Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients
Identifieur interne : 002170 ( PascalFrancis/Checkpoint ); précédent : 002169; suivant : 002171Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients
Auteurs : Matthew B. Stern [États-Unis] ; Kenneth L. Marek [États-Unis] ; Joseph Friedman [États-Unis] ; Robert A. Hauser [États-Unis] ; Peter A. Lewitt [États-Unis] ; Daniel Tarsy [États-Unis] ; C. Warren Olanow [États-Unis]Source :
- Movement disorders [ 0885-3185 ] ; 2004.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.
Affiliations:
- États-Unis
- Connecticut, Floride, Massachusetts, Michigan, Pennsylvanie, Rhode Island, État de New York
- Tampa
- Université de Floride du Sud
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Marek</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Yale University School of Medicine</s1><s2>New Haven, Connecticut</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Friedman, Joseph" sort="Friedman, Joseph" uniqKey="Friedman J" first="Joseph" last="Friedman">Joseph Friedman</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Brown University School of Medicine</s1><s2>Providence, Rhode Island</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Rhode Island</region></placeName></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. 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Warren Olanow</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Mount Sinai School of Medicine</s1><s2>New York, New York</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">04-0494461</idno><date when="2004">2004</date><idno type="stanalyst">PASCAL 04-0494461 INIST</idno><idno type="RBID">Pascal:04-0494461</idno><idno type="wicri:Area/PascalFrancis/Corpus">002099</idno><idno type="wicri:Area/PascalFrancis/Curation">000C22</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">002170</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients</title><author><name sortKey="Stern, Matthew B" sort="Stern, Matthew B" uniqKey="Stern M" first="Matthew B." last="Stern">Matthew B. Stern</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>University of Pennsylvania</s1><s2>Philadelphia, Pennsylvania</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Marek, Kenneth L" sort="Marek, Kenneth L" uniqKey="Marek K" first="Kenneth L." last="Marek">Kenneth L. Marek</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Yale University School of Medicine</s1><s2>New Haven, Connecticut</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Friedman, Joseph" sort="Friedman, Joseph" uniqKey="Friedman J" first="Joseph" last="Friedman">Joseph Friedman</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Brown University School of Medicine</s1><s2>Providence, Rhode Island</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Rhode Island</region></placeName></affiliation></author><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="04"><s1>University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>4 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="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter A." last="Lewitt">Peter A. Lewitt</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Departments of Neurology, Psychiatry and Behavioral Neuroscience, Wayne State University School of Medicine</s1><s2>Detroit</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Detroit</wicri:noRegion></affiliation><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Clinical Neuroscience Center</s1><s2>Southfield, Michigan</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Tarsy, Daniel" sort="Tarsy, Daniel" uniqKey="Tarsy D" first="Daniel" last="Tarsy">Daniel Tarsy</name><affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Beth Israel Deaconess Medical Center</s1><s2>Boston, Massachusetts</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C. Warren" last="Olanow">C. Warren Olanow</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Mount Sinai School of Medicine</s1><s2>New York, New York</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></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="2004">2004</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>Human</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Rasagiline</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Parkinson maladie</term><term>Rasagiline</term><term>Homme</term><term>Système nerveux pathologie</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious 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>19</s2></fA05><fA06><s2>8</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients</s1></fA08><fA11 i1="01" i2="1"><s1>STERN (Matthew B.)</s1></fA11><fA11 i1="02" i2="1"><s1>MAREK (Kenneth L.)</s1></fA11><fA11 i1="03" i2="1"><s1>FRIEDMAN (Joseph)</s1></fA11><fA11 i1="04" i2="1"><s1>HAUSER (Robert A.)</s1></fA11><fA11 i1="05" i2="1"><s1>LEWITT (Peter A.)</s1></fA11><fA11 i1="06" i2="1"><s1>TARSY (Daniel)</s1></fA11><fA11 i1="07" i2="1"><s1>OLANOW (C. Warren)</s1></fA11><fA14 i1="01"><s1>University of Pennsylvania</s1><s2>Philadelphia, Pennsylvania</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Yale University School of Medicine</s1><s2>New Haven, Connecticut</s2><s3>USA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Brown University School of Medicine</s1><s2>Providence, Rhode Island</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Departments of Neurology, Psychiatry and Behavioral Neuroscience, Wayne State University School of Medicine</s1><s2>Detroit</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Clinical Neuroscience Center</s1><s2>Southfield, Michigan</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="07"><s1>Beth Israel Deaconess Medical Center</s1><s2>Boston, Massachusetts</s2><s3>USA</s3><sZ>6 aut.</sZ></fA14><fA14 i1="08"><s1>Mount Sinai School of Medicine</s1><s2>New York, New York</s2><s3>USA</s3><sZ>7 aut.</sZ></fA14><fA20><s1>916-923</s1></fA20><fA21><s1>2004</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000122179160060</s5></fA43><fA44><s0>0000</s0><s1>© 2004 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>32 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>04-0494461</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>Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.</s0></fC01><fC02 i1="01" i2="X"><s0>002B17</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Parkinson maladie</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Parkinson disease</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Parkinson enfermedad</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Rasagiline</s0><s2>NK</s2><s2>FR</s2><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Rasagiline</s0><s2>NK</s2><s2>FR</s2><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Rasagilina</s0><s2>NK</s2><s2>FR</s2><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Homme</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Human</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Hombre</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Système nerveux pathologie</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>04</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Encéphale pathologie</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Cerebral disorder</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Encéfalo patología</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Extrapyramidal syndrome</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Maladie dégénérative</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Degenerative disease</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Central nervous system disease</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0><s5>40</s5></fC07><fN21><s1>278</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>États-Unis</li></country><region><li>Connecticut</li><li>Floride</li><li>Massachusetts</li><li>Michigan</li><li>Pennsylvanie</li><li>Rhode Island</li><li>État de New York</li></region><settlement><li>Tampa</li></settlement><orgName><li>Université de Floride du Sud</li></orgName></list><tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Stern, Matthew B" sort="Stern, Matthew B" uniqKey="Stern M" first="Matthew B." last="Stern">Matthew B. Stern</name></region><name sortKey="Friedman, Joseph" sort="Friedman, Joseph" uniqKey="Friedman J" first="Joseph" last="Friedman">Joseph Friedman</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter A." last="Lewitt">Peter A. Lewitt</name><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter A." last="Lewitt">Peter A. Lewitt</name><name sortKey="Marek, Kenneth L" sort="Marek, Kenneth L" uniqKey="Marek K" first="Kenneth L." last="Marek">Kenneth L. Marek</name><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C. Warren" last="Olanow">C. Warren Olanow</name><name sortKey="Tarsy, Daniel" sort="Tarsy, Daniel" uniqKey="Tarsy D" first="Daniel" last="Tarsy">Daniel Tarsy</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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