Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial.
Identifieur interne : 000015 ( PubMed/Checkpoint ); précédent : 000014; suivant : 000016Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial.
Auteurs : Andrew J. Lees [Royaume-Uni] ; Joaquim Ferreira [Portugal] ; Olivier Rascol [France] ; Werner Poewe [Autriche] ; José-Francisco Rocha [Portugal] ; Michelle Mccrory [Irlande (pays)] ; Patricio Soares-Da-Silva [Portugal]Source :
- JAMA neurology [ 2168-6157 ] ; 2017.
Abstract
Catechol O-methyltransferase (COMT) inhibitors are an established treatment for end-of-dose motor fluctuations associated with levodopa therapy in patients with Parkinson disease (PD). Current COMT inhibitors carry a high risk for toxic effects to hepatic cells or show moderate improvement. Opicapone was designed to be effective without the adverse effects.
DOI: 10.1001/jamaneurol.2016.4703
PubMed: 28027332
Affiliations:
- Autriche, France, Irlande (pays), Portugal, Royaume-Uni
- Angleterre, Midi-Pyrénées, Occitanie (région administrative), Tyrol (Land)
- Innsbruck, Toulouse
- Université de médecine d'Innsbruck
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Lees</name><affiliation wicri:level="2"><nlm:affiliation>Reta Lila Weston Institute, University College London, London, England.</nlm:affiliation><country>Royaume-Uni</country><placeName><region type="country">Angleterre</region></placeName><wicri:cityArea>Reta Lila Weston Institute, University College London, London</wicri:cityArea></affiliation></author><author><name sortKey="Ferreira, Joaquim" sort="Ferreira, Joaquim" uniqKey="Ferreira J" first="Joaquim" last="Ferreira">Joaquim Ferreira</name><affiliation wicri:level="1"><nlm:affiliation>Centro de Estudos Egas Moniz, Hospital de Santa Maria, Lisbon, Portugal.</nlm:affiliation><country xml:lang="fr">Portugal</country><wicri:regionArea>Centro de Estudos Egas Moniz, Hospital de Santa Maria, Lisbon</wicri:regionArea><wicri:noRegion>Lisbon</wicri:noRegion></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation 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Lees</name><affiliation wicri:level="2"><nlm:affiliation>Reta Lila Weston Institute, University College London, London, England.</nlm:affiliation><country>Royaume-Uni</country><placeName><region type="country">Angleterre</region></placeName><wicri:cityArea>Reta Lila Weston Institute, University College London, London</wicri:cityArea></affiliation></author><author><name sortKey="Ferreira, Joaquim" sort="Ferreira, Joaquim" uniqKey="Ferreira J" first="Joaquim" last="Ferreira">Joaquim Ferreira</name><affiliation wicri:level="1"><nlm:affiliation>Centro de Estudos Egas Moniz, Hospital de Santa Maria, Lisbon, Portugal.</nlm:affiliation><country xml:lang="fr">Portugal</country><wicri:regionArea>Centro de Estudos Egas Moniz, Hospital de Santa Maria, Lisbon</wicri:regionArea><wicri:noRegion>Lisbon</wicri:noRegion></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="3"><nlm:affiliation>Department of Clinical Pharmacology, Institut National de la Santé et de la Recherche Medicale (INSERM) and University Hospital of Toulouse, Toulouse, France4Department of Neurosciences, INSERM and University Hospital of Toulouse, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Pharmacology, Institut National de la Santé et de la Recherche Medicale (INSERM) and University Hospital of Toulouse, Toulouse, France4Department of Neurosciences, INSERM and University Hospital of Toulouse, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></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, Innsbruck Medical University, Innsbruck, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Innsbruck Medical University, 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="Rocha, Jose Francisco" sort="Rocha, Jose Francisco" uniqKey="Rocha J" first="José-Francisco" last="Rocha">José-Francisco Rocha</name><affiliation wicri:level="1"><nlm:affiliation>Department of Research and Development, BIAL-Portela & Ca SA, Sao Mamede do Coronado, Portugal.</nlm:affiliation><country xml:lang="fr">Portugal</country><wicri:regionArea>Department of Research and Development, BIAL-Portela & Ca SA, Sao Mamede do Coronado</wicri:regionArea><wicri:noRegion>Sao Mamede do Coronado</wicri:noRegion></affiliation></author><author><name sortKey="Mccrory, Michelle" sort="Mccrory, Michelle" uniqKey="Mccrory M" first="Michelle" last="Mccrory">Michelle Mccrory</name><affiliation wicri:level="1"><nlm:affiliation>Quintiles, Dublin, Ireland.</nlm:affiliation><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>Quintiles, Dublin</wicri:regionArea><wicri:noRegion>Dublin</wicri:noRegion></affiliation></author><author><name sortKey="Soares Da Silva, Patricio" sort="Soares Da Silva, Patricio" uniqKey="Soares Da Silva P" first="Patricio" last="Soares-Da-Silva">Patricio Soares-Da-Silva</name><affiliation wicri:level="1"><nlm:affiliation>Department of Research and Development, BIAL-Portela & Ca SA, Sao Mamede do Coronado, Portugal8Department of Pharmacology and Therapeutics, University Porto, Porto, Portugal.</nlm:affiliation><country xml:lang="fr">Portugal</country><wicri:regionArea>Department of Research and Development, BIAL-Portela & Ca SA, Sao Mamede do Coronado, Portugal8Department of Pharmacology and Therapeutics, University Porto, Porto</wicri:regionArea><wicri:noRegion>Porto</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">Catechol O-methyltransferase (COMT) inhibitors are an established treatment for end-of-dose motor fluctuations associated with levodopa therapy in patients with Parkinson disease (PD). Current COMT inhibitors carry a high risk for toxic effects to hepatic cells or show moderate improvement. Opicapone was designed to be effective without the adverse effects.</div></front></TEI><pubmed><MedlineCitation Status="In-Data-Review" Owner="NLM"><PMID Version="1">28027332</PMID><DateCreated><Year>2016</Year><Month>12</Month><Day>27</Day></DateCreated><DateRevised><Year>2017</Year><Month>02</Month><Day>13</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>Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial.</ArticleTitle><Pagination><MedlinePgn>197-206</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1001/jamaneurol.2016.4703</ELocationID><Abstract><AbstractText Label="Importance" NlmCategory="UNASSIGNED">Catechol O-methyltransferase (COMT) inhibitors are an established treatment for end-of-dose motor fluctuations associated with levodopa therapy in patients with Parkinson disease (PD). Current COMT inhibitors carry a high risk for toxic effects to hepatic cells or show moderate improvement. Opicapone was designed to be effective without the adverse effects.</AbstractText><AbstractText Label="Objective" NlmCategory="UNASSIGNED">To evaluate the efficacy and safety of 25- and 50-mg/d dosages of opicapone compared with placebo as adjunct to levodopa therapy in patients with PD experiencing end-of-dose motor fluctuations.</AbstractText><AbstractText Label="Design" NlmCategory="UNASSIGNED">This phase 3 international, multicenter outpatient study evaluated a 25- and a 50-mg/d dosage of opicapone in a randomized, double-blind, 14- to 15-week, placebo-controlled clinical trial, followed by a 1-year open-label phase during which all patients received active treatment with opicapone. Patients with PD who experienced signs of end-of-dose deterioration and had a mean total awake off-time (state of akinesia or decreased mobility) of at least 1.5 hours, not including morning akinesia, were enrolled. Data were collected from March 18, 2011, through June 25, 2013. Data from the evaluable population were analyzed from July 31, 2013, to July 31, 2014.</AbstractText><AbstractText Label="Main Outcomes and Measures" NlmCategory="UNASSIGNED">The primary efficacy outcome of the double-blind phase was the change from baseline in absolute off-time vs placebo based on patient diaries. The open-label phase focused on maintenance of treatment effect in off-time.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">A total of 427 patients (258 men [60.4%] and 169 women [39.6%]; mean [SD] age, 63.1 [8.8] years) were randomized to a 25-mg/d (n = 129) or a 50-mg/d (n = 154) dosage of opicapone or to placebo (n = 144). Of these, 376 patients completed the double-blind phase and entered the open-label phase, of whom 286 completed 1 year of open-label treatment. At the end of the double-blind phase, the least squares mean change (SE) in off-time was -64.5 (14.4) minutes for the placebo group, -101.7 (14.9) minutes for the 25-mg/d opicapone group, and -118.8 (13.8) minutes for the 50-mg/d opicapone group. The adjusted treatment difference vs placebo was significant for the 50-mg/d opicapone group (treatment effect, -54.3 [95% CI, -96.2 to -12.4] minutes; P = .008), but not for the 25-mg/d opicapone group (treatment effect, -37.2 [95% CI, -80.8 to 6.4] minutes; P = .11). The off-time reduction was sustained throughout the open-label phase (-126.3 minutes at 1-year open-label end point). The most common adverse events in the opicapone vs placebo groups were dyskinesia, constipation, and dry mouth. Fifty-one patients (11.9%) discontinued from the study during the double-blind phase.</AbstractText><AbstractText Label="Conclusions and Relevance" NlmCategory="UNASSIGNED">Treatment with a 50-mg once-daily dose of opicapone was associated with a significant reduction in mean daily off-time in levodopa-treated patients with PD and motor fluctuations, and this effect is maintained for at least 1 year. Opicapone was safe and well tolerated.</AbstractText><AbstractText Label="Trial Registration" NlmCategory="UNASSIGNED">clinicaltrials.gov Identifier: NCT01227655.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lees</LastName><ForeName>Andrew J</ForeName><Initials>AJ</Initials><AffiliationInfo><Affiliation>Reta Lila Weston Institute, University College London, London, England.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ferreira</LastName><ForeName>Joaquim</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Centro de Estudos Egas Moniz, Hospital de Santa Maria, Lisbon, Portugal.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rascol</LastName><ForeName>Olivier</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Department of Clinical Pharmacology, Institut National de la Santé et de la Recherche Medicale (INSERM) and University Hospital of Toulouse, Toulouse, France4Department of Neurosciences, INSERM and University Hospital of Toulouse, Toulouse, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Poewe</LastName><ForeName>Werner</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rocha</LastName><ForeName>José-Francisco</ForeName><Initials>JF</Initials><AffiliationInfo><Affiliation>Department of Research and Development, BIAL-Portela & Ca SA, Sao Mamede do Coronado, Portugal.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McCrory</LastName><ForeName>Michelle</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Quintiles, Dublin, Ireland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Soares-da-Silva</LastName><ForeName>Patricio</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Research and Development, BIAL-Portela & Ca SA, Sao Mamede do Coronado, Portugal8Department of Pharmacology and Therapeutics, University Porto, Porto, Portugal.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>BIPARK-2 Study Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="">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>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>12</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>12</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28027332</ArticleId><ArticleId IdType="pii">2594535</ArticleId><ArticleId IdType="doi">10.1001/jamaneurol.2016.4703</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Autriche</li><li>France</li><li>Irlande (pays)</li><li>Portugal</li><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Tyrol (Land)</li></region><settlement><li>Innsbruck</li><li>Toulouse</li></settlement><orgName><li>Université de médecine d'Innsbruck</li></orgName></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Lees, Andrew J" sort="Lees, Andrew J" uniqKey="Lees A" first="Andrew J" last="Lees">Andrew J. Lees</name></region></country><country name="Portugal"><noRegion><name sortKey="Ferreira, Joaquim" sort="Ferreira, Joaquim" uniqKey="Ferreira J" first="Joaquim" last="Ferreira">Joaquim Ferreira</name></noRegion><name sortKey="Rocha, Jose Francisco" sort="Rocha, Jose Francisco" uniqKey="Rocha J" first="José-Francisco" last="Rocha">José-Francisco Rocha</name><name sortKey="Soares Da Silva, Patricio" sort="Soares Da Silva, Patricio" uniqKey="Soares Da Silva P" first="Patricio" last="Soares-Da-Silva">Patricio Soares-Da-Silva</name></country><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</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="Irlande (pays)"><noRegion><name sortKey="Mccrory, Michelle" sort="Mccrory, Michelle" uniqKey="Mccrory M" first="Michelle" last="Mccrory">Michelle Mccrory</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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