1Chulalongkorn Centre of Excellence for Parkinson’s Disease and Related Disorders, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand
2The Academy of Science, The Royal Society of Thailand, Bangkok, Thailand
3Medical Headquarters, Eisai Co., Ltd., Tokyo, Japan
4Clinical Evidence Generation, Deep Human Biology Learning, Eisai Co., Ltd., Tokyo, Japan
5Department of Neurology of Changhua Christian Hospital, Changhua, Taiwan
6Department of Neurology, Sungkyunkwan University School of Medicine, Seoul, Korea
7Neuroscience Center, Samsung Medical Center, Seoul, Korea
Copyright © 2023 The Korean Movement Disorder Society
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Conflicts of Interest
Employees of Eisai Co. Ltd. were involved in the study design; the collection, analysis, and interpretation of data; and the decision to submit the article for publication. Roongroj Bhidayasiri, Shey Lin Wu, Jin Whan Cho received support for the present manuscript including the provision of study materials and medical writing support from Eisai Co. Ltd., as well as consulting fees from Eisai Co. Ltd.
Funding Statement
This work was sponsored by Eisai Co. Ltd. The clinical trial was sponsored by Newron Pharmaceuticals and Merck Serono.
Author contributions
Conceptualization: Roongroj Bhidayasiri, Takayuki Ishida. Data curation: Ippei Suzuki. Formal analysis: Ippei Suzuki. Funding acquisition: Takayuki Ishida. Investigation: Takayuki Ishida, Takanori Kamei, Ryan Edbert Husni, Ippei Suzuki. Methodology: Takayuki Ishida, Takanori Kamei, Ryan Edbert Husni, Ippei Suzuki. Project administration: Takayuki Ishida. Supervision: Roongroj Bhidayasiri, Takayuki Ishida. Validation: Ippei Suzuki. Visualization: Takayuki Ishida, Takanori Kamei. Writing—original draft: Takayuki Ishida. Writing—review & editing: Roongroj Bhidayasiri, Takanori Kamei, Ryan Edbert Husni, Ippei Suzuki, Shey Lin Wu, Jin Whan Cho.
Number of patients in each subgroup: Asian patients who received safinamide (n = 88) vs. placebo (n = 85); Caucasian patients who received safinamide (n = 183) vs. placebo (n = 188). ADL, activities of daily living; CI, confidence interval; LS mean, least squares mean; PDQ-39, 39item Parkinson Disease Questionnaire.
TEAE |
Asian patients (n = 173) |
Caucasian patients (n = 371) |
p-value for interaction* | |||
---|---|---|---|---|---|---|
Placebo (n = 85) | Safinamide (n = 88) | Placebo (n = 188) | Safinamide (n = 183) | |||
Summary | ||||||
Any TEAE | 54 (63.5) | 54 (61.4) | 135 (71.8) | 131 (71.6) | 0.8634 | |
Mild | 49 (57.6) | 49 (55.7) | 112 (59.6) | 113 (61.7) | 0.6601 | |
Moderate | 10 (11.8) | 19 (21.6) | 61 (32.4) | 66 (36.1) | 0.3043 | |
Severe | 1 (1.2) | 4 (4.5) | 23 (12.2) | 15 (8.2) | 0.1960 | |
Any study-drug-related TEAE | 13 (15.3) | 18 (20.5) | 63 (33.5) | 60 (32.8) | 0.5238 | |
Any TEAE causing discontinuation from study | 2 (2.4) | 0 (0.0) | 8 (4.3) | 12 (6.6) | 0.8544 | |
Any SAE | 2 (2.4) | 4 (4.5) | 24 (12.8) | 14 (7.7) | 0.2022 | |
Any study-drug-related SAE | 1 (1.2) | 0 (0.0) | 5 (2.7) | 3 (1.6) | 0.8815 | |
Death | 0 (0.0) | 1 (1.1) | 2 (1.1) | 0 (0.0) | 0.8811 | |
Severity of dyskinesia | 0.7166 | |||||
Mild | 3 (3.5) | 7 (8.0) | 6 (3.2) | 8 (4.4) | ||
Moderate | 0 (0.0) | 3 (3.4) | 5 (2.7) | 17 (9.3) | ||
Severe | 0 (0.0) | 2 (2.3) | 1 (0.5) | 3 (1.6) |