Movement Disorders (revue)

Attention, ce site est en cours de développement !
Attention, site généré par des moyens informatiques à partir de corpus bruts.
Les informations ne sont donc pas validées.

One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?

Identifieur interne : 002372 ( PascalFrancis/Corpus ); précédent : 002371; suivant : 002373

One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?

Auteurs : Claudia Trenkwalder ; Victor Collado Seidel ; Jörg Kazenwadel ; Thomas C. Wetter ; Wolfgang Oertel ; Roland Selzer ; Ralf Kohnen

Source :

RBID : Pascal:04-0095339

Descripteurs français

English descriptors

Abstract

To investigate the long-term efficacy and safety of sustained-release (SR) in combination with regular-release (RR) levodopa/benserazide in the treatment of restless legs syndrome (RLS), an open-label, prospective, extension study of a preceding double-blind crossover trial was performed for 12 months. Twenty-three severely disturbed RLS patients (7 men, 16 women) received a combination of RR and SR levodopa. Patients were treated on average for 10 months with a mean daily dose of 203 ± 101 mg of RR and of 185 ± 93 mg of SR levodopa. The mean daily total dose was 388 ± 162 mg levodopa. Efficacy was documented using patient's rating scales, sleep diaries, and investigator's global ratings with the Clinical Global Impressions (CGI). Ten of 23 patients completed the 1-year extension. Between baseline of the crossover trial and endpoint of the extension study (last-observation-carried-forward method, intention-to-treat population), quality of sleep improved (+3.5 ± 1.9, 7-point scale), sleep latency was shortened (-131 ± 152 minutes), and total sleep time lengthened (+ 190 ± 136 minutes). Severity of RLS at time of falling asleep (-6.5 ± 3.4, 11-point scale) and during the night (-6.0 ± 3.5) was markedly lower at the end of the extension but severity of RLS during the day (+1.9 ± 5.0) slightly increased. Of 13 dropouts, 8 patients discontinued therapy because of worsening RLS during the day. This trial shows that long-term treatment with the combination of RR and SR levodopa/benserazide in RLS patients with late-night problems was efficacious and not limited by tolerability problems in 40% of patients, whereas in the majority of patients, aggravating daytime problems required termination of the levodopa therapy within the 1-year treatment period.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

pA  
A01 01  1    @0 0885-3185
A03   1    @0 Mov. disord.
A05       @2 18
A06       @2 10
A08 01  1  ENG  @1 One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?
A11 01  1    @1 TRENKWALDER (Claudia)
A11 02  1    @1 SEIDEL (Victor Collado)
A11 03  1    @1 KAZENWADEL (Jörg)
A11 04  1    @1 WETTER (Thomas C.)
A11 05  1    @1 OERTEL (Wolfgang)
A11 06  1    @1 SELZER (Roland)
A11 07  1    @1 KOHNEN (Ralf)
A14 01      @1 Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology @2 Goettingen @3 DEU @Z 1 aut. @Z 2 aut. @Z 4 aut.
A14 02      @1 Hoffmann-La Roche AG @2 Basel @3 CHE @Z 3 aut.
A14 03      @1 Department of Neurology, Philipps University of Marburg @2 Marburg @3 DEU @Z 5 aut.
A14 04      @1 Hoffmann-La Roche AG @2 Grenzach @3 DEU @Z 6 aut.
A14 05      @1 IMEREM Institute for Medical Research Management and Biometrics GmbH @2 Nuernberg @3 DEU @Z 7 aut.
A20       @1 1184-1189
A21       @1 2003
A23 01      @0 ENG
A43 01      @1 INIST @2 20953 @5 354000113383090140
A44       @0 0000 @1 © 2004 INIST-CNRS. All rights reserved.
A45       @0 19 ref.
A47 01  1    @0 04-0095339
A60       @1 P @3 CC
A61       @0 A
A64 01  1    @0 Movement disorders
A66 01      @0 USA
C01 01    ENG  @0 To investigate the long-term efficacy and safety of sustained-release (SR) in combination with regular-release (RR) levodopa/benserazide in the treatment of restless legs syndrome (RLS), an open-label, prospective, extension study of a preceding double-blind crossover trial was performed for 12 months. Twenty-three severely disturbed RLS patients (7 men, 16 women) received a combination of RR and SR levodopa. Patients were treated on average for 10 months with a mean daily dose of 203 ± 101 mg of RR and of 185 ± 93 mg of SR levodopa. The mean daily total dose was 388 ± 162 mg levodopa. Efficacy was documented using patient's rating scales, sleep diaries, and investigator's global ratings with the Clinical Global Impressions (CGI). Ten of 23 patients completed the 1-year extension. Between baseline of the crossover trial and endpoint of the extension study (last-observation-carried-forward method, intention-to-treat population), quality of sleep improved (+3.5 ± 1.9, 7-point scale), sleep latency was shortened (-131 ± 152 minutes), and total sleep time lengthened (+ 190 ± 136 minutes). Severity of RLS at time of falling asleep (-6.5 ± 3.4, 11-point scale) and during the night (-6.0 ± 3.5) was markedly lower at the end of the extension but severity of RLS during the day (+1.9 ± 5.0) slightly increased. Of 13 dropouts, 8 patients discontinued therapy because of worsening RLS during the day. This trial shows that long-term treatment with the combination of RR and SR levodopa/benserazide in RLS patients with late-night problems was efficacious and not limited by tolerability problems in 40% of patients, whereas in the majority of patients, aggravating daytime problems required termination of the levodopa therapy within the 1-year treatment period.
C02 01  X    @0 002B02B06
C03 01  X  FRE  @0 Impatience membre inférieur syndrome @5 01
C03 01  X  ENG  @0 Restless legs syndrome @5 01
C03 01  X  SPA  @0 Acroparestesia nocturna @5 01
C03 02  X  FRE  @0 Lévodopa @2 NK @2 FR @5 04
C03 02  X  ENG  @0 Levodopa @2 NK @2 FR @5 04
C03 02  X  SPA  @0 Levodopa @2 NK @2 FR @5 04
C03 03  X  FRE  @0 Chimiothérapie @5 05
C03 03  X  ENG  @0 Chemotherapy @5 05
C03 03  X  SPA  @0 Quimioterapia @5 05
C03 04  X  FRE  @0 Association médicamenteuse @5 06
C03 04  X  ENG  @0 Drug combination @5 06
C03 04  X  SPA  @0 Asociación medicamentosa @5 06
C03 05  X  FRE  @0 Bensérazide @2 NK @2 FR @5 07
C03 05  X  ENG  @0 Benserazide @2 NK @2 FR @5 07
C03 05  X  SPA  @0 Benserazida @2 NK @2 FR @5 07
C03 06  X  FRE  @0 Forme libération contrôlée @5 10
C03 06  X  ENG  @0 Controlled release form @5 10
C03 06  X  SPA  @0 Forma liberación controlada @5 10
C03 07  X  FRE  @0 Long terme @5 11
C03 07  X  ENG  @0 Long term @5 11
C03 07  X  SPA  @0 Largo plazo @5 11
C03 08  X  FRE  @0 Etude double insu @5 13
C03 08  X  ENG  @0 Double blind study @5 13
C03 08  X  SPA  @0 Estudio doble ciego @5 13
C03 09  X  FRE  @0 Essai croisé @5 14
C03 09  X  ENG  @0 Crossover study @5 14
C03 09  X  SPA  @0 Ensayo cruzado @5 14
C03 10  X  FRE  @0 Toxicité @5 16
C03 10  X  ENG  @0 Toxicity @5 16
C03 10  X  SPA  @0 Toxicidad @5 16
C03 11  X  FRE  @0 Traitement @5 17
C03 11  X  ENG  @0 Treatment @5 17
C03 11  X  SPA  @0 Tratamiento @5 17
C03 12  X  FRE  @0 Protocole thérapeutique @5 18
C03 12  X  ENG  @0 Therapeutic protocol @5 18
C03 12  X  SPA  @0 Protocolo terapéutico @5 18
C03 13  X  FRE  @0 Pronostic @5 19
C03 13  X  ENG  @0 Prognosis @5 19
C03 13  X  SPA  @0 Pronóstico @5 19
C03 14  X  FRE  @0 Homme @5 20
C03 14  X  ENG  @0 Human @5 20
C03 14  X  SPA  @0 Hombre @5 20
C07 01  X  FRE  @0 Système nerveux pathologie @5 37
C07 01  X  ENG  @0 Nervous system diseases @5 37
C07 01  X  SPA  @0 Sistema nervioso patología @5 37
C07 02  X  FRE  @0 Trouble neurologique @5 38
C07 02  X  ENG  @0 Neurological disorder @5 38
C07 02  X  SPA  @0 Trastorno neurológico @5 38
C07 03  X  FRE  @0 Trouble sensibilité @5 39
C07 03  X  ENG  @0 Sensitivity disorder @5 39
C07 03  X  SPA  @0 Trastorno sensibilidad @5 39
C07 04  X  FRE  @0 Antiparkinsonien @5 45
C07 04  X  ENG  @0 Antiparkinson agent @5 45
C07 04  X  SPA  @0 Antiparkinsoniano @5 45
C07 05  X  FRE  @0 Decarboxylase @2 FE @5 53
C07 05  X  ENG  @0 Decarboxylase @2 FE @5 53
C07 05  X  SPA  @0 Decarboxylase @2 FE @5 53
C07 06  X  FRE  @0 Carboxy-lyases @2 FE
C07 06  X  ENG  @0 Carboxy-lyases @2 FE
C07 06  X  SPA  @0 Carboxy-lyases @2 FE
C07 07  X  FRE  @0 Carbon-carbon lyases @2 FE
C07 07  X  ENG  @0 Carbon-carbon lyases @2 FE
C07 07  X  SPA  @0 Carbon-carbon lyases @2 FE
C07 08  X  FRE  @0 Lyases @2 FE
C07 08  X  ENG  @0 Lyases @2 FE
C07 08  X  SPA  @0 Lyases @2 FE
C07 09  X  FRE  @0 Enzyme @2 FE
C07 09  X  ENG  @0 Enzyme @2 FE
C07 09  X  SPA  @0 Enzima @2 FE
C07 10  X  FRE  @0 Inhibiteur enzyme @5 54
C07 10  X  ENG  @0 Enzyme inhibitor @5 54
C07 10  X  SPA  @0 Inhibidor enzima @5 54
C07 11  X  FRE  @0 Forme pharmaceutique @5 61
C07 11  X  ENG  @0 Dosage form @5 61
C07 11  X  SPA  @0 Forma farmacéutica @5 61
N21       @1 061
N82       @1 PSI

Format Inist (serveur)

NO : PASCAL 04-0095339 INIST
ET : One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?
AU : TRENKWALDER (Claudia); SEIDEL (Victor Collado); KAZENWADEL (Jörg); WETTER (Thomas C.); OERTEL (Wolfgang); SELZER (Roland); KOHNEN (Ralf)
AF : Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology/Goettingen/Allemagne (1 aut., 2 aut., 4 aut.); Hoffmann-La Roche AG/Basel/Suisse (3 aut.); Department of Neurology, Philipps University of Marburg/Marburg/Allemagne (5 aut.); Hoffmann-La Roche AG/Grenzach/Allemagne (6 aut.); IMEREM Institute for Medical Research Management and Biometrics GmbH/Nuernberg/Allemagne (7 aut.)
DT : Publication en série; Courte communication, note brève; Niveau analytique
SO : Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2003; Vol. 18; No. 10; Pp. 1184-1189; Bibl. 19 ref.
LA : Anglais
EA : To investigate the long-term efficacy and safety of sustained-release (SR) in combination with regular-release (RR) levodopa/benserazide in the treatment of restless legs syndrome (RLS), an open-label, prospective, extension study of a preceding double-blind crossover trial was performed for 12 months. Twenty-three severely disturbed RLS patients (7 men, 16 women) received a combination of RR and SR levodopa. Patients were treated on average for 10 months with a mean daily dose of 203 ± 101 mg of RR and of 185 ± 93 mg of SR levodopa. The mean daily total dose was 388 ± 162 mg levodopa. Efficacy was documented using patient's rating scales, sleep diaries, and investigator's global ratings with the Clinical Global Impressions (CGI). Ten of 23 patients completed the 1-year extension. Between baseline of the crossover trial and endpoint of the extension study (last-observation-carried-forward method, intention-to-treat population), quality of sleep improved (+3.5 ± 1.9, 7-point scale), sleep latency was shortened (-131 ± 152 minutes), and total sleep time lengthened (+ 190 ± 136 minutes). Severity of RLS at time of falling asleep (-6.5 ± 3.4, 11-point scale) and during the night (-6.0 ± 3.5) was markedly lower at the end of the extension but severity of RLS during the day (+1.9 ± 5.0) slightly increased. Of 13 dropouts, 8 patients discontinued therapy because of worsening RLS during the day. This trial shows that long-term treatment with the combination of RR and SR levodopa/benserazide in RLS patients with late-night problems was efficacious and not limited by tolerability problems in 40% of patients, whereas in the majority of patients, aggravating daytime problems required termination of the levodopa therapy within the 1-year treatment period.
CC : 002B02B06
FD : Impatience membre inférieur syndrome; Lévodopa; Chimiothérapie; Association médicamenteuse; Bensérazide; Forme libération contrôlée; Long terme; Etude double insu; Essai croisé; Toxicité; Traitement; Protocole thérapeutique; Pronostic; Homme
FG : Système nerveux pathologie; Trouble neurologique; Trouble sensibilité; Antiparkinsonien; Decarboxylase; Carboxy-lyases; Carbon-carbon lyases; Lyases; Enzyme; Inhibiteur enzyme; Forme pharmaceutique
ED : Restless legs syndrome; Levodopa; Chemotherapy; Drug combination; Benserazide; Controlled release form; Long term; Double blind study; Crossover study; Toxicity; Treatment; Therapeutic protocol; Prognosis; Human
EG : Nervous system diseases; Neurological disorder; Sensitivity disorder; Antiparkinson agent; Decarboxylase; Carboxy-lyases; Carbon-carbon lyases; Lyases; Enzyme; Enzyme inhibitor; Dosage form
SD : Acroparestesia nocturna; Levodopa; Quimioterapia; Asociación medicamentosa; Benserazida; Forma liberación controlada; Largo plazo; Estudio doble ciego; Ensayo cruzado; Toxicidad; Tratamiento; Protocolo terapéutico; Pronóstico; Hombre
LO : INIST-20953.354000113383090140
ID : 04-0095339

Links to Exploration step

Pascal:04-0095339

Le document en format XML

<record>
<TEI>
<teiHeader>
<fileDesc>
<titleStmt>
<title xml:lang="en" level="a">One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?</title>
<author>
<name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology</s1>
<s2>Goettingen</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Seidel, Victor Collado" sort="Seidel, Victor Collado" uniqKey="Seidel V" first="Victor Collado" last="Seidel">Victor Collado Seidel</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology</s1>
<s2>Goettingen</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Kazenwadel, Jorg" sort="Kazenwadel, Jorg" uniqKey="Kazenwadel J" first="Jörg" last="Kazenwadel">Jörg Kazenwadel</name>
<affiliation>
<inist:fA14 i1="02">
<s1>Hoffmann-La Roche AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Wetter, Thomas C" sort="Wetter, Thomas C" uniqKey="Wetter T" first="Thomas C." last="Wetter">Thomas C. Wetter</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology</s1>
<s2>Goettingen</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Oertel, Wolfgang" sort="Oertel, Wolfgang" uniqKey="Oertel W" first="Wolfgang" last="Oertel">Wolfgang Oertel</name>
<affiliation>
<inist:fA14 i1="03">
<s1>Department of Neurology, Philipps University of Marburg</s1>
<s2>Marburg</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Selzer, Roland" sort="Selzer, Roland" uniqKey="Selzer R" first="Roland" last="Selzer">Roland Selzer</name>
<affiliation>
<inist:fA14 i1="04">
<s1>Hoffmann-La Roche AG</s1>
<s2>Grenzach</s2>
<s3>DEU</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Kohnen, Ralf" sort="Kohnen, Ralf" uniqKey="Kohnen R" first="Ralf" last="Kohnen">Ralf Kohnen</name>
<affiliation>
<inist:fA14 i1="05">
<s1>IMEREM Institute for Medical Research Management and Biometrics GmbH</s1>
<s2>Nuernberg</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</titleStmt>
<publicationStmt>
<idno type="wicri:source">INIST</idno>
<idno type="inist">04-0095339</idno>
<date when="2003">2003</date>
<idno type="stanalyst">PASCAL 04-0095339 INIST</idno>
<idno type="RBID">Pascal:04-0095339</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">002372</idno>
</publicationStmt>
<sourceDesc>
<biblStruct>
<analytic>
<title xml:lang="en" level="a">One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?</title>
<author>
<name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology</s1>
<s2>Goettingen</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Seidel, Victor Collado" sort="Seidel, Victor Collado" uniqKey="Seidel V" first="Victor Collado" last="Seidel">Victor Collado Seidel</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology</s1>
<s2>Goettingen</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Kazenwadel, Jorg" sort="Kazenwadel, Jorg" uniqKey="Kazenwadel J" first="Jörg" last="Kazenwadel">Jörg Kazenwadel</name>
<affiliation>
<inist:fA14 i1="02">
<s1>Hoffmann-La Roche AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Wetter, Thomas C" sort="Wetter, Thomas C" uniqKey="Wetter T" first="Thomas C." last="Wetter">Thomas C. Wetter</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology</s1>
<s2>Goettingen</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Oertel, Wolfgang" sort="Oertel, Wolfgang" uniqKey="Oertel W" first="Wolfgang" last="Oertel">Wolfgang Oertel</name>
<affiliation>
<inist:fA14 i1="03">
<s1>Department of Neurology, Philipps University of Marburg</s1>
<s2>Marburg</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Selzer, Roland" sort="Selzer, Roland" uniqKey="Selzer R" first="Roland" last="Selzer">Roland Selzer</name>
<affiliation>
<inist:fA14 i1="04">
<s1>Hoffmann-La Roche AG</s1>
<s2>Grenzach</s2>
<s3>DEU</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Kohnen, Ralf" sort="Kohnen, Ralf" uniqKey="Kohnen R" first="Ralf" last="Kohnen">Ralf Kohnen</name>
<affiliation>
<inist:fA14 i1="05">
<s1>IMEREM Institute for Medical Research Management and Biometrics GmbH</s1>
<s2>Nuernberg</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</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="2003">2003</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>Benserazide</term>
<term>Chemotherapy</term>
<term>Controlled release form</term>
<term>Crossover study</term>
<term>Double blind study</term>
<term>Drug combination</term>
<term>Human</term>
<term>Levodopa</term>
<term>Long term</term>
<term>Prognosis</term>
<term>Restless legs syndrome</term>
<term>Therapeutic protocol</term>
<term>Toxicity</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Impatience membre inférieur syndrome</term>
<term>Lévodopa</term>
<term>Chimiothérapie</term>
<term>Association médicamenteuse</term>
<term>Bensérazide</term>
<term>Forme libération contrôlée</term>
<term>Long terme</term>
<term>Etude double insu</term>
<term>Essai croisé</term>
<term>Toxicité</term>
<term>Traitement</term>
<term>Protocole thérapeutique</term>
<term>Pronostic</term>
<term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">To investigate the long-term efficacy and safety of sustained-release (SR) in combination with regular-release (RR) levodopa/benserazide in the treatment of restless legs syndrome (RLS), an open-label, prospective, extension study of a preceding double-blind crossover trial was performed for 12 months. Twenty-three severely disturbed RLS patients (7 men, 16 women) received a combination of RR and SR levodopa. Patients were treated on average for 10 months with a mean daily dose of 203 ± 101 mg of RR and of 185 ± 93 mg of SR levodopa. The mean daily total dose was 388 ± 162 mg levodopa. Efficacy was documented using patient's rating scales, sleep diaries, and investigator's global ratings with the Clinical Global Impressions (CGI). Ten of 23 patients completed the 1-year extension. Between baseline of the crossover trial and endpoint of the extension study (last-observation-carried-forward method, intention-to-treat population), quality of sleep improved (+3.5 ± 1.9, 7-point scale), sleep latency was shortened (-131 ± 152 minutes), and total sleep time lengthened (+ 190 ± 136 minutes). Severity of RLS at time of falling asleep (-6.5 ± 3.4, 11-point scale) and during the night (-6.0 ± 3.5) was markedly lower at the end of the extension but severity of RLS during the day (+1.9 ± 5.0) slightly increased. Of 13 dropouts, 8 patients discontinued therapy because of worsening RLS during the day. This trial shows that long-term treatment with the combination of RR and SR levodopa/benserazide in RLS patients with late-night problems was efficacious and not limited by tolerability problems in 40% of patients, whereas in the majority of patients, aggravating daytime problems required termination of the levodopa therapy within the 1-year treatment period.</div>
</front>
</TEI>
<inist>
<standard h6="B">
<pA>
<fA01 i1="01" i2="1">
<s0>0885-3185</s0>
</fA01>
<fA03 i2="1">
<s0>Mov. disord.</s0>
</fA03>
<fA05>
<s2>18</s2>
</fA05>
<fA06>
<s2>10</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG">
<s1>One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?</s1>
</fA08>
<fA11 i1="01" i2="1">
<s1>TRENKWALDER (Claudia)</s1>
</fA11>
<fA11 i1="02" i2="1">
<s1>SEIDEL (Victor Collado)</s1>
</fA11>
<fA11 i1="03" i2="1">
<s1>KAZENWADEL (Jörg)</s1>
</fA11>
<fA11 i1="04" i2="1">
<s1>WETTER (Thomas C.)</s1>
</fA11>
<fA11 i1="05" i2="1">
<s1>OERTEL (Wolfgang)</s1>
</fA11>
<fA11 i1="06" i2="1">
<s1>SELZER (Roland)</s1>
</fA11>
<fA11 i1="07" i2="1">
<s1>KOHNEN (Ralf)</s1>
</fA11>
<fA14 i1="01">
<s1>Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology</s1>
<s2>Goettingen</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="02">
<s1>Hoffmann-La Roche AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="03">
<s1>Department of Neurology, Philipps University of Marburg</s1>
<s2>Marburg</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="04">
<s1>Hoffmann-La Roche AG</s1>
<s2>Grenzach</s2>
<s3>DEU</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="05">
<s1>IMEREM Institute for Medical Research Management and Biometrics GmbH</s1>
<s2>Nuernberg</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA20>
<s1>1184-1189</s1>
</fA20>
<fA21>
<s1>2003</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>20953</s2>
<s5>354000113383090140</s5>
</fA43>
<fA44>
<s0>0000</s0>
<s1>© 2004 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>19 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>04-0095339</s0>
</fA47>
<fA60>
<s1>P</s1>
<s3>CC</s3>
</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>To investigate the long-term efficacy and safety of sustained-release (SR) in combination with regular-release (RR) levodopa/benserazide in the treatment of restless legs syndrome (RLS), an open-label, prospective, extension study of a preceding double-blind crossover trial was performed for 12 months. Twenty-three severely disturbed RLS patients (7 men, 16 women) received a combination of RR and SR levodopa. Patients were treated on average for 10 months with a mean daily dose of 203 ± 101 mg of RR and of 185 ± 93 mg of SR levodopa. The mean daily total dose was 388 ± 162 mg levodopa. Efficacy was documented using patient's rating scales, sleep diaries, and investigator's global ratings with the Clinical Global Impressions (CGI). Ten of 23 patients completed the 1-year extension. Between baseline of the crossover trial and endpoint of the extension study (last-observation-carried-forward method, intention-to-treat population), quality of sleep improved (+3.5 ± 1.9, 7-point scale), sleep latency was shortened (-131 ± 152 minutes), and total sleep time lengthened (+ 190 ± 136 minutes). Severity of RLS at time of falling asleep (-6.5 ± 3.4, 11-point scale) and during the night (-6.0 ± 3.5) was markedly lower at the end of the extension but severity of RLS during the day (+1.9 ± 5.0) slightly increased. Of 13 dropouts, 8 patients discontinued therapy because of worsening RLS during the day. This trial shows that long-term treatment with the combination of RR and SR levodopa/benserazide in RLS patients with late-night problems was efficacious and not limited by tolerability problems in 40% of patients, whereas in the majority of patients, aggravating daytime problems required termination of the levodopa therapy within the 1-year treatment period.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B02B06</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Impatience membre inférieur syndrome</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Restless legs syndrome</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Acroparestesia nocturna</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Lévodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Chimiothérapie</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Chemotherapy</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Quimioterapia</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Association médicamenteuse</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Drug combination</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Asociación medicamentosa</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Bensérazide</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Benserazide</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Benserazida</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Forme libération contrôlée</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Controlled release form</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Forma liberación controlada</s0>
<s5>10</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Long terme</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Long term</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Largo plazo</s0>
<s5>11</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Etude double insu</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Double blind study</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Estudio doble ciego</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Essai croisé</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Crossover study</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Ensayo cruzado</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Toxicité</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Toxicity</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Toxicidad</s0>
<s5>16</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Traitement</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Treatment</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Tratamiento</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Protocole thérapeutique</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Therapeutic protocol</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Protocolo terapéutico</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>Pronostic</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>Prognosis</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA">
<s0>Pronóstico</s0>
<s5>19</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE">
<s0>Homme</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG">
<s0>Human</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>20</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Système nerveux pathologie</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Nervous system diseases</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Sistema nervioso patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Trouble neurologique</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Neurological disorder</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Trastorno neurológico</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Trouble sensibilité</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Sensitivity disorder</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Trastorno sensibilidad</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Antiparkinsonien</s0>
<s5>45</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Antiparkinson agent</s0>
<s5>45</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Antiparkinsoniano</s0>
<s5>45</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Decarboxylase</s0>
<s2>FE</s2>
<s5>53</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Decarboxylase</s0>
<s2>FE</s2>
<s5>53</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Decarboxylase</s0>
<s2>FE</s2>
<s5>53</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Carboxy-lyases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Carboxy-lyases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Carboxy-lyases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="07" i2="X" l="FRE">
<s0>Carbon-carbon lyases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="07" i2="X" l="ENG">
<s0>Carbon-carbon lyases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="07" i2="X" l="SPA">
<s0>Carbon-carbon lyases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="08" i2="X" l="FRE">
<s0>Lyases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="08" i2="X" l="ENG">
<s0>Lyases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="08" i2="X" l="SPA">
<s0>Lyases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="09" i2="X" l="FRE">
<s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="09" i2="X" l="ENG">
<s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="09" i2="X" l="SPA">
<s0>Enzima</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="10" i2="X" l="FRE">
<s0>Inhibiteur enzyme</s0>
<s5>54</s5>
</fC07>
<fC07 i1="10" i2="X" l="ENG">
<s0>Enzyme inhibitor</s0>
<s5>54</s5>
</fC07>
<fC07 i1="10" i2="X" l="SPA">
<s0>Inhibidor enzima</s0>
<s5>54</s5>
</fC07>
<fC07 i1="11" i2="X" l="FRE">
<s0>Forme pharmaceutique</s0>
<s5>61</s5>
</fC07>
<fC07 i1="11" i2="X" l="ENG">
<s0>Dosage form</s0>
<s5>61</s5>
</fC07>
<fC07 i1="11" i2="X" l="SPA">
<s0>Forma farmacéutica</s0>
<s5>61</s5>
</fC07>
<fN21>
<s1>061</s1>
</fN21>
<fN82>
<s1>PSI</s1>
</fN82>
</pA>
</standard>
<server>
<NO>PASCAL 04-0095339 INIST</NO>
<ET>One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?</ET>
<AU>TRENKWALDER (Claudia); SEIDEL (Victor Collado); KAZENWADEL (Jörg); WETTER (Thomas C.); OERTEL (Wolfgang); SELZER (Roland); KOHNEN (Ralf)</AU>
<AF>Max Planck Institute of Psychiatry, Munich and Department of Clinical Neurophysiology/Goettingen/Allemagne (1 aut., 2 aut., 4 aut.); Hoffmann-La Roche AG/Basel/Suisse (3 aut.); Department of Neurology, Philipps University of Marburg/Marburg/Allemagne (5 aut.); Hoffmann-La Roche AG/Grenzach/Allemagne (6 aut.); IMEREM Institute for Medical Research Management and Biometrics GmbH/Nuernberg/Allemagne (7 aut.)</AF>
<DT>Publication en série; Courte communication, note brève; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2003; Vol. 18; No. 10; Pp. 1184-1189; Bibl. 19 ref.</SO>
<LA>Anglais</LA>
<EA>To investigate the long-term efficacy and safety of sustained-release (SR) in combination with regular-release (RR) levodopa/benserazide in the treatment of restless legs syndrome (RLS), an open-label, prospective, extension study of a preceding double-blind crossover trial was performed for 12 months. Twenty-three severely disturbed RLS patients (7 men, 16 women) received a combination of RR and SR levodopa. Patients were treated on average for 10 months with a mean daily dose of 203 ± 101 mg of RR and of 185 ± 93 mg of SR levodopa. The mean daily total dose was 388 ± 162 mg levodopa. Efficacy was documented using patient's rating scales, sleep diaries, and investigator's global ratings with the Clinical Global Impressions (CGI). Ten of 23 patients completed the 1-year extension. Between baseline of the crossover trial and endpoint of the extension study (last-observation-carried-forward method, intention-to-treat population), quality of sleep improved (+3.5 ± 1.9, 7-point scale), sleep latency was shortened (-131 ± 152 minutes), and total sleep time lengthened (+ 190 ± 136 minutes). Severity of RLS at time of falling asleep (-6.5 ± 3.4, 11-point scale) and during the night (-6.0 ± 3.5) was markedly lower at the end of the extension but severity of RLS during the day (+1.9 ± 5.0) slightly increased. Of 13 dropouts, 8 patients discontinued therapy because of worsening RLS during the day. This trial shows that long-term treatment with the combination of RR and SR levodopa/benserazide in RLS patients with late-night problems was efficacious and not limited by tolerability problems in 40% of patients, whereas in the majority of patients, aggravating daytime problems required termination of the levodopa therapy within the 1-year treatment period.</EA>
<CC>002B02B06</CC>
<FD>Impatience membre inférieur syndrome; Lévodopa; Chimiothérapie; Association médicamenteuse; Bensérazide; Forme libération contrôlée; Long terme; Etude double insu; Essai croisé; Toxicité; Traitement; Protocole thérapeutique; Pronostic; Homme</FD>
<FG>Système nerveux pathologie; Trouble neurologique; Trouble sensibilité; Antiparkinsonien; Decarboxylase; Carboxy-lyases; Carbon-carbon lyases; Lyases; Enzyme; Inhibiteur enzyme; Forme pharmaceutique</FG>
<ED>Restless legs syndrome; Levodopa; Chemotherapy; Drug combination; Benserazide; Controlled release form; Long term; Double blind study; Crossover study; Toxicity; Treatment; Therapeutic protocol; Prognosis; Human</ED>
<EG>Nervous system diseases; Neurological disorder; Sensitivity disorder; Antiparkinson agent; Decarboxylase; Carboxy-lyases; Carbon-carbon lyases; Lyases; Enzyme; Enzyme inhibitor; Dosage form</EG>
<SD>Acroparestesia nocturna; Levodopa; Quimioterapia; Asociación medicamentosa; Benserazida; Forma liberación controlada; Largo plazo; Estudio doble ciego; Ensayo cruzado; Toxicidad; Tratamiento; Protocolo terapéutico; Pronóstico; Hombre</SD>
<LO>INIST-20953.354000113383090140</LO>
<ID>04-0095339</ID>
</server>
</inist>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/PascalFrancis/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002372 | SxmlIndent | more

Ou

HfdSelect -h $EXPLOR_AREA/Data/PascalFrancis/Corpus/biblio.hfd -nk 002372 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Santé
   |area=    MovDisordV3
   |flux=    PascalFrancis
   |étape=   Corpus
   |type=    RBID
   |clé=     Pascal:04-0095339
   |texte=   One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?
}}

Wicri

This area was generated with Dilib version V0.6.23.
Data generation: Sun Jul 3 12:29:32 2016. Site generation: Wed Feb 14 10:52:30 2024