A pilot, double‐blind, placebo‐controlled trial of pregabalin (Lyrica) in the treatment of essential tremor
Identifieur interne : 002A53 ( Main/Corpus ); précédent : 002A52; suivant : 002A54A pilot, double‐blind, placebo‐controlled trial of pregabalin (Lyrica) in the treatment of essential tremor
Auteurs : Theresa A. Zesiewicz ; Christopher L. Ward ; Robert A. Hauser ; Jason L. Salemi ; Shaila Siraj ; Maria-Carmen Wilson ; Kelly L. SullivanSource :
- Movement Disorders [ 0885-3185 ] ; 2007-08-15.
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Abstract
We performed a pilot, double‐blind, placebo‐controlled, randomized trial to evaluate the efficacy and tolerability of pregabalin (PGB, Lyrica), an antiepileptic agent, in treating essential tremor (ET). Twenty two patients with ET were randomly assigned to receive PGB or placebo. PGB was initiated at 50 mg/day and was escalated by 75 mg/day every 4 days to a maximum dose of 600 mg/day. Patients were evaluated by accelerometry and the Fahn–Tolosa–Marin (FTM) rating scale. There was a significant reduction in tremor amplitude in the PGB group compared with the placebo group, as measured by accelerometry, at a mean dose of 286.76 ± 100.05 mg/day. Action tremor limb scores on the FTM also improved in the PGB group compared with the placebo group (P‐value for multilevel modeling = 0.04). PGB was fairly well tolerated, with about one‐third of patients dropping out of the study because of adverse events. PGB provided significant improvements in accelerometry and in action tremor limb scores on the FTM. However, larger studies are needed to further evaluate the potential effect of PGB on ET. © 2007 Movement Disorder Society
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DOI: 10.1002/mds.21629
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Zesiewicz</name><affiliation><mods:affiliation>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>James A. Haley Veterans Administration Hospital, University of South Florida, Tampa, Florida, USA</mods:affiliation></affiliation></author><author><name sortKey="Ward, Christopher L" sort="Ward, Christopher L" uniqKey="Ward C" first="Christopher L." last="Ward">Christopher L. 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Twenty two patients with ET were randomly assigned to receive PGB or placebo. PGB was initiated at 50 mg/day and was escalated by 75 mg/day every 4 days to a maximum dose of 600 mg/day. Patients were evaluated by accelerometry and the Fahn–Tolosa–Marin (FTM) rating scale. There was a significant reduction in tremor amplitude in the PGB group compared with the placebo group, as measured by accelerometry, at a mean dose of 286.76 ± 100.05 mg/day. Action tremor limb scores on the FTM also improved in the PGB group compared with the placebo group (P‐value for multilevel modeling = 0.04). PGB was fairly well tolerated, with about one‐third of patients dropping out of the study because of adverse events. PGB provided significant improvements in accelerometry and in action tremor limb scores on the FTM. However, larger studies are needed to further evaluate the potential effect of PGB on ET. © 2007 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Theresa A. Zesiewicz MD</name><affiliations><json:string>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</json:string><json:string>Department of Neurology, University of South Florida, Tampa, Florida, USA</json:string><json:string>Department of Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</json:string><json:string>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</json:string><json:string>James A. Haley Veterans Administration Hospital, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Christopher L. Ward LMT</name><affiliations><json:string>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</json:string><json:string>Department of Neurology, University of South Florida, Tampa, Florida, USA</json:string><json:string>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Robert A. 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Salemi MPH</name><affiliations><json:string>Birth Defects Surveillance Program, Department of Pediatrics, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Shaila Siraj BS</name><affiliations><json:string>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</json:string><json:string>Department of Neurology, University of South Florida, Tampa, Florida, USA</json:string><json:string>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Maria‐Carmen Wilson MD</name><affiliations><json:string>Department of Neurology, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Kelly L. Sullivan MSPH</name><affiliations><json:string>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</json:string><json:string>Department of Neurology, University of South Florida, Tampa, Florida, USA</json:string><json:string>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>pregabalin</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Lyrica</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>essential tremor</value></json:item></subject><articleId><json:string>MDS21629</json:string></articleId><language><json:string>eng</json:string></language><abstract>We performed a pilot, double‐blind, placebo‐controlled, randomized trial to evaluate the efficacy and tolerability of pregabalin (PGB, Lyrica), an antiepileptic agent, in treating essential tremor (ET). Twenty two patients with ET were randomly assigned to receive PGB or placebo. PGB was initiated at 50 mg/day and was escalated by 75 mg/day every 4 days to a maximum dose of 600 mg/day. Patients were evaluated by accelerometry and the Fahn–Tolosa–Marin (FTM) rating scale. There was a significant reduction in tremor amplitude in the PGB group compared with the placebo group, as measured by accelerometry, at a mean dose of 286.76 ± 100.05 mg/day. Action tremor limb scores on the FTM also improved in the PGB group compared with the placebo group (P‐value for multilevel modeling = 0.04). PGB was fairly well tolerated, with about one‐third of patients dropping out of the study because of adverse events. PGB provided significant improvements in accelerometry and in action tremor limb scores on the FTM. 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Twenty two patients with ET were randomly assigned to receive PGB or placebo. PGB was initiated at 50 mg/day and was escalated by 75 mg/day every 4 days to a maximum dose of 600 mg/day. Patients were evaluated by accelerometry and the Fahn–Tolosa–Marin (FTM) rating scale. There was a significant reduction in tremor amplitude in the PGB group compared with the placebo group, as measured by accelerometry, at a mean dose of 286.76 ± 100.05 mg/day. Action tremor limb scores on the FTM also improved in the PGB group compared with the placebo group (P‐value for multilevel modeling = 0.04). PGB was fairly well tolerated, with about one‐third of patients dropping out of the study because of adverse events. PGB provided significant improvements in accelerometry and in action tremor limb scores on the FTM. However, larger studies are needed to further evaluate the potential effect of PGB on ET. © 2007 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>pregabalin</term></item><item><term>Lyrica</term></item><item><term>essential tremor</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Brief Report</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2007-02-16">Received</change><change when="2007-05-18">Registration</change><change when="2007-08-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/552DF6F3F874F4E834C63BDF4AE4DEE779D090E3/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="subtitle">Official Journal of the Movement Disorder Society</title><title type="short">Mov. 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Downs Blvd, MDC Box 55, Tampa, Florida 33612</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS21629.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="1"></count><count type="tableTotal" number="2"></count><count type="referenceTotal" number="15"></count><count type="wordTotal" number="2552"></count></countGroup><titleGroup><title type="main" xml:lang="en">A pilot, double‐blind, placebo‐controlled trial of pregabalin (Lyrica) in the treatment of essential tremor<link href="#fn1"></link></title><title type="short" xml:lang="en">Pregabalin in the Treatment of Essential Tremor</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1 #af2 #af3 #af4 #af5" corresponding="yes"><personName><givenNames>Theresa A.</givenNames><familyName>Zesiewicz</familyName><degrees>MD</degrees></personName><contactDetails><email>tzesiewi@hsc.usf.edu</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af1 #af2 #af4"><personName><givenNames>Christopher L.</givenNames><familyName>Ward</familyName><degrees>LMT</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af1 #af2 #af3 #af4"><personName><givenNames>Robert A.</givenNames><familyName>Hauser</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Jason L.</givenNames><familyName>Salemi</familyName><degrees>MPH</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af1 #af2 #af4"><personName><givenNames>Shaila</givenNames><familyName>Siraj</familyName><degrees>BS</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Maria‐Carmen</givenNames><familyName>Wilson</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af1 #af2 #af4"><personName><givenNames>Kelly L.</givenNames><familyName>Sullivan</familyName><degrees>MSPH</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Department of Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>James A. Haley Veterans Administration Hospital, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="US" type="organization"><unparsedAffiliation>Birth Defects Surveillance Program, Department of Pediatrics, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">pregabalin</keyword><keyword xml:id="kwd2">Lyrica</keyword><keyword xml:id="kwd3">essential tremor</keyword></keywordGroup><supportingInformation><p> This article includes supplementary video clips, available online at <url href="http://www.interscience.wiley.com/jpages/0885-3185/suppmat"> http://www.interscience.wiley.com/jpages/0885‐3185/suppmat </url> . </p><supportingInfoItem><mediaResource alt="supporting information" href="urn-x:wiley:08853185:media:mds21629:mds21629-MDS21629"></mediaResource><caption>Segment 2. It shows the patient's tremor treated with PGB 300 mg/day. In the study, accelerometry scores significantly improved, as did action rating scale scores on the Fahn‐Tolosa‐Marin rating scale.</caption></supportingInfoItem></supportingInformation><abstractGroup><abstract type="main" xml:lang="fr"><title type="main">Abstract</title><p>We performed a pilot, double‐blind, placebo‐controlled, randomized trial to evaluate the efficacy and tolerability of pregabalin (PGB, Lyrica), an antiepileptic agent, in treating essential tremor (ET). Twenty two patients with ET were randomly assigned to receive PGB or placebo. PGB was initiated at 50 mg/day and was escalated by 75 mg/day every 4 days to a maximum dose of 600 mg/day. Patients were evaluated by accelerometry and the Fahn–Tolosa–Marin (FTM) rating scale. There was a significant reduction in tremor amplitude in the PGB group compared with the placebo group, as measured by accelerometry, at a mean dose of 286.76 ± 100.05 mg/day. Action tremor limb scores on the FTM also improved in the PGB group compared with the placebo group (<i>P</i>‐value for multilevel modeling = 0.04). PGB was fairly well tolerated, with about one‐third of patients dropping out of the study because of adverse events. PGB provided significant improvements in accelerometry and in action tremor limb scores on the FTM. However, larger studies are needed to further evaluate the potential effect of PGB on ET. © 2007 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>The authors have confirmed with the Editor that their work complies with the Journal's Editorial policy on ghost writing [Mov Disord 2005;20(12):1536].</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>A pilot, double‐blind, placebo‐controlled trial of pregabalin (Lyrica) in the treatment of essential tremor</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Pregabalin in the Treatment of Essential Tremor</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>A pilot, double‐blind, placebo‐controlled trial of pregabalin (Lyrica) in the treatment of essential tremor</title></titleInfo><name type="personal"><namePart type="given">Theresa A.</namePart><namePart type="family">Zesiewicz</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Department of Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>James A. Haley Veterans Administration Hospital, University of South Florida, Tampa, Florida, USA</affiliation><description>Correspondence: University of South Florida, 12901 Bruce B. Downs Blvd, MDC Box 55, Tampa, Florida 33612</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Christopher L.</namePart><namePart type="family">Ward</namePart><namePart type="termsOfAddress">LMT</namePart><affiliation>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert A.</namePart><namePart type="family">Hauser</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Department of Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jason L.</namePart><namePart type="family">Salemi</namePart><namePart type="termsOfAddress">MPH</namePart><affiliation>Birth Defects Surveillance Program, Department of Pediatrics, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Shaila</namePart><namePart type="family">Siraj</namePart><namePart type="termsOfAddress">BS</namePart><affiliation>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Maria‐Carmen</namePart><namePart type="family">Wilson</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kelly L.</namePart><namePart type="family">Sullivan</namePart><namePart type="termsOfAddress">MSPH</namePart><affiliation>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>National Parkinson Foundation Center of Excellence, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2007-08-15</dateIssued><dateCaptured encoding="w3cdtf">2007-02-16</dateCaptured><dateValid encoding="w3cdtf">2007-05-18</dateValid><copyrightDate encoding="w3cdtf">2007</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">1</extent><extent unit="tables">2</extent><extent unit="references">15</extent><extent unit="words">2552</extent></physicalDescription><abstract lang="fr">We performed a pilot, double‐blind, placebo‐controlled, randomized trial to evaluate the efficacy and tolerability of pregabalin (PGB, Lyrica), an antiepileptic agent, in treating essential tremor (ET). Twenty two patients with ET were randomly assigned to receive PGB or placebo. PGB was initiated at 50 mg/day and was escalated by 75 mg/day every 4 days to a maximum dose of 600 mg/day. Patients were evaluated by accelerometry and the Fahn–Tolosa–Marin (FTM) rating scale. There was a significant reduction in tremor amplitude in the PGB group compared with the placebo group, as measured by accelerometry, at a mean dose of 286.76 ± 100.05 mg/day. Action tremor limb scores on the FTM also improved in the PGB group compared with the placebo group (P‐value for multilevel modeling = 0.04). PGB was fairly well tolerated, with about one‐third of patients dropping out of the study because of adverse events. PGB provided significant improvements in accelerometry and in action tremor limb scores on the FTM. However, larger studies are needed to further evaluate the potential effect of PGB on ET. © 2007 Movement Disorder Society</abstract><note type="content">*The authors have confirmed with the Editor that their work complies with the Journal's Editorial policy on ghost writing [Mov Disord 2005;20(12):1536].</note><subject lang="en"><genre>Keywords</genre><topic>pregabalin</topic><topic>Lyrica</topic><topic>essential tremor</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><note type="content"> This article includes supplementary video clips, available online at http://www.interscience.wiley.com/jpages/0885‐3185/suppmat .Supporting Info Item: Segment 2. It shows the patient's tremor treated with PGB 300 mg/day. In the study, accelerometry scores significantly improved, as did action rating scale scores on the Fahn‐Tolosa‐Marin rating scale. - </note><subject><genre>article category</genre><topic>Brief Report</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>1660</start><end>1663</end><total>4</total></extent></part></relatedItem><identifier type="istex">552DF6F3F874F4E834C63BDF4AE4DEE779D090E3</identifier><identifier type="DOI">10.1002/mds.21629</identifier><identifier type="ArticleID">MDS21629</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2007 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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