Efficacy of rasagiline monotherapy for early Parkinson disease: A systematic review and meta-analysis of randomized controlled trials

Abstract

Background: Rasagiline monotherapy is approved in early Parkinson’s disease (PD) for motor benefit. However, the efficacy and optimal rasagiline dosage in improving Unified Parkinson’s Disease Rating Scale (UPDRS) subscale scores between Japanese and Caucasian individuals remain uncertain. Aims: To investigate the efficacy of rasagiline monotherapy and evaluate differences between early PD patients in Eastern and Western countries. Methods: The study design involved the meta-analysis of randomized controlled trials identified using electronic databases. Results: The mean difference (MD) in total UPDRS scores indicated no significant difference between the 1 and 2 mg rasagiline (MD = −0.00, 95% confidence interval (CI) = −0.82 to 0.81). Compared with the placebo, the MD of UPDRS part I scores significantly improved in the 1 mg (MD = −0.33, 95% CI = −0.57 to −0.10) but not in the 2 mg. For UPDRS part II scores, the MD significantly improved in the 1 mg (MD = −0.87, 95% CI = −1.48 to −0.27) and 2 mg (MD = −0.98, 95% CI = −1.28 to −0.68). Regarding the UPDRS part III, the MD significantly improved in both (1 mg: MD = −2.41, 95% CI = −3.26 to −1.56; 2 mg: MD = −2.05, 95% CI = −2.64 to −1.46). The most commonly reported adverse events were headaches, back pain, and dizziness, with no statistical difference between the 1 mg rasagiline and placebo groups. Subgroup analysis revealed similar effects between Asian and Western participants. Conclusion: Rasagiline monotherapy at 1 mg per day is recommended for patients with early PD because of the benefits for motor, nonmotor functions, and safety.

Safety and Effectiveness of Rasagiline in Chinese Patients with Parkinson’s Disease: A Prospective, Multicenter, Non-interventional Post-marketing Study

“…According to Phase 3 clinical trials in China [ 12 , 13 ] and Japan [ 16 , 17 ], in the monotherapy and adjunct therapy groups, the incidence of TEAEs and SAEs in rasagiline groups was similar to those of placebo. This is consistent with a recent meta-analysis of clinical trials, which showed no statistical difference in reported AEs between the 1 mg rasagiline and placebo groups, indicating satisfactory safety and tolerability of rasagiline, especially in an Asian subpopulation [ 18 ]. In this study, the real-world incidence rates of ADRs and SADRs were numerically lower than TEAEs and SAEs reported in randomized controlled clinical trials, providing supplementary evidence beyond clinical trials which set strict screening criteria for participants.…”

A comprehensive overview of post-stroke depression treatment options

“…It is contraindicated in patients with impaired liver function (Green, 2011). Recent studies in this field suggest that the efficacy of agomelatine in treating PSD is likely comparable to that of SSRIs and may improve stroke outcomes with better safety (Yao et al ., 2021; Chen et al ., 2023). However, confirmatory randomized controlled trials on agomelatine for the treatment of PSD are essential in the future.…”