Rasagiline improves quality of life in patients with early Parkinson's disease
Identifieur interne : 004A21 ( Main/Merge ); précédent : 004A20; suivant : 004A22Rasagiline improves quality of life in patients with early Parkinson's disease
Auteurs : Kevin M. Biglan [États-Unis] ; Steven Schwid [États-Unis] ; Shirley Eberly [États-Unis] ; Karen Blindauer [États-Unis] ; Stanley Fahn [États-Unis] ; Tamar Goren [Israël] ; Karl Kieburtz [États-Unis] ; David Oakes [États-Unis] ; Sandra Plumb [États-Unis] ; Andrew Siderowf [États-Unis] ; Matthew Stern [États-Unis] ; Ira Shoulson [États-Unis]Source :
- Movement disorders [ 0885-3185 ] ; 2006.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
Abstract
The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second-generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once-daily rasagiline I mg/day, rasagiline 2 mg/ day, or placebo in a 6-month, double-blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active-treatment phase in which those receiving I mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of -2.91 units (-5.19, -0.64, P = 0.01) for the 1 mg/day group and -2.74 units (-5.02, -0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self-image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline.
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Biglan</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Department of Neurology, Johns Hopkins University</s1><s2>Baltimore, Maryland</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Schwid, Steven" sort="Schwid, Steven" uniqKey="Schwid S" first="Steven" last="Schwid">Steven Schwid</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurology, University of Rochester</s1><s2>Rochester, New York</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Eberly, Shirley" sort="Eberly, Shirley" uniqKey="Eberly S" first="Shirley" last="Eberly">Shirley Eberly</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Department of Biostatistics, University of Rochester</s1><s2>New York</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Blindauer, Karen" sort="Blindauer, Karen" uniqKey="Blindauer K" first="Karen" last="Blindauer">Karen Blindauer</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Department of Neurology, Medical College of Wisconsin</s1><s2>Milwaukee, Wisconsin</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Wisconsin</region></placeName></affiliation></author><author><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurology, University of Rochester</s1><s2>Rochester, New York</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Goren, Tamar" sort="Goren, Tamar" uniqKey="Goren T" first="Tamar" last="Goren">Tamar Goren</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Teva Pharmaceutical Industries, Ltd</s1><s2>Netanya</s2><s3>ISR</s3><sZ>6 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Netanya</wicri:noRegion></affiliation></author><author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurology, University of Rochester</s1><s2>Rochester, New York</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurology, University of Rochester</s1><s2>Rochester, New York</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Department of Biostatistics, University of Rochester</s1><s2>New York</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Plumb, Sandra" sort="Plumb, Sandra" uniqKey="Plumb S" first="Sandra" last="Plumb">Sandra Plumb</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurology, University of Rochester</s1><s2>Rochester, New York</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Siderowf, Andrew" sort="Siderowf, Andrew" uniqKey="Siderowf A" first="Andrew" last="Siderowf">Andrew Siderowf</name><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Department of Neurology. University of Pennsylvania</s1><s2>Philadelphia, Pennsylvania</s2><s3>USA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Stern, Matthew" sort="Stern, Matthew" uniqKey="Stern M" first="Matthew" last="Stern">Matthew Stern</name><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Department of Neurology. University of Pennsylvania</s1><s2>Philadelphia, Pennsylvania</s2><s3>USA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurology, University of Rochester</s1><s2>Rochester, New York</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 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="2006">2006</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>Quality of life</term><term>Rasagiline</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Parkinson maladie</term><term>Rasagiline</term><term>Qualité vie</term><term>Homme</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second-generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once-daily rasagiline I mg/day, rasagiline 2 mg/ day, or placebo in a 6-month, double-blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active-treatment phase in which those receiving I mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of -2.91 units (-5.19, -0.64, P = 0.01) for the 1 mg/day group and -2.74 units (-5.02, -0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self-image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline.</div></front></TEI><affiliations><list><country><li>Israël</li><li>États-Unis</li></country><region><li>Maryland</li><li>Pennsylvanie</li><li>Wisconsin</li><li>État de New York</li></region></list><tree><country name="États-Unis"><region name="Maryland"><name sortKey="Biglan, Kevin M" sort="Biglan, Kevin M" uniqKey="Biglan K" first="Kevin M." last="Biglan">Kevin M. Biglan</name></region><name sortKey="Blindauer, Karen" sort="Blindauer, Karen" uniqKey="Blindauer K" first="Karen" last="Blindauer">Karen Blindauer</name><name sortKey="Eberly, Shirley" sort="Eberly, Shirley" uniqKey="Eberly S" first="Shirley" last="Eberly">Shirley Eberly</name><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name><name sortKey="Plumb, Sandra" sort="Plumb, Sandra" uniqKey="Plumb S" first="Sandra" last="Plumb">Sandra Plumb</name><name sortKey="Schwid, Steven" sort="Schwid, Steven" uniqKey="Schwid S" first="Steven" last="Schwid">Steven Schwid</name><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name><name sortKey="Siderowf, Andrew" sort="Siderowf, Andrew" uniqKey="Siderowf A" first="Andrew" last="Siderowf">Andrew Siderowf</name><name sortKey="Stern, Matthew" sort="Stern, Matthew" uniqKey="Stern M" first="Matthew" last="Stern">Matthew Stern</name></country><country name="Israël"><noRegion><name sortKey="Goren, Tamar" sort="Goren, Tamar" uniqKey="Goren T" first="Tamar" last="Goren">Tamar Goren</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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