Trial of subtherapeutic pergolide in de novo Parkinson's disease
Identifieur interne : 001396 ( Main/Exploration ); précédent : 001395; suivant : 001397Trial of subtherapeutic pergolide in de novo Parkinson's disease
Auteurs : Katherine Grosset [Royaume-Uni] ; Donald Grosset [Royaume-Uni] ; Andrew Lees (neurologue) [Royaume-Uni]Source :
- 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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Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2005-03">2005-03</date><biblScope unit="volume">20</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="363">363</biblScope><biblScope unit="page" to="366">366</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">2DCDAC6475C77863690B5706D941F6E193C111FD</idno><idno type="DOI">10.1002/mds.20361</idno><idno type="ArticleID">MDS20361</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>delaying levodopa</term><term>neuroprotective</term><term>subtherapeutic pergolide</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><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. 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