Objective: Objective: This randomized, double-blind, placebo-controlled, delayed-start trial aimed to investigate the efficacy in symptom improvement and disease-modifying effect of rasagiline for Chinese patients with early-stage Parkinson’s disease (PD).

Background: Background: Rasagiline is an irreversible selective monoamine oxidase B (MAO-B) inhibitor. Previous studies in European and American populations suggest that rasagiline 1 mg/day may have disease-modifying effects. However, PD is a highly heterogeneous disease and the efficacy response to drugs may be various among different genetic profiles and populations. Whether 1 mg/day rasagiline also has a disease-modifying effect in Chinese patients needs to be further verified by studies including the Chinese population.

Method: Methods: Patients aged 30-80 years with a diagnosis of idiopathic PD and Hoehn & Yahr stage of 1-2.5 at baseline were enrolled and randomly assigned to either the early-start group (rasagiline 1 mg/day for 48 weeks) or the delayed-start group (placebo for 24 weeks followed by rasagiline 1 mg/day for 24 weeks). A total of 226 patients were enrolled, with 113 in each group; 90 patients in the early-start group and 86 patients in the delayed-start group completed the 48-week follow-ups. The primary outcome was the change in the Unified Parkinson’s Disease Rating Scale (UPDRS) I-III score from baseline to Week 24 and 48.

Results: Results: No clinically relevant difference was observed in the baseline characteristics of patients. A significant difference in the change of UPDRS I-III score change from baseline to Week 24 was observed, favoring to the early-start group. The significance of the difference remained at Week 48, after the delayed-start group used rasagiline for 24 weeks, favoring to the early-start group. Comparing the slope values (rate of worsening) of the two groups, there was a statistically significant difference between the two groups from the baseline to Week 24 (p=0.003), while no significant difference in the slope value from Week 24 to Week 48 (p=0.461).

Conclusion: Conclusions: Early treatment with rasagiline 1 mg/day was effective in improving symptoms for Chinese patients with early-stage PD, and the early-start treatment showed a potential disease-modifying effect.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/rasagiline-in-chinese-patients-with-early-stage-parkinsons-disease-a-randomized-double-blind-placebo-controlled-delayed-start-trial/