Rasagiline improves quality of life in patients with early Parkinson's disease
Identifieur interne : 003223 ( Main/Curation ); précédent : 003222; suivant : 003224Rasagiline 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 ] ; 2006-05.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Aged, Analysis of Variance, Chi-Square Distribution, Dose-Response Relationship, Drug, Double-Blind Method, Female, Human, Humans, Indans (therapeutic use), Male, Middle Aged, Nervous system diseases, Neuroprotective Agents (therapeutic use), Neuropsychological Tests, Parkinson Disease (drug therapy), Parkinson Disease (psychology), Parkinson disease, Parkinson's disease, Quality of Life, Quality of life, Questionnaires, Rasagiline, Severity of Illness Index, Time Factors, Treatment Outcome, quality of life, rasagiline.
- MESH :
- chemical , therapeutic use : Indans, Neuroprotective Agents.
- drug therapy : Parkinson Disease.
- psychology : Parkinson Disease.
- Aged, Analysis of Variance, Chi-Square Distribution, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Neuropsychological Tests, Quality of Life, Questionnaires, Severity of Illness Index, Time Factors, Treatment Outcome.
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 1 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 1 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. © 2006 Movement Disorder Society
Url:
DOI: 10.1002/mds.20764
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<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 1 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 1 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. © 2006 Movement Disorder Society</div>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Rasagiline improves quality of life in patients with early Parkinson's disease</title>
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<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>
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</placeName>
</affiliation>
</author>
<author><name sortKey="Eberly, Shirley" sort="Eberly, Shirley" uniqKey="Eberly S" first="Shirley" last="Eberly">Shirley Eberly</name>
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<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>
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<country>États-Unis</country>
<placeName><region type="state">Wisconsin</region>
</placeName>
</affiliation>
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<author><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name>
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<author><name sortKey="Goren, Tamar" sort="Goren, Tamar" uniqKey="Goren T" first="Tamar" last="Goren">Tamar Goren</name>
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<s3>ISR</s3>
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<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>
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<author><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name>
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<placeName><region type="state">État de New York</region>
</placeName>
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<affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Department of Biostatistics, University of Rochester</s1>
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</placeName>
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<author><name sortKey="Plumb, Sandra" sort="Plumb, Sandra" uniqKey="Plumb S" first="Sandra" last="Plumb">Sandra Plumb</name>
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</placeName>
</affiliation>
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<author><name sortKey="Siderowf, Andrew" sort="Siderowf, Andrew" uniqKey="Siderowf A" first="Andrew" last="Siderowf">Andrew Siderowf</name>
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<country>États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
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<author><name sortKey="Stern, Matthew" sort="Stern, Matthew" uniqKey="Stern M" first="Matthew" last="Stern">Matthew Stern</name>
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<s2>Philadelphia, Pennsylvania</s2>
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<author><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name>
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</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>
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<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>
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<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>
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<author><name sortKey="Schwid, Steven" sort="Schwid, Steven" uniqKey="Schwid S" first="Steven" last="Schwid">Steven Schwid</name>
</author>
<author><name sortKey="Eberly, Shirley" sort="Eberly, Shirley" uniqKey="Eberly S" first="Shirley" last="Eberly">Shirley Eberly</name>
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<author><name sortKey="Blindauer, Karen" sort="Blindauer, Karen" uniqKey="Blindauer K" first="Karen" last="Blindauer">Karen Blindauer</name>
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<wicri:regionArea>Department of Neurology, Johns Hopkins University, Baltimore, Maryland</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
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<author><name sortKey="Schwid, Steven" sort="Schwid, Steven" uniqKey="Schwid S" first="Steven" last="Schwid">Steven Schwid</name>
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<wicri:regionArea>Department of Neurology, University of Rochester, Rochester, New York</wicri:regionArea>
<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>
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<wicri:regionArea>Department of Biostatistics, University of Rochester, New York</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
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<author><name sortKey="Blindauer, Karen" sort="Blindauer, Karen" uniqKey="Blindauer K" first="Karen" last="Blindauer">Karen Blindauer</name>
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<wicri:regionArea>Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisconsin</wicri:regionArea>
<placeName><region type="state">Wisconsin</region>
</placeName>
</affiliation>
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<author><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name>
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</placeName>
</affiliation>
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<author><name sortKey="Goren, Tamar" sort="Goren, Tamar" uniqKey="Goren T" first="Tamar" last="Goren">Tamar Goren</name>
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<wicri:noRegion>Netanya</wicri:noRegion>
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<author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name>
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<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
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<author><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name>
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<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Biostatistics, University of Rochester, New York</wicri:regionArea>
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</placeName>
</affiliation>
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<author><name sortKey="Plumb, Sandra" sort="Plumb, Sandra" uniqKey="Plumb S" first="Sandra" last="Plumb">Sandra Plumb</name>
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</placeName>
</affiliation>
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<author><name sortKey="Siderowf, Andrew" sort="Siderowf, Andrew" uniqKey="Siderowf A" first="Andrew" last="Siderowf">Andrew Siderowf</name>
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<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>
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<wicri:regionArea>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea>
<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"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, University of Rochester, Rochester, New York</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
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<monogr></monogr>
<series><title level="j">Movement Disorders</title>
<title level="j" type="sub">Official Journal of the Movement Disorder Society</title>
<title level="j" type="abbrev">Mov. Disord.</title>
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<biblScope unit="page" from="616">616</biblScope>
<biblScope unit="page" to="623">623</biblScope>
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<idno type="istex">FAC4E07EB855AFF17AC19C92C821D2EA53FF80D0</idno>
<idno type="DOI">10.1002/mds.20764</idno>
<idno type="ArticleID">MDS20764</idno>
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<seriesStmt><idno type="ISSN">0885-3185</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term>
<term>Analysis of Variance</term>
<term>Chi-Square Distribution</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Indans (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neuroprotective Agents (therapeutic use)</term>
<term>Neuropsychological Tests</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson Disease (psychology)</term>
<term>Parkinson's disease</term>
<term>Quality of Life</term>
<term>Questionnaires</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
<term>quality of life</term>
<term>rasagiline</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Indans</term>
<term>Neuroprotective Agents</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Analysis of Variance</term>
<term>Chi-Square Distribution</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neuropsychological Tests</term>
<term>Quality of Life</term>
<term>Questionnaires</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
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<langUsage><language ident="en">en</language>
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<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 1 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 1 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. © 2006 Movement Disorder Society</div>
</front>
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