Movement Disorders (revue)

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Ropinirole is effective on motor function when used as an adjunct to levodopa in parkinson's disease : STRONG study

Identifieur interne : 001802 ( PascalFrancis/Curation ); précédent : 001801; suivant : 001803

Ropinirole is effective on motor function when used as an adjunct to levodopa in parkinson's disease : STRONG study

Auteurs : Yoshikuni Mizuno [Japon] ; Takashi Abe [Japon] ; Kazuko Hasegawa [Japon] ; Sadako Kuno [Japon] ; Tomoyoshi Kondo [Japon] ; Mitsutoshi Yamamoto [Japon] ; Mitsuyoshi Nakashima [Japon] ; Ichiro Kanazawa [Japon]

Source :

RBID : Pascal:08-0015784

Descripteurs français

English descriptors

Abstract

We report the results of a randomized, double-blind, placebo-controlled, 16-week study to evaluate the efficacy and safety of ropinirole, 0.75 to 15.0 mg/day, as an adjunct to levodopa. A total of 243 patients were randomly assigned into placebo or ropinirole groups. The mean (standard deviation) dose of ropinirole at endpoint was 7.12 (2.88) mg/day. The primary endpoint-the mean reduction in the Unified Parkinson's Disease Rating Scale (UPDRS) total motor score-was significantly greater for the ropinirole group than the placebo group (-9.5 vs. -4.5, P = 0.00001). The mean reduction in the UPDRS total activities of daily living (ADL) score was also significantly greater for ropinirole than for placebo (-2.7 vs. - 1.0, P = 0.0002). The percentage of patients showing at least a 20% reduction in the percentage of time spent "off' was significantly greater for the ropinirole group than for the placebo group (58.7% vs. 38.6%, P = 0.030). A total of 84.3 and 65.6% of the patients experienced adverse events while receiving ropinirole or placebo, respectively. The results showed that ropinirole was more effective than placebo in improving motor function and ADL when used as an adjunct to levodopa in patients with advanced Parkinson's disease.
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A08 01  1  ENG  @1 Ropinirole is effective on motor function when used as an adjunct to levodopa in parkinson's disease : STRONG study
A11 01  1    @1 MIZUNO (Yoshikuni)
A11 02  1    @1 ABE (Takashi)
A11 03  1    @1 HASEGAWA (Kazuko)
A11 04  1    @1 KUNO (Sadako)
A11 05  1    @1 KONDO (Tomoyoshi)
A11 06  1    @1 YAMAMOTO (Mitsutoshi)
A11 07  1    @1 NAKASHIMA (Mitsuyoshi)
A11 08  1    @1 KANAZAWA (Ichiro)
A14 01      @1 Department of Neurology, Juntendo University School of Medicine @2 Tokyo @3 JPN @Z 1 aut.
A14 02      @1 Department of Neurology, Iwate Medical University @2 Morioka @3 JPN @Z 2 aut.
A14 03      @1 Department of Neurology, National Hospital Organization, Sagamihara National Hospital @2 Sagamihara @3 JPN @Z 3 aut.
A14 04      @1 Department of Clinical Research, National Hospital Organization, Utano National Hospital @2 Kyoto @3 JPN @Z 4 aut.
A14 05      @1 Department of Neurology, National Center of Neurology and Psychiatry @2 Tokyo @3 JPN @Z 4 aut. @Z 8 aut.
A14 06      @1 Department of Neurology, Wakayama Medical University @2 Wakayama @3 JPN @Z 5 aut.
A14 07      @1 Department of Neurology, Kagawa Prefectual Central Hospital @2 Takamatsu @3 JPN @Z 6 aut.
A14 08      @1 Department of Clinical Pharmacology, Hamamatsu Institute of Clinical Pharmacology and Therapeutics @2 Hamamatsu @3 JPN @Z 7 aut.
A17 01  1    @1 STRONG Study Group @3 JPN
A20       @1 1860-1865
A21       @1 2007
A23 01      @0 ENG
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A44       @0 0000 @1 © 2008 INIST-CNRS. All rights reserved.
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C01 01    ENG  @0 We report the results of a randomized, double-blind, placebo-controlled, 16-week study to evaluate the efficacy and safety of ropinirole, 0.75 to 15.0 mg/day, as an adjunct to levodopa. A total of 243 patients were randomly assigned into placebo or ropinirole groups. The mean (standard deviation) dose of ropinirole at endpoint was 7.12 (2.88) mg/day. The primary endpoint-the mean reduction in the Unified Parkinson's Disease Rating Scale (UPDRS) total motor score-was significantly greater for the ropinirole group than the placebo group (-9.5 vs. -4.5, P = 0.00001). The mean reduction in the UPDRS total activities of daily living (ADL) score was also significantly greater for ropinirole than for placebo (-2.7 vs. - 1.0, P = 0.0002). The percentage of patients showing at least a 20% reduction in the percentage of time spent "off' was significantly greater for the ropinirole group than for the placebo group (58.7% vs. 38.6%, P = 0.030). A total of 84.3 and 65.6% of the patients experienced adverse events while receiving ropinirole or placebo, respectively. The results showed that ropinirole was more effective than placebo in improving motor function and ADL when used as an adjunct to levodopa in patients with advanced Parkinson's disease.
C02 01  X    @0 002B17
C02 02  X    @0 002B17G
C02 03  X    @0 002B02U01
C03 01  X  FRE  @0 Pathologie du système nerveux @5 01
C03 01  X  ENG  @0 Nervous system diseases @5 01
C03 01  X  SPA  @0 Sistema nervioso patología @5 01
C03 02  X  FRE  @0 Maladie de Parkinson @2 NM @5 02
C03 02  X  ENG  @0 Parkinson disease @2 NM @5 02
C03 02  X  SPA  @0 Parkinson enfermedad @2 NM @5 02
C03 03  X  FRE  @0 Ropinirole @2 NK @2 FR @5 09
C03 03  X  ENG  @0 Ropinirole @2 NK @2 FR @5 09
C03 03  X  SPA  @0 Ropinirol @2 NK @2 FR @5 09
C03 04  X  FRE  @0 Lévodopa @2 NK @2 FR @5 10
C03 04  X  ENG  @0 Levodopa @2 NK @2 FR @5 10
C03 04  X  SPA  @0 Levodopa @2 NK @2 FR @5 10
C03 05  X  FRE  @0 Traitement @5 11
C03 05  X  ENG  @0 Treatment @5 11
C03 05  X  SPA  @0 Tratamiento @5 11
C07 01  X  FRE  @0 Pathologie de l'encéphale @5 37
C07 01  X  ENG  @0 Cerebral disorder @5 37
C07 01  X  SPA  @0 Encéfalo patología @5 37
C07 02  X  FRE  @0 Syndrome extrapyramidal @5 38
C07 02  X  ENG  @0 Extrapyramidal syndrome @5 38
C07 02  X  SPA  @0 Extrapiramidal síndrome @5 38
C07 03  X  FRE  @0 Maladie dégénérative @5 39
C07 03  X  ENG  @0 Degenerative disease @5 39
C07 03  X  SPA  @0 Enfermedad degenerativa @5 39
C07 04  X  FRE  @0 Pathologie du système nerveux central @5 40
C07 04  X  ENG  @0 Central nervous system disease @5 40
C07 04  X  SPA  @0 Sistema nervosio central patología @5 40
N21       @1 009
N44 01      @1 OTO
N82       @1 OTO

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Pascal:08-0015784

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<div type="abstract" xml:lang="en">We report the results of a randomized, double-blind, placebo-controlled, 16-week study to evaluate the efficacy and safety of ropinirole, 0.75 to 15.0 mg/day, as an adjunct to levodopa. A total of 243 patients were randomly assigned into placebo or ropinirole groups. The mean (standard deviation) dose of ropinirole at endpoint was 7.12 (2.88) mg/day. The primary endpoint-the mean reduction in the Unified Parkinson's Disease Rating Scale (UPDRS) total motor score-was significantly greater for the ropinirole group than the placebo group (-9.5 vs. -4.5, P = 0.00001). The mean reduction in the UPDRS total activities of daily living (ADL) score was also significantly greater for ropinirole than for placebo (-2.7 vs. - 1.0, P = 0.0002). The percentage of patients showing at least a 20% reduction in the percentage of time spent "off' was significantly greater for the ropinirole group than for the placebo group (58.7% vs. 38.6%, P = 0.030). A total of 84.3 and 65.6% of the patients experienced adverse events while receiving ropinirole or placebo, respectively. The results showed that ropinirole was more effective than placebo in improving motor function and ADL when used as an adjunct to levodopa in patients with advanced Parkinson's disease.</div>
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<s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>We report the results of a randomized, double-blind, placebo-controlled, 16-week study to evaluate the efficacy and safety of ropinirole, 0.75 to 15.0 mg/day, as an adjunct to levodopa. A total of 243 patients were randomly assigned into placebo or ropinirole groups. The mean (standard deviation) dose of ropinirole at endpoint was 7.12 (2.88) mg/day. The primary endpoint-the mean reduction in the Unified Parkinson's Disease Rating Scale (UPDRS) total motor score-was significantly greater for the ropinirole group than the placebo group (-9.5 vs. -4.5, P = 0.00001). The mean reduction in the UPDRS total activities of daily living (ADL) score was also significantly greater for ropinirole than for placebo (-2.7 vs. - 1.0, P = 0.0002). The percentage of patients showing at least a 20% reduction in the percentage of time spent "off' was significantly greater for the ropinirole group than for the placebo group (58.7% vs. 38.6%, P = 0.030). A total of 84.3 and 65.6% of the patients experienced adverse events while receiving ropinirole or placebo, respectively. The results showed that ropinirole was more effective than placebo in improving motor function and ADL when used as an adjunct to levodopa in patients with advanced Parkinson's disease.</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>002B02U01</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Pathologie du système nerveux</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>Maladie de Parkinson</s0>
<s2>NM</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Parkinson disease</s0>
<s2>NM</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Parkinson enfermedad</s0>
<s2>NM</s2>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Ropinirole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Ropinirole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Ropinirol</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Lévodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Traitement</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Treatment</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Tratamiento</s0>
<s5>11</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Pathologie de l'encéphale</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>Syndrome extrapyramidal</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>Pathologie du système nerveux central</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>009</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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