Movement Disorders (revue)

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Rasagiline improves quality of life in patients with early Parkinson's disease

Identifieur interne : 001926 ( PascalFrancis/Checkpoint ); précédent : 001925; suivant : 001927

Rasagiline 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 :

RBID : Pascal:06-0289026

Descripteurs français

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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Pascal:06-0289026

Le document en format XML

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<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>
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<s1>PLUMB (Sandra)</s1>
</fA11>
<fA11 i1="10" i2="1">
<s1>SIDEROWF (Andrew)</s1>
</fA11>
<fA11 i1="11" i2="1">
<s1>STERN (Matthew)</s1>
</fA11>
<fA11 i1="12" i2="1">
<s1>SHOULSON (Ira)</s1>
</fA11>
<fA14 i1="01">
<s1>Department of Neurology, Johns Hopkins University</s1>
<s2>Baltimore, Maryland</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</fA14>
<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>
</fA14>
<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>
</fA14>
<fA14 i1="04">
<s1>Department of Neurology, Medical College of Wisconsin</s1>
<s2>Milwaukee, Wisconsin</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05">
<s1>Teva Pharmaceutical Industries, Ltd</s1>
<s2>Netanya</s2>
<s3>ISR</s3>
<sZ>6 aut.</sZ>
</fA14>
<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>
</fA14>
<fA17 i1="01" i2="1">
<s1>Parkinson Study Group</s1>
<s3>USA</s3>
</fA17>
<fA20>
<s1>616-623</s1>
</fA20>
<fA21>
<s1>2006</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>20953</s2>
<s5>354000142568210040</s5>
</fA43>
<fA44>
<s0>0000</s0>
<s1>© 2006 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>20 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>06-0289026</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>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.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002B17G</s0>
</fC02>
<fC02 i1="03" i2="X">
<s0>002B17F</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Système nerveux pathologie</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Nervous system diseases</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Sistema nervioso patología</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Parkinson maladie</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Parkinson disease</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Parkinson enfermedad</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Rasagiline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Rasagiline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Rasagilina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Qualité vie</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Quality of life</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Calidad vida</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Homme</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Human</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>11</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>184</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<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>

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