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 : 000042 ( PubMed/Checkpoint ); précédent : 000041; suivant : 000043Rotigotine 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 ; Erwin Surmann ; Werner PoeweSource :
- Journal of neural transmission (Vienna, Austria : 1996) ; 2013.
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.
DOI: 10.1007/s00702-012-0925-5
PubMed: 23208198
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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.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">23208198</PMID><DateCreated><Year>2013</Year><Month>06</Month><Day>20</Day></DateCreated><DateCompleted><Year>2014</Year><Month>01</Month><Day>29</Day></DateCompleted><DateRevised><Year>2015</Year><Month>10</Month><Day>26</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1435-1463</ISSN><JournalIssue CitedMedium="Internet"><Volume>120</Volume><Issue>7</Issue><PubDate><Year>2013</Year><Month>Jul</Month></PubDate></JournalIssue><Title>Journal of neural transmission (Vienna, Austria : 1996)</Title><ISOAbbreviation>J Neural Transm (Vienna)</ISOAbbreviation></Journal><ArticleTitle>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.</ArticleTitle><Pagination><MedlinePgn>1069-81</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1007/s00702-012-0925-5</ELocationID><Abstract><AbstractText>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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>LeWitt</LastName><ForeName>Peter A</ForeName><Initials>PA</Initials><AffiliationInfo><Affiliation>Department of Neurology, Henry Ford Hospital, Detroit, MI, USA. plewitt1@hfhs.org</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boroojerdi</LastName><ForeName>Babak</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Surmann</LastName><ForeName>Erwin</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Poewe</LastName><ForeName>Werner</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><CollectiveName>SP716 Study Group</CollectiveName></Author><Author ValidYN="Y"><CollectiveName>SP715 Study 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UI="D013876">Thiophenes</NameOfSubstance></Chemical><Chemical><RegistryNumber>92206-54-7</RegistryNumber><NameOfSubstance UI="C047508">N 0437</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Drugs Today (Barc). 2010 Jul;46(7):483-505</RefSource><PMID Version="1">20683503</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet Neurol. 2009 Oct;8(10):929-37</RefSource><PMID Version="1">19709931</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2005 May;20(5):602-10</RefSource><PMID Version="1">15726540</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2000 May 18;342(20):1484-91</RefSource><PMID Version="1">10816186</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>JAMA. 2000 Oct 18;284(15):1931-8</RefSource><PMID 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sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name></noCountry><country name="États-Unis"><region name="Michigan"><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter" last="Lewitt">Peter. 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