Long-term Outcome of Early Versus Delayed Rasagiline Treatment in Early Parkinson's Disease
Identifieur interne : 000E20 ( PascalFrancis/Checkpoint ); précédent : 000E19; suivant : 000E21Long-term Outcome of Early Versus Delayed Rasagiline Treatment in Early Parkinson's Disease
Auteurs : Robert A. Hauser [États-Unis] ; Mark F. Lew [États-Unis] ; Howard I. Hurtig [États-Unis] ; William G. Ondo [États-Unis] ; Joanne Wojcieszek [États-Unis] ; Cheryl J. Fitzer-Attas [Israël]Source :
- Movement disorders [ 0885-3185 ] ; 2009.
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Abstract
The purpose of this study was to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study. Subjects who chose to participate in an open-label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5-year follow-up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early-start versus delayed-start rasagiline group. Although the interaction between treatment and time was significant, values for the early-start group were better than the delayed-start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early-start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long-term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD.
Affiliations:
- Israël, États-Unis
- Californie, Floride, Indiana, Pennsylvanie, Texas
- Tampa
- Université de Floride du Sud
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Lew</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurology, Keck/University of Southern California School of Medicine</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Hurtig, Howard I" sort="Hurtig, Howard I" uniqKey="Hurtig H" first="Howard I." last="Hurtig">Howard I. Hurtig</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System</s1><s2>Philadelphia, Pennsylvania</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G." last="Ondo">William G. 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Fitzer-Attas</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Teva Pharmaceutical Industries Ltd</s1><s2>Petach Tikva</s2><s3>ISR</s3><sZ>6 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Teva Pharmaceutical Industries Ltd</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">09-0171575</idno><date when="2009">2009</date><idno type="stanalyst">PASCAL 09-0171575 INIST</idno><idno type="RBID">Pascal:09-0171575</idno><idno type="wicri:Area/PascalFrancis/Corpus">000F47</idno><idno type="wicri:Area/PascalFrancis/Curation">001D72</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000E20</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Long-term Outcome of Early Versus Delayed Rasagiline Treatment in Early Parkinson's Disease</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Parkinsons's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></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"><inist:fA14 i1="02"><s1>Department of Neurology, Keck/University of Southern California School of Medicine</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Hurtig, Howard I" sort="Hurtig, Howard I" uniqKey="Hurtig H" first="Howard I." last="Hurtig">Howard I. Hurtig</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System</s1><s2>Philadelphia, Pennsylvania</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G." last="Ondo">William G. Ondo</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Department of Neurology, Baylor College of Medicine</s1><s2>Houston, Texas</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Wojcieszek, Joanne" sort="Wojcieszek, Joanne" uniqKey="Wojcieszek J" first="Joanne" last="Wojcieszek">Joanne Wojcieszek</name><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Department of Neurology, Indiana University School of Medicine</s1><s2>Indianapolis, Indiana</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Indiana</region></placeName></affiliation></author><author><name sortKey="Fitzer Attas, Cheryl J" sort="Fitzer Attas, Cheryl J" uniqKey="Fitzer Attas C" first="Cheryl J." last="Fitzer-Attas">Cheryl J. Fitzer-Attas</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Teva Pharmaceutical Industries Ltd</s1><s2>Petach Tikva</s2><s3>ISR</s3><sZ>6 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Teva Pharmaceutical Industries Ltd</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Comparative study</term><term>Long term</term><term>Modification</term><term>Monoamine oxidase B inhibitor</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Prognosis</term><term>Rasagiline</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Long terme</term><term>Pronostic</term><term>Etude comparative</term><term>Rasagiline</term><term>Traitement</term><term>Modification</term><term>Inhibiteur de la monoamine oxidase B</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The purpose of this study was to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study. Subjects who chose to participate in an open-label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5-year follow-up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early-start versus delayed-start rasagiline group. Although the interaction between treatment and time was significant, values for the early-start group were better than the delayed-start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early-start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long-term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0885-3185</s0></fA01><fA03 i2="1"><s0>Mov. disord.</s0></fA03><fA05><s2>24</s2></fA05><fA06><s2>4</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Long-term Outcome of Early Versus Delayed Rasagiline Treatment in Early Parkinson's Disease</s1></fA08><fA11 i1="01" i2="1"><s1>HAUSER (Robert A.)</s1></fA11><fA11 i1="02" i2="1"><s1>LEW (Mark F.)</s1></fA11><fA11 i1="03" i2="1"><s1>HURTIG (Howard I.)</s1></fA11><fA11 i1="04" i2="1"><s1>ONDO (William G.)</s1></fA11><fA11 i1="05" i2="1"><s1>WOJCIESZEK (Joanne)</s1></fA11><fA11 i1="06" i2="1"><s1>FITZER-ATTAS (Cheryl J.)</s1></fA11><fA14 i1="01"><s1>Parkinsons's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Department of Neurology, Keck/University of Southern California School of Medicine</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System</s1><s2>Philadelphia, Pennsylvania</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Department of Neurology, Baylor College of Medicine</s1><s2>Houston, Texas</s2><s3>USA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Department of Neurology, Indiana University School of Medicine</s1><s2>Indianapolis, Indiana</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Teva Pharmaceutical Industries Ltd</s1><s2>Petach Tikva</s2><s3>ISR</s3><sZ>6 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>TEMPO Open-label Study Group</s1><s3>INC</s3></fA17><fA20><s1>564-573</s1></fA20><fA21><s1>2009</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000187465460110</s5></fA43><fA44><s0>0000</s0><s1>© 2009 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>23 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>09-0171575</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Movement disorders</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>The purpose of this study was to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study. Subjects who chose to participate in an open-label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5-year follow-up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early-start versus delayed-start rasagiline group. Although the interaction between treatment and time was significant, values for the early-start group were better than the delayed-start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early-start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long-term clinical benefit, even in the face of treatment with other dopaminergic agents. 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Hauser</name></region><name sortKey="Hurtig, Howard I" sort="Hurtig, Howard I" uniqKey="Hurtig H" first="Howard I." last="Hurtig">Howard I. Hurtig</name><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G." last="Ondo">William G. Ondo</name><name sortKey="Wojcieszek, Joanne" sort="Wojcieszek, Joanne" uniqKey="Wojcieszek J" first="Joanne" last="Wojcieszek">Joanne Wojcieszek</name></country><country name="Israël"><noRegion><name sortKey="Fitzer Attas, Cheryl J" sort="Fitzer Attas, Cheryl J" uniqKey="Fitzer Attas C" first="Cheryl J." last="Fitzer-Attas">Cheryl J. Fitzer-Attas</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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