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
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DOI: 10.1002/mds.20361
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<front><div type="abstract" xml:lang="en">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</div>
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<p>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 (<i>P</i>
= 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</p>
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<abstract lang="en">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</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. Disord.</title>
</titleInfo>
<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>2005</date>
<detail type="volume"><caption>vol.</caption>
<number>20</number>
</detail>
<detail type="issue"><caption>no.</caption>
<number>3</number>
</detail>
<extent unit="pages"><start>363</start>
<end>366</end>
<total>4</total>
</extent>
</part>
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<identifier type="istex">2DCDAC6475C77863690B5706D941F6E193C111FD</identifier>
<identifier type="DOI">10.1002/mds.20361</identifier>
<identifier type="ArticleID">MDS20361</identifier>
<accessCondition type="use and reproduction" contentType="copyright">Copyright © 2004 Movement Disorder Society</accessCondition>
<recordInfo><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin>
<recordContentSource>WILEY</recordContentSource>
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