PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease
Identifieur interne : 000213 ( Main/Exploration ); précédent : 000212; suivant : 000214PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease
Auteurs : Fabrizio Stocchi [Italie] ; Luigi Giorgi [Royaume-Uni] ; Brian Hunter [Royaume-Uni] ; Anthony Hv Schapira [Royaume-Uni]Source :
- Movement Disorders [ 0885-3185 ] ; 2011-06.
English descriptors
Abstract
Background: PREPARED was a randomized, parallel‐group, double‐blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD). Methods: Patients received once‐daily PR (2–24 mg/d; n = 177) or three‐times‐daily IR (0.75–24 mg/d; n = 173) for 24 weeks. The primary endpoint was the proportion of patients maintaining ≥20% reduction from baseline in “off” time over two consecutive visits at Week 24 last observation carried forward (LOCF). Results: At Week 24 LOCF, PR significantly increased the proportion of patients maintaining ≥20% reduction in “off” time versus IR (adjusted odds ratio: 1.82; 95% CI: 1.16, 2.86; P = 0.009). Mean (SD) doses at Week 24 LOCF were: PR, 18.6 (6.5) mg/d; IR, 10.4 (6.4) mg/d; mean (SD) reductions from baseline in levodopa (L‐dopa) dose were –162 (226) mg and –113 (138) mg, respectively. Adverse events (AEs) were reported by 72% of patients in the PR group and 61% in the IR group; 12% and 9% of patients, respectively, withdrew from the study due to an AE, and 6% and 5%, respectively, reported serious AEs. Conclusions: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving ≥20% maintained reduction in time spent “off” compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of L‐dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. © 2011 Movement Disorder Society
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DOI: 10.1002/mds.23498
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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="2011-06">2011-06</date><biblScope unit="volume">26</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="1259">1259</biblScope><biblScope unit="page" to="1265">1265</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">49FDA753190EDFEEB695C4DF604D6BFAA634EB3E</idno><idno type="DOI">10.1002/mds.23498</idno><idno type="ArticleID">MDS23498</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>motor fluctuations</term><term>once‐daily treatment</term><term>ropinirole</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: PREPARED was a randomized, parallel‐group, double‐blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD). Methods: Patients received once‐daily PR (2–24 mg/d; n = 177) or three‐times‐daily IR (0.75–24 mg/d; n = 173) for 24 weeks. The primary endpoint was the proportion of patients maintaining ≥20% reduction from baseline in “off” time over two consecutive visits at Week 24 last observation carried forward (LOCF). Results: At Week 24 LOCF, PR significantly increased the proportion of patients maintaining ≥20% reduction in “off” time versus IR (adjusted odds ratio: 1.82; 95% CI: 1.16, 2.86; P = 0.009). Mean (SD) doses at Week 24 LOCF were: PR, 18.6 (6.5) mg/d; IR, 10.4 (6.4) mg/d; mean (SD) reductions from baseline in levodopa (L‐dopa) dose were –162 (226) mg and –113 (138) mg, respectively. Adverse events (AEs) were reported by 72% of patients in the PR group and 61% in the IR group; 12% and 9% of patients, respectively, withdrew from the study due to an AE, and 6% and 5%, respectively, reported serious AEs. Conclusions: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving ≥20% maintained reduction in time spent “off” compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of L‐dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. © 2011 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Italie</li><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Latium</li></region><settlement><li>Londres</li><li>Rome</li></settlement></list><tree><country name="Italie"><region name="Latium"><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></region></country><country name="Royaume-Uni"><noRegion><name sortKey="Giorgi, Luigi" sort="Giorgi, Luigi" uniqKey="Giorgi L" first="Luigi" last="Giorgi">Luigi Giorgi</name></noRegion><name sortKey="Hunter, Brian" sort="Hunter, Brian" uniqKey="Hunter B" first="Brian" last="Hunter">Brian Hunter</name><name sortKey="Schapira, Anthony Hv" sort="Schapira, Anthony Hv" uniqKey="Schapira A" first="Anthony Hv" last="Schapira">Anthony Hv Schapira</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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