor Sc" uniqKey="Fung V" first="Victor Sc" last="Fung">Victor Sc Fung</name><affiliation wicri:level="1"><nlm:aff id="au5"><institution>Movement Disorders Unit, Westmead Hospital and Sydney Medical School</institution><addr-line>Sydney, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name><affiliation wicri:level="1"><nlm:aff id="au6"><institution>Charité-University Medicine Berlin</institution><addr-line>Berlin, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F" last="Lew">Mark F. Lew</name><affiliation wicri:level="2"><nlm:aff id="au7"><institution>Keck/USC School of Medicine</institution><addr-line>Los Angeles, California, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Los Angeles, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Odin, Per" sort="Odin, Per" uniqKey="Odin P" first="Per" last="Odin">Per Odin</name><affiliation wicri:level="1"><nlm:aff id="au8"><institution>Klinikum-Bremerhaven, Bremerhaven, Germany and Skane University Hospital</institution><addr-line>Lund, Sweden</addr-line></nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Lund</wicri:regionArea></affiliation></author><author><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name><affiliation wicri:level="1"><nlm:aff id="au9"><institution>Walton Center for Neurology and Neurosurgery</institution><addr-line>Liverpool, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Liverpool</wicri:regionArea></affiliation></author><author><name sortKey="Yakupov, Eduard Z" sort="Yakupov, Eduard Z" uniqKey="Yakupov E" first="Eduard Z" last="Yakupov">Eduard Z. Yakupov</name><affiliation wicri:level="1"><nlm:aff id="au10"><institution>Kazan State Medical University</institution><addr-line>Kazan, Russia</addr-line></nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea>Kazan</wicri:regionArea></affiliation></author><author><name sortKey="Chouinard, Sylvain" sort="Chouinard, Sylvain" uniqKey="Chouinard S" first="Sylvain" last="Chouinard">Sylvain Chouinard</name><affiliation wicri:level="1"><nlm:aff id="au11"><institution>University of Montreal</institution><addr-line>Montreal, Quebec, Canada</addr-line></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Montreal, Quebec</wicri:regionArea><wicri:noRegion>Quebec</wicri:noRegion></affiliation></author><author><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name><affiliation wicri:level="1"><nlm:aff id="au12"><institution>University of Alberta</institution><addr-line>Edmonton, Alberta, Canada</addr-line></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Edmonton, Alberta</wicri:regionArea><wicri:noRegion>Alberta</wicri:noRegion></affiliation></author><author><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Hall, Coleen M" sort="Hall, Coleen M" uniqKey="Hall C" first="Coleen M" last="Hall">Coleen M. Hall</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Robieson, Weining Z" sort="Robieson, Weining Z" uniqKey="Robieson W" first="Weining Z" last="Robieson">Weining Z. Robieson</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Benesh, Janet A" sort="Benesh, Janet A" uniqKey="Benesh J" first="Janet A" last="Benesh">Janet A. Benesh</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Espay, Alberto J" sort="Espay, Alberto J" uniqKey="Espay A" first="Alberto J" last="Espay">Alberto J. Espay</name><affiliation wicri:level="2"><nlm:aff id="au14"><institution>University of Cincinnati Academic Health Center</institution><addr-line>Cincinnati, Ohio, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Cincinnati, Ohio</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author></analytic><series><title level="j">Movement Disorders</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. <sc>l</sc>-dopa-carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG-J), which reduces <sc>l-</sc>dopa-plasma–level fluctuations and can translate to reduced motor complications. We present final results of the largest international, prospective, 54-week, open-label LCIG study. PD patients with severe motor fluctuations (>3 h/day “off” time) despite optimized therapy received LCIG monotherapy. Additional PD medications were allowed >28 days post-LCIG initiation. Safety was the primary endpoint measured through adverse events (AEs), device complications, and number of completers. Secondary endpoints included diary-assessed off time, “on” time with/without troublesome dyskinesia, UPDRS, and health-related quality-of-life (HRQoL) outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG-J and 272 (76.8%) completed the study. Most AEs were mild/moderate and transient; complication of device insertion (34.9%) was the most common. Twenty-seven (7.6%) patients withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly complication of device insertion (6.5%). Mean daily off time decreased by 4.4 h/65.6% (<italic>P</italic> < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (<italic>P</italic> < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (<italic>P</italic> = 0.023). Improvements persisted from week 4 through study completion. UPDRS and HRQoL outcomes were also improved throughout. In the advanced PD population, LCIG's safety profile consisted primarily of AEs associated with the device/procedure, <sc>l-</sc>dopa/carbidopa, and advanced PD. LCIG was generally well tolerated and demonstrated clinically significant improvements in motor function, daily activities, and HRQoL sustained over 54 weeks. © 2014 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Hauser, Ra" uniqKey="Hauser R">RA Hauser</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hornykiewicz, O" uniqKey="Hornykiewicz O">O Hornykiewicz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lundqvist, C" uniqKey="Lundqvist C">C Lundqvist</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Antonini, A" uniqKey="Antonini A">A Antonini</name></author><author><name sortKey="Chaudhuri, Kr" uniqKey="Chaudhuri K">KR Chaudhuri</name></author><author><name sortKey="Martinez Martin, P" uniqKey="Martinez Martin P">P Martinez-Martin</name></author><author><name sortKey="Odin, P" uniqKey="Odin P">P 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Fernandez</name></region><name sortKey="Benesh, Janet A" sort="Benesh, Janet A" uniqKey="Benesh J" first="Janet A" last="Benesh">Janet A. Benesh</name><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name><name sortKey="Espay, Alberto J" sort="Espay, Alberto J" uniqKey="Espay A" first="Alberto J" last="Espay">Alberto J. Espay</name><name sortKey="Hall, Coleen M" sort="Hall, Coleen M" uniqKey="Hall C" first="Coleen M" last="Hall">Coleen M. Hall</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F" last="Lew">Mark F. Lew</name><name sortKey="Robieson, Weining Z" sort="Robieson, Weining Z" uniqKey="Robieson W" first="Weining Z" last="Robieson">Weining Z. Robieson</name><name sortKey="Standaert, David G" sort="Standaert, David G" uniqKey="Standaert D" first="David G" last="Standaert">David G. Standaert</name></country><country name="Canada"><noRegion><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name></noRegion><name sortKey="Chouinard, Sylvain" sort="Chouinard, Sylvain" uniqKey="Chouinard S" first="Sylvain" last="Chouinard">Sylvain Chouinard</name><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name></country><country name="Australie"><noRegion><name sortKey="Fung, Victor Sc" sort="Fung, Victor Sc" uniqKey="Fung V" first="Victor Sc" last="Fung">Victor Sc Fung</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name></noRegion></country><country name="Suède"><noRegion><name sortKey="Odin, Per" sort="Odin, Per" uniqKey="Odin P" first="Per" last="Odin">Per Odin</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name></noRegion></country><country name="Russie"><noRegion><name sortKey="Yakupov, Eduard Z" sort="Yakupov, Eduard Z" uniqKey="Yakupov E" first="Eduard Z" last="Yakupov">Eduard Z. 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