Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease.
Identifieur interne : 000443 ( PubMed/Corpus ); précédent : 000442; suivant : 000444Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease.
Auteurs : Rupam Borgohain ; Jozsef Szasz ; Paolo Stanzione ; Chandrashekhar Meshram ; Mohit H. Bhatt ; Dana Chirilineau ; Fabrizio Stocchi ; Valentina Lucini ; Rodolfo Giuliani ; Emma Forrest ; Patricia Rice ; Ravi AnandSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2014.
English descriptors
- KwdEn :
- Aged, Alanine (analogs & derivatives), Alanine (therapeutic use), Antiparkinson Agents (therapeutic use), Benzylamines (therapeutic use), Dose-Response Relationship, Drug, Double-Blind Method, Dyskinesia, Drug-Induced, Female, Humans, International Cooperation, Levodopa (therapeutic use), Longitudinal Studies, Male, Middle Aged, Parkinson Disease (drug therapy), Treatment Outcome.
- MESH :
- chemical , analogs & derivatives : Alanine.
- chemical , therapeutic use : Alanine, Antiparkinson Agents, Benzylamines, Levodopa.
- drug therapy : Parkinson Disease.
- Aged, Dose-Response Relationship, Drug, Double-Blind Method, Dyskinesia, Drug-Induced, Female, Humans, International Cooperation, Longitudinal Studies, Male, Middle Aged, Treatment Outcome.
Abstract
In a 6-month double-blind, placebo-controlled study of Parkinson's disease patients with motor fluctuations, safinamide 50 and 100 mg/d significantly increased ON-time without increasing dyskinesia. Further long-term safinamide use in these patients was evaluated over an additional 18 months. Patients continued on their randomized placebo, 50, or 100 mg/d safinamide. The primary endpoint was change in Dyskinesia Rating Scale total score during ON-time over 24 months. Other efficacy endpoints included change in ON-time without troublesome dyskinesia, changes in individual diary categories, depressive symptoms, and quality of life measures. Change in Dyskinesia Rating Scale was not significantly different in safinamide versus placebo groups, despite decreased mean total Dyskinesia Rating Scale with safinamide compared with an almost unchanged score in placebo. Ad hoc subgroup analysis of moderate to severe dyskinetic patients at baseline (36% of patients) showed a decrease with safinamide 100 mg/d compared with placebo (P = 0.0317). Improvements in motor function, activities of daily living, depressive symptoms, clinical status, and quality of life at 6 months remained significant at 24 months. Adverse events and discontinuation rates were similar with safinamide and placebo. This 2-year, controlled study of add-on safinamide in mid-to-late Parkinson's disease with motor fluctuations, although not demonstrating an overall difference in dyskinesias between patients and controls, showed improvement in dyskinesia in patients at least moderately dyskinetic at baseline. The study additionally demonstrated significant clinical benefits in ON-time (without troublesome dyskinesia), OFF-time, activities of daily living, motor symptoms, quality of life, and symptoms of depression.
DOI: 10.1002/mds.25961
PubMed: 25044402
Links to Exploration step
pubmed:25044402Le document en format XML
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Bhatt</name></author><author><name sortKey="Chirilineau, Dana" sort="Chirilineau, Dana" uniqKey="Chirilineau D" first="Dana" last="Chirilineau">Dana Chirilineau</name></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></author><author><name sortKey="Lucini, Valentina" sort="Lucini, Valentina" uniqKey="Lucini V" first="Valentina" last="Lucini">Valentina Lucini</name></author><author><name sortKey="Giuliani, Rodolfo" sort="Giuliani, Rodolfo" uniqKey="Giuliani R" first="Rodolfo" last="Giuliani">Rodolfo Giuliani</name></author><author><name sortKey="Forrest, Emma" sort="Forrest, Emma" uniqKey="Forrest E" first="Emma" last="Forrest">Emma Forrest</name></author><author><name sortKey="Rice, Patricia" sort="Rice, Patricia" uniqKey="Rice P" first="Patricia" last="Rice">Patricia Rice</name></author><author><name sortKey="Anand, Ravi" sort="Anand, Ravi" uniqKey="Anand R" first="Ravi" last="Anand">Ravi Anand</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:25044402</idno><idno type="pmid">25044402</idno><idno type="doi">10.1002/mds.25961</idno><idno type="wicri:Area/PubMed/Corpus">000443</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease.</title><author><name sortKey="Borgohain, Rupam" sort="Borgohain, Rupam" uniqKey="Borgohain R" first="Rupam" last="Borgohain">Rupam Borgohain</name><affiliation><nlm:affiliation>Nizam's Institute of Medical Sciences, Hyderabad, India.</nlm:affiliation></affiliation></author><author><name sortKey="Szasz, Jozsef" sort="Szasz, Jozsef" uniqKey="Szasz J" first="Jozsef" last="Szasz">Jozsef Szasz</name></author><author><name sortKey="Stanzione, Paolo" sort="Stanzione, Paolo" uniqKey="Stanzione P" first="Paolo" last="Stanzione">Paolo Stanzione</name></author><author><name sortKey="Meshram, Chandrashekhar" sort="Meshram, Chandrashekhar" uniqKey="Meshram C" first="Chandrashekhar" last="Meshram">Chandrashekhar Meshram</name></author><author><name sortKey="Bhatt, Mohit H" sort="Bhatt, Mohit H" uniqKey="Bhatt M" first="Mohit H" last="Bhatt">Mohit H. Bhatt</name></author><author><name sortKey="Chirilineau, Dana" sort="Chirilineau, Dana" uniqKey="Chirilineau D" first="Dana" last="Chirilineau">Dana Chirilineau</name></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></author><author><name sortKey="Lucini, Valentina" sort="Lucini, Valentina" uniqKey="Lucini V" first="Valentina" last="Lucini">Valentina Lucini</name></author><author><name sortKey="Giuliani, Rodolfo" sort="Giuliani, Rodolfo" uniqKey="Giuliani R" first="Rodolfo" last="Giuliani">Rodolfo Giuliani</name></author><author><name sortKey="Forrest, Emma" sort="Forrest, Emma" uniqKey="Forrest E" first="Emma" last="Forrest">Emma Forrest</name></author><author><name sortKey="Rice, Patricia" sort="Rice, Patricia" uniqKey="Rice P" first="Patricia" last="Rice">Patricia Rice</name></author><author><name sortKey="Anand, Ravi" sort="Anand, Ravi" uniqKey="Anand R" first="Ravi" last="Anand">Ravi Anand</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Alanine (analogs & derivatives)</term><term>Alanine (therapeutic use)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Benzylamines (therapeutic use)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Dyskinesia, Drug-Induced</term><term>Female</term><term>Humans</term><term>International Cooperation</term><term>Levodopa (therapeutic use)</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Alanine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Alanine</term><term>Antiparkinson Agents</term><term>Benzylamines</term><term>Levodopa</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Dyskinesia, Drug-Induced</term><term>Female</term><term>Humans</term><term>International Cooperation</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In a 6-month double-blind, placebo-controlled study of Parkinson's disease patients with motor fluctuations, safinamide 50 and 100 mg/d significantly increased ON-time without increasing dyskinesia. Further long-term safinamide use in these patients was evaluated over an additional 18 months. Patients continued on their randomized placebo, 50, or 100 mg/d safinamide. The primary endpoint was change in Dyskinesia Rating Scale total score during ON-time over 24 months. Other efficacy endpoints included change in ON-time without troublesome dyskinesia, changes in individual diary categories, depressive symptoms, and quality of life measures. Change in Dyskinesia Rating Scale was not significantly different in safinamide versus placebo groups, despite decreased mean total Dyskinesia Rating Scale with safinamide compared with an almost unchanged score in placebo. Ad hoc subgroup analysis of moderate to severe dyskinetic patients at baseline (36% of patients) showed a decrease with safinamide 100 mg/d compared with placebo (P = 0.0317). Improvements in motor function, activities of daily living, depressive symptoms, clinical status, and quality of life at 6 months remained significant at 24 months. Adverse events and discontinuation rates were similar with safinamide and placebo. This 2-year, controlled study of add-on safinamide in mid-to-late Parkinson's disease with motor fluctuations, although not demonstrating an overall difference in dyskinesias between patients and controls, showed improvement in dyskinesia in patients at least moderately dyskinetic at baseline. The study additionally demonstrated significant clinical benefits in ON-time (without troublesome dyskinesia), OFF-time, activities of daily living, motor symptoms, quality of life, and symptoms of depression.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">25044402</PMID><DateCreated><Year>2014</Year><Month>09</Month><Day>11</Day></DateCreated><DateCompleted><Year>2015</Year><Month>05</Month><Day>14</Day></DateCompleted><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>29</Volume><Issue>10</Issue><PubDate><Year>2014</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease.</ArticleTitle><Pagination><MedlinePgn>1273-80</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.25961</ELocationID><Abstract><AbstractText>In a 6-month double-blind, placebo-controlled study of Parkinson's disease patients with motor fluctuations, safinamide 50 and 100 mg/d significantly increased ON-time without increasing dyskinesia. Further long-term safinamide use in these patients was evaluated over an additional 18 months. Patients continued on their randomized placebo, 50, or 100 mg/d safinamide. The primary endpoint was change in Dyskinesia Rating Scale total score during ON-time over 24 months. Other efficacy endpoints included change in ON-time without troublesome dyskinesia, changes in individual diary categories, depressive symptoms, and quality of life measures. Change in Dyskinesia Rating Scale was not significantly different in safinamide versus placebo groups, despite decreased mean total Dyskinesia Rating Scale with safinamide compared with an almost unchanged score in placebo. Ad hoc subgroup analysis of moderate to severe dyskinetic patients at baseline (36% of patients) showed a decrease with safinamide 100 mg/d compared with placebo (P = 0.0317). Improvements in motor function, activities of daily living, depressive symptoms, clinical status, and quality of life at 6 months remained significant at 24 months. Adverse events and discontinuation rates were similar with safinamide and placebo. This 2-year, controlled study of add-on safinamide in mid-to-late Parkinson's disease with motor fluctuations, although not demonstrating an overall difference in dyskinesias between patients and controls, showed improvement in dyskinesia in patients at least moderately dyskinetic at baseline. The study additionally demonstrated significant clinical benefits in ON-time (without troublesome dyskinesia), OFF-time, activities of daily living, motor symptoms, quality of life, and symptoms of depression.</AbstractText><CopyrightInformation>© 2014 International Parkinson and Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Borgohain</LastName><ForeName>Rupam</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Nizam's Institute of Medical Sciences, Hyderabad, India.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Szasz</LastName><ForeName>Jozsef</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Stanzione</LastName><ForeName>Paolo</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Meshram</LastName><ForeName>Chandrashekhar</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Bhatt</LastName><ForeName>Mohit H</ForeName><Initials>MH</Initials></Author><Author ValidYN="Y"><LastName>Chirilineau</LastName><ForeName>Dana</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Stocchi</LastName><ForeName>Fabrizio</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Lucini</LastName><ForeName>Valentina</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Giuliani</LastName><ForeName>Rodolfo</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Forrest</LastName><ForeName>Emma</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Rice</LastName><ForeName>Patricia</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Anand</LastName><ForeName>Ravi</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><CollectiveName>Study 018 Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>07</Month><Day>10</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001596">Benzylamines</NameOfSubstance></Chemical><Chemical><RegistryNumber>46627O600J</RegistryNumber><NameOfSubstance UI="D007980">Levodopa</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 MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000409">Alanine</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000031">analogs & derivatives</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000978">Antiparkinson Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D001596">Benzylamines</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004409">Dyskinesia, Drug-Induced</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007391">International Cooperation</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007980">Levodopa</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008137">Longitudinal Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">add-on</Keyword><Keyword MajorTopicYN="N">dopamine</Keyword><Keyword MajorTopicYN="N">levodopa</Keyword><Keyword MajorTopicYN="N">motor function</Keyword><Keyword MajorTopicYN="N">safinamide, Parkinson's disease</Keyword></KeywordList><InvestigatorList><Investigator ValidYN="Y"><LastName>Sahadulla</LastName><ForeName>M Illiyas</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kardan</LastName><ForeName>U</ForeName><Initials>U</Initials></Investigator><Investigator ValidYN="Y"><LastName>Keshava</LastName><ForeName>B S</ForeName><Initials>BS</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kishore</LastName><ForeName>A</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kothari</LastName><ForeName>S S</ForeName><Initials>SS</Initials></Investigator><Investigator ValidYN="Y"><LastName>Murthy</LastName><ForeName>J M Krishna</ForeName><Initials>JM</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kumar</LastName><ForeName>S</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Pal</LastName><ForeName>P Kumar</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Mehta</LastName><ForeName>N</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Prabhakar</LastName><ForeName>S</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Prabhakar</LastName><ForeName>S Kr</ForeName><Initials>SK</Initials></Investigator><Investigator ValidYN="Y"><LastName>Pradhan</LastName><ForeName>S</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Roy</LastName><ForeName>A K</ForeName><Initials>AK</Initials></Investigator><Investigator ValidYN="Y"><LastName>Sankhla</LastName><ForeName>C</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Sethi</LastName><ForeName>P K</ForeName><Initials>PK</Initials></Investigator><Investigator ValidYN="Y"><LastName>Shah</LastName><ForeName>A B</ForeName><Initials>AB</Initials></Investigator><Investigator ValidYN="Y"><LastName>Shankar</LastName><ForeName>N</ForeName><Initials>N</Initials></Investigator><Investigator 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ValidYN="Y"><LastName>Szasz</LastName><ForeName>J</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ticmeanu</LastName><ForeName>M</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Avarello</LastName><ForeName>T</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bonuccelli</LastName><ForeName>U</ForeName><Initials>U</Initials></Investigator><Investigator ValidYN="Y"><LastName>Eleopra</LastName><ForeName>R</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Onofrj</LastName><ForeName>M</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Quatrale</LastName><ForeName>R</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Stanzione</LastName><ForeName>P</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Stocchi</LastName><ForeName>F</ForeName><Initials>F</Initials></Investigator></InvestigatorList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>1</Month><Day>9</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2014</Year><Month>5</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>6</Month><Day>2</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2014</Year><Month>7</Month><Day>10</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>7</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>7</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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