Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial.
Identifieur interne : 000101 ( PubMed/Checkpoint ); précédent : 000100; suivant : 000102Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial.
Auteurs : Anthony H V. Schapira [Royaume-Uni] ; Susan H. Fox [Canada] ; Robert A. Hauser ; Joseph Jankovic [États-Unis] ; Wolfgang H. Jost [Allemagne] ; Christopher Kenney [États-Unis] ; Jaime Kulisevsky [Espagne] ; Rajesh Pahwa ; Werner Poewe [Autriche] ; Ravi Anand [Suisse]Source :
- JAMA neurology [ 2168-6157 ] ; 2017.
Abstract
Although levodopa remains the most effective oral pharmacotherapy for Parkinson disease (PD), its use is often limited by wearing off effect and dyskinesias. Management of such complications continues to be a significant challenge.
DOI: 10.1001/jamaneurol.2016.4467
PubMed: 27942720
Affiliations:
- Allemagne, Autriche, Canada, Espagne, Royaume-Uni, Suisse, États-Unis
- Angleterre, Californie, Catalogne, Grand Londres, Ontario, Texas, Tyrol (Land)
- Barcelone, Houston, Innsbruck, Londres, Toronto
- Baylor College of Medicine, Université de Toronto, Université de médecine d'Innsbruck
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Schapira</name><affiliation wicri:level="3"><nlm:affiliation>Department of Clinical Neurosciences, University College London Institute of Neurology, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Clinical Neurosciences, University College London Institute of Neurology, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Fox, Susan H" sort="Fox, Susan H" uniqKey="Fox S" first="Susan H" last="Fox">Susan H. Fox</name><affiliation wicri:level="4"><nlm:affiliation>Department of Medicine, Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. 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Jost</name><affiliation wicri:level="1"><nlm:affiliation>Parkinson-Klinik, Wolfach, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Parkinson-Klinik, Wolfach</wicri:regionArea><wicri:noRegion>Wolfach</wicri:noRegion><wicri:noRegion>Wolfach</wicri:noRegion><wicri:noRegion>Wolfach</wicri:noRegion></affiliation></author><author><name sortKey="Kenney, Christopher" sort="Kenney, Christopher" uniqKey="Kenney C" first="Christopher" last="Kenney">Christopher Kenney</name><affiliation wicri:level="2"><nlm:affiliation>Biotie Therapies Inc, San Francisco, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Biotie Therapies Inc, San Francisco</wicri:cityArea></affiliation></author><author><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name><affiliation wicri:level="3"><nlm:affiliation>Servicio de Neurología, Sant Pau Hospital, Universidad Autonoma de Barcelona, Universitat Oberta de Catalunya, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Servicio de Neurología, Sant Pau Hospital, Universidad Autonoma de Barcelona, Universitat Oberta de Catalunya, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Pahwa, Rajesh" sort="Pahwa, Rajesh" uniqKey="Pahwa R" first="Rajesh" last="Pahwa">Rajesh Pahwa</name><affiliation><nlm:affiliation>Department of Neurology, University of Kansas Medical Center, Kansas City.</nlm:affiliation><wicri:noCountry code="subField">Kansas City</wicri:noCountry></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:affiliation>Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Medical University Innsbruck, Innsbruck</wicri:regionArea><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Anand, Ravi" sort="Anand, Ravi" uniqKey="Anand R" first="Ravi" last="Anand">Ravi Anand</name><affiliation wicri:level="1"><nlm:affiliation>APC, St Moritz, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>APC, St Moritz</wicri:regionArea><wicri:noRegion>St Moritz</wicri:noRegion></affiliation></author></analytic><series><title level="j">JAMA neurology</title><idno type="eISSN">2168-6157</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Although levodopa remains the most effective oral pharmacotherapy for Parkinson disease (PD), its use is often limited by wearing off effect and dyskinesias. Management of such complications continues to be a significant challenge.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27942720</PMID><DateCreated><Year>2016</Year><Month>12</Month><Day>12</Day></DateCreated><DateRevised><Year>2017</Year><Month>02</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2168-6157</ISSN><JournalIssue CitedMedium="Internet"><Volume>74</Volume><Issue>2</Issue><PubDate><Year>2017</Year><Month>Feb</Month><Day>01</Day></PubDate></JournalIssue><Title>JAMA neurology</Title><ISOAbbreviation>JAMA Neurol</ISOAbbreviation></Journal><ArticleTitle>Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial.</ArticleTitle><Pagination><MedlinePgn>216-224</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1001/jamaneurol.2016.4467</ELocationID><Abstract><AbstractText Label="Importance" NlmCategory="UNASSIGNED">Although levodopa remains the most effective oral pharmacotherapy for Parkinson disease (PD), its use is often limited by wearing off effect and dyskinesias. Management of such complications continues to be a significant challenge.</AbstractText><AbstractText Label="Objective" NlmCategory="UNASSIGNED">To investigate the efficacy and safety of safinamide (an oral aminoamide derivative with dopaminergic and nondopaminergic actions) in levodopa-treated patients with motor fluctuations.</AbstractText><AbstractText Label="Design, Setting, and Participants" NlmCategory="UNASSIGNED">From March 5, 2009, through February 23, 2012, patients from academic PD care centers were randomized (1:1 ratio) to receive double-blind adjunctive safinamide or placebo for 24 weeks. All patients had idiopathic PD with "off" time (time when medication effect has worn off and parkinsonian features, including bradykinesia and rigidity, return) of greater than 1.5 hours per day (excluding morning akinesia). Their pharmacotherapy included oral levodopa plus benserazide or carbidopa in a regimen that had been stable for 4 weeks or longer. During screening, each patient's regimen was optimized to minimize motor fluctuations. Study eligibility required that after 4 weeks of optimized treatment, the patients still have more than 1.5 hours per day of off time. Adverse events caused the premature study discontinuation of 12 individuals (4.4%) in the safinamide group and 10 individuals (3.6%) in the placebo group.</AbstractText><AbstractText Label="Interventions" NlmCategory="UNASSIGNED">Patients took safinamide or placebo as 1 tablet daily with breakfast. If no tolerability issues arose by day 14, the starting dose, 50 mg, was increased to 100 mg.</AbstractText><AbstractText Label="Main Outcomes and Measures" NlmCategory="UNASSIGNED">The prespecified primary outcome was each treatment group's mean change from baseline to week 24 (or last "on" treatment value) in daily "on" time (relief of parkinsonian motor features) without troublesome dyskinesia, as assessed from diary data.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">At 119 centers, 549 patients were randomized (mean [SD] age, 61.9 [9.0] years; 334 male [60.8%] and 371 white [67.6%]): 274 to safinamide and 275 to placebo. Among them, 245 (89.4%) receiving safinamide and 241 (87.6%) receiving placebo completed the study. Mean (SD) change in daily on time without troublesome dyskinesia was +1.42 (2.80) hours for safinamide, from a baseline of 9.30 (2.41) hours, vs +0.57 (2.47) hours for placebo, from a baseline of 9.06 (2.50) hours (least-squares mean difference, 0.96 hour; 95% CI, 0.56-1.37 hours; P < .001, analysis of covariance). The most frequently reported adverse event was dyskinesia (in 40 [14.6%] vs 15 [5.5%] and as a severe event in 5 [1.8%] vs 1 [0.4%]).</AbstractText><AbstractText Label="Conclusions and Relevance" NlmCategory="UNASSIGNED">The outcomes of this trial support safinamide as an effective adjunct to levodopa in patients with PD and motor fluctuations to improve on time without troublesome dyskinesia and reduce wearing off.</AbstractText><AbstractText Label="Trial Registration" NlmCategory="UNASSIGNED">clinicaltrials.gov Identifier NCT00627640.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Schapira</LastName><ForeName>Anthony H V</ForeName><Initials>AH</Initials><AffiliationInfo><Affiliation>Department of Clinical Neurosciences, University College London Institute of Neurology, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fox</LastName><ForeName>Susan H</ForeName><Initials>SH</Initials><AffiliationInfo><Affiliation>Department of Medicine, Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>Department of Neurology, University of South Florida College of Medicine, Tampa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jankovic</LastName><ForeName>Joseph</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jost</LastName><ForeName>Wolfgang H</ForeName><Initials>WH</Initials><AffiliationInfo><Affiliation>Parkinson-Klinik, Wolfach, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kenney</LastName><ForeName>Christopher</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Biotie Therapies Inc, San Francisco, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kulisevsky</LastName><ForeName>Jaime</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Servicio de Neurología, Sant Pau Hospital, Universidad Autonoma de Barcelona, Universitat Oberta de Catalunya, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pahwa</LastName><ForeName>Rajesh</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Department of Neurology, University of Kansas Medical Center, Kansas City.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Poewe</LastName><ForeName>Werner</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Anand</LastName><ForeName>Ravi</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>APC, St Moritz, Switzerland.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00627640</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>JAMA Neurol</MedlineTA><NlmUniqueID>101589536</NlmUniqueID><ISSNLinking>2168-6149</ISSNLinking></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>12</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>12</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>12</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27942720</ArticleId><ArticleId IdType="pii">2591318</ArticleId><ArticleId IdType="doi">10.1001/jamaneurol.2016.4467</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Autriche</li><li>Canada</li><li>Espagne</li><li>Royaume-Uni</li><li>Suisse</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Californie</li><li>Catalogne</li><li>Grand Londres</li><li>Ontario</li><li>Texas</li><li>Tyrol (Land)</li></region><settlement><li>Barcelone</li><li>Houston</li><li>Innsbruck</li><li>Londres</li><li>Toronto</li></settlement><orgName><li>Baylor College of Medicine</li><li>Université de Toronto</li><li>Université de médecine d'Innsbruck</li></orgName></list><tree><noCountry><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><name sortKey="Pahwa, Rajesh" sort="Pahwa, Rajesh" uniqKey="Pahwa R" first="Rajesh" last="Pahwa">Rajesh Pahwa</name></noCountry><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H V" last="Schapira">Anthony H V. Schapira</name></region></country><country name="Canada"><region name="Ontario"><name sortKey="Fox, Susan H" sort="Fox, Susan H" uniqKey="Fox S" first="Susan H" last="Fox">Susan H. Fox</name></region></country><country name="États-Unis"><region name="Texas"><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name></region><name sortKey="Kenney, Christopher" sort="Kenney, Christopher" uniqKey="Kenney C" first="Christopher" last="Kenney">Christopher Kenney</name></country><country name="Allemagne"><noRegion><name sortKey="Jost, Wolfgang H" sort="Jost, Wolfgang H" uniqKey="Jost W" first="Wolfgang H" last="Jost">Wolfgang H. Jost</name></noRegion></country><country name="Espagne"><region name="Catalogne"><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name></region></country><country name="Autriche"><region name="Tyrol (Land)"><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></region></country><country name="Suisse"><noRegion><name sortKey="Anand, Ravi" sort="Anand, Ravi" uniqKey="Anand R" first="Ravi" last="Anand">Ravi Anand</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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