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.
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DOI: 10.1186/2047-9158-3-11
PubMed: 25114789
PubMed Central: 4128609
Affiliations:
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Inc, Ridgefield, CT</wicri:regionArea><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name><affiliation wicri:level="3"><nlm:aff id="I11">Boehringer Ingelheim France S.A.S, Reims, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Boehringer Ingelheim France S.A.S, Reims</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Champagne-Ardenne</region><settlement type="city">Reims</settlement></placeName></affiliation></author><author><name sortKey="Chen, Shengdi" sort="Chen, Shengdi" uniqKey="Chen S" first="Shengdi" last="Chen">Shengdi Chen</name><affiliation wicri:level="1"><nlm:aff id="I12">Department of Neurology, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China</nlm:aff><country xml:lang="fr">République populaire de 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first="Shenggang" last="Sun">Shenggang Sun</name><affiliation wicri:level="1"><nlm:aff id="I2">Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan</wicri:regionArea><wicri:noRegion>Wuhan</wicri:noRegion></affiliation></author><author><name sortKey="Zhu, Suiqiang" sort="Zhu, Suiqiang" uniqKey="Zhu S" first="Suiqiang" last="Zhu">Suiqiang Zhu</name><affiliation wicri:level="1"><nlm:aff id="I3">Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan</wicri:regionArea><wicri:noRegion>Wuhan</wicri:noRegion></affiliation></author><author><name sortKey="Liu, Chunfeng" sort="Liu, Chunfeng" uniqKey="Liu C" first="Chunfeng" last="Liu">Chunfeng Liu</name><affiliation wicri:level="1"><nlm:aff id="I4">The Second Affiliated Hospital of Soochow University, Suzhou, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>The Second Affiliated Hospital of Soochow University, Suzhou</wicri:regionArea><wicri:noRegion>Suzhou</wicri:noRegion></affiliation></author><author><name sortKey="Liu, Yiming" sort="Liu, Yiming" uniqKey="Liu Y" first="Yiming" last="Liu">Yiming Liu</name><affiliation wicri:level="1"><nlm:aff id="I5">Qilu Hospital affiliated to Shandong University, Jinan, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Qilu Hospital affiliated to Shandong University, Jinan</wicri:regionArea><wicri:noRegion>Jinan</wicri:noRegion></affiliation></author><author><name sortKey="Di, Qing" sort="Di, Qing" uniqKey="Di Q" first="Qing" last="Di">Qing Di</name><affiliation wicri:level="1"><nlm:aff id="I6">Nanjing Brain Hospital, Nanjing, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Nanjing Brain Hospital, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Shang, Huifang" sort="Shang, Huifang" uniqKey="Shang H" first="Huifang" last="Shang">Huifang Shang</name><affiliation wicri:level="1"><nlm:aff id="I7">West China Hospital affiliated to Sichuan University, Chengdu, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>West China Hospital affiliated to Sichuan University, Chengdu</wicri:regionArea><wicri:noRegion>Chengdu</wicri:noRegion></affiliation></author><author><name sortKey="Ren, Yan" sort="Ren, Yan" uniqKey="Ren Y" first="Yan" last="Ren">Yan Ren</name><affiliation wicri:level="1"><nlm:aff id="I8">First Affiliated Hospital of China Medical University, Shenyang, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>First Affiliated Hospital of China Medical University, Shenyang</wicri:regionArea><wicri:noRegion>Shenyang</wicri:noRegion></affiliation></author><author><name sortKey="Lu, Changhong" sort="Lu, Changhong" uniqKey="Lu C" first="Changhong" last="Lu">Changhong Lu</name><affiliation wicri:level="1"><nlm:aff id="I9">Boehringer Ingelheim International Trading (Shanghai) Co, Ltd, Shanghai, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Boehringer Ingelheim International Trading (Shanghai) Co, Ltd, Shanghai</wicri:regionArea><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author><author><name sortKey="Gordon, Mark Forrest" sort="Gordon, Mark Forrest" uniqKey="Gordon M" first="Mark Forrest" last="Gordon">Mark Forrest Gordon</name><affiliation wicri:level="2"><nlm:aff id="I10">Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT</wicri:regionArea><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name><affiliation wicri:level="3"><nlm:aff id="I11">Boehringer Ingelheim France S.A.S, Reims, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Boehringer Ingelheim France S.A.S, Reims</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Champagne-Ardenne</region><settlement type="city">Reims</settlement></placeName></affiliation></author><author><name sortKey="Chen, Shengdi" sort="Chen, Shengdi" uniqKey="Chen S" first="Shengdi" last="Chen">Shengdi Chen</name><affiliation wicri:level="1"><nlm:aff id="I12">Department of Neurology, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Neurology, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai</wicri:regionArea><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author></analytic><series><title level="j">Translational Neurodegeneration</title><idno type="eISSN">2047-9158</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><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><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Olesen, J" uniqKey="Olesen J">J Olesen</name></author><author><name sortKey="Gustavsson, A" uniqKey="Gustavsson A">A Gustavsson</name></author><author><name sortKey="Svensson, M" uniqKey="Svensson M">M Svensson</name></author><author><name sortKey="Wittchen, Hu" uniqKey="Wittchen H">HU Wittchen</name></author><author><name sortKey="Jonsson, B" uniqKey="Jonsson B">B Jönsson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tian, Yy" uniqKey="Tian Y">YY Tian</name></author><author><name sortKey="Tang, Cj" uniqKey="Tang C">CJ Tang</name></author><author><name sortKey="Wu, J" uniqKey="Wu J">J Wu</name></author><author><name sortKey="Zhou, Js" uniqKey="Zhou J">JS Zhou</name></author></analytic></biblStruct><biblStruct><analytic><author><name 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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></author><author><name sortKey="Schapira, Ah" uniqKey="Schapira A">AH Schapira</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hubble, Jp" uniqKey="Hubble J">JP Hubble</name></author><author><name sortKey="Koller, Wc" uniqKey="Koller W">WC Koller</name></author><author><name sortKey="Cutler, Nr" uniqKey="Cutler N">NR Cutler</name></author><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></author><author><name sortKey="Elvin, A" uniqKey="Elvin A">A Elvin</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>France</li><li>République populaire de Chine</li><li>États-Unis</li></country><region><li>Champagne-Ardenne</li><li>Connecticut</li><li>Grand Est</li></region><settlement><li>Reims</li></settlement></list><tree><country name="République populaire de Chine"><noRegion><name sortKey="Wang, Ying" sort="Wang, Ying" uniqKey="Wang Y" first="Ying" last="Wang">Ying Wang</name></noRegion><name sortKey="Chen, Shengdi" sort="Chen, Shengdi" uniqKey="Chen S" first="Shengdi" last="Chen">Shengdi Chen</name><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><country name="États-Unis"><region name="Connecticut"><name sortKey="Gordon, Mark Forrest" sort="Gordon, Mark Forrest" uniqKey="Gordon M" first="Mark Forrest" last="Gordon">Mark Forrest Gordon</name></region></country><country name="France"><region name="Grand Est"><name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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