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Adjunct rasagiline to treat Parkinson's disease with motor fluctuations: a randomized, double-blind study in China

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单位: [1]Beijing Union Med Coll Hosp, Dept Neurol, 53 Dongdan N St, Beijing, Peoples R China [2]Guangzhou Med Univ, Affiliated Hosp 1, Dept Neurol, Guangzhou, Guangdong, Peoples R China [3]Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Dept Neurol, Shanghai, Peoples R China [4]Soochow Univ, Affiliated Hosp 2, Dept Neurol, Suzhou, Peoples R China [5]Sichuan Univ, West China Hosp, Dept Neurol, Chengdu, Sichuan, Peoples R China [6]Shanghai Jiao Tong Univ, Renji Hosp, Dept Neurol, Sch Med, Shanghai, Peoples R China [7]Fudan Univ, Huashan Hosp, Dept Neurol, Shanghai, Peoples R China [8]Huazhong Univ Sci & Technol,Tongji Med Coll,Tongji Hosp,Dept Neurol,Wuhan,Hubei,Peoples R China [9]Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Neurol, Xian, Shaanxi, Peoples R China [10]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China [11]Beijing Hosp, Dept Neurol, Beijing, Peoples R China [12]Peking Univ, Hosp 1, Dept Neurol, Beijing, Peoples R China [13]Guangzhou Med Univ, Affiliated Hosp 2, Dept Neurol, Guangzhou, Guangdong, Peoples R China [14]Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Dept Neurol, Wuhan, Hubei, Peoples R China [15]Zhejiang Univ, Affiliated Hosp 2, Sch Med, Dept Neurol, Hangzhou, Zhejiang, Peoples R China [16]Capital Med Univ, Beijing Friendship Hosp, Dept Neurol, Beijing, Peoples R China [17]Guangzhou First Peoples Hosp, Dept Neurol, Guangzhou, Guangdong, Peoples R China [18]Fourth Mil Med Univ, Affiliated Hosp 1, Xijing Hosp, Dept Neurol, Xian, Shaanxi, Peoples R China
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关键词: Parkinson's disease Rasagiline Adjunct Motor fluctuations OFF time Quality of life China

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Background: The use of adjunct rasagiline in levodopa-treated patients with Parkinson's disease and motor fluctuations is supported by findings from large-scale clinical studies. This study is to investigate the efficacy and safety of adjunct rasagiline in Chinese patients with Parkinson's disease, as a product registration study. Methods: This 16-week, randomized, double-blind, parallel-group, multicenter, placebo-controlled study of rasagiline 1 mg/day included levodopa-treated patients with Parkinson's disease and motor fluctuations. The primary efficacy endpoint was mean change from baseline in total daily OFF time over 16 weeks. Secondary endpoints were Clinical Global Impressions - Improvement (CGI-I), and change in Unified Parkinson's Disease Rating Scale (UPDRS) Activities of daily living (ADL) and Motor scores. Patient well-being (EQ-5D), and the frequency of adverse events were also assessed. Results: In total, 324 levodopa-treated patients were randomized to rasagiline 1 mg/day (n = 165) or placebo (n = 159). Over 16 weeks, rasagiline statistically significantly reduced the mean [95% confidence interval] total daily OFF time versus placebo (-0.5 h [-0.92, -0.07]; p = 0.023). There were also statistically significant improvements versus placebo in CGI-I (-0.4 points [-0.61, -0.22]; p < 0.001), UPDRS-ADL OFF (-1.0 points [-1.75, -0.27]; p = 0.008), and UPDRS-Motor ON (-1.6 points [-3.05, -0.14]; p = 0.032) scores, as well as the EQ-5D utility index (p < 0.05). Rasagiline was safe and well tolerated. Conclusions: In levodopa-treated Chinese patients with Parkinson's disease and motor fluctuations, adjunct rasagiline 1 mg/day statistically significantly reduced OFF time, and improved daily function and overall well-being, versus placebo. Consistent with findings in other countries, adjunct rasagiline was proven efficacious and well tolerated in Chinese patients.

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大类 | 1 区 医学
小类 | 1 区 神经科学
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第一作者单位: [1]Beijing Union Med Coll Hosp, Dept Neurol, 53 Dongdan N St, Beijing, Peoples R China
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