A Double-Blind, Delayed-Start Trial of Rasagiline in Parkinson's Disease
Identifieur interne : 000590 ( PascalFrancis/Corpus ); précédent : 000589; suivant : 000591A Double-Blind, Delayed-Start Trial of Rasagiline in Parkinson's Disease
Auteurs : C. Warren Olanow ; Olivier Rascol ; Robert Hauser ; Paul D. Feigin ; Joseph Jankovic ; Anthony Lang ; William Langston ; Eldad Melamed ; Werner Poewe ; Fabrizio Stocchi ; Eduardo TolosaSource :
- The New England journal of medicine [ 0028-4793 ] ; 2009.
Descripteurs français
- Pascal (Inist)
English descriptors
Abstract
BACKGROUND A therapy that slows disease progression is the major unmet need in Parkinson's disease. METHODS In this double-blind trial, we examined the possibility that rasagiline has disease-modifying effects in Parkinson's disease. A total of 1176 subjects with untreated Parkinson's disease were randomly assigned to receive rasagiline (at a dose of either 1 mg or 2 mg per day) for 72 weeks (the early-start group) or placebo for 36 weeks followed by rasagiline (at a dose of either 1 mg or 2 mg per day) for 36 weeks (the delayed-start group). To determine a positive result with either dose, the early-start treatment group had to meet each of three hierarchical end points of the primary analysis based on the Unified Parkinson's Disease Rating Scale (UPDRS, a 176-point scale, with higher numbers indicating more severe disease): superiority to placebo in the rate of change in the UPDRS score between weeks 12 and 36, superiority to delayed-start treatment in the change in the score between baseline and week 72, and noninferiority to delayed-start treatment in the rate of change in the score between weeks 48 and 72. RESULTS Early-start treatment with rasagiline at a dose of 1 mg per day met all end points in the primary analysis: a smaller mean (±SE) increase (rate of worsening) in the UPDRS score between weeks 12 and 36 (0.09±0.02 points per week in the early-start group vs. 0.14±0.01 points per week in the placebo group, P=0.01), less worsening in the score between baseline and week 72 (2.82±0.53 points in the early-start group vs. 4.52±0.5G points in the delayed-start group, P=0.02), and noninferiority between the two groups with respect to the rate of change in the UPDRS score between weeks 48 and 72 (0.085±0.02 points per week in the early-start group vs. 0.085±0.02 points per week in the delayed-start group, P<0.001). All three end points were not met with rasagiline at a dose of 2 mg per day, since the change in the UPDRS score between baseline and week 72 was not significantly different in the two groups (3.47±0.50 points in the early-start group and 3.11±0.50 points in the delayed-start group, P=0.60). CONCLUSIONS Early treatment with rasagiline at a dose of 1 mg per day provided benefits that were consistent with a possible disease-modifying effect, but early treatment with rasagiline at a dose of 2 mg per day did not. Because the two doses were associated with different outcomes, the study results must be interpreted with caution. (ClinicalTrials. gov number, NCT00256204.).
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Format Inist (serveur)
| NO : | FRANCIS 09-0410176 INIST |
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| ET : | A Double-Blind, Delayed-Start Trial of Rasagiline in Parkinson's Disease |
| AU : | OLANOW (C. Warren); RASCOL (Olivier); HAUSER (Robert); FEIGIN (Paul D.); JANKOVIC (Joseph); LANG (Anthony); LANGSTON (William); MELAMED (Eldad); POEWE (Werner); STOCCHI (Fabrizio); TOLOSA (Eduardo) |
| AF : | Department of Neurology and Neuroscience, Mount Sinai School of Medicine/New York/Etats-Unis (1 aut.); INSERM CIC-9302 and UMR-825, Departments of Clinical Pharmacology and Neurosciences, Centre Hospitalier Universitaire and University of Toulouse, Faculty of Medicine/Toulouse/France (2 aut.); Department of Neurology, University of South Florida/Tampa/Etats-Unis (3 aut.); Department of Industrial Engineering and Management, Technion-Israel Institute of Technology/Haifa/Israël (4 aut.); Department of Neurology, Baylor College of Medicine/Houston/Etats-Unis (5 aut.); Division of Neurology, University of Toronto/Toronto/Canada (6 aut.); California Parkinson Institute/Sunnyvale/Etats-Unis (7 aut.); Department of Neurology, Rabin Medical Center, Beilinson Campus/Petah Tikva/Israël (8 aut.); Sackler School of Medicine/Tel Aviv/Israël (8 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (9 aut.); Institute of Neurology, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Pisana/Rome/Italie (10 aut.); Department of Neurology, University of Barcelona/Barcelona/Espagne (11 aut.); Centro de Investigacíon Biomédica en Red Sobre Enfermedades Neurodegenerativas/Madrid/Espagne (11 aut.) |
| DT : | Publication en série; Niveau analytique |
| SO : | The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2009; Vol. 361; No. 13; Pp. 1268-1278; Bibl. 27 ref. |
| LA : | Anglais |
| EA : | BACKGROUND A therapy that slows disease progression is the major unmet need in Parkinson's disease. METHODS In this double-blind trial, we examined the possibility that rasagiline has disease-modifying effects in Parkinson's disease. A total of 1176 subjects with untreated Parkinson's disease were randomly assigned to receive rasagiline (at a dose of either 1 mg or 2 mg per day) for 72 weeks (the early-start group) or placebo for 36 weeks followed by rasagiline (at a dose of either 1 mg or 2 mg per day) for 36 weeks (the delayed-start group). To determine a positive result with either dose, the early-start treatment group had to meet each of three hierarchical end points of the primary analysis based on the Unified Parkinson's Disease Rating Scale (UPDRS, a 176-point scale, with higher numbers indicating more severe disease): superiority to placebo in the rate of change in the UPDRS score between weeks 12 and 36, superiority to delayed-start treatment in the change in the score between baseline and week 72, and noninferiority to delayed-start treatment in the rate of change in the score between weeks 48 and 72. RESULTS Early-start treatment with rasagiline at a dose of 1 mg per day met all end points in the primary analysis: a smaller mean (±SE) increase (rate of worsening) in the UPDRS score between weeks 12 and 36 (0.09±0.02 points per week in the early-start group vs. 0.14±0.01 points per week in the placebo group, P=0.01), less worsening in the score between baseline and week 72 (2.82±0.53 points in the early-start group vs. 4.52±0.5G points in the delayed-start group, P=0.02), and noninferiority between the two groups with respect to the rate of change in the UPDRS score between weeks 48 and 72 (0.085±0.02 points per week in the early-start group vs. 0.085±0.02 points per week in the delayed-start group, P<0.001). All three end points were not met with rasagiline at a dose of 2 mg per day, since the change in the UPDRS score between baseline and week 72 was not significantly different in the two groups (3.47±0.50 points in the early-start group and 3.11±0.50 points in the delayed-start group, P=0.60). CONCLUSIONS Early treatment with rasagiline at a dose of 1 mg per day provided benefits that were consistent with a possible disease-modifying effect, but early treatment with rasagiline at a dose of 2 mg per day did not. Because the two doses were associated with different outcomes, the study results must be interpreted with caution. (ClinicalTrials. gov number, NCT00256204.). |
| CC : | 770D03M |
| FD : | Rasagiline; Etude double insu; Retard; Maladie de Parkinson; Médecine; Antiparkinsonien |
| FG : | Inhibiteur de la monoamine oxidase B; Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central; Pathologie du système nerveux |
| ED : | Rasagiline; Double blind study; Delay; Parkinson disease; Medicine; Antiparkinson agent |
| EG : | Monoamine oxidase B inhibitor; Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease; Nervous system diseases |
| SD : | Rasagilina; Estudio doble ciego; Retraso; Parkinson enfermedad; Medicina; Antiparkinsoniano |
| LO : | INIST-6013.354000171975430070 |
| ID : | 09-0410176 |
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Warren Olanow</name><affiliation><inist:fA14 i1="01"><s1>Department of Neurology and Neuroscience, Mount Sinai School of Medicine</s1><s2>New York</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><inist:fA14 i1="02"><s1>INSERM CIC-9302 and UMR-825, Departments of Clinical Pharmacology and Neurosciences, Centre Hospitalier Universitaire and University of Toulouse, Faculty of Medicine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Hauser, Robert" sort="Hauser, Robert" uniqKey="Hauser R" first="Robert" last="Hauser">Robert Hauser</name><affiliation><inist:fA14 i1="03"><s1>Department of Neurology, University of South Florida</s1><s2>Tampa</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Feigin, Paul D" sort="Feigin, Paul D" uniqKey="Feigin P" first="Paul D." last="Feigin">Paul D. 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Warren" last="Olanow">C. Warren Olanow</name><affiliation><inist:fA14 i1="01"><s1>Department of Neurology and Neuroscience, Mount Sinai School of Medicine</s1><s2>New York</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><inist:fA14 i1="02"><s1>INSERM CIC-9302 and UMR-825, Departments of Clinical Pharmacology and Neurosciences, Centre Hospitalier Universitaire and University of Toulouse, Faculty of Medicine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Hauser, Robert" sort="Hauser, Robert" uniqKey="Hauser R" first="Robert" last="Hauser">Robert Hauser</name><affiliation><inist:fA14 i1="03"><s1>Department of Neurology, University of South Florida</s1><s2>Tampa</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Feigin, Paul D" sort="Feigin, Paul D" uniqKey="Feigin P" first="Paul D." last="Feigin">Paul D. Feigin</name><affiliation><inist:fA14 i1="04"><s1>Department of Industrial Engineering and Management, Technion-Israel Institute of Technology</s1><s2>Haifa</s2><s3>ISR</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation><inist:fA14 i1="05"><s1>Department of Neurology, Baylor College of Medicine</s1><s2>Houston</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Lang, Anthony" sort="Lang, Anthony" uniqKey="Lang A" first="Anthony" last="Lang">Anthony Lang</name><affiliation><inist:fA14 i1="06"><s1>Division of Neurology, University of Toronto</s1><s2>Toronto</s2><s3>CAN</s3><sZ>6 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Langston, William" sort="Langston, William" uniqKey="Langston W" first="William" last="Langston">William Langston</name><affiliation><inist:fA14 i1="07"><s1>California Parkinson Institute</s1><s2>Sunnyvale</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Melamed, Eldad" sort="Melamed, Eldad" uniqKey="Melamed E" first="Eldad" last="Melamed">Eldad Melamed</name><affiliation><inist:fA14 i1="08"><s1>Department of Neurology, Rabin Medical Center, Beilinson Campus</s1><s2>Petah Tikva</s2><s3>ISR</s3><sZ>8 aut.</sZ></inist:fA14></affiliation><affiliation><inist:fA14 i1="09"><s1>Sackler School of Medicine</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>8 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><inist:fA14 i1="10"><s1>Department of Neurology, Innsbruck Medical University</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>9 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation><inist:fA14 i1="11"><s1>Institute of Neurology, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Pisana</s1><s2>Rome</s2><s3>ITA</s3><sZ>10 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation><inist:fA14 i1="12"><s1>Department of Neurology, University of Barcelona</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>11 aut.</sZ></inist:fA14></affiliation><affiliation><inist:fA14 i1="13"><s1>Centro de Investigacíon Biomédica en Red Sobre Enfermedades Neurodegenerativas</s1><s2>Madrid</s2><s3>ESP</s3><sZ>11 aut.</sZ></inist:fA14></affiliation></author></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiparkinson agent</term><term>Delay</term><term>Double blind study</term><term>Medicine</term><term>Parkinson disease</term><term>Rasagiline</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Rasagiline</term><term>Etude double insu</term><term>Retard</term><term>Maladie de Parkinson</term><term>Médecine</term><term>Antiparkinsonien</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND A therapy that slows disease progression is the major unmet need in Parkinson's disease. METHODS In this double-blind trial, we examined the possibility that rasagiline has disease-modifying effects in Parkinson's disease. A total of 1176 subjects with untreated Parkinson's disease were randomly assigned to receive rasagiline (at a dose of either 1 mg or 2 mg per day) for 72 weeks (the early-start group) or placebo for 36 weeks followed by rasagiline (at a dose of either 1 mg or 2 mg per day) for 36 weeks (the delayed-start group). To determine a positive result with either dose, the early-start treatment group had to meet each of three hierarchical end points of the primary analysis based on the Unified Parkinson's Disease Rating Scale (UPDRS, a 176-point scale, with higher numbers indicating more severe disease): superiority to placebo in the rate of change in the UPDRS score between weeks 12 and 36, superiority to delayed-start treatment in the change in the score between baseline and week 72, and noninferiority to delayed-start treatment in the rate of change in the score between weeks 48 and 72. RESULTS Early-start treatment with rasagiline at a dose of 1 mg per day met all end points in the primary analysis: a smaller mean (±SE) increase (rate of worsening) in the UPDRS score between weeks 12 and 36 (0.09±0.02 points per week in the early-start group vs. 0.14±0.01 points per week in the placebo group, P=0.01), less worsening in the score between baseline and week 72 (2.82±0.53 points in the early-start group vs. 4.52±0.5G points in the delayed-start group, P=0.02), and noninferiority between the two groups with respect to the rate of change in the UPDRS score between weeks 48 and 72 (0.085±0.02 points per week in the early-start group vs. 0.085±0.02 points per week in the delayed-start group, P<0.001). All three end points were not met with rasagiline at a dose of 2 mg per day, since the change in the UPDRS score between baseline and week 72 was not significantly different in the two groups (3.47±0.50 points in the early-start group and 3.11±0.50 points in the delayed-start group, P=0.60). CONCLUSIONS Early treatment with rasagiline at a dose of 1 mg per day provided benefits that were consistent with a possible disease-modifying effect, but early treatment with rasagiline at a dose of 2 mg per day did not. Because the two doses were associated with different outcomes, the study results must be interpreted with caution. (ClinicalTrials. gov number, NCT00256204.).</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0028-4793</s0></fA01><fA02 i1="01"><s0>NEJMAG</s0></fA02><fA03 i2="1"><s0>N. Engl. j. med.</s0></fA03><fA05><s2>361</s2></fA05><fA06><s2>13</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>A Double-Blind, Delayed-Start Trial of Rasagiline in Parkinson's Disease</s1></fA08><fA11 i1="01" i2="1"><s1>OLANOW (C. Warren)</s1></fA11><fA11 i1="02" i2="1"><s1>RASCOL (Olivier)</s1></fA11><fA11 i1="03" i2="1"><s1>HAUSER (Robert)</s1></fA11><fA11 i1="04" i2="1"><s1>FEIGIN (Paul D.)</s1></fA11><fA11 i1="05" i2="1"><s1>JANKOVIC (Joseph)</s1></fA11><fA11 i1="06" i2="1"><s1>LANG (Anthony)</s1></fA11><fA11 i1="07" i2="1"><s1>LANGSTON (William)</s1></fA11><fA11 i1="08" i2="1"><s1>MELAMED (Eldad)</s1></fA11><fA11 i1="09" i2="1"><s1>POEWE (Werner)</s1></fA11><fA11 i1="10" i2="1"><s1>STOCCHI (Fabrizio)</s1></fA11><fA11 i1="11" i2="1"><s1>TOLOSA (Eduardo)</s1></fA11><fA14 i1="01"><s1>Department of Neurology and Neuroscience, Mount Sinai School of Medicine</s1><s2>New York</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>INSERM CIC-9302 and UMR-825, Departments of Clinical Pharmacology and Neurosciences, Centre Hospitalier Universitaire and University of Toulouse, Faculty of Medicine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Department of Neurology, University of South Florida</s1><s2>Tampa</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Department of Industrial Engineering and Management, Technion-Israel Institute of Technology</s1><s2>Haifa</s2><s3>ISR</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Department of Neurology, Baylor College of Medicine</s1><s2>Houston</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Division of Neurology, University of Toronto</s1><s2>Toronto</s2><s3>CAN</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>California Parkinson Institute</s1><s2>Sunnyvale</s2><s3>USA</s3><sZ>7 aut.</sZ></fA14><fA14 i1="08"><s1>Department of Neurology, Rabin Medical Center, Beilinson Campus</s1><s2>Petah Tikva</s2><s3>ISR</s3><sZ>8 aut.</sZ></fA14><fA14 i1="09"><s1>Sackler School of Medicine</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>8 aut.</sZ></fA14><fA14 i1="10"><s1>Department of Neurology, Innsbruck Medical University</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>9 aut.</sZ></fA14><fA14 i1="11"><s1>Institute of Neurology, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Pisana</s1><s2>Rome</s2><s3>ITA</s3><sZ>10 aut.</sZ></fA14><fA14 i1="12"><s1>Department of Neurology, University of Barcelona</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>11 aut.</sZ></fA14><fA14 i1="13"><s1>Centro de Investigacíon Biomédica en Red Sobre Enfermedades Neurodegenerativas</s1><s2>Madrid</s2><s3>ESP</s3><sZ>11 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>ADAGIO Study Investigators</s1><s3>INC</s3></fA17><fA20><s1>1268-1278</s1></fA20><fA21><s1>2009</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>6013</s2><s5>354000171975430070</s5></fA43><fA44><s0>0000</s0><s1>© 2009 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>27 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>09-0410176</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>The New England journal of medicine</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>BACKGROUND A therapy that slows disease progression is the major unmet need in Parkinson's disease. METHODS In this double-blind trial, we examined the possibility that rasagiline has disease-modifying effects in Parkinson's disease. A total of 1176 subjects with untreated Parkinson's disease were randomly assigned to receive rasagiline (at a dose of either 1 mg or 2 mg per day) for 72 weeks (the early-start group) or placebo for 36 weeks followed by rasagiline (at a dose of either 1 mg or 2 mg per day) for 36 weeks (the delayed-start group). To determine a positive result with either dose, the early-start treatment group had to meet each of three hierarchical end points of the primary analysis based on the Unified Parkinson's Disease Rating Scale (UPDRS, a 176-point scale, with higher numbers indicating more severe disease): superiority to placebo in the rate of change in the UPDRS score between weeks 12 and 36, superiority to delayed-start treatment in the change in the score between baseline and week 72, and noninferiority to delayed-start treatment in the rate of change in the score between weeks 48 and 72. RESULTS Early-start treatment with rasagiline at a dose of 1 mg per day met all end points in the primary analysis: a smaller mean (±SE) increase (rate of worsening) in the UPDRS score between weeks 12 and 36 (0.09±0.02 points per week in the early-start group vs. 0.14±0.01 points per week in the placebo group, P=0.01), less worsening in the score between baseline and week 72 (2.82±0.53 points in the early-start group vs. 4.52±0.5G points in the delayed-start group, P=0.02), and noninferiority between the two groups with respect to the rate of change in the UPDRS score between weeks 48 and 72 (0.085±0.02 points per week in the early-start group vs. 0.085±0.02 points per week in the delayed-start group, P<0.001). All three end points were not met with rasagiline at a dose of 2 mg per day, since the change in the UPDRS score between baseline and week 72 was not significantly different in the two groups (3.47±0.50 points in the early-start group and 3.11±0.50 points in the delayed-start group, P=0.60). CONCLUSIONS Early treatment with rasagiline at a dose of 1 mg per day provided benefits that were consistent with a possible disease-modifying effect, but early treatment with rasagiline at a dose of 2 mg per day did not. Because the two doses were associated with different outcomes, the study results must be interpreted with caution. (ClinicalTrials. gov number, NCT00256204.).</s0></fC01><fC02 i1="01" i2="X"><s0>770D03M</s0><s1>IV</s1></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Rasagiline</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Rasagiline</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Rasagilina</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Etude double insu</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Double blind study</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Estudio doble ciego</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Retard</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Delay</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Retraso</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Maladie de Parkinson</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Parkinson disease</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Parkinson enfermedad</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Médecine</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Medicine</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Medicina</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Antiparkinsonien</s0><s5>25</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Antiparkinson agent</s0><s5>25</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Antiparkinsoniano</s0><s5>25</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Inhibiteur de la monoamine oxidase B</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Monoamine oxidase B inhibitor</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Inhibidor monoamine oxidase B</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Pathologie de l'encéphale</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Cerebral disorder</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Encéfalo patología</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Syndrome extrapyramidal</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Maladie dégénérative</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Degenerative disease</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0><s5>40</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Pathologie du système nerveux central</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Central nervous system disease</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0><s5>41</s5></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Pathologie du système nerveux</s0><s5>42</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>42</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>42</s5></fC07><fN21><s1>299</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard><server><NO>FRANCIS 09-0410176 INIST</NO><ET>A Double-Blind, Delayed-Start Trial of Rasagiline in Parkinson's Disease</ET><AU>OLANOW (C. Warren); RASCOL (Olivier); HAUSER (Robert); FEIGIN (Paul D.); JANKOVIC (Joseph); LANG (Anthony); LANGSTON (William); MELAMED (Eldad); POEWE (Werner); STOCCHI (Fabrizio); TOLOSA (Eduardo)</AU><AF>Department of Neurology and Neuroscience, Mount Sinai School of Medicine/New York/Etats-Unis (1 aut.); INSERM CIC-9302 and UMR-825, Departments of Clinical Pharmacology and Neurosciences, Centre Hospitalier Universitaire and University of Toulouse, Faculty of Medicine/Toulouse/France (2 aut.); Department of Neurology, University of South Florida/Tampa/Etats-Unis (3 aut.); Department of Industrial Engineering and Management, Technion-Israel Institute of Technology/Haifa/Israël (4 aut.); Department of Neurology, Baylor College of Medicine/Houston/Etats-Unis (5 aut.); Division of Neurology, University of Toronto/Toronto/Canada (6 aut.); California Parkinson Institute/Sunnyvale/Etats-Unis (7 aut.); Department of Neurology, Rabin Medical Center, Beilinson Campus/Petah Tikva/Israël (8 aut.); Sackler School of Medicine/Tel Aviv/Israël (8 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (9 aut.); Institute of Neurology, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Pisana/Rome/Italie (10 aut.); Department of Neurology, University of Barcelona/Barcelona/Espagne (11 aut.); Centro de Investigacíon Biomédica en Red Sobre Enfermedades Neurodegenerativas/Madrid/Espagne (11 aut.)</AF><DT>Publication en série; Niveau analytique</DT><SO>The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2009; Vol. 361; No. 13; Pp. 1268-1278; Bibl. 27 ref.</SO><LA>Anglais</LA><EA>BACKGROUND A therapy that slows disease progression is the major unmet need in Parkinson's disease. METHODS In this double-blind trial, we examined the possibility that rasagiline has disease-modifying effects in Parkinson's disease. A total of 1176 subjects with untreated Parkinson's disease were randomly assigned to receive rasagiline (at a dose of either 1 mg or 2 mg per day) for 72 weeks (the early-start group) or placebo for 36 weeks followed by rasagiline (at a dose of either 1 mg or 2 mg per day) for 36 weeks (the delayed-start group). To determine a positive result with either dose, the early-start treatment group had to meet each of three hierarchical end points of the primary analysis based on the Unified Parkinson's Disease Rating Scale (UPDRS, a 176-point scale, with higher numbers indicating more severe disease): superiority to placebo in the rate of change in the UPDRS score between weeks 12 and 36, superiority to delayed-start treatment in the change in the score between baseline and week 72, and noninferiority to delayed-start treatment in the rate of change in the score between weeks 48 and 72. RESULTS Early-start treatment with rasagiline at a dose of 1 mg per day met all end points in the primary analysis: a smaller mean (±SE) increase (rate of worsening) in the UPDRS score between weeks 12 and 36 (0.09±0.02 points per week in the early-start group vs. 0.14±0.01 points per week in the placebo group, P=0.01), less worsening in the score between baseline and week 72 (2.82±0.53 points in the early-start group vs. 4.52±0.5G points in the delayed-start group, P=0.02), and noninferiority between the two groups with respect to the rate of change in the UPDRS score between weeks 48 and 72 (0.085±0.02 points per week in the early-start group vs. 0.085±0.02 points per week in the delayed-start group, P<0.001). All three end points were not met with rasagiline at a dose of 2 mg per day, since the change in the UPDRS score between baseline and week 72 was not significantly different in the two groups (3.47±0.50 points in the early-start group and 3.11±0.50 points in the delayed-start group, P=0.60). CONCLUSIONS Early treatment with rasagiline at a dose of 1 mg per day provided benefits that were consistent with a possible disease-modifying effect, but early treatment with rasagiline at a dose of 2 mg per day did not. Because the two doses were associated with different outcomes, the study results must be interpreted with caution. (ClinicalTrials. gov number, NCT00256204.).</EA><CC>770D03M</CC><FD>Rasagiline; Etude double insu; Retard; Maladie de Parkinson; Médecine; Antiparkinsonien</FD><FG>Inhibiteur de la monoamine oxidase B; Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central; Pathologie du système nerveux</FG><ED>Rasagiline; Double blind study; Delay; Parkinson disease; Medicine; Antiparkinson agent</ED><EG>Monoamine oxidase B inhibitor; Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease; Nervous system diseases</EG><SD>Rasagilina; Estudio doble ciego; Retraso; Parkinson enfermedad; Medicina; Antiparkinsoniano</SD><LO>INIST-6013.354000171975430070</LO><ID>09-0410176</ID></server></inist></record>Pour manipuler ce document sous Unix (Dilib)
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