Efficacy and safety of rasagiline as an adjunct to levodopa treatment in Chinese patients with Parkinson's disease: a randomized, double-blind, parallel-controlled, multi-centre trial

Author:

Zhang Lina1,Zhang Zhiqin1,Chen Yangmei1,Qin Xinyue2,Zhou Huadong3,Zhang Chaodong4,Sun Hongbin5,Tang Ronghua6,Zheng Jinou7,Yi Lin8,Deng Liying9,Li Jinfang1

Affiliation:

1. Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China

2. Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China

3. Department of Neurology, The Third Affiliated Hospital of Third Military Medical University, Chongqing, China

4. Department of Neurology, The First Affiliated Hospital of China Medical University, Liaoning, China

5. Department of Neurology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Sichuan, China

6. Department of Neurology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Hubei, China

7. Department of Neurology, The First Affiliated Hospital of Guangxi Medical University, Guangxi, China

8. Department of Neurology, The Second Affiliated Hospital of Dalian Medical University, Liaoning, China

9. Department of Neurology, The Second Affiliated Hospital of Nanchang University, China

Abstract

Abstract Rasagiline mesylate is a highly potent, selective and irreversible monoamine oxidase type B (MAOB) inhibitor and is effective as monotherapy or adjunct to levodopa for patients with Parkinson's disease (PD). However, few studies have evaluated the efficacy and safety of rasagiline in the Chinese population. This study was designed to investigate the safety and efficacy of rasagiline as adjunctive therapy to levodopa treatment in Chinese PD patients. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial conducted over a 12-wk period that enrolled 244 PD patients with motor fluctuations. Participants were randomly assigned to oral rasagiline mesylate (1 mg) or placebo, once daily. Altogether, 219 patients completed the trial. Rasagiline showed significantly greater efficacy compared with placebo. During the treatment period, the primary efficacy variable – mean adjusted total daily off time – decreased from baseline by 1.7 h in patients treated with 1.0 mg/d rasagiline compared to placebo (p < 0.05). Scores using the Unified Parkinson's Disease Rating Scale also improved during rasagiline treatment. Rasagiline was well tolerated. This study demonstrated that rasagiline mesylate is effective and well tolerated as an adjunct to levodopa treatment in Chinese PD patients with fluctuations.

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Psychiatry and Mental health,Pharmacology

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