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Efficacy and safety of rasagiline in Chinese patients with early Parkinson's disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study.

ABSTRACT: Background:Rasagiline is a monoamine oxidase-B inhibitor used for Parkinson's disease (PD) treatment, but its effectiveness on Chinese patients is unclear. This study aimed to evaluate the efficacy and safety of rasagiline monotherapy in Chinese patients with early PD. Methods:A 26-weeks, randomized, double-blind, placebo-controlled study has been performed at 15 sites in China and enrolled outpatients (?35 years old) with idiopathic PD without a history of using any dopaminergic drugs. Participants were randomized 1:1 to receive rasagiline 1 mg once daily or placebo. The primary endpoint was the change of the Unified Parkinson's Disease Rating Scale (UPDRS) total score from baseline to 26 weeks treatment. Secondary endpoints included changes in UPDRS subscale scores from part I to III. Health status was assessed with the PD Questionnaire (PDQ)-39 and EuroQol-Five-Dimension (EQ-5D) questionnaire. Safety profile was collected until 30 weeks after randomization. Results:A total of 130 patients (n?=?65/group) were recruited, and 127 (rasagiline, n?=?64; placebo, n?=?63) were included in the full analysis set. Baseline characteristics were comparable between the two groups. The decrease in the mean UPDRS total score was greater in the rasagiline group than in the placebo group (-?3.18?±?0.95 vs. -?0.18?±?0.98, P?=?0.025), and the mean UPDRS part I non-motor symptoms score (-?0.54?±?0.15 vs. -0.08?±?0.15, P?=?0.003) were significantly decreased in the rasagiline group compared with placebo treated patients. An improvement trend was observed in the active treatment group for the subscales evaluation with parts II and III, while the difference to placebo was not statistically significant. Life quality assessed by the EQ-5D visual analog scale improved in the rasagiline group but worsened in placebo treated patients. The overall incidence of treatment-emergent adverse events (AEs) was slightly lower in the rasagiline group (41.5%) than in the placebo group (46.2%). Conclusions:Rasagiline is effective, safe, and well tolerated as monotherapy for the treatment of Chinese PD patients. Trial registration:Clinicaltrials.gov: NCT01556165. Registered 13 Mar 2012.

SUBMITTER: Zhang Z

PROVIDER: S-EPMC6282325 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Efficacy and safety of rasagiline in Chinese patients with early Parkinson's disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study.

Zhang Zhenxin Z Wang Jian J Chen Shengdi S Liu Chunfeng C Zhang Baorong B Peng Rong R Sun Shenggang S Sun Xiangru X Zhao Gang G Qu Qiumin Q Li Yansheng Y Zhu Suiqiang S Pan Xiaoping X Shao Ming M Wang Yanping Y

Translational neurodegeneration 20181206

<h4>Background</h4>Rasagiline is a monoamine oxidase-B inhibitor used for Parkinson's disease (PD) treatment, but its effectiveness on Chinese patients is unclear. This study aimed to evaluate the efficacy and safety of rasagiline monotherapy in Chinese patients with early PD.<h4>Methods</h4>A 26-weeks, randomized, double-blind, placebo-controlled study has been performed at 15 sites in China and enrolled outpatients (≥35 years old) with idiopathic PD without a history of using any dopaminergic ...[more]

PMID: 30534374

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Project description:Background: Chronic urticaria is a bothersome skin disease, and Chinese herbal medicine (CHM) is commonly used as adjuvant therapy. This study aimed to evaluate the effectiveness and safety of the mixture of two CHM formula, Xiao-Feng-San (XFS) and Qing-Shang-Fang-Feng-Tang (QSFFT), in treating urticaria through a randomized, double-blind, placebo-controlled clinical trial. Methods: 78 participants entered the screening phase between November 2012 and August 2015. Participants were randomly and equally allocated in either CHM group (2 gm XFS and 2 gm QSFFT four times a day and 5 mg levocetirizine once daily for 28 days followed by 5 mg levocetirizine once daily alone for 28 days) or control group (placebo and 5 mg levocetirizine daily followed by 5 mg levocetirizine once daily for 28 days alone). Symptom improvement was set as the primary outcome, and the influence on sleep quality and changes in serum markers were used as secondary outcomes. Per protocol design was applied to the final analysis. Results: A total of 56 participants entered the final analysis stage. Participants in the CHM group had more prominent symptom relief on day 56 (the weekly urticaria activity score, UAS7, as 9.9 ± 9.2 vs. 15.6 ± 10.8, p = 0.038). In the CHM group, participants' symptom severity reduced progressively (trend analysis, p < 0.001) while the decreasing trend was less favored in the control group (trend analysis, p = 0.056). The life quality improved gradually in both groups, while the differences between CHM and control groups were statistically insignificant. For urticaria-related cytokines, interferon-? seemed to decrease positively in the CHM group (about 30.8% reduction from baseline, trend analysis p = 0.013). For safety issue, the CHM prescription was well-tolerated with no noticeable long-term side effects when compared to the control group. At 6-month follow-up of symptom changes after the end of the trial, the CHM group participants reported positive results in no recurrence or ?50% improvement (36.3% in CHM group vs. 20% in Control group, p = 0.103). Conclusions: The combination of XFS and QSFFT tended to be feasible and tolerable adjuvant therapy for urticaria in addition to standard therapy. However, larger study population with longer follow-up duration may be still needed. Trial registration: NCT01715740 (ClinicalTrials.gov).

Dataset Information

Efficacy and safety of rasagiline in Chinese patients with early Parkinson's disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study.

Publications

Efficacy and safety of rasagiline in Chinese patients with early Parkinson's disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study.

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