The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson’s disease: a randomized, double-blind, double-dummy, parallel-group study
Identifieur interne : 001476 ( Ncbi/Checkpoint ); précédent : 001475; suivant : 001477The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson’s disease: a randomized, double-blind, double-dummy, parallel-group study
Auteurs : Ying Wang [République populaire de Chine] ; Shenggang Sun [République populaire de Chine] ; Suiqiang Zhu [République populaire de Chine] ; Chunfeng Liu [République populaire de Chine] ; Yiming Liu [République populaire de Chine] ; Qing Di [République populaire de Chine] ; Huifang Shang [République populaire de Chine] ; Yan Ren [République populaire de Chine] ; Changhong Lu [République populaire de Chine] ; Mark Forrest Gordon [États-Unis] ; Nolwenn Juhel [France] ; Shengdi Chen [République populaire de Chine]Source :
- Translational Neurodegeneration [ 2047-9158 ] ; 2014.
Abstract
To evaluate the non-inferiority of pramipexole extended-release (ER) versus immediate-release (IR) in Chinese patients with Parkinson’s disease (PD) in a double-blind, randomized, parallel-group study.
Subjects were Chinese patients with idiopathic PD with diagnosis ≥ 2 years prior to trial, age ≥ 30 years old at diagnosis, and Modified Hoehn and Yahr score 2-4 during ‘on’-time. Subjects received treatment with pramipexole ER (n=234) or IR (n=239). Non-inferiority was based on the primary endpoint, the change from baseline to end of maintenance (week 18) in the UPDRS (Parts II + III) total score.
For the primary endpoint, the adjusted mean changes (standard error) of UPDRS Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed effect) and baseline (covariate). The adjusted mean between group difference was 0.8 for the 2-sided 95% CI (-1.047, 2.566). Since the lower limit of the 2-sided 95% CI (-1.047) for treatment difference was higher than the non-inferiority margin of -4, non-inferiority between pramipexole ER and IR was demonstrated. The incidence of adverse events (AEs) was 68.8% in the ER arm and 73.6% in the IR arm with few severe AEs (ER: 2.1%; IR: 3.8%).
Based on the UPDRS II + III score, pramipexole ER was non-inferior to pramipexole IR. The safety profiles of pramipexole ER and IR were similar. These results were based on comparable mean daily doses and durations of treatment for both formulations.
Url:
DOI: 10.1186/2047-9158-3-11
PubMed: 25114789
PubMed Central: 4128609
Affiliations:
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<author><name sortKey="Wang, Ying" sort="Wang, Ying" uniqKey="Wang Y" first="Ying" last="Wang">Ying Wang</name>
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<author><name sortKey="Zhu, Suiqiang" sort="Zhu, Suiqiang" uniqKey="Zhu S" first="Suiqiang" last="Zhu">Suiqiang Zhu</name>
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<author><name sortKey="Liu, Chunfeng" sort="Liu, Chunfeng" uniqKey="Liu C" first="Chunfeng" last="Liu">Chunfeng Liu</name>
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<author><name sortKey="Liu, Yiming" sort="Liu, Yiming" uniqKey="Liu Y" first="Yiming" last="Liu">Yiming Liu</name>
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<author><name sortKey="Chen, Shengdi" sort="Chen, Shengdi" uniqKey="Chen S" first="Shengdi" last="Chen">Shengdi Chen</name>
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<series><title level="j">Translational Neurodegeneration</title>
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<front><div type="abstract" xml:lang="en"><sec><title>Objective</title>
<p>To evaluate the non-inferiority of pramipexole extended-release (ER) versus immediate-release (IR) in Chinese patients with Parkinson’s disease (PD) in a double-blind, randomized, parallel-group study.</p>
</sec>
<sec><title>Methods</title>
<p>Subjects were Chinese patients with idiopathic PD with diagnosis ≥ 2 years prior to trial, age ≥ 30 years old at diagnosis, and Modified Hoehn and Yahr score 2-4 during ‘on’-time. Subjects received treatment with pramipexole ER (n=234) or IR (n=239). Non-inferiority was based on the primary endpoint, the change from baseline to end of maintenance (week 18) in the UPDRS (Parts II + III) total score.</p>
</sec>
<sec><title>Results</title>
<p>For the primary endpoint, the adjusted mean changes (standard error) of UPDRS Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed effect) and baseline (covariate). The adjusted mean between group difference was 0.8 for the 2-sided 95% CI (-1.047, 2.566). Since the lower limit of the 2-sided 95% CI (-1.047) for treatment difference was higher than the non-inferiority margin of -4, non-inferiority between pramipexole ER and IR was demonstrated. The incidence of adverse events (AEs) was 68.8% in the ER arm and 73.6% in the IR arm with few severe AEs (ER: 2.1%; IR: 3.8%).</p>
</sec>
<sec><title>Conclusion</title>
<p>Based on the UPDRS II + III score, pramipexole ER was non-inferior to pramipexole IR. The safety profiles of pramipexole ER and IR were similar. These results were based on comparable mean daily doses and durations of treatment for both formulations.</p>
</sec>
</div>
</front>
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<author><name sortKey="Tsoi, Th" uniqKey="Tsoi T">TH Tsoi</name>
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<author><name sortKey="Mok, V" uniqKey="Mok V">V Mok</name>
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<author><name sortKey="Barone, P" uniqKey="Barone P">P Barone</name>
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<author><name sortKey="Hauser, Ra" uniqKey="Hauser R">RA Hauser</name>
</author>
<author><name sortKey="Mizuno, Y" uniqKey="Mizuno Y">Y Mizuno</name>
</author>
<author><name sortKey="Haaksma, M" uniqKey="Haaksma M">M Haaksma</name>
</author>
<author><name sortKey="Salin, L" uniqKey="Salin L">L Salin</name>
</author>
<author><name sortKey="Juhel, N" uniqKey="Juhel N">N Juhel</name>
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<author><name sortKey="Cutler, Nr" uniqKey="Cutler N">NR Cutler</name>
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<author><name sortKey="Sramek, Jj" uniqKey="Sramek J">JJ Sramek</name>
</author>
<author><name sortKey="Friedman, J" uniqKey="Friedman J">J Friedman</name>
</author>
<author><name sortKey="Goetz, C" uniqKey="Goetz C">C Goetz</name>
</author>
<author><name sortKey="Ranhosky, A" uniqKey="Ranhosky A">A Ranhosky</name>
</author>
<author><name sortKey="Korts, D" uniqKey="Korts D">D Korts</name>
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<li>République populaire de Chine</li>
<li>États-Unis</li>
</country>
<region><li>Champagne-Ardenne</li>
<li>Connecticut</li>
<li>Grand Est</li>
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<settlement><li>Reims</li>
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<name sortKey="Di, Qing" sort="Di, Qing" uniqKey="Di Q" first="Qing" last="Di">Qing Di</name>
<name sortKey="Liu, Chunfeng" sort="Liu, Chunfeng" uniqKey="Liu C" first="Chunfeng" last="Liu">Chunfeng Liu</name>
<name sortKey="Liu, Yiming" sort="Liu, Yiming" uniqKey="Liu Y" first="Yiming" last="Liu">Yiming Liu</name>
<name sortKey="Lu, Changhong" sort="Lu, Changhong" uniqKey="Lu C" first="Changhong" last="Lu">Changhong Lu</name>
<name sortKey="Ren, Yan" sort="Ren, Yan" uniqKey="Ren Y" first="Yan" last="Ren">Yan Ren</name>
<name sortKey="Shang, Huifang" sort="Shang, Huifang" uniqKey="Shang H" first="Huifang" last="Shang">Huifang Shang</name>
<name sortKey="Sun, Shenggang" sort="Sun, Shenggang" uniqKey="Sun S" first="Shenggang" last="Sun">Shenggang Sun</name>
<name sortKey="Zhu, Suiqiang" sort="Zhu, Suiqiang" uniqKey="Zhu S" first="Suiqiang" last="Zhu">Suiqiang Zhu</name>
</country>
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<country name="France"><region name="Grand Est"><name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name>
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