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 : 002373One-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 KohnenSource :
- Movement disorders [ 0885-3185 ] ; 2003.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
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.
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Pour connaître la documentation sur le format Inist Standard.
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Format Inist (serveur)
NO : | PASCAL 04-0095339 INIST |
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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 |
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Pascal:04-0095339Le document en format XML
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<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>
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<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>
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