title: 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.
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.
authors.affiliation: Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
authors.forename: Lina
authors.initials: L
authors.lastname: Zhang
authors.forename: Zhiqin
authors.initials: Z
authors.lastname: Zhang
authors.forename: Yangmei
authors.initials: Y
authors.lastname: Chen
authors.forename: Xinyue
authors.initials: X
authors.lastname: Qin
authors.forename: Huadong
authors.initials: H
authors.lastname: Zhou
authors.forename: Chaodong
authors.initials: C
authors.lastname: Zhang
authors.forename: Hongbin
authors.initials: H
authors.lastname: Sun
authors.forename: Ronghua
authors.initials: R
authors.lastname: Tang
authors.forename: Jinou
authors.initials: J
authors.lastname: Zheng
authors.forename: Lin
authors.initials: L
authors.lastname: Yi
authors.forename: Liying
authors.initials: L
authors.lastname: Deng
authors.forename: Jinfang
authors.initials: J
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D044466:Asian People; D003072:Cognition Disorders / Q000188:drug therapy / Q000209:etiology; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D007980:Levodopa / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy*
chemical_list: D000978:Antiparkinson Agents; D007189:Indans; D018696:Neuroprotective Agents; C031967:rasagiline; D007980:Levodopa