Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: final 12-month, open-label results.
Identifieur interne : 000194 ( Main/Exploration ); précédent : 000193; suivant : 000195Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: final 12-month, open-label results.
Auteurs : Hubert H. Fernandez [États-Unis] ; David G. Standaert ; Robert A. Hauser ; Anthony E. Lang ; Victor S C. Fung ; Fabian Klostermann ; Mark F. Lew ; Per Odin ; Malcolm Steiger ; Eduard Z. Yakupov ; Sylvain Chouinard ; Oksana Suchowersky ; Jordan Dubow ; Coleen M. Hall ; Krai Chatamra ; Weining Z. Robieson ; Janet A. Benesh ; Alberto J. EspaySource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2015.
Abstract
Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. L-dopa-carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG-J), which reduces L-dopa-plasma-level fluctuations and can translate to reduced motor complications. We present final results of the largest international, prospective, 54-week, open-label LCIG study. PD patients with severe motor fluctuations (>3 h/day "off" time) despite optimized therapy received LCIG monotherapy. Additional PD medications were allowed >28 days post-LCIG initiation. Safety was the primary endpoint measured through adverse events (AEs), device complications, and number of completers. Secondary endpoints included diary-assessed off time, "on" time with/without troublesome dyskinesia, UPDRS, and health-related quality-of-life (HRQoL) outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG-J and 272 (76.8%) completed the study. Most AEs were mild/moderate and transient; complication of device insertion (34.9%) was the most common. Twenty-seven (7.6%) patients withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly complication of device insertion (6.5%). Mean daily off time decreased by 4.4 h/65.6% (P < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (P < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (P = 0.023). Improvements persisted from week 4 through study completion. UPDRS and HRQoL outcomes were also improved throughout. In the advanced PD population, LCIG's safety profile consisted primarily of AEs associated with the device/procedure, l-dopa/carbidopa, and advanced PD. LCIG was generally well tolerated and demonstrated clinically significant improvements in motor function, daily activities, and HRQoL sustained over 54 weeks.
DOI: 10.1002/mds.26123
PubMed: 25545465
Affiliations:
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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="Standaert, David G" sort="Standaert, David G" uniqKey="Standaert D" first="David G" last="Standaert">David G. Standaert</name></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name></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></author><author><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name></author><author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F" last="Lew">Mark F. Lew</name></author><author><name sortKey="Odin, Per" sort="Odin, Per" uniqKey="Odin P" first="Per" last="Odin">Per Odin</name></author><author><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name></author><author><name sortKey="Yakupov, Eduard Z" sort="Yakupov, Eduard Z" uniqKey="Yakupov E" first="Eduard Z" last="Yakupov">Eduard Z. Yakupov</name></author><author><name sortKey="Chouinard, Sylvain" sort="Chouinard, Sylvain" uniqKey="Chouinard S" first="Sylvain" last="Chouinard">Sylvain Chouinard</name></author><author><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name></author><author><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name></author><author><name sortKey="Hall, Coleen M" sort="Hall, Coleen M" uniqKey="Hall C" first="Coleen M" last="Hall">Coleen M. Hall</name></author><author><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name></author><author><name sortKey="Robieson, Weining Z" sort="Robieson, Weining Z" uniqKey="Robieson W" first="Weining Z" last="Robieson">Weining Z. Robieson</name></author><author><name sortKey="Benesh, Janet A" sort="Benesh, Janet A" uniqKey="Benesh J" first="Janet A" last="Benesh">Janet A. Benesh</name></author><author><name sortKey="Espay, Alberto J" sort="Espay, Alberto J" uniqKey="Espay A" first="Alberto J" last="Espay">Alberto J. Espay</name></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="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. L-dopa-carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG-J), which reduces L-dopa-plasma-level fluctuations and can translate to reduced motor complications. We present final results of the largest international, prospective, 54-week, open-label LCIG study. PD patients with severe motor fluctuations (>3 h/day "off" time) despite optimized therapy received LCIG monotherapy. Additional PD medications were allowed >28 days post-LCIG initiation. Safety was the primary endpoint measured through adverse events (AEs), device complications, and number of completers. Secondary endpoints included diary-assessed off time, "on" time with/without troublesome dyskinesia, UPDRS, and health-related quality-of-life (HRQoL) outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG-J and 272 (76.8%) completed the study. Most AEs were mild/moderate and transient; complication of device insertion (34.9%) was the most common. Twenty-seven (7.6%) patients withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly complication of device insertion (6.5%). Mean daily off time decreased by 4.4 h/65.6% (P < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (P < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (P = 0.023). Improvements persisted from week 4 through study completion. UPDRS and HRQoL outcomes were also improved throughout. In the advanced PD population, LCIG's safety profile consisted primarily of AEs associated with the device/procedure, l-dopa/carbidopa, and advanced PD. LCIG was generally well tolerated and demonstrated clinically significant improvements in motor function, daily activities, and HRQoL sustained over 54 weeks.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Ohio</li></region></list><tree><noCountry><name sortKey="Benesh, Janet A" sort="Benesh, Janet A" uniqKey="Benesh J" first="Janet A" last="Benesh">Janet A. Benesh</name><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name><name sortKey="Chouinard, Sylvain" sort="Chouinard, Sylvain" uniqKey="Chouinard S" first="Sylvain" last="Chouinard">Sylvain Chouinard</name><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name><name sortKey="Espay, Alberto J" sort="Espay, Alberto J" uniqKey="Espay A" first="Alberto J" last="Espay">Alberto J. Espay</name><name sortKey="Fung, Victor S C" sort="Fung, Victor S C" uniqKey="Fung V" first="Victor S C" last="Fung">Victor S C. Fung</name><name sortKey="Hall, Coleen M" sort="Hall, Coleen M" uniqKey="Hall C" first="Coleen M" last="Hall">Coleen M. Hall</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F" last="Lew">Mark F. Lew</name><name sortKey="Odin, Per" sort="Odin, Per" uniqKey="Odin P" first="Per" last="Odin">Per Odin</name><name sortKey="Robieson, Weining Z" sort="Robieson, Weining Z" uniqKey="Robieson W" first="Weining Z" last="Robieson">Weining Z. Robieson</name><name sortKey="Standaert, David G" sort="Standaert, David G" uniqKey="Standaert D" first="David G" last="Standaert">David G. Standaert</name><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name><name sortKey="Yakupov, Eduard Z" sort="Yakupov, Eduard Z" uniqKey="Yakupov E" first="Eduard Z" last="Yakupov">Eduard Z. Yakupov</name></noCountry><country name="États-Unis"><region name="Ohio"><name sortKey="Fernandez, Hubert H" sort="Fernandez, Hubert H" uniqKey="Fernandez H" first="Hubert H" last="Fernandez">Hubert H. Fernandez</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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