Trial of subtherapeutic pergolide in de novo Parkinson's disease
Identifieur interne : 003E39 ( Main/Exploration ); précédent : 003E38; suivant : 003E40Trial 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 ] ; 2004.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
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.
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aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Glasgow</wicri:noRegion></affiliation></author><author><name sortKey="Grosset, Donald" sort="Grosset, Donald" uniqKey="Grosset D" first="Donald" last="Grosset">Donald Grosset</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Institute of Neurological Sciences, Southern General Hospital</s1><s2>Glasgow</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Glasgow</wicri:noRegion></affiliation></author><author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees (neurologue)</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>University College London</s1><s2>London</s2><s3>GBR</s3><sZ>3 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><orgName>National Hospital for Neurology and Neurosurgery</orgName></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2004">2004</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>De novo</term><term>Levodopa</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Pergolide</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Pergolide</term><term>De novo</term><term>Parkinson maladie</term><term>Lévodopa</term></keywords></textClass></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. The study shows no evidence of a neuroprotective effect but indicates a mild symptomatic benefit from pergolide at a dose normally considered subtherapeutic.</div></front></TEI><affiliations><list><country><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Grand Londres</li></region><settlement><li>Londres</li></settlement><orgName><li>National Hospital for Neurology and Neurosurgery</li></orgName></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Grosset, Katherine" sort="Grosset, Katherine" uniqKey="Grosset K" first="Katherine" last="Grosset">Katherine Grosset</name></noRegion><name sortKey="Grosset, Donald" sort="Grosset, Donald" uniqKey="Grosset D" first="Donald" last="Grosset">Donald Grosset</name><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees (neurologue)</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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