Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing-off
Identifieur interne : 001689 ( PascalFrancis/Checkpoint ); précédent : 001688; suivant : 001690Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing-off
Auteurs : Günther Deuschl [Allemagne] ; Antanas Vaitkus [Lituanie] ; Gabriele-Cornelia Fox [Allemagne] ; Torsten Roscher [Allemagne] ; Dieter Schremmer [Allemagne] ; Ariel Gordin [Allemagne]Source :
- Movement disorders [ 0885-3185 ] ; 2007.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
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.
Affiliations:
- Allemagne, Lituanie
- Bavière, District de Haute-Bavière, Hambourg, Schleswig-Holstein
- Hambourg, Kiel, Munich
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Christian-Albrechts-Universität</s1><s2>Kiel</s2><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><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"><inist:fA14 i1="02"><s1>Department of Neurology, Kaunas Medical University</s1><s2>Kaunas</s2><s3>LTU</s3><sZ>2 aut.</sZ></inist:fA14><country>Lituanie</country><wicri:noRegion>Kaunas</wicri:noRegion></affiliation></author><author><name sortKey="Fox, Gabriele Cornelia" sort="Fox, Gabriele Cornelia" uniqKey="Fox G" first="Gabriele-Cornelia" last="Fox">Gabriele-Cornelia Fox</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Medical Department, Orion Pharma</s1><s2>Hamburg</s2><s3>DEU</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><settlement type="city">Hambourg</settlement><region type="land" nuts="2">Hambourg</region></placeName></affiliation></author><author><name sortKey="Roscher, Torsten" sort="Roscher, Torsten" uniqKey="Roscher T" first="Torsten" last="Roscher">Torsten Roscher</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Medical Department, Orion Pharma</s1><s2>Hamburg</s2><s3>DEU</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><settlement type="city">Hambourg</settlement><region type="land" nuts="2">Hambourg</region></placeName></affiliation></author><author><name sortKey="Schremmer, Dieter" sort="Schremmer, Dieter" uniqKey="Schremmer D" first="Dieter" last="Schremmer">Dieter Schremmer</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Biometrics, GKM</s1><s2>München</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><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:level="3"><inist:fA14 i1="03"><s1>Medical Department, Orion Pharma</s1><s2>Hamburg</s2><s3>DEU</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><settlement type="city">Hambourg</settlement><region type="land" nuts="2">Hambourg</region></placeName></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="2007">2007</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>Cabergoline</term><term>Clinical trial</term><term>Comparative study</term><term>Entacapone</term><term>Human</term><term>Nervous system diseases</term><term>Parkinson disease</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Parkinson maladie</term><term>Entacapone</term><term>Etude comparative</term><term>Cabergoline</term><term>Homme</term><term>Essai clinique</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</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 ∼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><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>22</s2></fA05><fA06><s2>11</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing-off</s1></fA08><fA11 i1="01" i2="1"><s1>DEUSCHL (Günther)</s1></fA11><fA11 i1="02" i2="1"><s1>VAITKUS (Antanas)</s1></fA11><fA11 i1="03" i2="1"><s1>FOX (Gabriele-Cornelia)</s1></fA11><fA11 i1="04" i2="1"><s1>ROSCHER (Torsten)</s1></fA11><fA11 i1="05" i2="1"><s1>SCHREMMER (Dieter)</s1></fA11><fA11 i1="06" i2="1"><s1>GORDIN (Ariel)</s1></fA11><fA14 i1="01"><s1>Department of Neurology, Christian-Albrechts-Universität</s1><s2>Kiel</s2><s3>DEU</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Department of Neurology, Kaunas Medical University</s1><s2>Kaunas</s2><s3>LTU</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Medical Department, Orion Pharma</s1><s2>Hamburg</s2><s3>DEU</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></fA14><fA14 i1="04"><s1>Department of Biometrics, GKM</s1><s2>München</s2><s3>DEU</s3><sZ>5 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>CAMP Study Group</s1><s3>GEO</s3></fA17><fA20><s1>1550-1555</s1></fA20><fA21><s1>2007</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000149744800050</s5></fA43><fA44><s0>0000</s0><s1>© 2007 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>21 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>07-0448788</s0></fA47><fA60><s1>P</s1></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>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B17</s0></fC02><fC02 i1="02" i2="X"><s0>002B17F</s0></fC02><fC02 i1="03" i2="X"><s0>002B16B</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Système nerveux pathologie</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Parkinson maladie</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Parkinson disease</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Parkinson enfermedad</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Entacapone</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Entacapone</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Entacapona</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Etude comparative</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Comparative study</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Estudio comparativo</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Cabergoline</s0><s2>NK</s2><s2>FR</s2><s5>11</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Cabergoline</s0><s2>NK</s2><s2>FR</s2><s5>11</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Cabergolina</s0><s2>NK</s2><s2>FR</s2><s5>11</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Homme</s0><s5>12</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Human</s0><s5>12</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Hombre</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Essai clinique</s0><s5>13</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Clinical trial</s0><s5>13</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Ensayo clínico</s0><s5>13</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Encéphale pathologie</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Cerebral disorder</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Encéfalo patología</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Extrapyramidal syndrome</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Maladie dégénérative</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Degenerative disease</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Central nervous system disease</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0><s5>40</s5></fC07><fN21><s1>295</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>Allemagne</li><li>Lituanie</li></country><region><li>Bavière</li><li>District de Haute-Bavière</li><li>Hambourg</li><li>Schleswig-Holstein</li></region><settlement><li>Hambourg</li><li>Kiel</li><li>Munich</li></settlement></list><tree><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="Fox, Gabriele Cornelia" sort="Fox, Gabriele Cornelia" 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><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)
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