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La maladie de Parkinson au Canada (serveur d'exploration)

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Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD

Identifieur interne : 000C18 ( PascalFrancis/Corpus ); précédent : 000C17; suivant : 000C19

Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD

Auteurs : Oksana Suchowersky ; Peter Bailey ; E. Pourcher ; Lynne Bulger ; Giovanni Facciponte

Source :

RBID : Pascal:01-0392679

Descripteurs français

English descriptors

Abstract

The efficacy and safety of two dosages of tolcapone were compared in a 12-week crossover trial involving 118 nonfluctuating patients with PD on a stable dose of levodopa (L-Dopa). At trial onset, all patients received open-label tolcapone 100 mg three times daily for 4 weeks. At week 4, 116 eligible patients entered an 8-week double-blind treatment period and were randomized to receive tolcapone three times daily at either 100 mg (group 1; n = 58) or 200 mg (group 2; n = 58) until week 8, followed by the alternative tolcapone dosage until week 12. Ratings included Unified Parkinson's Disease Rating Scale (UPDRS), Schwab & England, and patient diaries, assessed at baseline and at 4, 8, and 12 weeks. At week 4, the investigator's global assessment (IGA) of efficacy showed improvement in 76% of patients. The mean total daily L-Dopa dose and mean UPDRS scores for subscales II and III decreased significantly (p < 0.001). During the double-blind treatment period, IGA showed improvements at either or both dosages in 61% of patients; further changes in other efficacy variables were minimal and were similar with both tolcapone dosages. The most frequent adverse events were dopaminergic (nausea and dyskinesia); the most frequent nondopaminergic adverse event was diarrhea. The incidence of adverse events during double-blind treatment was slightly higher with tolcapone 200 mg three times daily (33%) than with tolcapone 100 mg three times daily (24%). The authors conclude that tolcapone dosages of 100 mg three times daily and 200 mg three times daily are well tolerated and equally effective in improving function in L-Dopa-treated nonfluctuating patients with PD.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A08 01  1  ENG  @1 Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD
A11 01  1    @1 SUCHOWERSKY (Oksana)
A11 02  1    @1 BAILEY (Peter)
A11 03  1    @1 POURCHER (E.)
A11 04  1    @1 BULGER (Lynne)
A11 05  1    @1 FACCIPONTE (Giovanni)
A14 01      @1 Department of Clinical Neurosciences, Faculty of Medicine, University of Calgary @2 Calgary, Alberta @3 USA
A14 02      @1 Faculty of Medicine, Dalhousie University @2 Saint John, New Brunswick @3 USA
A14 03      @1 Department of Neurological Sciences, Hopital de l'Enfant Jesus @2 Quebec City, Quebec @3 CAN
A14 04      @1 Clinical Research, Hoffman-La Roche @2 Mississanga, Ontario @3 CAN
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A21       @1 2001
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A44       @0 0000 @1 © 2001 INIST-CNRS. All rights reserved.
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C01 01    ENG  @0 The efficacy and safety of two dosages of tolcapone were compared in a 12-week crossover trial involving 118 nonfluctuating patients with PD on a stable dose of levodopa (L-Dopa). At trial onset, all patients received open-label tolcapone 100 mg three times daily for 4 weeks. At week 4, 116 eligible patients entered an 8-week double-blind treatment period and were randomized to receive tolcapone three times daily at either 100 mg (group 1; n = 58) or 200 mg (group 2; n = 58) until week 8, followed by the alternative tolcapone dosage until week 12. Ratings included Unified Parkinson's Disease Rating Scale (UPDRS), Schwab & England, and patient diaries, assessed at baseline and at 4, 8, and 12 weeks. At week 4, the investigator's global assessment (IGA) of efficacy showed improvement in 76% of patients. The mean total daily L-Dopa dose and mean UPDRS scores for subscales II and III decreased significantly (p < 0.001). During the double-blind treatment period, IGA showed improvements at either or both dosages in 61% of patients; further changes in other efficacy variables were minimal and were similar with both tolcapone dosages. The most frequent adverse events were dopaminergic (nausea and dyskinesia); the most frequent nondopaminergic adverse event was diarrhea. The incidence of adverse events during double-blind treatment was slightly higher with tolcapone 200 mg three times daily (33%) than with tolcapone 100 mg three times daily (24%). The authors conclude that tolcapone dosages of 100 mg three times daily and 200 mg three times daily are well tolerated and equally effective in improving function in L-Dopa-treated nonfluctuating patients with PD.
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Format Inist (serveur)

NO : PASCAL 01-0392679 INIST
ET : Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD
AU : SUCHOWERSKY (Oksana); BAILEY (Peter); POURCHER (E.); BULGER (Lynne); FACCIPONTE (Giovanni)
AF : Department of Clinical Neurosciences, Faculty of Medicine, University of Calgary/Calgary, Alberta/Etats-Unis; Faculty of Medicine, Dalhousie University/Saint John, New Brunswick/Etats-Unis; Department of Neurological Sciences, Hopital de l'Enfant Jesus/Quebec City, Quebec/Canada; Clinical Research, Hoffman-La Roche/Mississanga, Ontario/Canada
DT : Publication en série; Niveau analytique
SO : Clinical neuropharmacology; ISSN 0362-5664; Coden CLNEDB; Etats-Unis; Da. 2001; Vol. 24; No. 4; Pp. 214-220; Bibl. 19 ref.
LA : Anglais
EA : The efficacy and safety of two dosages of tolcapone were compared in a 12-week crossover trial involving 118 nonfluctuating patients with PD on a stable dose of levodopa (L-Dopa). At trial onset, all patients received open-label tolcapone 100 mg three times daily for 4 weeks. At week 4, 116 eligible patients entered an 8-week double-blind treatment period and were randomized to receive tolcapone three times daily at either 100 mg (group 1; n = 58) or 200 mg (group 2; n = 58) until week 8, followed by the alternative tolcapone dosage until week 12. Ratings included Unified Parkinson's Disease Rating Scale (UPDRS), Schwab & England, and patient diaries, assessed at baseline and at 4, 8, and 12 weeks. At week 4, the investigator's global assessment (IGA) of efficacy showed improvement in 76% of patients. The mean total daily L-Dopa dose and mean UPDRS scores for subscales II and III decreased significantly (p < 0.001). During the double-blind treatment period, IGA showed improvements at either or both dosages in 61% of patients; further changes in other efficacy variables were minimal and were similar with both tolcapone dosages. The most frequent adverse events were dopaminergic (nausea and dyskinesia); the most frequent nondopaminergic adverse event was diarrhea. The incidence of adverse events during double-blind treatment was slightly higher with tolcapone 200 mg three times daily (33%) than with tolcapone 100 mg three times daily (24%). The authors conclude that tolcapone dosages of 100 mg three times daily and 200 mg three times daily are well tolerated and equally effective in improving function in L-Dopa-treated nonfluctuating patients with PD.
CC : 002B02B06
FD : Parkinson maladie; Lévodopa; Antiparkinsonien; Tolcapone; Traitement; Chimiothérapie; Homme; Association médicamenteuse; Interaction médicamenteuse; Toxicité; Long terme; Essai thérapeutique contrôlé; Dose répétée; Dose forte; Dose faible; Voie orale
FG : Système nerveux pathologie; Système nerveux central pathologie; Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative
ED : Parkinson disease; Levodopa; Antiparkinson agent; Tolcapone; Treatment; Chemotherapy; Human; Drug combination; Drug interaction; Toxicity; Long term; Controlled therapeutic trial; Multiple dose; High dose; Low dose; Oral administration
EG : Nervous system diseases; Central nervous system disease; Cerebral disorder; Extrapyramidal syndrome; Degenerative disease
SD : Parkinson enfermedad; Levodopa; Antiparkinsoniano; Tolcapona; Tratamiento; Quimioterapia; Hombre; Asociación medicamentosa; Interacción medicamentosa; Toxicidad; Largo plazo; Ensayo terapéutico controlado; Dosis múltiple; Dosis fuerte; Dosis débil; Vía oral
LO : INIST-16720.354000097153440040
ID : 01-0392679

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Pascal:01-0392679

Le document en format XML

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<s0>The efficacy and safety of two dosages of tolcapone were compared in a 12-week crossover trial involving 118 nonfluctuating patients with PD on a stable dose of levodopa (L-Dopa). At trial onset, all patients received open-label tolcapone 100 mg three times daily for 4 weeks. At week 4, 116 eligible patients entered an 8-week double-blind treatment period and were randomized to receive tolcapone three times daily at either 100 mg (group 1; n = 58) or 200 mg (group 2; n = 58) until week 8, followed by the alternative tolcapone dosage until week 12. Ratings included Unified Parkinson's Disease Rating Scale (UPDRS), Schwab & England, and patient diaries, assessed at baseline and at 4, 8, and 12 weeks. At week 4, the investigator's global assessment (IGA) of efficacy showed improvement in 76% of patients. The mean total daily L-Dopa dose and mean UPDRS scores for subscales II and III decreased significantly (p < 0.001). During the double-blind treatment period, IGA showed improvements at either or both dosages in 61% of patients; further changes in other efficacy variables were minimal and were similar with both tolcapone dosages. The most frequent adverse events were dopaminergic (nausea and dyskinesia); the most frequent nondopaminergic adverse event was diarrhea. The incidence of adverse events during double-blind treatment was slightly higher with tolcapone 200 mg three times daily (33%) than with tolcapone 100 mg three times daily (24%). The authors conclude that tolcapone dosages of 100 mg three times daily and 200 mg three times daily are well tolerated and equally effective in improving function in L-Dopa-treated nonfluctuating patients with PD.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B02B06</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Parkinson maladie</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Parkinson disease</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Parkinson enfermedad</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Lévodopa</s0>
<s5>04</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Levodopa</s0>
<s5>04</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Levodopa</s0>
<s5>04</s5>
</fC03>
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<s0>Antiparkinsonien</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
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<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
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<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Tolcapone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Tolcapone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>07</s5>
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<fC03 i1="04" i2="X" l="SPA">
<s0>Tolcapona</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>07</s5>
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<s0>Traitement</s0>
<s5>10</s5>
</fC03>
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<s0>Treatment</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Tratamiento</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Chimiothérapie</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Chemotherapy</s0>
<s5>11</s5>
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<fC03 i1="06" i2="X" l="SPA">
<s0>Quimioterapia</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Homme</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Human</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>12</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Association médicamenteuse</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Drug combination</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Asociación medicamentosa</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Interaction médicamenteuse</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Drug interaction</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Interacción medicamentosa</s0>
<s5>14</s5>
</fC03>
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<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>Long terme</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Long term</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Largo plazo</s0>
<s5>17</s5>
</fC03>
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<s0>Essai thérapeutique contrôlé</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Controlled therapeutic trial</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Ensayo terapéutico controlado</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>Dose répétée</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>Multiple dose</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA">
<s0>Dosis múltiple</s0>
<s5>19</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE">
<s0>Dose forte</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG">
<s0>High dose</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA">
<s0>Dosis fuerte</s0>
<s5>20</s5>
</fC03>
<fC03 i1="15" i2="X" l="FRE">
<s0>Dose faible</s0>
<s5>21</s5>
</fC03>
<fC03 i1="15" i2="X" l="ENG">
<s0>Low dose</s0>
<s5>21</s5>
</fC03>
<fC03 i1="15" i2="X" l="SPA">
<s0>Dosis débil</s0>
<s5>21</s5>
</fC03>
<fC03 i1="16" i2="X" l="FRE">
<s0>Voie orale</s0>
<s5>22</s5>
</fC03>
<fC03 i1="16" i2="X" l="ENG">
<s0>Oral administration</s0>
<s5>22</s5>
</fC03>
<fC03 i1="16" i2="X" l="SPA">
<s0>Vía oral</s0>
<s5>22</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>Système nerveux central pathologie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Central nervous system disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Sistema nervosio central patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Encéphale pathologie</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Cerebral disorder</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Encéfalo patología</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Extrapyramidal syndrome</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Extrapyramidal syndrome</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Extrapiramidal síndrome</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Maladie dégénérative</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Degenerative disease</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Enfermedad degenerativa</s0>
<s5>41</s5>
</fC07>
<fN21>
<s1>274</s1>
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<server>
<NO>PASCAL 01-0392679 INIST</NO>
<ET>Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD</ET>
<AU>SUCHOWERSKY (Oksana); BAILEY (Peter); POURCHER (E.); BULGER (Lynne); FACCIPONTE (Giovanni)</AU>
<AF>Department of Clinical Neurosciences, Faculty of Medicine, University of Calgary/Calgary, Alberta/Etats-Unis; Faculty of Medicine, Dalhousie University/Saint John, New Brunswick/Etats-Unis; Department of Neurological Sciences, Hopital de l'Enfant Jesus/Quebec City, Quebec/Canada; Clinical Research, Hoffman-La Roche/Mississanga, Ontario/Canada</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Clinical neuropharmacology; ISSN 0362-5664; Coden CLNEDB; Etats-Unis; Da. 2001; Vol. 24; No. 4; Pp. 214-220; Bibl. 19 ref.</SO>
<LA>Anglais</LA>
<EA>The efficacy and safety of two dosages of tolcapone were compared in a 12-week crossover trial involving 118 nonfluctuating patients with PD on a stable dose of levodopa (L-Dopa). At trial onset, all patients received open-label tolcapone 100 mg three times daily for 4 weeks. At week 4, 116 eligible patients entered an 8-week double-blind treatment period and were randomized to receive tolcapone three times daily at either 100 mg (group 1; n = 58) or 200 mg (group 2; n = 58) until week 8, followed by the alternative tolcapone dosage until week 12. Ratings included Unified Parkinson's Disease Rating Scale (UPDRS), Schwab & England, and patient diaries, assessed at baseline and at 4, 8, and 12 weeks. At week 4, the investigator's global assessment (IGA) of efficacy showed improvement in 76% of patients. The mean total daily L-Dopa dose and mean UPDRS scores for subscales II and III decreased significantly (p < 0.001). During the double-blind treatment period, IGA showed improvements at either or both dosages in 61% of patients; further changes in other efficacy variables were minimal and were similar with both tolcapone dosages. The most frequent adverse events were dopaminergic (nausea and dyskinesia); the most frequent nondopaminergic adverse event was diarrhea. The incidence of adverse events during double-blind treatment was slightly higher with tolcapone 200 mg three times daily (33%) than with tolcapone 100 mg three times daily (24%). The authors conclude that tolcapone dosages of 100 mg three times daily and 200 mg three times daily are well tolerated and equally effective in improving function in L-Dopa-treated nonfluctuating patients with PD.</EA>
<CC>002B02B06</CC>
<FD>Parkinson maladie; Lévodopa; Antiparkinsonien; Tolcapone; Traitement; Chimiothérapie; Homme; Association médicamenteuse; Interaction médicamenteuse; Toxicité; Long terme; Essai thérapeutique contrôlé; Dose répétée; Dose forte; Dose faible; Voie orale</FD>
<FG>Système nerveux pathologie; Système nerveux central pathologie; Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative</FG>
<ED>Parkinson disease; Levodopa; Antiparkinson agent; Tolcapone; Treatment; Chemotherapy; Human; Drug combination; Drug interaction; Toxicity; Long term; Controlled therapeutic trial; Multiple dose; High dose; Low dose; Oral administration</ED>
<EG>Nervous system diseases; Central nervous system disease; Cerebral disorder; Extrapyramidal syndrome; Degenerative disease</EG>
<SD>Parkinson enfermedad; Levodopa; Antiparkinsoniano; Tolcapona; Tratamiento; Quimioterapia; Hombre; Asociación medicamentosa; Interacción medicamentosa; Toxicidad; Largo plazo; Ensayo terapéutico controlado; Dosis múltiple; Dosis fuerte; Dosis débil; Vía oral</SD>
<LO>INIST-16720.354000097153440040</LO>
<ID>01-0392679</ID>
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