Twice‐daily, low‐dose pramipexole in early Parkinson's disease: A randomized, placebo‐controlled trial
Identifieur interne : 000475 ( Main/Corpus ); précédent : 000474; suivant : 000476Twice‐daily, low‐dose pramipexole in early Parkinson's disease: A randomized, placebo‐controlled trial
Auteurs : Karl KieburtzSource :
- Movement Disorders [ 0885-3185 ] ; 2011-01.
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- KwdEn :
Abstract
To compare the safety and efficacy of low dosages of pramipexole given twice daily (bid) in early Parkinson's disease (PD) with those of a standard 3 times daily (tid) regimen in a randomized, double‐blind, placebo controlled trial involving 311 early PD patients not receiving dopaminergic treatment. Subjects were randomly assigned and followed on assigned treatment for 12 weeks with pramipexole at dosages of 0.5 mg bid, 0.75 mg bid, or 0.5 mg tid, or matching placebo. All subjects were dosed 3 times daily, with placebo if necessary, to maintain blinding. The primary outcome was the change from baseline to Week 12 in the Unified Parkinson Disease Rating Scale (UPDRS) total score (Parts I–III). All active dosages had similar antiparkinson efficacy showing reductions of 4–5 UPDRS points relative to placebo (p < 0.0001) for each comparison. Somnolence, fatigue, nausea, constipation, and peripheral edema were more common in the active treatment groups than in the placebo group, but their frequency did not vary by dosage. In this fixed dosage, randomized study pramipexole administered twice daily at a total daily dosage of 1.0–1.5 mg daily was of comparable efficacy and tolerability to a dosage of 0.5 mg tid over a 12‐week treatment period in early PD. © 2010 Movement Disorder Society
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DOI: 10.1002/mds.23396
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Subjects were randomly assigned and followed on assigned treatment for 12 weeks with pramipexole at dosages of 0.5 mg bid, 0.75 mg bid, or 0.5 mg tid, or matching placebo. All subjects were dosed 3 times daily, with placebo if necessary, to maintain blinding. The primary outcome was the change from baseline to Week 12 in the Unified Parkinson Disease Rating Scale (UPDRS) total score (Parts I–III). All active dosages had similar antiparkinson efficacy showing reductions of 4–5 UPDRS points relative to placebo (p < 0.0001) for each comparison. Somnolence, fatigue, nausea, constipation, and peripheral edema were more common in the active treatment groups than in the placebo group, but their frequency did not vary by dosage. In this fixed dosage, randomized study pramipexole administered twice daily at a total daily dosage of 1.0–1.5 mg daily was of comparable efficacy and tolerability to a dosage of 0.5 mg tid over a 12‐week treatment period in early PD. © 2010 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Karl Kieburtz</name><affiliations><json:string>University of Rochester Medical Center, Rochester, New York, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>clinical trials</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>parmipexole</value></json:item></subject><articleId><json:string>MDS23396</json:string></articleId><language><json:string>eng</json:string></language><abstract>To compare the safety and efficacy of low dosages of pramipexole given twice daily (bid) in early Parkinson's disease (PD) with those of a standard 3 times daily (tid) regimen in a randomized, double‐blind, placebo controlled trial involving 311 early PD patients not receiving dopaminergic treatment. Subjects were randomly assigned and followed on assigned treatment for 12 weeks with pramipexole at dosages of 0.5 mg bid, 0.75 mg bid, or 0.5 mg tid, or matching placebo. All subjects were dosed 3 times daily, with placebo if necessary, to maintain blinding. The primary outcome was the change from baseline to Week 12 in the Unified Parkinson Disease Rating Scale (UPDRS) total score (Parts I–III). All active dosages had similar antiparkinson efficacy showing reductions of 4–5 UPDRS points relative to placebo (p > 0.0001) for each comparison. Somnolence, fatigue, nausea, constipation, and peripheral edema were more common in the active treatment groups than in the placebo group, but their frequency did not vary by dosage. 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Subjects were randomly assigned and followed on assigned treatment for 12 weeks with pramipexole at dosages of 0.5 mg bid, 0.75 mg bid, or 0.5 mg tid, or matching placebo. All subjects were dosed 3 times daily, with placebo if necessary, to maintain blinding. The primary outcome was the change from baseline to Week 12 in the Unified Parkinson Disease Rating Scale (UPDRS) total score (Parts I–III). All active dosages had similar antiparkinson efficacy showing reductions of 4–5 UPDRS points relative to placebo (p < 0.0001) for each comparison. Somnolence, fatigue, nausea, constipation, and peripheral edema were more common in the active treatment groups than in the placebo group, but their frequency did not vary by dosage. 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Hope Ave., Ste. 223, Rochester, NY 14620</correspondenceTo><objectNameGroup><objectName elementName="appendix">APPENDIX</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS23396.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="21"></count><count type="wordTotal" number="7938"></count></countGroup><titleGroup><title type="main" xml:lang="en">Twice‐daily, low‐dose pramipexole in early Parkinson's disease: A randomized, placebo‐controlled trial</title><title type="short" xml:lang="en">Low‐Dose Pramipexole in PD</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes" noteRef="#fn1"><personName><givenNames>Karl</givenNames><familyName>Kieburtz</familyName></personName><contactDetails><email>karl.kieburtz@ctcc.rochester.edu</email></contactDetails></creator><creator xml:id="au2" creatorRole="author"><groupName>The Parkinson Study Group PramiBID Investigators</groupName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>University of Rochester Medical Center, Rochester, New York, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">clinical trials</keyword><keyword xml:id="kwd2">Parkinson's disease</keyword><keyword xml:id="kwd3">parmipexole</keyword></keywordGroup><fundingInfo><fundingAgency>Boehringer‐ Ingelheim Pharmaceuticals, Inc.</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>To compare the safety and efficacy of low dosages of pramipexole given twice daily (bid) in early Parkinson's disease (PD) with those of a standard 3 times daily (tid) regimen in a randomized, double‐blind, placebo controlled trial involving 311 early PD patients not receiving dopaminergic treatment. Subjects were randomly assigned and followed on assigned treatment for 12 weeks with pramipexole at dosages of 0.5 mg bid, 0.75 mg bid, or 0.5 mg tid, or matching placebo. All subjects were dosed 3 times daily, with placebo if necessary, to maintain blinding. The primary outcome was the change from baseline to Week 12 in the Unified Parkinson Disease Rating Scale (UPDRS) total score (Parts I–III). All active dosages had similar antiparkinson efficacy showing reductions of 4–5 UPDRS points relative to placebo (p < 0.0001) for each comparison. Somnolence, fatigue, nausea, constipation, and peripheral edema were more common in the active treatment groups than in the placebo group, but their frequency did not vary by dosage. In this fixed dosage, randomized study pramipexole administered twice daily at a total daily dosage of 1.0–1.5 mg daily was of comparable efficacy and tolerability to a dosage of 0.5 mg tid over a 12‐week treatment period in early PD. © 2010 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn12" numbered="no"><p>Potential conflict of interest: Nothing to report.</p></note><note xml:id="fn1"><p>Phone: 585‐275‐0553; Fax: 585‐461‐3554.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Twice‐daily, low‐dose pramipexole in early Parkinson's disease: A randomized, placebo‐controlled trial</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Low‐Dose Pramipexole in PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Twice‐daily, low‐dose pramipexole in early Parkinson's disease: A randomized, placebo‐controlled trial</title></titleInfo><name type="personal"><namePart type="given">Karl</namePart><namePart type="family">Kieburtz</namePart><affiliation>University of Rochester Medical Center, Rochester, New York, USA</affiliation><description>Phone: 585‐275‐0553; Fax: 585‐461‐3554.</description><description>Correspondence: University of Rochester Medical Center, 1351 Mt. Hope Ave., Ste. 223, Rochester, NY 14620</description><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>The Parkinson Study Group PramiBID Investigators</namePart><description>University of Rochester Medical Center, Rochester, New York, USA</description></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">2011-01</dateIssued><dateCaptured encoding="w3cdtf">2010-02-08</dateCaptured><dateValid encoding="w3cdtf">2010-07-19</dateValid><copyrightDate encoding="w3cdtf">2011</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">2</extent><extent unit="tables">3</extent><extent unit="references">21</extent><extent unit="words">7938</extent></physicalDescription><abstract lang="en">To compare the safety and efficacy of low dosages of pramipexole given twice daily (bid) in early Parkinson's disease (PD) with those of a standard 3 times daily (tid) regimen in a randomized, double‐blind, placebo controlled trial involving 311 early PD patients not receiving dopaminergic treatment. Subjects were randomly assigned and followed on assigned treatment for 12 weeks with pramipexole at dosages of 0.5 mg bid, 0.75 mg bid, or 0.5 mg tid, or matching placebo. All subjects were dosed 3 times daily, with placebo if necessary, to maintain blinding. The primary outcome was the change from baseline to Week 12 in the Unified Parkinson Disease Rating Scale (UPDRS) total score (Parts I–III). All active dosages had similar antiparkinson efficacy showing reductions of 4–5 UPDRS points relative to placebo (p < 0.0001) for each comparison. Somnolence, fatigue, nausea, constipation, and peripheral edema were more common in the active treatment groups than in the placebo group, but their frequency did not vary by dosage. In this fixed dosage, randomized study pramipexole administered twice daily at a total daily dosage of 1.0–1.5 mg daily was of comparable efficacy and tolerability to a dosage of 0.5 mg tid over a 12‐week treatment period in early PD. © 2010 Movement Disorder Society</abstract><note type="funding">Boehringer‐ Ingelheim Pharmaceuticals, Inc.</note><subject lang="en"><genre>Keywords</genre><topic>clinical trials</topic><topic>Parkinson's disease</topic><topic>parmipexole</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. 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