Pardoprunox in Early Parkinson's Disease: Results from 2 Large, Randomized Double-Blind Trials
Identifieur interne : 000519 ( PascalFrancis/Corpus ); précédent : 000518; suivant : 000520Pardoprunox in Early Parkinson's Disease: Results from 2 Large, Randomized Double-Blind Trials
Auteurs : Cristina Sampaio ; Juliana Bronzova ; Robert A. Hauser ; Anthony E. Lang ; Olivier Rascol ; Serge V. Van De Witte ; Ad TheeuwesSource :
- Movement disorders [ 0885-3185 ] ; 2011.
Descripteurs français
- Pascal (Inist)
English descriptors
Abstract
This report presents the results of 2 randomized trials-Rembrandt and Vermeer-on the efficacy and safety of pardoprunox in patients with early Parkinson's disease. Patients with Parkinson's disease with a Unified Parkinson's Disease Rating Scale-Motor score > 10 and modified Hoehn and Yahr stage ≤ 3 were randomized to pardoprunox (fixed doses of 6 mg/day [n = 115] or 12 mg/day [n = 118] or a flexible-dose range of 12-42 mg/day [n = 116]) or placebo (n = 119) in Rembrandt and pardoprunox 12-42 mg/day (n = 108), pramipexole 1.5-4.5 mg/day (n = 116), or placebo (n = 110) in Vermeer. Pardoprunox showed a significant benefit over placebo in the primary efficacy variable, least-square mean change from baseline in Unified Parkinson's Disease Rating Scale-Motor score: Rembrandt-fixed doses of 6 and 12 mg/day, -6.0 and -4.7 points, respectively; flexible-dose 12-42 mg/day, -5.5 points; placebo, -2.9 points; Vermeer-flexible-dose 12-42 mg/ day, -4.9 points; placebo, -2.5 points; pramipexole, -5.7 points. No minimum effective dose was established. Secondary efficacy parameters supported the results of the primary efficacy variable. Pardoprunox tolerability was dose related: flexible-dose 12-42 mg/day showed the highest dropout rate due to treatment-emergent adverse events (Rembrandt, 56.0%; Vermeer, 46.3%) and overall incidence of treatment-emergent adverse events (Rembrandt, 97.4%; Vermeer, 92.6%), primarily due to nausea, somnolence, and dizziness. Because pardoprunox showed similar efficacy across all dose groups, these observations suggest that the 12-42 mg/day dose range was higher than therapeutically required. Furthermore, the early onset of treatment-emergent adverse events and dropouts observed for pardoprunox suggest that titration was too rapid. Pardoprunox significantly improved motor symptoms in patients with early Parkinson's disease, but further investigation into the dose and titration schedule is required to improve tolerability.
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| NO : | PASCAL 11-0353386 INIST |
|---|---|
| ET : | Pardoprunox in Early Parkinson's Disease: Results from 2 Large, Randomized Double-Blind Trials |
| AU : | SAMPAIO (Cristina); BRONZOVA (Juliana); HAUSER (Robert A.); LANG (Anthony E.); RASCOL (Olivier); VAN DE WITTE (Serge V.); THEEUWES (Ad) |
| AF : | Laboratório de Farmacologia Clinica e Terapêutica e Instituto de Medicina Molecular, Faculdade de Medicina de Lisboa, Edifício do Hospital de Santa Maria/Lisboa/Portugal (1 aut.); Solvay/Abbott/Pays-Bas (2 aut., 6 aut., 7 aut.); University of South Florida/Tampa, Florida/Etats-Unis (3 aut.); Toronto Western Hospital, University of Toronto/Toronto, Ontario/Canada (4 aut.); Department of Clinical Pharmacology, Faculty of Medicine, University Hospital of Toulouse/Toulouse/France (5 aut.) |
| DT : | Publication en série; Niveau analytique |
| SO : | Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2011; Vol. 26; No. 8; Pp. 1464-1476; Bibl. 17 ref. |
| LA : | Anglais |
| EA : | This report presents the results of 2 randomized trials-Rembrandt and Vermeer-on the efficacy and safety of pardoprunox in patients with early Parkinson's disease. Patients with Parkinson's disease with a Unified Parkinson's Disease Rating Scale-Motor score > 10 and modified Hoehn and Yahr stage ≤ 3 were randomized to pardoprunox (fixed doses of 6 mg/day [n = 115] or 12 mg/day [n = 118] or a flexible-dose range of 12-42 mg/day [n = 116]) or placebo (n = 119) in Rembrandt and pardoprunox 12-42 mg/day (n = 108), pramipexole 1.5-4.5 mg/day (n = 116), or placebo (n = 110) in Vermeer. Pardoprunox showed a significant benefit over placebo in the primary efficacy variable, least-square mean change from baseline in Unified Parkinson's Disease Rating Scale-Motor score: Rembrandt-fixed doses of 6 and 12 mg/day, -6.0 and -4.7 points, respectively; flexible-dose 12-42 mg/day, -5.5 points; placebo, -2.9 points; Vermeer-flexible-dose 12-42 mg/ day, -4.9 points; placebo, -2.5 points; pramipexole, -5.7 points. No minimum effective dose was established. Secondary efficacy parameters supported the results of the primary efficacy variable. Pardoprunox tolerability was dose related: flexible-dose 12-42 mg/day showed the highest dropout rate due to treatment-emergent adverse events (Rembrandt, 56.0%; Vermeer, 46.3%) and overall incidence of treatment-emergent adverse events (Rembrandt, 97.4%; Vermeer, 92.6%), primarily due to nausea, somnolence, and dizziness. Because pardoprunox showed similar efficacy across all dose groups, these observations suggest that the 12-42 mg/day dose range was higher than therapeutically required. Furthermore, the early onset of treatment-emergent adverse events and dropouts observed for pardoprunox suggest that titration was too rapid. Pardoprunox significantly improved motor symptoms in patients with early Parkinson's disease, but further investigation into the dose and titration schedule is required to improve tolerability. |
| CC : | 002B17; 002B17G |
| FD : | Maladie de Parkinson; Pathologie du système nerveux; Pardoprunox; Agoniste partiel; Stimulant dopaminergique |
| FG : | Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central |
| ED : | Parkinson disease; Nervous system diseases; Pardoprunox; Partial agonist; Dopamine agonist |
| EG : | Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease |
| SD : | Parkinson enfermedad; Sistema nervioso patología; Pardoprunox; Agonista parcial; Estimulante dopaminérgico |
| LO : | INIST-20953.354000508552620140 |
| ID : | 11-0353386 |
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Hauser</name><affiliation><inist:fA14 i1="03"><s1>University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name><affiliation><inist:fA14 i1="04"><s1>Toronto Western Hospital, University of Toronto</s1><s2>Toronto, Ontario</s2><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><inist:fA14 i1="05"><s1>Department of Clinical Pharmacology, Faculty of Medicine, University Hospital of Toulouse</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Van De Witte, Serge V" sort="Van De Witte, Serge V" uniqKey="Van De Witte S" first="Serge V." last="Van De Witte">Serge V. Van De Witte</name><affiliation><inist:fA14 i1="02"><s1>Solvay</s1><s2>Abbott</s2><s3>NLD</s3><sZ>2 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Theeuwes, Ad" sort="Theeuwes, Ad" uniqKey="Theeuwes A" first="Ad" last="Theeuwes">Ad Theeuwes</name><affiliation><inist:fA14 i1="02"><s1>Solvay</s1><s2>Abbott</s2><s3>NLD</s3><sZ>2 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">11-0353386</idno><date when="2011">2011</date><idno type="stanalyst">PASCAL 11-0353386 INIST</idno><idno type="RBID">Pascal:11-0353386</idno><idno type="wicri:Area/PascalFrancis/Corpus">000519</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Pardoprunox in Early Parkinson's Disease: Results from 2 Large, Randomized Double-Blind Trials</title><author><name sortKey="Sampaio, Cristina" sort="Sampaio, Cristina" uniqKey="Sampaio C" first="Cristina" last="Sampaio">Cristina Sampaio</name><affiliation><inist:fA14 i1="01"><s1>Laboratório de Farmacologia Clinica e Terapêutica e Instituto de Medicina Molecular, Faculdade de Medicina de Lisboa, Edifício do Hospital de Santa Maria</s1><s2>Lisboa</s2><s3>PRT</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Bronzova, Juliana" sort="Bronzova, Juliana" uniqKey="Bronzova J" first="Juliana" last="Bronzova">Juliana Bronzova</name><affiliation><inist:fA14 i1="02"><s1>Solvay</s1><s2>Abbott</s2><s3>NLD</s3><sZ>2 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation><inist:fA14 i1="03"><s1>University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name><affiliation><inist:fA14 i1="04"><s1>Toronto Western Hospital, University of Toronto</s1><s2>Toronto, Ontario</s2><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><inist:fA14 i1="05"><s1>Department of Clinical Pharmacology, Faculty of Medicine, University Hospital of Toulouse</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Van De Witte, Serge V" sort="Van De Witte, Serge V" uniqKey="Van De Witte S" first="Serge V." last="Van De Witte">Serge V. Van De Witte</name><affiliation><inist:fA14 i1="02"><s1>Solvay</s1><s2>Abbott</s2><s3>NLD</s3><sZ>2 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Theeuwes, Ad" sort="Theeuwes, Ad" uniqKey="Theeuwes A" first="Ad" last="Theeuwes">Ad Theeuwes</name><affiliation><inist:fA14 i1="02"><s1>Solvay</s1><s2>Abbott</s2><s3>NLD</s3><sZ>2 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14></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="2011">2011</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>Dopamine agonist</term><term>Nervous system diseases</term><term>Pardoprunox</term><term>Parkinson disease</term><term>Partial agonist</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Pardoprunox</term><term>Agoniste partiel</term><term>Stimulant dopaminergique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This report presents the results of 2 randomized trials-Rembrandt and Vermeer-on the efficacy and safety of pardoprunox in patients with early Parkinson's disease. Patients with Parkinson's disease with a Unified Parkinson's Disease Rating Scale-Motor score > 10 and modified Hoehn and Yahr stage ≤ 3 were randomized to pardoprunox (fixed doses of 6 mg/day [n = 115] or 12 mg/day [n = 118] or a flexible-dose range of 12-42 mg/day [n = 116]) or placebo (n = 119) in Rembrandt and pardoprunox 12-42 mg/day (n = 108), pramipexole 1.5-4.5 mg/day (n = 116), or placebo (n = 110) in Vermeer. Pardoprunox showed a significant benefit over placebo in the primary efficacy variable, least-square mean change from baseline in Unified Parkinson's Disease Rating Scale-Motor score: Rembrandt-fixed doses of 6 and 12 mg/day, -6.0 and -4.7 points, respectively; flexible-dose 12-42 mg/day, -5.5 points; placebo, -2.9 points; Vermeer-flexible-dose 12-42 mg/ day, -4.9 points; placebo, -2.5 points; pramipexole, -5.7 points. No minimum effective dose was established. Secondary efficacy parameters supported the results of the primary efficacy variable. Pardoprunox tolerability was dose related: flexible-dose 12-42 mg/day showed the highest dropout rate due to treatment-emergent adverse events (Rembrandt, 56.0%; Vermeer, 46.3%) and overall incidence of treatment-emergent adverse events (Rembrandt, 97.4%; Vermeer, 92.6%), primarily due to nausea, somnolence, and dizziness. Because pardoprunox showed similar efficacy across all dose groups, these observations suggest that the 12-42 mg/day dose range was higher than therapeutically required. Furthermore, the early onset of treatment-emergent adverse events and dropouts observed for pardoprunox suggest that titration was too rapid. Pardoprunox significantly improved motor symptoms in patients with early Parkinson's disease, but further investigation into the dose and titration schedule is required to improve tolerability.</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>26</s2></fA05><fA06><s2>8</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Pardoprunox in Early Parkinson's Disease: Results from 2 Large, Randomized Double-Blind Trials</s1></fA08><fA11 i1="01" i2="1"><s1>SAMPAIO (Cristina)</s1></fA11><fA11 i1="02" i2="1"><s1>BRONZOVA (Juliana)</s1></fA11><fA11 i1="03" i2="1"><s1>HAUSER (Robert A.)</s1></fA11><fA11 i1="04" i2="1"><s1>LANG (Anthony E.)</s1></fA11><fA11 i1="05" i2="1"><s1>RASCOL (Olivier)</s1></fA11><fA11 i1="06" i2="1"><s1>VAN DE WITTE (Serge V.)</s1></fA11><fA11 i1="07" i2="1"><s1>THEEUWES (Ad)</s1></fA11><fA14 i1="01"><s1>Laboratório de Farmacologia Clinica e Terapêutica e Instituto de Medicina Molecular, Faculdade de Medicina de Lisboa, Edifício do Hospital de Santa Maria</s1><s2>Lisboa</s2><s3>PRT</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Solvay</s1><s2>Abbott</s2><s3>NLD</s3><sZ>2 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></fA14><fA14 i1="03"><s1>University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Toronto Western Hospital, University of Toronto</s1><s2>Toronto, Ontario</s2><s3>CAN</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Department of Clinical Pharmacology, Faculty of Medicine, University Hospital of Toulouse</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>5 aut.</sZ></fA14><fA20><s1>1464-1476</s1></fA20><fA21><s1>2011</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000508552620140</s5></fA43><fA44><s0>0000</s0><s1>© 2011 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>17 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>11-0353386</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>This report presents the results of 2 randomized trials-Rembrandt and Vermeer-on the efficacy and safety of pardoprunox in patients with early Parkinson's disease. Patients with Parkinson's disease with a Unified Parkinson's Disease Rating Scale-Motor score > 10 and modified Hoehn and Yahr stage ≤ 3 were randomized to pardoprunox (fixed doses of 6 mg/day [n = 115] or 12 mg/day [n = 118] or a flexible-dose range of 12-42 mg/day [n = 116]) or placebo (n = 119) in Rembrandt and pardoprunox 12-42 mg/day (n = 108), pramipexole 1.5-4.5 mg/day (n = 116), or placebo (n = 110) in Vermeer. Pardoprunox showed a significant benefit over placebo in the primary efficacy variable, least-square mean change from baseline in Unified Parkinson's Disease Rating Scale-Motor score: Rembrandt-fixed doses of 6 and 12 mg/day, -6.0 and -4.7 points, respectively; flexible-dose 12-42 mg/day, -5.5 points; placebo, -2.9 points; Vermeer-flexible-dose 12-42 mg/ day, -4.9 points; placebo, -2.5 points; pramipexole, -5.7 points. No minimum effective dose was established. Secondary efficacy parameters supported the results of the primary efficacy variable. Pardoprunox tolerability was dose related: flexible-dose 12-42 mg/day showed the highest dropout rate due to treatment-emergent adverse events (Rembrandt, 56.0%; Vermeer, 46.3%) and overall incidence of treatment-emergent adverse events (Rembrandt, 97.4%; Vermeer, 92.6%), primarily due to nausea, somnolence, and dizziness. Because pardoprunox showed similar efficacy across all dose groups, these observations suggest that the 12-42 mg/day dose range was higher than therapeutically required. Furthermore, the early onset of treatment-emergent adverse events and dropouts observed for pardoprunox suggest that titration was too rapid. Pardoprunox significantly improved motor symptoms in patients with early Parkinson's disease, but further investigation into the dose and titration schedule is required to improve tolerability.</s0></fC01><fC02 i1="01" i2="X"><s0>002B17</s0></fC02><fC02 i1="02" i2="X"><s0>002B17G</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Maladie de Parkinson</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Parkinson disease</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Parkinson enfermedad</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Pathologie du système nerveux</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Pardoprunox</s0><s2>FR</s2><s5>09</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Pardoprunox</s0><s2>FR</s2><s5>09</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Pardoprunox</s0><s2>FR</s2><s5>09</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Agoniste partiel</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Partial agonist</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Agonista parcial</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Stimulant dopaminergique</s0><s5>11</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Dopamine agonist</s0><s5>11</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Estimulante dopaminérgico</s0><s5>11</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'encéphale</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>Syndrome extrapyramidal</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>Pathologie du système nerveux central</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>241</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard><server><NO>PASCAL 11-0353386 INIST</NO><ET>Pardoprunox in Early Parkinson's Disease: Results from 2 Large, Randomized Double-Blind Trials</ET><AU>SAMPAIO (Cristina); BRONZOVA (Juliana); HAUSER (Robert A.); LANG (Anthony E.); RASCOL (Olivier); VAN DE WITTE (Serge V.); THEEUWES (Ad)</AU><AF>Laboratório de Farmacologia Clinica e Terapêutica e Instituto de Medicina Molecular, Faculdade de Medicina de Lisboa, Edifício do Hospital de Santa Maria/Lisboa/Portugal (1 aut.); Solvay/Abbott/Pays-Bas (2 aut., 6 aut., 7 aut.); University of South Florida/Tampa, Florida/Etats-Unis (3 aut.); Toronto Western Hospital, University of Toronto/Toronto, Ontario/Canada (4 aut.); Department of Clinical Pharmacology, Faculty of Medicine, University Hospital of Toulouse/Toulouse/France (5 aut.)</AF><DT>Publication en série; Niveau analytique</DT><SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2011; Vol. 26; No. 8; Pp. 1464-1476; Bibl. 17 ref.</SO><LA>Anglais</LA><EA>This report presents the results of 2 randomized trials-Rembrandt and Vermeer-on the efficacy and safety of pardoprunox in patients with early Parkinson's disease. Patients with Parkinson's disease with a Unified Parkinson's Disease Rating Scale-Motor score > 10 and modified Hoehn and Yahr stage ≤ 3 were randomized to pardoprunox (fixed doses of 6 mg/day [n = 115] or 12 mg/day [n = 118] or a flexible-dose range of 12-42 mg/day [n = 116]) or placebo (n = 119) in Rembrandt and pardoprunox 12-42 mg/day (n = 108), pramipexole 1.5-4.5 mg/day (n = 116), or placebo (n = 110) in Vermeer. Pardoprunox showed a significant benefit over placebo in the primary efficacy variable, least-square mean change from baseline in Unified Parkinson's Disease Rating Scale-Motor score: Rembrandt-fixed doses of 6 and 12 mg/day, -6.0 and -4.7 points, respectively; flexible-dose 12-42 mg/day, -5.5 points; placebo, -2.9 points; Vermeer-flexible-dose 12-42 mg/ day, -4.9 points; placebo, -2.5 points; pramipexole, -5.7 points. No minimum effective dose was established. Secondary efficacy parameters supported the results of the primary efficacy variable. Pardoprunox tolerability was dose related: flexible-dose 12-42 mg/day showed the highest dropout rate due to treatment-emergent adverse events (Rembrandt, 56.0%; Vermeer, 46.3%) and overall incidence of treatment-emergent adverse events (Rembrandt, 97.4%; Vermeer, 92.6%), primarily due to nausea, somnolence, and dizziness. Because pardoprunox showed similar efficacy across all dose groups, these observations suggest that the 12-42 mg/day dose range was higher than therapeutically required. Furthermore, the early onset of treatment-emergent adverse events and dropouts observed for pardoprunox suggest that titration was too rapid. Pardoprunox significantly improved motor symptoms in patients with early Parkinson's disease, but further investigation into the dose and titration schedule is required to improve tolerability.</EA><CC>002B17; 002B17G</CC><FD>Maladie de Parkinson; Pathologie du système nerveux; Pardoprunox; Agoniste partiel; Stimulant dopaminergique</FD><FG>Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central</FG><ED>Parkinson disease; Nervous system diseases; Pardoprunox; Partial agonist; Dopamine agonist</ED><EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG><SD>Parkinson enfermedad; Sistema nervioso patología; Pardoprunox; Agonista parcial; Estimulante dopaminérgico</SD><LO>INIST-20953.354000508552620140</LO><ID>11-0353386</ID></server></inist></record>Pour manipuler ce document sous Unix (Dilib)
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