Integrated safety of levodopa‐carbidopa intestinal gel from prospective clinical trials
Identifieur interne : 001E13 ( Ncbi/Merge ); précédent : 001E12; suivant : 001E14Integrated safety of levodopa‐carbidopa intestinal gel from prospective clinical trials
Auteurs : Anthony E. Lang ; Ramon L. Rodriguez ; James T. Boyd ; Sylvain Chouinard ; Cindy Zadikoff ; Alberto J. Espay ; John T. Slevin ; Hubert H. Fernandez ; Mark F. Lew ; David A. Stein ; Per Odin ; Victor S. C. Fung ; Fabian Klostermann ; Alfonso Fasano ; Peter V. Draganov ; Nathan Schmulewitz ; Weining Z. Robieson ; Susan Eaton ; Krai Chatamra ; Janet A. Benesh ; Jordan DubowSource :
- Movement Disorders [ 0885-3185 ] ; 2015.
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.
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).
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.
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. © 2015 International Parkinson and Movement Disorder Society
Url:
DOI: 10.1002/mds.26485
PubMed: 26695437
PubMed Central: 5064722
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PMC:5064722Le document en format XML
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<term>Carbidopa (adverse effects)</term>
<term>Clinical Trials, Phase III as Topic (statistics & numerical data)</term>
<term>Drug Combinations</term>
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<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>
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<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Carbidopa</term>
<term>Levodopa</term>
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<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Carbidopa</term>
<term>Levodopa</term>
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<term>Drug Combinations</term>
<term>Female</term>
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<front><div type="abstract" xml:lang="en"><title>ABSTRACT</title>
<sec id="mds26485-sec-0001"><title>Background</title>
<p>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.</p>
</sec>
<sec id="mds26485-sec-0002"><title>Methods</title>
<p>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).</p>
</sec>
<sec id="mds26485-sec-0003"><title>Results</title>
<p>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.</p>
</sec>
<sec id="mds26485-sec-0004"><title>Conclusion</title>
<p>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. © 2015 International Parkinson and Movement Disorder Society</p>
</sec>
</div>
</front>
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</author>
<author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name>
<affiliation><nlm:aff id="mds26485-aff-0009"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0010"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Odin, Per" sort="Odin, Per" uniqKey="Odin P" first="Per" last="Odin">Per Odin</name>
<affiliation><nlm:aff id="mds26485-aff-0011"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0012"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name>
<affiliation><nlm:aff id="mds26485-aff-0013"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Fasano, Alfonso" sort="Fasano, Alfonso" uniqKey="Fasano A" first="Alfonso" last="Fasano">Alfonso Fasano</name>
<affiliation><nlm:aff id="mds26485-aff-0001"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0002"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Schmulewitz, Nathan" sort="Schmulewitz, Nathan" uniqKey="Schmulewitz N" first="Nathan" last="Schmulewitz">Nathan Schmulewitz</name>
<affiliation><nlm:aff id="mds26485-aff-0006"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Eaton, Susan" sort="Eaton, Susan" uniqKey="Eaton S" first="Susan" last="Eaton">Susan Eaton</name>
<affiliation><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name>
<affiliation><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name>
<affiliation><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">26695437</idno>
<idno type="pmc">5064722</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5064722</idno>
<idno type="RBID">PMC:5064722</idno>
<idno type="doi">10.1002/mds.26485</idno>
<date when="2015">2015</date>
<idno type="wicri:Area/Pmc/Corpus">000A40</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000A40</idno>
<idno type="wicri:Area/Pmc/Curation">000A40</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000A40</idno>
<idno type="wicri:Area/Pmc/Checkpoint">000279</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000279</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Integrated safety of levodopa‐carbidopa intestinal gel from prospective clinical trials</title>
<author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name>
<affiliation><nlm:aff id="mds26485-aff-0001"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0002"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0003"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Chouinard, Sylvain" sort="Chouinard, Sylvain" uniqKey="Chouinard S" first="Sylvain" last="Chouinard">Sylvain Chouinard</name>
<affiliation><nlm:aff id="mds26485-aff-0004"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Zadikoff, Cindy" sort="Zadikoff, Cindy" uniqKey="Zadikoff C" first="Cindy" last="Zadikoff">Cindy Zadikoff</name>
<affiliation><nlm:aff id="mds26485-aff-0005"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0006"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0007"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0008"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0009"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0010"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Odin, Per" sort="Odin, Per" uniqKey="Odin P" first="Per" last="Odin">Per Odin</name>
<affiliation><nlm:aff id="mds26485-aff-0011"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0012"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name>
<affiliation><nlm:aff id="mds26485-aff-0013"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Fasano, Alfonso" sort="Fasano, Alfonso" uniqKey="Fasano A" first="Alfonso" last="Fasano">Alfonso Fasano</name>
<affiliation><nlm:aff id="mds26485-aff-0001"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0002"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Schmulewitz, Nathan" sort="Schmulewitz, Nathan" uniqKey="Schmulewitz N" first="Nathan" last="Schmulewitz">Nathan Schmulewitz</name>
<affiliation><nlm:aff id="mds26485-aff-0006"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Eaton, Susan" sort="Eaton, Susan" uniqKey="Eaton S" first="Susan" last="Eaton">Susan Eaton</name>
<affiliation><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name>
<affiliation><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</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><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</affiliation>
</author>
<author><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name>
<affiliation><nlm:aff id="mds26485-aff-0014"></nlm:aff>
</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="2015">2015</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><title>ABSTRACT</title>
<sec id="mds26485-sec-0001"><title>Background</title>
<p>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.</p>
</sec>
<sec id="mds26485-sec-0002"><title>Methods</title>
<p>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).</p>
</sec>
<sec id="mds26485-sec-0003"><title>Results</title>
<p>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.</p>
</sec>
<sec id="mds26485-sec-0004"><title>Conclusion</title>
<p>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. © 2015 International Parkinson and Movement Disorder Society</p>
</sec>
</div>
</front>
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<pubmed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Integrated safety of levodopa-carbidopa intestinal gel from prospective clinical trials.</title>
<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="4"><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>
<orgName type="university">Université de Toronto</orgName>
<placeName><settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Floride</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Vermont</region>
</placeName>
</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>
<wicri:noRegion>Quebec</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Zadikoff, Cindy" sort="Zadikoff, Cindy" uniqKey="Zadikoff C" first="Cindy" last="Zadikoff">Cindy Zadikoff</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</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: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>
<placeName><region type="state">Ohio</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Kentucky</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Ohio</region>
</placeName>
</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: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>
<placeName><region type="state">Californie</region>
</placeName>
</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="2"><nlm:affiliation>Quintiles, San Diego, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Quintiles, San Diego, 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: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>
<wicri:noRegion>Lund</wicri:noRegion>
</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="3"><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>
<placeName><settlement type="city">Sydney</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name>
<affiliation wicri:level="3"><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>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Fasano, Alfonso" sort="Fasano, Alfonso" uniqKey="Fasano A" first="Alfonso" last="Fasano">Alfonso Fasano</name>
<affiliation wicri:level="4"><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>
<orgName type="university">Université de Toronto</orgName>
<placeName><settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Floride</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schmulewitz, Nathan" sort="Schmulewitz, Nathan" uniqKey="Schmulewitz N" first="Nathan" last="Schmulewitz">Nathan Schmulewitz</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Ohio</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Eaton, Susan" sort="Eaton, Susan" uniqKey="Eaton S" first="Susan" last="Eaton">Susan Eaton</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PubMed</idno>
<date when="2016">2016</date>
<idno type="RBID">pubmed:26695437</idno>
<idno type="pmid">26695437</idno>
<idno type="doi">10.1002/mds.26485</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Integrated safety of levodopa-carbidopa intestinal gel from prospective clinical trials.</title>
<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="4"><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>
<orgName type="university">Université de Toronto</orgName>
<placeName><settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Floride</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Vermont</region>
</placeName>
</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>
<wicri:noRegion>Quebec</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Zadikoff, Cindy" sort="Zadikoff, Cindy" uniqKey="Zadikoff C" first="Cindy" last="Zadikoff">Cindy Zadikoff</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</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: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>
<placeName><region type="state">Ohio</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Kentucky</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Ohio</region>
</placeName>
</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: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>
<placeName><region type="state">Californie</region>
</placeName>
</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="2"><nlm:affiliation>Quintiles, San Diego, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Quintiles, San Diego, 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: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>
<wicri:noRegion>Lund</wicri:noRegion>
</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="3"><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>
<placeName><settlement type="city">Sydney</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name>
<affiliation wicri:level="3"><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>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Fasano, Alfonso" sort="Fasano, Alfonso" uniqKey="Fasano A" first="Alfonso" last="Fasano">Alfonso Fasano</name>
<affiliation wicri:level="4"><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>
<orgName type="university">Université de Toronto</orgName>
<placeName><settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Floride</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schmulewitz, Nathan" sort="Schmulewitz, Nathan" uniqKey="Schmulewitz N" first="Nathan" last="Schmulewitz">Nathan Schmulewitz</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Ohio</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Eaton, Susan" sort="Eaton, Susan" uniqKey="Eaton S" first="Susan" last="Eaton">Susan Eaton</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</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="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name>
<affiliation wicri:level="2"><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>
<placeName><region type="state">Illinois</region>
</placeName>
</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>
</double>
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