Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off
Identifieur interne : 001059 ( Main/Exploration ); précédent : 001058; suivant : 001060Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off
Auteurs : Günther Deuschl [Allemagne] ; Antanas Vaitkus [Lituanie] ; Gabriele-Cornelia Fox ; Torsten Roscher ; Dieter Schremmer [Allemagne] ; Ariel GordinSource :
- Movement Disorders [ 0885-3185 ] ; 2007-08-15.
English descriptors
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 ∼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. © 2007 Movement Disorder Society
Url:
DOI: 10.1002/mds.21473
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off</title><author><name sortKey="Deuschl, Gunther" sort="Deuschl, Gunther" uniqKey="Deuschl G" first="Günther" last="Deuschl">Günther Deuschl</name></author><author><name sortKey="Vaitkus, Antanas" sort="Vaitkus, Antanas" uniqKey="Vaitkus A" first="Antanas" last="Vaitkus">Antanas Vaitkus</name></author><author><name sortKey="Fox, Gabriele Ornelia" sort="Fox, Gabriele Ornelia" 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">ISTEX</idno><idno type="RBID">ISTEX:03604EDF2C723CCF8974422A855C42649A8AA539</idno><date when="2007" year="2007">2007</date><idno type="doi">10.1002/mds.21473</idno><idno type="url">https://api.istex.fr/document/03604EDF2C723CCF8974422A855C42649A8AA539/fulltext/pdf</idno><idno type="wicri:Area/Main/Corpus">001A78</idno><idno type="wicri:Area/Main/Curation">001819</idno><idno type="wicri:Area/Main/Exploration">001059</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off</title><author><name sortKey="Deuschl, Gunther" sort="Deuschl, Gunther" uniqKey="Deuschl G" first="Günther" last="Deuschl">Günther Deuschl</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, Christian‐Albrechts‐Universität, Kiel</wicri:regionArea><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author><author><name sortKey="Vaitkus, Antanas" sort="Vaitkus, Antanas" uniqKey="Vaitkus A" first="Antanas" last="Vaitkus">Antanas Vaitkus</name><affiliation wicri:level="1"><country xml:lang="fr">Lituanie</country><wicri:regionArea>Department of Neurology, Kaunas Medical University, Kaunas</wicri:regionArea><wicri:noRegion>Kaunas</wicri:noRegion></affiliation></author><author><name sortKey="Fox, Gabriele Ornelia" sort="Fox, Gabriele Ornelia" uniqKey="Fox G" first="Gabriele-Cornelia" last="Fox">Gabriele-Cornelia Fox</name><affiliation><wicri:noCountry code="subField">Germany/Finland</wicri:noCountry></affiliation></author><author><name sortKey="Roscher, Torsten" sort="Roscher, Torsten" uniqKey="Roscher T" first="Torsten" last="Roscher">Torsten Roscher</name><affiliation><wicri:noCountry code="subField">Germany/Finland</wicri:noCountry></affiliation></author><author><name sortKey="Schremmer, Dieter" sort="Schremmer, Dieter" uniqKey="Schremmer D" first="Dieter" last="Schremmer">Dieter Schremmer</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Biometrics, GKM, München</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region><settlement type="city">Munich</settlement></placeName></affiliation></author><author><name sortKey="Gordin, Ariel" sort="Gordin, Ariel" uniqKey="Gordin A" first="Ariel" last="Gordin">Ariel Gordin</name><affiliation><wicri:noCountry code="subField">Germany/Finland</wicri:noCountry></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2007-08-15">2007-08-15</date><biblScope unit="volume">22</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1550">1550</biblScope><biblScope unit="page" to="1555">1555</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">03604EDF2C723CCF8974422A855C42649A8AA539</idno><idno type="DOI">10.1002/mds.21473</idno><idno type="ArticleID">MDS21473</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>COMT inhibition</term><term>Cabergoline</term><term>Entacapone</term><term>Parkinson's disease</term><term>clinical trial</term><term>wearing‐off</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></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 ∼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. © 2007 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Lituanie</li></country><region><li>Bavière</li><li>District de Haute-Bavière</li><li>Schleswig-Holstein</li></region><settlement><li>Kiel</li><li>Munich</li></settlement></list><tree><noCountry><name sortKey="Fox, Gabriele Ornelia" sort="Fox, Gabriele Ornelia" uniqKey="Fox G" first="Gabriele-Cornelia" last="Fox">Gabriele-Cornelia Fox</name><name sortKey="Gordin, Ariel" sort="Gordin, Ariel" uniqKey="Gordin A" first="Ariel" last="Gordin">Ariel Gordin</name><name sortKey="Roscher, Torsten" sort="Roscher, Torsten" uniqKey="Roscher T" first="Torsten" last="Roscher">Torsten Roscher</name></noCountry><country name="Allemagne"><region name="Schleswig-Holstein"><name sortKey="Deuschl, Gunther" sort="Deuschl, Gunther" uniqKey="Deuschl G" first="Günther" last="Deuschl">Günther Deuschl</name></region><name sortKey="Schremmer, Dieter" sort="Schremmer, Dieter" uniqKey="Schremmer D" first="Dieter" last="Schremmer">Dieter Schremmer</name></country><country name="Lituanie"><noRegion><name sortKey="Vaitkus, Antanas" sort="Vaitkus, Antanas" uniqKey="Vaitkus A" first="Antanas" last="Vaitkus">Antanas Vaitkus</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/ParkinsonV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001059 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001059 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Sante
|area= ParkinsonV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:03604EDF2C723CCF8974422A855C42649A8AA539
|texte= Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off
}}
| This area was generated with Dilib version V0.6.23. |  |