The safety and efficacy of safinamide mesylate for the treatment of Parkinson's disease.
Identifieur interne : 000218 ( PubMed/Corpus ); précédent : 000217; suivant : 000219The safety and efficacy of safinamide mesylate for the treatment of Parkinson's disease.
Auteurs : Santiago Perez-Lloret ; Olivier RascolSource :
- Expert review of neurotherapeutics [ 1744-8360 ] ; 2016.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Alanine, Benzylamines, Monoamine Oxidase Inhibitors.
- chemical , analogs & derivatives : Alanine.
- chemical , pharmacology : Alanine, Benzylamines, Monoamine Oxidase Inhibitors.
- drug therapy : Parkinson Disease.
- Animals, Humans.
Abstract
Safinamide (brand name Xadago®, Zambon S.p.A) is a third-generation reversible MAO-B inhibitor, which also blocks sodium voltage-sensitive channels and modulates stimulated release of glutamate. Safinamide was recently licensed by EMA for the treatment of PD as add-on therapy to a stable dose of levodopa alone or in combination with other PD medicinal products in mid-to advanced-stage fluctuating patients. It is also under review by the US FDA. Studies in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-treated monkeys and 6OHDA-lesioned rats suggest antiparkinsonian efficacy and antidyskinesic effects. Randomized, double-blind, placebo-controlled trials have shown efficacy for the treatment of motor symptoms in stable PD patients on dopamine agonists and in fluctuating PD patients on levodopa. Significant improvement in daily ON time was also observed in the latter. This effect was maintained for at least 2 years in double-blind conditions and, interestingly, without significant worsening of dyskinesia. Clinical studies have not detected any specific safety issue other than those already known with MAO-B inhibitors.
DOI: 10.1586/14737175.2016.1150783
PubMed: 26849427
Links to Exploration step
pubmed:26849427Le document en format XML
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Safinamide was recently licensed by EMA for the treatment of PD as add-on therapy to a stable dose of levodopa alone or in combination with other PD medicinal products in mid-to advanced-stage fluctuating patients. It is also under review by the US FDA. Studies in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-treated monkeys and 6OHDA-lesioned rats suggest antiparkinsonian efficacy and antidyskinesic effects. Randomized, double-blind, placebo-controlled trials have shown efficacy for the treatment of motor symptoms in stable PD patients on dopamine agonists and in fluctuating PD patients on levodopa. Significant improvement in daily ON time was also observed in the latter. This effect was maintained for at least 2 years in double-blind conditions and, interestingly, without significant worsening of dyskinesia. Clinical studies have not detected any specific safety issue other than those already known with MAO-B inhibitors.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26849427</PMID><DateCreated><Year>2016</Year><Month>02</Month><Day>27</Day></DateCreated><DateCompleted><Year>2016</Year><Month>12</Month><Day>13</Day></DateCompleted><DateRevised><Year>2016</Year><Month>12</Month><Day>30</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1744-8360</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><Issue>3</Issue><PubDate><Year>2016</Year></PubDate></JournalIssue><Title>Expert review of neurotherapeutics</Title><ISOAbbreviation>Expert Rev Neurother</ISOAbbreviation></Journal><ArticleTitle>The safety and efficacy of safinamide mesylate for the treatment of Parkinson's disease.</ArticleTitle><Pagination><MedlinePgn>245-58</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1586/14737175.2016.1150783</ELocationID><Abstract><AbstractText>Safinamide (brand name Xadago®, Zambon S.p.A) is a third-generation reversible MAO-B inhibitor, which also blocks sodium voltage-sensitive channels and modulates stimulated release of glutamate. Safinamide was recently licensed by EMA for the treatment of PD as add-on therapy to a stable dose of levodopa alone or in combination with other PD medicinal products in mid-to advanced-stage fluctuating patients. It is also under review by the US FDA. Studies in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-treated monkeys and 6OHDA-lesioned rats suggest antiparkinsonian efficacy and antidyskinesic effects. Randomized, double-blind, placebo-controlled trials have shown efficacy for the treatment of motor symptoms in stable PD patients on dopamine agonists and in fluctuating PD patients on levodopa. Significant improvement in daily ON time was also observed in the latter. This effect was maintained for at least 2 years in double-blind conditions and, interestingly, without significant worsening of dyskinesia. Clinical studies have not detected any specific safety issue other than those already known with MAO-B inhibitors.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Perez-Lloret</LastName><ForeName>Santiago</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>a Institute of Cardiologic Research, National Scientific and Research Council (ININCA-CONICET), Faculty of Medicine , University of Buenos Aires , Buenos Aires , Argentina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rascol</LastName><ForeName>Olivier</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>b Department of Clinical Pharmacology and Neurosciences , NeuroToul Excellence Center for Neurodegenerative Disorders, University Hospital and University of Toulouse 3 , Toulouse , France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>c INSERM CIC1436 and UMR825 , Toulouse , France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>d NS-Park Network, INSERM , Toulouse , France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>02</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Expert Rev Neurother</MedlineTA><NlmUniqueID>101129944</NlmUniqueID><ISSNLinking>1473-7175</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001596">Benzylamines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D008996">Monoamine Oxidase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>90ENL74SIG</RegistryNumber><NameOfSubstance UI="C092797">safinamide</NameOfSubstance></Chemical><Chemical><RegistryNumber>OF5P57N2ZX</RegistryNumber><NameOfSubstance UI="D000409">Alanine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000409" MajorTopicYN="N">Alanine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName><QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000818" MajorTopicYN="N">Animals</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001596" MajorTopicYN="N">Benzylamines</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008996" MajorTopicYN="N">Monoamine Oxidase Inhibitors</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010300" MajorTopicYN="N">Parkinson Disease</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">MAO-B inhibitors</Keyword><Keyword MajorTopicYN="N">Parkinson’s disease</Keyword><Keyword MajorTopicYN="N">antiparkinsonian treatment</Keyword><Keyword MajorTopicYN="N">dopamine agonists</Keyword><Keyword MajorTopicYN="N">dyskinesia</Keyword><Keyword MajorTopicYN="N">levodopa</Keyword><Keyword MajorTopicYN="N">motor fluctuations</Keyword><Keyword MajorTopicYN="N">safinamide</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>2</Month><Day>6</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>2</Month><Day>6</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>12</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26849427</ArticleId><ArticleId IdType="doi">10.1586/14737175.2016.1150783</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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