Integrated safety of levodopa-carbidopa intestinal gel from prospective clinical trials.
Identifieur interne : 000267 ( PubMed/Curation ); précédent : 000266; suivant : 000268Integrated safety of levodopa-carbidopa intestinal gel from prospective clinical trials.
Auteurs : Anthony E. Lang [Canada] ; Ramon L. Rodriguez [États-Unis] ; James T. Boyd [États-Unis] ; Sylvain Chouinard [Canada] ; Cindy Zadikoff [États-Unis] ; Alberto J. Espay [États-Unis] ; John T. Slevin [États-Unis] ; Hubert H. Fernandez [États-Unis] ; Mark F. Lew [États-Unis] ; David A. Stein [États-Unis] ; Per Odin [Suède] ; Victor S C. Fung [Australie] ; Fabian Klostermann [Allemagne] ; Alfonso Fasano [Canada] ; Peter V. Draganov [États-Unis] ; Nathan Schmulewitz [États-Unis] ; Weining Z. Robieson [États-Unis] ; Susan Eaton [États-Unis] ; Krai Chatamra [États-Unis] ; Janet A. Benesh [États-Unis] ; Jordan Dubow [États-Unis]Source :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2016.
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Carbidopa (administration & dosage), Carbidopa (adverse effects), Clinical Trials, Phase III as Topic (statistics & numerical data), Drug Combinations, Female, Gastric Bypass (adverse effects), Gels, Humans, Infusions, Parenteral (adverse effects), Levodopa (administration & dosage), Levodopa (adverse effects), Male, Middle Aged, Multicenter Studies as Topic (statistics & numerical data), Outcome Assessment (Health Care) (statistics & numerical data), Parkinson Disease (drug therapy), Prospective Studies.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Carbidopa, Levodopa.
- chemical , adverse effects : Antiparkinson Agents, Carbidopa, Levodopa.
- adverse effects : Gastric Bypass, Infusions, Parenteral.
- drug therapy : Parkinson Disease.
- statistics & numerical data : Clinical Trials, Phase III as Topic, Multicenter Studies as Topic, Outcome Assessment (Health Care).
- Aged, Drug Combinations, Female, Gels, Humans, Male, Middle Aged, Prospective Studies.
Abstract
Continuous administration of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy.
DOI: 10.1002/mds.26485
PubMed: 26695437
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Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Rodriguez, Ramon L" sort="Rodriguez, Ramon L" uniqKey="Rodriguez R" first="Ramon L" last="Rodriguez">Ramon L. Rodriguez</name><affiliation wicri:level="1"><nlm:affiliation>University of Florida College of Medicine, Gainesville, Florida, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Florida College of Medicine, Gainesville, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Boyd, James T" sort="Boyd, James T" uniqKey="Boyd J" first="James T" last="Boyd">James T. 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Fung</name><affiliation wicri:level="1"><nlm:affiliation>Westmead Hospital and Sydney Medical School, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Westmead Hospital and Sydney Medical School, 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:affiliation>Charité-University Medicine Berlin, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Charité-University Medicine Berlin, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Fasano, Alfonso" sort="Fasano, Alfonso" uniqKey="Fasano A" first="Alfonso" last="Fasano">Alfonso Fasano</name><affiliation wicri:level="1"><nlm:affiliation>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Draganov, Peter V" sort="Draganov, Peter V" uniqKey="Draganov P" first="Peter V" last="Draganov">Peter V. 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Lang</name><affiliation wicri:level="1"><nlm:affiliation>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Rodriguez, Ramon L" sort="Rodriguez, Ramon L" uniqKey="Rodriguez R" first="Ramon L" last="Rodriguez">Ramon L. Rodriguez</name><affiliation wicri:level="1"><nlm:affiliation>University of Florida College of Medicine, Gainesville, Florida, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Florida College of Medicine, Gainesville, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Boyd, James T" sort="Boyd, James T" uniqKey="Boyd J" first="James T" last="Boyd">James T. Boyd</name><affiliation wicri:level="1"><nlm:affiliation>University of Vermont College of Medicine, Burlington, Vermont, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Vermont College of Medicine, Burlington, Vermont</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:affiliation>University of Montreal, Montreal, Quebec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>University of Montreal, Montreal, Quebec</wicri:regionArea></affiliation></author><author><name sortKey="Zadikoff, Cindy" sort="Zadikoff, Cindy" uniqKey="Zadikoff C" first="Cindy" last="Zadikoff">Cindy Zadikoff</name><affiliation wicri:level="1"><nlm:affiliation>Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Feinberg School of Medicine, Northwestern University, Chicago, 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="1"><nlm:affiliation>University of Cincinnati Academic Health Center, Cincinnati, Ohio, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Cincinnati Academic Health Center, Cincinnati, Ohio</wicri:regionArea></affiliation></author><author><name sortKey="Slevin, John T" sort="Slevin, John T" uniqKey="Slevin J" first="John T" last="Slevin">John T. Slevin</name><affiliation wicri:level="1"><nlm:affiliation>University of Kentucky Medical Center, Lexington, Kentucky, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Kentucky Medical Center, Lexington, Kentucky</wicri:regionArea></affiliation></author><author><name sortKey="Fernandez, Hubert H" sort="Fernandez, Hubert H" uniqKey="Fernandez H" first="Hubert H" last="Fernandez">Hubert H. Fernandez</name><affiliation wicri:level="1"><nlm:affiliation>Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio</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="1"><nlm:affiliation>Keck/University of Southern California School of Medicine, Los Angeles, California, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Keck/University of Southern California School of Medicine, Los Angeles, California</wicri:regionArea></affiliation></author><author><name sortKey="Stein, David A" sort="Stein, David A" uniqKey="Stein D" first="David A" last="Stein">David A. Stein</name><affiliation wicri:level="1"><nlm:affiliation>Quintiles, San Diego, California, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Quintiles, San Diego, California</wicri:regionArea></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:affiliation>Klinikim-Bremerhaven, Germany and Skane University Hospital, Lund, Sweden.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Klinikim-Bremerhaven, Germany and Skane University Hospital, Lund</wicri:regionArea></affiliation></author><author><name sortKey="Fung, Victor S C" sort="Fung, Victor S C" uniqKey="Fung V" first="Victor S C" last="Fung">Victor S C. Fung</name><affiliation wicri:level="1"><nlm:affiliation>Westmead Hospital and Sydney Medical School, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Westmead Hospital and Sydney Medical School, 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:affiliation>Charité-University Medicine Berlin, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Charité-University Medicine Berlin, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Fasano, Alfonso" sort="Fasano, Alfonso" uniqKey="Fasano A" first="Alfonso" last="Fasano">Alfonso Fasano</name><affiliation wicri:level="1"><nlm:affiliation>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Draganov, Peter V" sort="Draganov, Peter V" uniqKey="Draganov P" first="Peter V" last="Draganov">Peter V. Draganov</name><affiliation wicri:level="1"><nlm:affiliation>University of Florida College of Medicine, Gainesville, Florida, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Florida College of Medicine, Gainesville, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Schmulewitz, Nathan" sort="Schmulewitz, Nathan" uniqKey="Schmulewitz N" first="Nathan" last="Schmulewitz">Nathan Schmulewitz</name><affiliation wicri:level="1"><nlm:affiliation>University of Cincinnati Academic Health Center, Cincinnati, Ohio, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Cincinnati Academic Health Center, Cincinnati, Ohio</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:affiliation>AbbVie Inc, North Chicago, Illinois, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc, North Chicago, Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Eaton, Susan" sort="Eaton, Susan" uniqKey="Eaton S" first="Susan" last="Eaton">Susan Eaton</name><affiliation wicri:level="1"><nlm:affiliation>AbbVie Inc, North Chicago, Illinois, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc, North Chicago, 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:affiliation>AbbVie Inc, North Chicago, Illinois, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc, North Chicago, 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:affiliation>AbbVie Inc, North Chicago, Illinois, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc, North Chicago, Illinois</wicri:regionArea></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:affiliation>AbbVie Inc, North Chicago, Illinois, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc, North Chicago, Illinois</wicri:regionArea></affiliation></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="2016" type="published">2016</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>Clinical Trials, Phase III as Topic (statistics & numerical data)</term><term>Drug Combinations</term><term>Female</term><term>Gastric Bypass (adverse effects)</term><term>Gels</term><term>Humans</term><term>Infusions, Parenteral (adverse effects)</term><term>Levodopa (administration & dosage)</term><term>Levodopa (adverse effects)</term><term>Male</term><term>Middle Aged</term><term>Multicenter Studies as Topic (statistics & numerical data)</term><term>Outcome Assessment (Health Care) (statistics & numerical data)</term><term>Parkinson Disease (drug therapy)</term><term>Prospective Studies</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" qualifier="adverse effects" xml:lang="en"><term>Gastric Bypass</term><term>Infusions, Parenteral</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Clinical Trials, Phase III as Topic</term><term>Multicenter Studies as Topic</term><term>Outcome Assessment (Health Care)</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Drug Combinations</term><term>Female</term><term>Gels</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Prospective Studies</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Continuous administration of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26695437</PMID><DateCreated><Year>2016</Year><Month>04</Month><Day>15</Day></DateCreated><DateCompleted><Year>2017</Year><Month>01</Month><Day>17</Day></DateCompleted><DateRevised><Year>2017</Year><Month>02</Month><Day>20</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>31</Volume><Issue>4</Issue><PubDate><Year>2016</Year><Month>Apr</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Integrated safety of levodopa-carbidopa intestinal gel from prospective clinical trials.</ArticleTitle><Pagination><MedlinePgn>538-46</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.26485</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Continuous administration of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Safety data from 4 studies were summarized using 2 overlapping data sets, permitting the separation of procedure/device-associated (n = 395) from non-procedure/device adverse events (n = 412).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">At the data cutoff, median exposure to levodopa-carbidopa intestinal gel was 911 days (range, 1-1980 days) with 963 total patient-years of exposure. Procedure/device adverse events occurred in 300 patients (76%), and serious adverse events occurred in 68 (17%); most frequently reported procedure/device adverse events and serious adverse events were complications of device insertion (41% and 8%, respectively) and abdominal pain (36% and 4%, respectively). Non-procedure/device adverse events occurred in 92% (379), with most frequently reported being insomnia (23%) and falls (23%); 42% (171) had non-procedure/device serious adverse events, with most frequently reported being pneumonia (5%) and PD symptoms (2%). Adverse events led to discontinuation in 17% (72), most frequently because of complication of device insertion (2.4%). There were 34 treatment-emergent deaths (8.3%) in the overlapping data sets, 2 of which (0.5%) were considered "possibly related" to the treatment system.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">In the largest collection of levodopa-carbidopa intestinal gel safety data from prospective clinical studies, procedure/device events were frequently reported and occasionally life threatening. Most non-procedure/device events were typical for levodopa treatment and an elderly population. These factors combined with high treatment efficacy led to a relatively low discontinuation rate in advanced PD patients.</AbstractText><CopyrightInformation>© 2015 International Parkinson and Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lang</LastName><ForeName>Anthony E</ForeName><Initials>AE</Initials><AffiliationInfo><Affiliation>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rodriguez</LastName><ForeName>Ramon L</ForeName><Initials>RL</Initials><AffiliationInfo><Affiliation>University of Florida College of Medicine, Gainesville, Florida, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boyd</LastName><ForeName>James T</ForeName><Initials>JT</Initials><AffiliationInfo><Affiliation>University of Vermont College of Medicine, Burlington, Vermont, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chouinard</LastName><ForeName>Sylvain</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>University of Montreal, Montreal, Quebec, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zadikoff</LastName><ForeName>Cindy</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Espay</LastName><ForeName>Alberto J</ForeName><Initials>AJ</Initials><AffiliationInfo><Affiliation>University of Cincinnati Academic Health Center, Cincinnati, Ohio, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Slevin</LastName><ForeName>John T</ForeName><Initials>JT</Initials><AffiliationInfo><Affiliation>University of Kentucky Medical Center, Lexington, Kentucky, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fernandez</LastName><ForeName>Hubert H</ForeName><Initials>HH</Initials><AffiliationInfo><Affiliation>Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lew</LastName><ForeName>Mark F</ForeName><Initials>MF</Initials><AffiliationInfo><Affiliation>Keck/University of Southern California School of Medicine, Los Angeles, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stein</LastName><ForeName>David A</ForeName><Initials>DA</Initials><AffiliationInfo><Affiliation>Quintiles, San Diego, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Odin</LastName><ForeName>Per</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Klinikim-Bremerhaven, Germany and Skane University Hospital, Lund, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fung</LastName><ForeName>Victor S C</ForeName><Initials>VS</Initials><AffiliationInfo><Affiliation>Westmead Hospital and Sydney Medical School, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Klostermann</LastName><ForeName>Fabian</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Charité-University Medicine Berlin, Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fasano</LastName><ForeName>Alfonso</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Draganov</LastName><ForeName>Peter V</ForeName><Initials>PV</Initials><AffiliationInfo><Affiliation>University of Florida College of Medicine, Gainesville, Florida, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schmulewitz</LastName><ForeName>Nathan</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>University of Cincinnati Academic Health Center, Cincinnati, Ohio, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robieson</LastName><ForeName>Weining Z</ForeName><Initials>WZ</Initials><AffiliationInfo><Affiliation>AbbVie Inc, North Chicago, Illinois, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Eaton</LastName><ForeName>Susan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>AbbVie Inc, North Chicago, Illinois, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chatamra</LastName><ForeName>Krai</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>AbbVie Inc, North Chicago, Illinois, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Benesh</LastName><ForeName>Janet A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>AbbVie Inc, North Chicago, Illinois, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dubow</LastName><ForeName>Jordan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>AbbVie Inc, North Chicago, Illinois, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>UL1 TR001427</GrantID><Acronym>TR</Acronym><Agency>NCATS NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>12</Month><Day>23</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="D005782">Gels</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C009265">carbidopa, levodopa drug 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effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017326" MajorTopicYN="N">Clinical Trials, Phase III as Topic</DescriptorName><QualifierName UI="Q000706" MajorTopicYN="Y">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015390" MajorTopicYN="N">Gastric Bypass</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005782" MajorTopicYN="N">Gels</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007263" MajorTopicYN="N">Infusions, Parenteral</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007980" MajorTopicYN="N">Levodopa</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015337" MajorTopicYN="N">Multicenter Studies as Topic</DescriptorName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017063" MajorTopicYN="N">Outcome Assessment (Health Care)</DescriptorName><QualifierName UI="Q000706" MajorTopicYN="Y">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010300" MajorTopicYN="N">Parkinson Disease</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Levodopa-carbidopa intestinal gel</Keyword><Keyword MajorTopicYN="N">Parkinson's disease</Keyword><Keyword MajorTopicYN="N">infusion</Keyword><Keyword MajorTopicYN="N">percutaneous endoscopic gastrojejunostomy</Keyword><Keyword MajorTopicYN="N">safety</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>02</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>10</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>10</Month><Day>28</Day></PubMedPubDate><PubMedPubDate 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