Efficacy and tolerability of Entacapone versus Cabergoline in parkinsonian patients suffering from wearing-off.
Identifieur interne : 001C35 ( Ncbi/Curation ); précédent : 001C34; suivant : 001C36Efficacy and tolerability of Entacapone versus Cabergoline in parkinsonian patients suffering from wearing-off.
Auteurs : Günther Deuschl [Allemagne] ; Antanas Vaitkus ; Gabriele-Cornelia Fox ; Torsten Roscher ; Dieter Schremmer ; Ariel GordinSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2007.
English descriptors
- KwdEn :
- Aged, Analysis of Variance, Antiparkinson Agents (therapeutic use), Catechols (therapeutic use), Double-Blind Method, Drug Administration Schedule, Drug Tolerance (physiology), Dyskinesias (etiology), Ergolines (therapeutic use), Female, Humans, Male, Medical Records, Middle Aged, Nitriles (therapeutic use), Parkinson Disease (drug therapy), Parkinson Disease (physiopathology), Psychiatric Status Rating Scales, Questionnaires.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Catechols, Ergolines, Nitriles.
- drug therapy : Parkinson Disease.
- etiology : Dyskinesias.
- physiology : Drug Tolerance.
- physiopathology : Parkinson Disease.
- Aged, Analysis of Variance, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Medical Records, Middle Aged, Psychiatric Status Rating Scales, Questionnaires.
Abstract
In this 12-wk, multi-center, randomized, open-label, rater-blinded study, efficacy and tolerability of Entacapone (ENT) or Cabergoline (CBG) in conjunction with levodopa were compared in 161 older Parkinson's disease patients with wearing-off. Patients received either ENT, 3 to 5 times daily, or CBG, titrated according to requirements to a maximum of 6 mg/d. A significant decrease of nearly 2 hours in the daily OFF-time (primary efficacy variable) was recorded in both treatment groups. The non-inferiority test failed despite a trend in favor of ENT. Reduction in OFF-time occurred faster in the ENT compared to the CBG treated patients. A decrease of approximately 20% was detected in parts II and III of the UPDRS, with no differences between the groups. Forty-three percent of the patients in the ENT group reported dyskinesias at baseline, and 35% at the final visit. The corresponding figures in the CBG group were 46% and 43%. Quality of life, measured by PDQ-39, increased substantially with both ENT and CBG. The mean daily dosage at the final visit was 698 mg for ENT (plus 447 mg levodopa) and 3.45 mg for CBG (plus 475 mg levodopa). Adverse events (AE), leading to discontinuation, were reported in 8.5% of the ENT and 13.9% of the CBG treated patients. Nausea was the most common AE in each group, corresponding figures being 7.3% with ENT and 25.3% with CBG (P=0.0024). A probable or possible causal relationship with ENT was reported in 41% and with CBG in 64% of the AE. Among these, only one serious AE (dehydration) was recorded with each treatment group. ENT and CBG reduced the patient's motor complications effectively and to a similar degree. The clinical benefit was more quickly apparent with ENT, which also showed a more favorable AE profile than CBG.
DOI: 10.1002/mds.21473
PubMed: 17516484
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uniqKey="Fox G" first="Gabriele-Cornelia" last="Fox">Gabriele-Cornelia Fox</name></author><author><name sortKey="Roscher, Torsten" sort="Roscher, Torsten" uniqKey="Roscher T" first="Torsten" last="Roscher">Torsten Roscher</name></author><author><name sortKey="Schremmer, Dieter" sort="Schremmer, Dieter" uniqKey="Schremmer D" first="Dieter" last="Schremmer">Dieter Schremmer</name></author><author><name sortKey="Gordin, Ariel" sort="Gordin, Ariel" uniqKey="Gordin A" first="Ariel" last="Gordin">Ariel Gordin</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2007">2007</date><idno type="doi">10.1002/mds.21473</idno><idno type="RBID">pubmed:17516484</idno><idno type="pmid">17516484</idno><idno type="wicri:Area/PubMed/Corpus">002704</idno><idno type="wicri:Area/PubMed/Curation">002704</idno><idno type="wicri:Area/PubMed/Checkpoint">002837</idno><idno type="wicri:Area/Ncbi/Merge">001C35</idno><idno 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sortKey="Fox, Gabriele Cornelia" sort="Fox, Gabriele Cornelia" uniqKey="Fox G" first="Gabriele-Cornelia" last="Fox">Gabriele-Cornelia Fox</name></author><author><name sortKey="Roscher, Torsten" sort="Roscher, Torsten" uniqKey="Roscher T" first="Torsten" last="Roscher">Torsten Roscher</name></author><author><name sortKey="Schremmer, Dieter" sort="Schremmer, Dieter" uniqKey="Schremmer D" first="Dieter" last="Schremmer">Dieter Schremmer</name></author><author><name sortKey="Gordin, Ariel" sort="Gordin, Ariel" uniqKey="Gordin A" first="Ariel" last="Gordin">Ariel Gordin</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="2007" type="published">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Analysis of Variance</term><term>Antiparkinson Agents (therapeutic 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xml:lang="en"><term>Drug Tolerance</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Analysis of Variance</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Medical Records</term><term>Middle Aged</term><term>Psychiatric Status Rating Scales</term><term>Questionnaires</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In this 12-wk, multi-center, randomized, open-label, rater-blinded study, efficacy and tolerability of Entacapone (ENT) or Cabergoline (CBG) in conjunction with levodopa were compared in 161 older Parkinson's disease patients with wearing-off. Patients received either ENT, 3 to 5 times daily, or CBG, titrated according to requirements to a maximum of 6 mg/d. A significant decrease of nearly 2 hours in the daily OFF-time (primary efficacy variable) was recorded in both treatment groups. The non-inferiority test failed despite a trend in favor of ENT. Reduction in OFF-time occurred faster in the ENT compared to the CBG treated patients. A decrease of approximately 20% was detected in parts II and III of the UPDRS, with no differences between the groups. Forty-three percent of the patients in the ENT group reported dyskinesias at baseline, and 35% at the final visit. The corresponding figures in the CBG group were 46% and 43%. Quality of life, measured by PDQ-39, increased substantially with both ENT and CBG. The mean daily dosage at the final visit was 698 mg for ENT (plus 447 mg levodopa) and 3.45 mg for CBG (plus 475 mg levodopa). Adverse events (AE), leading to discontinuation, were reported in 8.5% of the ENT and 13.9% of the CBG treated patients. Nausea was the most common AE in each group, corresponding figures being 7.3% with ENT and 25.3% with CBG (P=0.0024). A probable or possible causal relationship with ENT was reported in 41% and with CBG in 64% of the AE. Among these, only one serious AE (dehydration) was recorded with each treatment group. ENT and CBG reduced the patient's motor complications effectively and to a similar degree. The clinical benefit was more quickly apparent with ENT, which also showed a more favorable AE profile than CBG.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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