Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study) : a randomised, double-blind, parallel-group trial. Commentary
Identifieur interne : 003120 ( Main/Merge ); précédent : 003119; suivant : 003121Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study) : a randomised, double-blind, parallel-group trial. Commentary
Auteurs : Carl E. Clarke [Royaume-Uni] ; O. Rascol [France] ; D. J. Brooks [Royaume-Uni] ; E. Melamed [Israël] ; W. Oertel [Allemagne] ; Werner Poewe [Autriche] ; F. Stocchi [Italie] ; E. Tolosa [Espagne]Source :
- Lancet : (British edition) [ 0140-6736 ] ; 2005.
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Abstract
Background Rasagiline mesylate is a novel drug for Parkinson's disease with selective, irreversible monoamine oxidase B (MAO-B) inhibitor activity, and is effective as monotherapy in early disease. This study investigated rasagiline efficacy and safety in levodopa-treated patients with Parkinson's disease and motor fluctuations. Methods In an 18-week, double-blind, multicentre (74 hospitals and academic centres in Israel, Argentina, and Europe) trial, 687 outpatients were randomly assigned to oral rasagiline (231 individuals; 1 mg once daily), entacapone (227; 200 mg with every levodopa dose), or placebo (229). Primary outcome was change in total daily off-time (intention-to-treat population). Other measures included the clinical global improvement (CGI) score and unified Parkinson's disease rating scale (UPDRS) scores. Analysis was by intention to treat. Findings 88 (13%) patients who were assigned treatment did not complete the study (23 rasagiline, 30 entacapone, 35 placebo), mainly because of withdrawal of consent (n=34) and adverse events (n=34). Both rasagiline and entacapone reduced mean daily off-time (-1.18 h rasagiline and -1.2 h entacapone vs placebo -0.4 h; p=0.0001, p<0.0001, respectively) and increased daily on-time without troublesome dyskinesia (0.85 h vs placebo 0.03 h; p=0.0005 for both). We recorded significant mean improvements in CGI scores (-0.86 rasagiline and -0.72 entacapone vs -0.37 placebo; p<0.0001, p=0.0002, respectively). Changes in UPDRS scores also significantly improved for activities of daily living during off-time (-1.71 and -1.38 vs placebo; p<0.0001, p=0.0006, respectively) and motor function during on-time (-2.94 and -2.73 vs placebo; both p<0.0001). Frequency of adverse events was similar for all treatments. Interpretation Once-daily rasagiline reduces mean daily off-time and improves symptoms of Parkinson's disease in levodopa-treated patients with motor fluctuations, an effect similar to that of entacapone.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study) : a randomised, double-blind, parallel-group trial. Commentary</title><author><name sortKey="Clarke, Carl E" sort="Clarke, Carl E" uniqKey="Clarke C" first="Carl E." last="Clarke">Carl E. Clarke</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Birmingham and Department of Neurology, City Hospital</s1><s2>Birmingham B18 7QH</s2><s3>GBR</s3><sZ>1 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Birmingham B18 7QH</wicri:noRegion></affiliation></author><author><name sortKey="Rascol, O" sort="Rascol, O" uniqKey="Rascol O" first="O." last="Rascol">O. Rascol</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Clinical Pharmacology, University Hospital</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Brooks, D J" sort="Brooks, D J" uniqKey="Brooks D" first="D. J." last="Brooks">D. J. Brooks</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Division of Neuroscience, Faculty of Medicine, Imperial College, Hammersmith Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>3 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Melamed, E" sort="Melamed, E" uniqKey="Melamed E" first="E." last="Melamed">E. Melamed</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Neurology, Rabin Medical Centre, Tel Aviv University, Sackler School of Medicine</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>4 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Tel Aviv</wicri:noRegion></affiliation></author><author><name sortKey="Oertel, W" sort="Oertel, W" uniqKey="Oertel W" first="W." last="Oertel">W. Oertel</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Philipps-University of Marburg, Centre of Nervous Diseases</s1><s2>Marburg</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Poewe, W" sort="Poewe, W" uniqKey="Poewe W" first="W." last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Neurology, University of Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>6 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Stocchi, F" sort="Stocchi, F" uniqKey="Stocchi F" first="F." last="Stocchi">F. Stocchi</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Institute of Neurology, IRCCS Neuromed</s1><s2>Pozzilli</s2><s3>ITA</s3><sZ>7 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Pozzilli</wicri:noRegion></affiliation></author><author><name sortKey="Tolosa, E" sort="Tolosa, E" uniqKey="Tolosa E" first="E." last="Tolosa">E. Tolosa</name><affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Neurology Service, Institut de Malalties del Sistema Nervios, Hospital Clinic, Institut d'lnvestigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>8 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName><orgName type="university">Université de Barcelone</orgName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">05-0151757</idno><date when="2005">2005</date><idno type="stanalyst">PASCAL 05-0151757 INIST</idno><idno type="RBID">Pascal:05-0151757</idno><idno type="wicri:Area/PascalFrancis/Corpus">000D09</idno><idno type="wicri:Area/PascalFrancis/Curation">000725</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000A97</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000A97</idno><idno type="wicri:doubleKey">0140-6736:2005:Clarke C:rasagiline:as:an</idno><idno type="wicri:Area/Main/Merge">003120</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study) : a randomised, double-blind, parallel-group trial. Commentary</title><author><name sortKey="Clarke, Carl E" sort="Clarke, Carl E" uniqKey="Clarke C" first="Carl E." last="Clarke">Carl E. Clarke</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Birmingham and Department of Neurology, City Hospital</s1><s2>Birmingham B18 7QH</s2><s3>GBR</s3><sZ>1 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Birmingham B18 7QH</wicri:noRegion></affiliation></author><author><name sortKey="Rascol, O" sort="Rascol, O" uniqKey="Rascol O" first="O." last="Rascol">O. Rascol</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Clinical Pharmacology, University Hospital</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Brooks, D J" sort="Brooks, D J" uniqKey="Brooks D" first="D. J." last="Brooks">D. J. Brooks</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Division of Neuroscience, Faculty of Medicine, Imperial College, Hammersmith Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>3 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Melamed, E" sort="Melamed, E" uniqKey="Melamed E" first="E." last="Melamed">E. Melamed</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Neurology, Rabin Medical Centre, Tel Aviv University, Sackler School of Medicine</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>4 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Tel Aviv</wicri:noRegion></affiliation></author><author><name sortKey="Oertel, W" sort="Oertel, W" uniqKey="Oertel W" first="W." last="Oertel">W. Oertel</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Philipps-University of Marburg, Centre of Nervous Diseases</s1><s2>Marburg</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Poewe, W" sort="Poewe, W" uniqKey="Poewe W" first="W." last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Neurology, University of Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>6 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Stocchi, F" sort="Stocchi, F" uniqKey="Stocchi F" first="F." last="Stocchi">F. Stocchi</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Institute of Neurology, IRCCS Neuromed</s1><s2>Pozzilli</s2><s3>ITA</s3><sZ>7 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Pozzilli</wicri:noRegion></affiliation></author><author><name sortKey="Tolosa, E" sort="Tolosa, E" uniqKey="Tolosa E" first="E." last="Tolosa">E. Tolosa</name><affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Neurology Service, Institut de Malalties del Sistema Nervios, Hospital Clinic, Institut d'lnvestigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>8 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName><orgName type="university">Université de Barcelone</orgName></affiliation></author></analytic><series><title level="j" type="main">Lancet : (British edition)</title><title level="j" type="abbreviated">Lancet : (Br. ed.)</title><idno type="ISSN">0140-6736</idno><imprint><date when="2005">2005</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Lancet : (British edition)</title><title level="j" type="abbreviated">Lancet : (Br. ed.)</title><idno type="ISSN">0140-6736</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiparkinson agent</term><term>Clinical trial</term><term>Critical study</term><term>Double blind study</term><term>Fluctuations</term><term>Human</term><term>Levodopa</term><term>Medicine</term><term>Parkinson disease</term><term>Rasagiline</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Rasagiline</term><term>Lévodopa</term><term>Homme</term><term>Parkinson maladie</term><term>Fluctuation</term><term>Traitement</term><term>Etude double insu</term><term>Essai clinique</term><term>Etude critique</term><term>Médecine</term><term>Antiparkinsonien</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background Rasagiline mesylate is a novel drug for Parkinson's disease with selective, irreversible monoamine oxidase B (MAO-B) inhibitor activity, and is effective as monotherapy in early disease. This study investigated rasagiline efficacy and safety in levodopa-treated patients with Parkinson's disease and motor fluctuations. Methods In an 18-week, double-blind, multicentre (74 hospitals and academic centres in Israel, Argentina, and Europe) trial, 687 outpatients were randomly assigned to oral rasagiline (231 individuals; 1 mg once daily), entacapone (227; 200 mg with every levodopa dose), or placebo (229). Primary outcome was change in total daily off-time (intention-to-treat population). Other measures included the clinical global improvement (CGI) score and unified Parkinson's disease rating scale (UPDRS) scores. Analysis was by intention to treat. Findings 88 (13%) patients who were assigned treatment did not complete the study (23 rasagiline, 30 entacapone, 35 placebo), mainly because of withdrawal of consent (n=34) and adverse events (n=34). Both rasagiline and entacapone reduced mean daily off-time (-1.18 h rasagiline and -1.2 h entacapone vs placebo -0.4 h; p=0.0001, p<0.0001, respectively) and increased daily on-time without troublesome dyskinesia (0.85 h vs placebo 0.03 h; p=0.0005 for both). We recorded significant mean improvements in CGI scores (-0.86 rasagiline and -0.72 entacapone vs -0.37 placebo; p<0.0001, p=0.0002, respectively). Changes in UPDRS scores also significantly improved for activities of daily living during off-time (-1.71 and -1.38 vs placebo; p<0.0001, p=0.0006, respectively) and motor function during on-time (-2.94 and -2.73 vs placebo; both p<0.0001). Frequency of adverse events was similar for all treatments. Interpretation Once-daily rasagiline reduces mean daily off-time and improves symptoms of Parkinson's disease in levodopa-treated patients with motor fluctuations, an effect similar to that of entacapone.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Autriche</li><li>Espagne</li><li>France</li><li>Israël</li><li>Italie</li><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Catalogne</li><li>District de Giessen</li><li>Grand Londres</li><li>Hesse (Land)</li><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Tyrol (Land)</li></region><settlement><li>Barcelone</li><li>Innsbruck</li><li>Londres</li><li>Marbourg</li><li>Toulouse</li></settlement><orgName><li>Université de Barcelone</li><li>Université de médecine d'Innsbruck</li></orgName></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Clarke, Carl E" sort="Clarke, Carl E" uniqKey="Clarke C" first="Carl E." last="Clarke">Carl E. Clarke</name></noRegion><name sortKey="Brooks, D J" sort="Brooks, D J" uniqKey="Brooks D" first="D. J." last="Brooks">D. J. Brooks</name></country><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Rascol, O" sort="Rascol, O" uniqKey="Rascol O" first="O." last="Rascol">O. Rascol</name></region></country><country name="Israël"><noRegion><name sortKey="Melamed, E" sort="Melamed, E" uniqKey="Melamed E" first="E." last="Melamed">E. Melamed</name></noRegion></country><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Oertel, W" sort="Oertel, W" uniqKey="Oertel W" first="W." last="Oertel">W. Oertel</name></region></country><country name="Autriche"><region name="Tyrol (Land)"><name sortKey="Poewe, W" sort="Poewe, W" uniqKey="Poewe W" first="W." last="Poewe">Werner Poewe</name></region></country><country name="Italie"><noRegion><name sortKey="Stocchi, F" sort="Stocchi, F" uniqKey="Stocchi F" first="F." last="Stocchi">F. Stocchi</name></noRegion></country><country name="Espagne"><region name="Catalogne"><name sortKey="Tolosa, E" sort="Tolosa, E" uniqKey="Tolosa E" first="E." last="Tolosa">E. Tolosa</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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