Rotigotine transdermal system for long-term treatment of patients with advanced Parkinson’s disease: results of two open-label extension studies, CLEOPATRA-PD and PREFER
Identifieur interne : 000386 ( Ncbi/Checkpoint ); précédent : 000385; suivant : 000387Rotigotine transdermal system for long-term treatment of patients with advanced Parkinson’s disease: results of two open-label extension studies, CLEOPATRA-PD and PREFER
Auteurs : Peter Lewitt [États-Unis] ; Babak Boroojerdi [États-Unis] ; Erwin Surmann [Allemagne] ; Werner Poewe [Autriche]Source :
- Journal of Neural Transmission [ 0300-9564 ] ; 2012.
English descriptors
- KwdEn :
- Activities of Daily Living, Administration, Cutaneous, Adult, Aged, Aged, 80 and over, Dopamine Agonists (administration & dosage), Double-Blind Method, Female, Humans, Longitudinal Studies, Male, Middle Aged, Outcome Assessment (Health Care), Parkinson Disease (complications), Parkinson Disease (drug therapy), Parkinson Disease (psychology), Severity of Illness Index, Tetrahydronaphthalenes (administration & dosage), Thiophenes (administration & dosage), Time Factors.
- MESH :
- chemical , administration & dosage : Dopamine Agonists, Tetrahydronaphthalenes, Thiophenes.
- complications : Parkinson Disease.
- drug therapy : Parkinson Disease.
- psychology : Parkinson Disease.
- Activities of Daily Living, Administration, Cutaneous, Adult, Aged, Aged, 80 and over, Double-Blind Method, Female, Humans, Longitudinal Studies, Male, Middle Aged, Outcome Assessment (Health Care), Severity of Illness Index, Time Factors.
Abstract
Open-label extensions [studies SP516 (NCT00501969) and SP715 (NCT00594386)] of the CLEOPATRA-PD and PREFER studies were conducted to evaluate the safety, tolerability and efficacy of the dopaminergic agonist, rotigotine, over several years of follow-up in patients with advanced Parkinson’s disease (PD). Eligible subjects completing the double-blind trials received open-label adjunctive rotigotine (≤16 mg/24 h) for up to 4 and 6 years in Studies SP516 and SP715, respectively. Safety and tolerability were assessed using adverse events, vital signs and laboratory parameters, and efficacy assessed using the unified Parkinson’s disease rating scale (UPDRS). Of the 395 and 258 patients enrolled in the SP516 and SP715 studies, 48 and 45 % completed, respectively. Adverse events were typically dopaminergic effects [e.g., somnolence (18–25 %/patient-year), insomnia (5–7 %/patient-year), dyskinesias (4–8 %/patient-year) and hallucinations (4–8 %/patient-year)], or related to the transdermal application of a patch (application site reactions: 14–15 %/patient-year). There were no clinically relevant changes in vital signs or laboratory parameters in either study. Mean UPDRS part II (activities of daily living) and part III (motor function) total scores improved from double-blind baseline during dose titration, then gradually declined over the maintenance period. In study SP516, mean UPDRS part II and III total scores were 0.8 points above and 2.8 points below double-blind baseline, respectively, at end of treatment. In study SP715, mean UPDRS part II and III total scores were 4.1 points above and 0.2 points below baseline, respectively, at end of treatment. In these open-label studies, adjunctive rotigotine was efficacious with an acceptable safety and tolerability profile in patients with advanced PD for up to 6 years.
Url:
DOI: 10.1007/s00702-012-0925-5
PubMed: 23208198
PubMed Central: 3687107
Affiliations:
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PMC:3687107Le document en format XML
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Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><affiliation wicri:level="2"><nlm:aff id="Aff3">UCB Pharma, Raleigh, NC USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>UCB Pharma, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name><affiliation wicri:level="1"><nlm:aff id="Aff4">UCB Pharma, Monheim, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>UCB Pharma, Monheim</wicri:regionArea><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>Monheim</wicri:noRegion></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" 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USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Department of Neurology, Wayne State University School of Medicine, Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><affiliation wicri:level="2"><nlm:aff id="Aff3">UCB Pharma, Raleigh, NC USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>UCB Pharma, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name><affiliation wicri:level="1"><nlm:aff id="Aff4">UCB Pharma, Monheim, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>UCB Pharma, Monheim</wicri:regionArea><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>Monheim</wicri:noRegion></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Medical University of Innsbruck, Innsbruck, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Medical University of Innsbruck, Innsbruck</wicri:regionArea><wicri:noRegion>Innsbruck</wicri:noRegion></affiliation></author></analytic><series><title level="j">Journal of Neural Transmission</title><idno type="ISSN">0300-9564</idno><idno type="e-ISSN">1435-1463</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Activities of Daily Living</term><term>Administration, Cutaneous</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Dopamine Agonists (administration & dosage)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Outcome Assessment (Health Care)</term><term>Parkinson Disease (complications)</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (psychology)</term><term>Severity of Illness Index</term><term>Tetrahydronaphthalenes (administration & dosage)</term><term>Thiophenes (administration & dosage)</term><term>Time Factors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Dopamine Agonists</term><term>Tetrahydronaphthalenes</term><term>Thiophenes</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Activities of Daily Living</term><term>Administration, Cutaneous</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Outcome Assessment (Health Care)</term><term>Severity of Illness Index</term><term>Time Factors</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Open-label extensions [studies SP516 (NCT00501969) and SP715 (NCT00594386)] of the CLEOPATRA-PD and PREFER studies were conducted to evaluate the safety, tolerability and efficacy of the dopaminergic agonist, rotigotine, over several years of follow-up in patients with advanced Parkinson’s disease (PD). Eligible subjects completing the double-blind trials received open-label adjunctive rotigotine (≤16 mg/24 h) for up to 4 and 6 years in Studies SP516 and SP715, respectively. Safety and tolerability were assessed using adverse events, vital signs and laboratory parameters, and efficacy assessed using the unified Parkinson’s disease rating scale (UPDRS). Of the 395 and 258 patients enrolled in the SP516 and SP715 studies, 48 and 45 % completed, respectively. Adverse events were typically dopaminergic effects [e.g., somnolence (18–25 %/patient-year), insomnia (5–7 %/patient-year), dyskinesias (4–8 %/patient-year) and hallucinations (4–8 %/patient-year)], or related to the transdermal application of a patch (application site reactions: 14–15 %/patient-year). There were no clinically relevant changes in vital signs or laboratory parameters in either study. Mean UPDRS part II (activities of daily living) and part III (motor function) total scores improved from double-blind baseline during dose titration, then gradually declined over the maintenance period. In study SP516, mean UPDRS part II and III total scores were 0.8 points above and 2.8 points below double-blind baseline, respectively, at end of treatment. In study SP715, mean UPDRS part II and III total scores were 4.1 points above and 0.2 points below baseline, respectively, at end of treatment. In these open-label studies, adjunctive rotigotine was efficacious with an acceptable safety and tolerability profile in patients with advanced PD for up to 6 years.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Antonini, A" uniqKey="Antonini A">A Antonini</name></author><author><name sortKey="Tolosa, E" uniqKey="Tolosa E">E Tolosa</name></author><author><name sortKey="Mizuno, Y" uniqKey="Mizuno Y">Y Mizuno</name></author><author><name sortKey="Yamamoto, M" uniqKey="Yamamoto M">M Yamamoto</name></author><author><name sortKey="Poewe, Wh" uniqKey="Poewe W">WH Poewe</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Boroojerdi, B" uniqKey="Boroojerdi B">B Boroojerdi</name></author><author><name sortKey="Wolff, Hm" uniqKey="Wolff H">HM Wolff</name></author><author><name sortKey="Braun, M" uniqKey="Braun M">M Braun</name></author><author><name sortKey="Scheller, Dk" uniqKey="Scheller D">DK Scheller</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Giladi, N" uniqKey="Giladi N">N Giladi</name></author><author><name sortKey="Boroojerdi, B" uniqKey="Boroojerdi B">B Boroojerdi</name></author><author><name sortKey="Korczyn, Ad" uniqKey="Korczyn A">AD Korczyn</name></author><author><name sortKey="Burn, Dj" uniqKey="Burn D">DJ Burn</name></author><author><name sortKey="Clarke, Ce" uniqKey="Clarke C">CE Clarke</name></author><author><name sortKey="Schapira, Ah" uniqKey="Schapira A">AH Schapira</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hauser, Ra" uniqKey="Hauser R">RA Hauser</name></author><author><name sortKey="Rascol, O" uniqKey="Rascol O">O Rascol</name></author><author><name sortKey="Korczyn, Ad" uniqKey="Korczyn A">AD Korczyn</name></author><author><name sortKey="Jon Stoessl, A" uniqKey="Jon Stoessl A">A Jon Stoessl</name></author><author><name sortKey="Watts, Rl" uniqKey="Watts R">RL Watts</name></author><author><name sortKey="Poewe, W" uniqKey="Poewe W">W Poewe</name></author><author><name sortKey="De Deyn, Pp" uniqKey="De Deyn P">PP De Deyn</name></author><author><name sortKey="Lang, Ae" uniqKey="Lang A">AE Lang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Holloway, Rg" uniqKey="Holloway R">RG Holloway</name></author><author><name sortKey="Shoulson, I" uniqKey="Shoulson I">I Shoulson</name></author><author><name sortKey="Fahn, S" uniqKey="Fahn S">S Fahn</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jankovic, J" uniqKey="Jankovic J">J Jankovic</name></author><author><name sortKey="Watts, Rl" uniqKey="Watts R">RL Watts</name></author><author><name sortKey="Martin, W" uniqKey="Martin W">W Martin</name></author><author><name sortKey="Boroojerdi, B" uniqKey="Boroojerdi B">B Boroojerdi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jenner, P" uniqKey="Jenner P">P Jenner</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lewitt, Pa" uniqKey="Lewitt P">PA LeWitt</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lewitt, P" uniqKey="Lewitt P">P LeWitt</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lewitt, Pa" uniqKey="Lewitt P">PA LeWitt</name></author><author><name sortKey="Lyons, Ke" uniqKey="Lyons K">KE Lyons</name></author><author><name sortKey="Pahwa, R" uniqKey="Pahwa R">R Pahwa</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Moller, Jc" uniqKey="Moller J">JC Möller</name></author><author><name sortKey="Oertel, Wh" uniqKey="Oertel W">WH Oertel</name></author><author><name sortKey="Koster, J" uniqKey="Koster J">J Köster</name></author><author><name sortKey="Pezzoli, G" uniqKey="Pezzoli G">G Pezzoli</name></author><author><name sortKey="Provinciali, L" uniqKey="Provinciali L">L Provinciali</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nutt, Jg" uniqKey="Nutt J">JG Nutt</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Olanow, Cw" uniqKey="Olanow C">CW Olanow</name></author><author><name sortKey="Obeso, Ja" uniqKey="Obeso J">JA Obeso</name></author><author><name sortKey="Stocchi, F" uniqKey="Stocchi F">F Stocchi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Pahwa, R" uniqKey="Pahwa R">R Pahwa</name></author><author><name sortKey="Poewe, Wh" uniqKey="Poewe W">WH Poewe</name></author><author><name sortKey="Lyons, Ke" uniqKey="Lyons K">KE Lyons</name></author><author><name sortKey="Boroojerdi, B" uniqKey="Boroojerdi B">B Boroojerdi</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Pham, Dq" uniqKey="Pham D">DQ Pham</name></author><author><name sortKey="Nogid, A" uniqKey="Nogid A">A Nogid</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Poewe, Wh" uniqKey="Poewe W">WH Poewe</name></author><author><name sortKey="Rascol, O" uniqKey="Rascol O">O Rascol</name></author><author><name sortKey="Quinn, N" uniqKey="Quinn N">N Quinn</name></author><author><name sortKey="Tolosa, E" uniqKey="Tolosa E">E Tolosa</name></author><author><name sortKey="Oertel, Wh" uniqKey="Oertel W">WH Oertel</name></author><author><name sortKey="Martignoni, E" uniqKey="Martignoni E">E Martignoni</name></author><author><name sortKey="Rupp, M" uniqKey="Rupp M">M Rupp</name></author><author><name sortKey="Boroojerdi, B" uniqKey="Boroojerdi B">B Boroojerdi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rascol, O" uniqKey="Rascol O">O Rascol</name></author><author><name sortKey="Perez Lloret, S" uniqKey="Perez Lloret S">S Perez-Lloret</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rascol, O" uniqKey="Rascol O">O Rascol</name></author><author><name sortKey="Brooks, Dj" uniqKey="Brooks D">DJ Brooks</name></author><author><name sortKey="Korczyn, Ad" uniqKey="Korczyn A">AD Korczyn</name></author><author><name sortKey="De Deyn, Pp" uniqKey="De Deyn P">PP De Deyn</name></author><author><name sortKey="Clarke, Ce" uniqKey="Clarke C">CE Clarke</name></author><author><name sortKey="Lang, Ae" uniqKey="Lang A">AE Lang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Trenkwalder, C" uniqKey="Trenkwalder C">C Trenkwalder</name></author><author><name sortKey="Kies, B" uniqKey="Kies B">B Kies</name></author><author><name sortKey="Rudzinska, M" uniqKey="Rudzinska M">M Rudzinska</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Watts, Rl" uniqKey="Watts R">RL Watts</name></author><author><name sortKey="Jankovic, J" uniqKey="Jankovic J">J Jankovic</name></author><author><name sortKey="Waters, C" uniqKey="Waters C">C Waters</name></author><author><name sortKey="Rajput, A" uniqKey="Rajput A">A Rajput</name></author><author><name sortKey="Boroojerdi, B" uniqKey="Boroojerdi B">B Boroojerdi</name></author><author><name sortKey="Rao, J" uniqKey="Rao J">J Rao</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Autriche</li><li>États-Unis</li></country><region><li>Caroline du Nord</li><li>Michigan</li></region></list><tree><country name="États-Unis"><region name="Michigan"><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter" last="Lewitt">Peter Lewitt</name></region><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter" last="Lewitt">Peter Lewitt</name></country><country name="Allemagne"><noRegion><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name></noRegion></country><country name="Autriche"><noRegion><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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