Trial of subtherapeutic pergolide in de novo Parkinson's disease
Identifieur interne : 002862 ( Istex/Corpus ); précédent : 002861; suivant : 002863Trial of subtherapeutic pergolide in de novo Parkinson's disease
Auteurs : Katherine Grosset ; Donald Grosset ; Andrew LeesSource :
- Movement Disorders [ 0885-3185 ] ; 2005-03.
English descriptors
Abstract
The effect of pergolide 25 μg twice daily on levodopa initiation was assessed in a randomized, placebo‐controlled, parallel group, double‐blind multicenter trial in 106 untreated early Parkinson's disease patients. The primary endpoint of mean time until levodopa was 520 days (95% confidence interval [CI], 422–618 days) for pergolide versus 434 days (95% CI, 358–609 days) for placebo. However, this increase of 86 days for pergolide was not statistically significant. The wash‐in effect of pergolide was significant at 6 weeks (change in mean Unified Parkinson's Disease Rating Scale [UPDRS] 2 and 3 was −0.1 [95% CI, −1.4 to 1.3] for pergolide vs. 2.2 [95% CI, 1.1–3.3] for placebo). At termination, the change from baseline in mean UPDRS 2 and 3 score was 11.4 (95% CI, 8.8–14) for pergolide and 14.6 (95% CI, 12–17.2) for placebo (P = 0.08). There was no significant change in UPDRS 2 and 3 for the 83 patients achieving the planned 4‐week washout at termination (pergolide 1.2 [95% CI, −0.8 to 3.2] vs. placebo 0.0 [95% CI, −1.6 to 1.6]. Adverse events were infrequent and occurred equally for pergolide and placebo. The study shows no evidence of a neuroprotective effect but indicates a mild symptomatic benefit from pergolide at a dose normally considered subtherapeutic. © 2004 Movement Disorder Society
Url:
DOI: 10.1002/mds.20361
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ISTEX:2DCDAC6475C77863690B5706D941F6E193C111FDLe document en format XML
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The study shows no evidence of a neuroprotective effect but indicates a mild symptomatic benefit from pergolide at a dose normally considered subtherapeutic. © 2004 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Katherine Grosset MBChB</name><affiliations><json:string>Institute of Neurological Sciences, Southern General Hospital, Glasgow, United Kingdom</json:string></affiliations></json:item><json:item><name>Donald Grosset MD</name><affiliations><json:string>Institute of Neurological Sciences, Southern General Hospital, Glasgow, United Kingdom</json:string></affiliations></json:item><json:item><name>Andrew Lees MD</name><affiliations><json:string>University College London, London, United Kingdom</json:string></affiliations></json:item></author><subject><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>subtherapeutic pergolide</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>delaying levodopa</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>neuroprotective</value></json:item></subject><language><json:string>eng</json:string></language><abstract>The effect of pergolide 25 μg twice daily on levodopa initiation was assessed in a randomized, placebo‐controlled, parallel group, double‐blind multicenter trial in 106 untreated early Parkinson's disease patients. 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The primary endpoint of mean time until levodopa was 520 days (95% confidence interval [CI], 422–618 days) for pergolide versus 434 days (95% CI, 358–609 days) for placebo. However, this increase of 86 days for pergolide was not statistically significant. The wash‐in effect of pergolide was significant at 6 weeks (change in mean Unified Parkinson's Disease Rating Scale [UPDRS] 2 and 3 was −0.1 [95% CI, −1.4 to 1.3] for pergolide vs. 2.2 [95% CI, 1.1–3.3] for placebo). At termination, the change from baseline in mean UPDRS 2 and 3 score was 11.4 (95% CI, 8.8–14) for pergolide and 14.6 (95% CI, 12–17.2) for placebo (P = 0.08). There was no significant change in UPDRS 2 and 3 for the 83 patients achieving the planned 4‐week washout at termination (pergolide 1.2 [95% CI, −0.8 to 3.2] vs. placebo 0.0 [95% CI, −1.6 to 1.6]. Adverse events were infrequent and occurred equally for pergolide and placebo. The study shows no evidence of a neuroprotective effect but indicates a mild symptomatic benefit from pergolide at a dose normally considered subtherapeutic. © 2004 Movement Disorder Society</abstract><note type="funding">Lilly Pharmaceuticals</note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>subtherapeutic pergolide</topic><topic>delaying levodopa</topic><topic>neuroprotective</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. 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