Integrated safety of levodopa‐carbidopa intestinal gel from prospective clinical trials
Identifieur interne : 000A40 ( Pmc/Curation ); précédent : 000A39; suivant : 000A41Integrated 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.
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
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DOI: 10.1002/mds.26485
PubMed: 26695437
PubMed Central: 5064722
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<record><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><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. 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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><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Mov Disord</journal-id><journal-id journal-id-type="iso-abbrev">Mov. Disord</journal-id><journal-id journal-id-type="doi">10.1002/(ISSN)1531-8257</journal-id><journal-id journal-id-type="publisher-id">MDS</journal-id><journal-title-group><journal-title>Movement Disorders</journal-title></journal-title-group><issn pub-type="ppub">0885-3185</issn><issn pub-type="epub">1531-8257</issn><publisher><publisher-name>John Wiley and Sons Inc.</publisher-name><publisher-loc>Hoboken</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26695437</article-id><article-id pub-id-type="pmc">5064722</article-id><article-id pub-id-type="doi">10.1002/mds.26485</article-id><article-id pub-id-type="publisher-id">MDS26485</article-id><article-categories><subj-group subj-group-type="overline"><subject>Research Article</subject></subj-group><subj-group subj-group-type="heading"><subject>Research Articles</subject></subj-group></article-categories><title-group><article-title>Integrated safety of levodopa‐carbidopa intestinal gel from prospective clinical trials</article-title><alt-title alt-title-type="right-running-head">Safety of Levodopa‐Carbidopa Intestinal Gel</alt-title><alt-title alt-title-type="left-running-head">Lang et al</alt-title></title-group><contrib-group><contrib id="mds26485-cr-0001" contrib-type="author" corresp="yes"><name><surname>Lang</surname><given-names>Anthony E.</given-names></name><degrees>MD, FRCPC</degrees><xref ref-type="aff" rid="mds26485-aff-0001"><sup>1</sup></xref></contrib><contrib id="mds26485-cr-0002" contrib-type="author"><name><surname>Rodriguez</surname><given-names>Ramon L.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0002"><sup>2</sup></xref></contrib><contrib id="mds26485-cr-0003" contrib-type="author"><name><surname>Boyd</surname><given-names>James T.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0003"><sup>3</sup></xref></contrib><contrib id="mds26485-cr-0004" contrib-type="author"><name><surname>Chouinard</surname><given-names>Sylvain</given-names></name><degrees>MD, FRCPC</degrees><xref ref-type="aff" rid="mds26485-aff-0004"><sup>4</sup></xref></contrib><contrib id="mds26485-cr-0005" contrib-type="author"><name><surname>Zadikoff</surname><given-names>Cindy</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0005"><sup>5</sup></xref></contrib><contrib id="mds26485-cr-0006" contrib-type="author"><name><surname>Espay</surname><given-names>Alberto J.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0006"><sup>6</sup></xref></contrib><contrib id="mds26485-cr-0007" contrib-type="author"><name><surname>Slevin</surname><given-names>John T.</given-names></name><degrees>MD, MBA</degrees><xref ref-type="aff" rid="mds26485-aff-0007"><sup>7</sup></xref></contrib><contrib id="mds26485-cr-0008" contrib-type="author"><name><surname>Fernandez</surname><given-names>Hubert H.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0008"><sup>8</sup></xref></contrib><contrib id="mds26485-cr-0009" contrib-type="author"><name><surname>Lew</surname><given-names>Mark F.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0009"><sup>9</sup></xref></contrib><contrib id="mds26485-cr-0010" contrib-type="author"><name><surname>Stein</surname><given-names>David A.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0010"><sup>10</sup></xref></contrib><contrib id="mds26485-cr-0011" contrib-type="author"><name><surname>Odin</surname><given-names>Per</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="mds26485-aff-0011"><sup>11</sup></xref></contrib><contrib id="mds26485-cr-0012" contrib-type="author"><name><surname>Fung</surname><given-names>Victor S.C.</given-names></name><degrees>MBBS, PhD, FRACP</degrees><xref ref-type="aff" rid="mds26485-aff-0012"><sup>12</sup></xref></contrib><contrib id="mds26485-cr-0013" contrib-type="author"><name><surname>Klostermann</surname><given-names>Fabian</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="mds26485-aff-0013"><sup>13</sup></xref></contrib><contrib id="mds26485-cr-0014" contrib-type="author"><name><surname>Fasano</surname><given-names>Alfonso</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="mds26485-aff-0001"><sup>1</sup></xref></contrib><contrib id="mds26485-cr-0015" contrib-type="author"><name><surname>Draganov</surname><given-names>Peter V.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0002"><sup>2</sup></xref></contrib><contrib id="mds26485-cr-0016" contrib-type="author"><name><surname>Schmulewitz</surname><given-names>Nathan</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0006"><sup>6</sup></xref></contrib><contrib id="mds26485-cr-0017" contrib-type="author"><name><surname>Robieson</surname><given-names>Weining Z.</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="mds26485-aff-0014"><sup>14</sup></xref></contrib><contrib id="mds26485-cr-0018" contrib-type="author"><name><surname>Eaton</surname><given-names>Susan</given-names></name><degrees>PharmD</degrees><xref ref-type="aff" rid="mds26485-aff-0014"><sup>14</sup></xref></contrib><contrib id="mds26485-cr-0019" contrib-type="author"><name><surname>Chatamra</surname><given-names>Krai</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="mds26485-aff-0014"><sup>14</sup></xref></contrib><contrib id="mds26485-cr-0020" contrib-type="author"><name><surname>Benesh</surname><given-names>Janet A.</given-names></name><degrees>BSMT</degrees><xref ref-type="aff" rid="mds26485-aff-0014"><sup>14</sup></xref></contrib><contrib id="mds26485-cr-0021" contrib-type="author"><name><surname>Dubow</surname><given-names>Jordan</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="mds26485-aff-0014"><sup>14</sup></xref></contrib></contrib-group><aff id="mds26485-aff-0001"><label><sup>1</sup></label><named-content content-type="organisation-division">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</named-content><institution>University of Toronto</institution><named-content content-type="city">Toronto</named-content><named-content content-type="country-part">Ontario</named-content><country country="CA">Canada</country></aff><aff id="mds26485-aff-0002"><label><sup>2</sup></label><institution>University of Florida College of Medicine</institution><named-content content-type="city">Gainesville</named-content><named-content content-type="country-part">Florida</named-content><country country="US">USA</country></aff><aff id="mds26485-aff-0003"><label><sup>3</sup></label><institution>University of Vermont College of Medicine</institution><named-content content-type="city">Burlington</named-content><named-content content-type="country-part">Vermont</named-content><country country="US">USA</country></aff><aff id="mds26485-aff-0004"><label><sup>4</sup></label><institution>University of Montreal</institution><named-content content-type="city">Montreal</named-content><named-content content-type="country-part">Quebec</named-content><country country="CA">Canada</country></aff><aff id="mds26485-aff-0005"><label><sup>5</sup></label><named-content content-type="organisation-division">Feinberg School of Medicine</named-content><institution>Northwestern University</institution><named-content content-type="city">Chicago</named-content><named-content content-type="country-part">Illinois</named-content><country country="US">USA</country></aff><aff id="mds26485-aff-0006"><label><sup>6</sup></label><institution>University of Cincinnati Academic Health Center</institution><named-content content-type="city">Cincinnati</named-content><named-content content-type="country-part">Ohio</named-content><country country="US">USA</country></aff><aff id="mds26485-aff-0007"><label><sup>7</sup></label><institution>University of Kentucky Medical Center</institution><named-content content-type="city">Lexington</named-content><named-content content-type="country-part">Kentucky</named-content><country country="US">USA</country></aff><aff id="mds26485-aff-0008"><label><sup>8</sup></label><institution>Center for Neurological Restoration, Cleveland Clinic</institution><named-content content-type="city">Cleveland</named-content><named-content content-type="country-part">Ohio</named-content><country country="US">USA</country></aff><aff id="mds26485-aff-0009"><label><sup>9</sup></label><institution>Keck/University of Southern California School of Medicine</institution><named-content content-type="city">Los Angeles</named-content><named-content content-type="country-part">California</named-content><country country="US">USA</country></aff><aff id="mds26485-aff-0010"><label><sup>10</sup></label><institution>Quintiles</institution><named-content content-type="city">San Diego</named-content><named-content content-type="country-part">California</named-content><country country="US">USA</country></aff><aff id="mds26485-aff-0011"><label><sup>11</sup></label><named-content content-type="organisation-division">Klinikim‐Bremerhaven</named-content><institution>Germany and Skane University Hospital</institution><named-content content-type="city">Lund</named-content><country country="SE">Sweden</country></aff><aff id="mds26485-aff-0012"><label><sup>12</sup></label><institution>Westmead Hospital and Sydney Medical School</institution><named-content content-type="city">Sydney</named-content><country country="AU">Australia</country></aff><aff id="mds26485-aff-0013"><label><sup>13</sup></label><institution>Charité‐University Medicine Berlin</institution><named-content content-type="city">Berlin</named-content><country country="DE">Germany</country></aff><aff id="mds26485-aff-0014"><label><sup>14</sup></label><institution>AbbVie Inc</institution><named-content content-type="city">North Chicago</named-content><named-content content-type="country-part">Illinois</named-content><country country="US">USA</country></aff><author-notes><corresp id="correspondenceTo"><label>*</label><bold>Correspondence to</bold>: Anthony E. Lang, MD, FRCPC, Toronto Western Hospital, McLaughlin Pavilion, 7th Floor, Room 7‐403, 399 Bathurst St., Toronto, Ontario, Canada M5T 2S8, E‐mail: <email>lang@uhnresearch.ca</email></corresp></author-notes><pub-date pub-type="epub"><day>23</day><month>12</month><year>2015</year></pub-date><pub-date pub-type="ppub"><month>4</month><year>2016</year></pub-date><volume>31</volume><issue>4</issue><issue-id pub-id-type="doi">10.1002/mds.v31.4</issue-id><fpage>538</fpage><lpage>546</lpage><history><date date-type="received"><day>17</day><month>2</month><year>2015</year></date><date date-type="rev-recd"><day>23</day><month>10</month><year>2015</year></date><date date-type="accepted"><day>28</day><month>10</month><year>2015</year></date></history><permissions><pmc-comment> © 2016 International Parkinson and Movement Disorder Society </pmc-comment>
<copyright-statement content-type="article-copyright">© 2015 International Parkinson and Movement Disorder Society</copyright-statement><license license-type="creativeCommonsBy"><license-p>This is an open access article under the terms of the <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution</ext-link> License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.</license-p></license></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="file:MDS-31-538.pdf"></self-uri><abstract><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></abstract><kwd-group kwd-group-type="author-generated"><kwd id="mds26485-kwd-0001">Levodopa‐carbidopa intestinal gel</kwd><kwd id="mds26485-kwd-0002">infusion</kwd><kwd id="mds26485-kwd-0003">safety</kwd><kwd id="mds26485-kwd-0004">percutaneous endoscopic gastrojejunostomy</kwd><kwd id="mds26485-kwd-0005">Parkinson's disease</kwd></kwd-group><funding-group><award-group><funding-source>AbbVie Inc
</funding-source><award-id>NCT00357994/NCT00660387
</award-id><award-id>NCT00335153
</award-id><award-id>NCT00660673
</award-id><award-id>NCT00360568
</award-id></award-group></funding-group><counts><page-count count="11"></page-count></counts><custom-meta-group><custom-meta><meta-name>source-schema-version-number</meta-name><meta-value>2.0</meta-value></custom-meta><custom-meta><meta-name>component-id</meta-name><meta-value>mds26485</meta-value></custom-meta><custom-meta><meta-name>cover-date</meta-name><meta-value>April 2016</meta-value></custom-meta><custom-meta><meta-name>details-of-publishers-convertor</meta-name><meta-value>Converter:WILEY_ML3GV2_TO_NLMPMC version:4.9.4 mode:remove_FC converted:14.10.2016</meta-value></custom-meta></custom-meta-group></article-meta><notes><fn-group><fn id="mds26485-note-0001"><p><bold>Funding agencies</bold>: AbbVie Inc. funded these studies. AbbVie Inc. participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication.</p></fn><fn id="mds26485-note-0002"><p><bold>Relevant conflicts of interests/financial disclosures</bold>: A.E.L. has received compensation from AbbVie Inc. for participating in scientific advisory boards. R.L.R. was a study investigator and has received compensation from AbbVie Inc. for research and scientific advisory services. J.T.B., S.C., C.Z., M.F.L., and A.J.E. were study investigators and have received compensation from AbbVie Inc. for serving as a consultant, lecturer, and/or participating in scientific advisory boards. J.T.S. and F.K. were study investigators and have received compensation from AbbVie Inc. for participating in scientific advisory boards. H.H.F. was a study investigator and has served as a consultant for AbbVie Inc. through a contract between AbbVie Inc. and Cleveland Clinic Foundation; he has not received personal compensation from AbbVie Inc. D.A.S. was a medical monitor for the studies through a contract with his employer, Quintiles, and AbbVie Inc. P.O. was a study investigator in AbbVie Inc.–sponsored studies and has received compensation from AbbVie Inc. for serving as a consultant and lecturer. V.S.C.F. was a study investigator and has also received compensation from AbbVie Inc. for participating in scientific advisory boards; AbbVie Inc. contributed to funding for a Parkinson's disease nurse specialist in the form of an unrestricted grant to his institution. A.F. received compensation from AbbVie Inc. for serving as a lecturer and participating in scientific advisory boards. P.V.D. has received compensation from AbbVie Inc. for serving as a consultant, scientific adviser, and lecturer. N.S. has received compensation from AbbVie Inc. for serving as a consultant, scientific adviser and lecturer. J.D. is a former employee of AbbVie Inc. W.Z.R., S.E., K.C., and J.A.B. are employees of AbbVie Inc. and hold stock or stock options.</p></fn><fn id="mds26485-note-0021"><p>This article was published online on 23 December 2015. After online publication, updates were made to the text. This notice is included in the online and print versions to indicate that both have been corrected on 04 January 2016.</p></fn></fn-group></notes></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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