Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease
Identifieur interne : 001443 ( PascalFrancis/Checkpoint ); précédent : 001442; suivant : 001444Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease
Auteurs : Paolo Barone [Italie] ; Janice Lamb [Royaume-Uni] ; Amanda Ellis [Royaume-Uni] ; Zoe Clarke [Royaume-Uni]Source :
- Movement disorders [ 0885-3185 ] ; 2007.
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- Pascal (Inist)
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- topic : Homme.
English descriptors
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Abstract
The aims of this study were to assess the safety, tolerability, and efficacy of sumanirole, a highly selective D2 dopamine receptor agonist, versus placebo in subjects with advanced Parkinson's disease (PD), and to demonstrate noninferiority of sumanirole to ropinirole. In this flexible-dose, randomized, double-blind, double-dummy, parallel-group study, 948 subjects were treated with sumanirole 1 to 48 mg/day, ropinirole 0.75 to 24 mg/day, or placebo. Treatment consisted of 13 weeks of dose escalation, 26 weeks of maintenance, and 1 week of tapering. Approximately 70% of subjects treated with either sumanirole or ropinirole completed the study. Statistical significance (P < 0.0001) was achieved when both sumanirole and ropinirole groups were compared with placebo, with mean differences of -7.7 and -8.8 on combined sum of the Unified Parkinson's Disease Rating Scale (UPDRS) part II (average on and off) and part III total scores at the end of maintenance. Noninferiority of sumanirole to ropinirole was also demonstrated, with a sumanirole minus ropinirole difference of 1.17 (90% CI: -0.56 to 2.89). Both dopamine agonists, sumanirole and ropinirole, were statistically superior compared with placebo as adjunctive therapy for patients with advanced Parkinson's disease, based on UPDRS II + III total score. Noninferiority of sumanirole to ropinirole was established, with comparable tolerability profiles.
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Development</wicri:noRegion></affiliation></author><author><name sortKey="Ellis, Amanda" sort="Ellis, Amanda" uniqKey="Ellis A" first="Amanda" last="Ellis">Amanda Ellis</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Pfizer Global Research and Development</s1><s2>Sandwich, Kent</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Pfizer Global Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Clarke, Zoe" sort="Clarke, Zoe" uniqKey="Clarke Z" first="Zoe" last="Clarke">Zoe Clarke</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Pfizer Global Research and Development</s1><s2>Sandwich, Kent</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Pfizer Global Research and Development</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">07-0210946</idno><date when="2007">2007</date><idno type="stanalyst">PASCAL 07-0210946 INIST</idno><idno type="RBID">Pascal:07-0210946</idno><idno type="wicri:Area/PascalFrancis/Corpus">001756</idno><idno type="wicri:Area/PascalFrancis/Curation">001565</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001443</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease</title><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurological Sciences, University "Federico II"</s1><s2>Napoli</s2><s3>ITA</s3><sZ>1 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Napoli</wicri:noRegion></affiliation></author><author><name sortKey="Lamb, Janice" sort="Lamb, Janice" uniqKey="Lamb J" first="Janice" last="Lamb">Janice Lamb</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Pfizer Global Research and Development</s1><s2>Sandwich, Kent</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Pfizer Global Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Ellis, Amanda" sort="Ellis, Amanda" uniqKey="Ellis A" first="Amanda" last="Ellis">Amanda Ellis</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Pfizer Global Research and Development</s1><s2>Sandwich, Kent</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Pfizer Global Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Clarke, Zoe" sort="Clarke, Zoe" uniqKey="Clarke Z" first="Zoe" last="Clarke">Zoe Clarke</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Pfizer Global Research and Development</s1><s2>Sandwich, Kent</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Pfizer Global Research and Development</wicri:noRegion></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>Advanced stage</term><term>Comparative study</term><term>Dopamine agonist</term><term>Human</term><term>Levodopa</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Placebo</term><term>Ropinirole</term><term>Sumanirole</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Parkinson maladie</term><term>Sumanirole</term><term>Etude comparative</term><term>Placebo</term><term>Ropinirole</term><term>Traitement</term><term>Homme</term><term>Stade avancé</term><term>Stimulant dopaminergique</term><term>Lévodopa</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The aims of this study were to assess the safety, tolerability, and efficacy of sumanirole, a highly selective D<sub>2</sub> dopamine receptor agonist, versus placebo in subjects with advanced Parkinson's disease (PD), and to demonstrate noninferiority of sumanirole to ropinirole. In this flexible-dose, randomized, double-blind, double-dummy, parallel-group study, 948 subjects were treated with sumanirole 1 to 48 mg/day, ropinirole 0.75 to 24 mg/day, or placebo. Treatment consisted of 13 weeks of dose escalation, 26 weeks of maintenance, and 1 week of tapering. Approximately 70% of subjects treated with either sumanirole or ropinirole completed the study. Statistical significance (P < 0.0001) was achieved when both sumanirole and ropinirole groups were compared with placebo, with mean differences of -7.7 and -8.8 on combined sum of the Unified Parkinson's Disease Rating Scale (UPDRS) part II (average on and off) and part III total scores at the end of maintenance. Noninferiority of sumanirole to ropinirole was also demonstrated, with a sumanirole minus ropinirole difference of 1.17 (90% CI: -0.56 to 2.89). Both dopamine agonists, sumanirole and ropinirole, were statistically superior compared with placebo as adjunctive therapy for patients with advanced Parkinson's disease, based on UPDRS II + III total score. Noninferiority of sumanirole to ropinirole was established, with comparable tolerability profiles.</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>4</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease</s1></fA08><fA11 i1="01" i2="1"><s1>BARONE (Paolo)</s1></fA11><fA11 i1="02" i2="1"><s1>LAMB (Janice)</s1></fA11><fA11 i1="03" i2="1"><s1>ELLIS (Amanda)</s1></fA11><fA11 i1="04" i2="1"><s1>CLARKE (Zoe)</s1></fA11><fA14 i1="01"><s1>Department of Neurological Sciences, University "Federico II"</s1><s2>Napoli</s2><s3>ITA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Pfizer Global Research and Development</s1><s2>Sandwich, Kent</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>Sumanirole for Advanced Parkinson's Disease Study Group</s1><s3>INC</s3></fA17><fA20><s1>483-489</s1></fA20><fA21><s1>2007</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000145702210050</s5></fA43><fA44><s0>0000</s0><s1>© 2007 INIST-CNRS. 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