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.

International Parkinson and movement disorder society evidence‐based medicine review: Update on treatments for the motor symptoms of Parkinson's disease

“…MAO‐B Inhibitors . One new study evaluated rasagiline, and the outcome was “efficacious”; thus the practice implication remains as “clinically useful.” No new studies were published using selegiline, and the conclusions remain the same. There are no new safety concerns.…”

Rasagiline: A Review of Its Use in the Treatment of Idiopathic Parkinson’s Disease

“…Compared with placebo, adjunctive rasagiline significantly improved the symptoms of tremor (p = 0.002), rigidity (p = 0.002) and bradykinesia (p = 0.005), but not postural instability, at week 12 [36].…”

“…In addition to these large, pivotal, randomized, controlled trials, several other notable studies have assessed the efficacy of rasagiline as an adjunct to levodopa [36] or as both monotherapy and adjunctive therapy in community-based studies [37,38].…”

“…In a randomized, double-blind, placebo-controlled, multicentre study in Chinese patients (n = 244) treated with levodopa (mean of 515-521 mg/day) for a mean duration of 3.9-4.1 years, adjunctive rasagiline 1 mg/day for 12 weeks significantly (p \ 0.001) reduced the motor fluctuation off-time while awake (co-primary endpoint) by 1.06 h more than placebo and significantly (p \ 0.001) increased the on-time while awake (co-primary endpoint) by 0.87 h more than placebo [36]. Compared with placebo, adjunctive rasagiline significantly improved the symptoms of tremor (p = 0.002), rigidity (p = 0.002) and bradykinesia (p = 0.005), but not postural instability, at week 12 [36].…”

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

“…Oral rasagiline has been approved for the treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end-of-dose fluctuations [ 21 ] in North America, Europe, and some Asian countries. The clinical efficacy, safety, and tolerability of rasagiline have been established in four Phase III studies (and one Phase II study) in predominantly Caucasian populations [ 16 , 17 , 22 – 24 ], and two Phase III studies in Chinese patients [ 25 , 26 ]. Meta-analyses have reinforced these findings [ 27 – 29 ].…”