Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients
Identifieur interne : 005A08 ( Main/Merge ); précédent : 005A07; suivant : 005A09Double-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.
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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. 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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><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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