Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients
Identifieur interne : 002C71 ( Main/Exploration ); précédent : 002C70; suivant : 002C72Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients
Auteurs : Yoshikuni Mizuno [Japon] ; Ichiro Kanazawa [Japon] ; Sadako Kuno [Japon] ; Nobuo Yanagisawa [Japon] ; Mitsutoshi Yamamoto [Japon] ; Tomoyoshi Kondo [Japon]Source :
- Movement Disorders [ 0885-3185 ] ; 2007-01.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (therapeutic use), COMT inhibitor, Catechols (therapeutic use), Cross-Over Studies, Dose-Response Relationship, Drug, Double blind study, Double-Blind Method, Drug Evaluation, Drug Therapy, Combination, Entacapone, Female, Fluctuations, Human, Humans, Levodopa (therapeutic use), Male, Middle Aged, Nervous system diseases, Nitriles (therapeutic use), Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Placebo, Treatment, entacapone, treatment, wearing‐off fluctuation.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Catechols, Levodopa, Nitriles.
- drug therapy : Parkinson Disease.
- Aged, Cross-Over Studies, Dose-Response Relationship, Drug, Double-Blind Method, Drug Evaluation, Drug Therapy, Combination, Female, Humans, Male, Middle Aged.
Abstract
We conducted a multicenter randomized, placebo‐controlled double‐blind parallel‐group study in Japanese Parkinson's disease (PD) patients with wearing‐off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100‐mg and 200‐mg groups and by 0.5 hours for the placebo group (P < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing‐off fluctuations, although the safety and tolerability profile appeared more favorable for the 100‐mg dose. © 2006 Movement Disorder Society
Url:
DOI: 10.1002/mds.21218
Affiliations:
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Le document en format XML
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uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name><affiliation wicri:level="3"><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Neurology, Juntendo University School of Medicine, Tokyo</wicri:regionArea><placeName><settlement type="city">Tokyo</settlement></placeName></affiliation></author><author><name sortKey="Kanazawa, Ichiro" sort="Kanazawa, Ichiro" uniqKey="Kanazawa I" first="Ichiro" last="Kanazawa">Ichiro Kanazawa</name><affiliation wicri:level="3"><country xml:lang="fr">Japon</country><wicri:regionArea>National Center of Neurology and Psychiatry, Tokyo</wicri:regionArea><placeName><settlement type="city">Tokyo</settlement></placeName></affiliation></author><author><name sortKey="Kuno, Sadako" sort="Kuno, Sadako" uniqKey="Kuno S" first="Sadako" last="Kuno">Sadako Kuno</name><affiliation wicri:level="3"><country xml:lang="fr">Japon</country><wicri:regionArea>National Center of Neurology and Psychiatry, Tokyo</wicri:regionArea><placeName><settlement type="city">Tokyo</settlement></placeName></affiliation></author><author><name sortKey="Yanagisawa, Nobuo" sort="Yanagisawa, Nobuo" uniqKey="Yanagisawa N" first="Nobuo" last="Yanagisawa">Nobuo Yanagisawa</name><affiliation wicri:level="1"><country xml:lang="fr">Japon</country><wicri:regionArea>Kanto Rosai Hospital, Kanagawa</wicri:regionArea><wicri:noRegion>Kanagawa</wicri:noRegion></affiliation></author><author><name sortKey="Yamamoto, Mitsutoshi" sort="Yamamoto, Mitsutoshi" uniqKey="Yamamoto M" first="Mitsutoshi" last="Yamamoto">Mitsutoshi Yamamoto</name><affiliation wicri:level="1"><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Neurology, Kagawa Prefectural Central Hospital, Kagawa</wicri:regionArea><wicri:noRegion>Kagawa</wicri:noRegion></affiliation></author><author><name sortKey="Kondo, Tomoyoshi" sort="Kondo, Tomoyoshi" uniqKey="Kondo T" first="Tomoyoshi" last="Kondo">Tomoyoshi Kondo</name><affiliation wicri:level="1"><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Neurology, Wakayama Medical College, Wakayama</wicri:regionArea><wicri:noRegion>Wakayama</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</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="2007-01">2007-01</date><biblScope unit="vol">22</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="75">75</biblScope><biblScope unit="page" to="80">80</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">4541E5DBBD6525DA6DCA9215596100387273860D</idno><idno type="DOI">10.1002/mds.21218</idno><idno type="ArticleID">MDS21218</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Antiparkinson Agents (therapeutic use)</term><term>COMT inhibitor</term><term>Catechols (therapeutic use)</term><term>Cross-Over Studies</term><term>Dose-Response Relationship, Drug</term><term>Double blind study</term><term>Double-Blind Method</term><term>Drug Evaluation</term><term>Drug Therapy, Combination</term><term>Entacapone</term><term>Female</term><term>Fluctuations</term><term>Human</term><term>Humans</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Nitriles (therapeutic use)</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Placebo</term><term>Treatment</term><term>entacapone</term><term>treatment</term><term>wearing‐off fluctuation</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Catechols</term><term>Levodopa</term><term>Nitriles</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Cross-Over Studies</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Evaluation</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Entacapone</term><term>Etude double insu</term><term>Fluctuation</term><term>Homme</term><term>Parkinson maladie</term><term>Placebo</term><term>Système nerveux pathologie</term><term>Traitement</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We conducted a multicenter randomized, placebo‐controlled double‐blind parallel‐group study in Japanese Parkinson's disease (PD) patients with wearing‐off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100‐mg and 200‐mg groups and by 0.5 hours for the placebo group (P < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing‐off fluctuations, although the safety and tolerability profile appeared more favorable for the 100‐mg dose. © 2006 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Japon</li></country><settlement><li>Tokyo</li></settlement></list><tree><country name="Japon"><noRegion><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name></noRegion><name sortKey="Kanazawa, Ichiro" sort="Kanazawa, Ichiro" uniqKey="Kanazawa I" first="Ichiro" last="Kanazawa">Ichiro Kanazawa</name><name sortKey="Kondo, Tomoyoshi" sort="Kondo, Tomoyoshi" uniqKey="Kondo T" first="Tomoyoshi" last="Kondo">Tomoyoshi Kondo</name><name sortKey="Kuno, Sadako" sort="Kuno, Sadako" uniqKey="Kuno S" first="Sadako" last="Kuno">Sadako Kuno</name><name sortKey="Yamamoto, Mitsutoshi" sort="Yamamoto, Mitsutoshi" uniqKey="Yamamoto M" first="Mitsutoshi" last="Yamamoto">Mitsutoshi Yamamoto</name><name sortKey="Yanagisawa, Nobuo" sort="Yanagisawa, Nobuo" uniqKey="Yanagisawa N" first="Nobuo" last="Yanagisawa">Nobuo Yanagisawa</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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