Masahiro Nomoto1, Takayuki Ishida2, Michinori Koebis3, Takanori Kamei4, Ippei Suzuki5, Nobutaka Hattori6, Yoshio Tsuboi7. 1. Saiseikai Imabari Center for Health and Welfare, 7-6-1 Kitamura, Imabari, Ehime 799-1592, Japan. Electronic address: m-nomoto@imabari.saiseikai.or.jp. 2. Medical Headquarters, Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan. Electronic address: t8-ishida@hhc.eisai.co.jp. 3. Medical Headquarters, Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan. Electronic address: m-koebisu@hhc.eisai.co.jp. 4. Medical Headquarters, Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan. Electronic address: t2-kamei@hhc.eisai.co.jp. 5. Medicine Development Center, Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan. Electronic address: i6-suzuki@hhc.eisai.co.jp. 6. Department of Neurology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan. Electronic address: nhattori@juntendo.ac.jp. 7. Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp.
Abstract
INTRODUCTION: Patients with Parkinson's disease (PD) experience various motor and non-motor symptoms. We conducted a post hoc analysis of a Japanese phase 2/3 study of safinamide (50 or 100 mg/day) in patients with Parkinson's disease and wearing-off to evaluate response according to background factors. Safinamide efficacy against major motor symptoms was also assessed. METHODS: Multiple regression analyses in safinamide-treated patients (50 or 100 mg/day) assessed changes in daily ON-time without troublesome dyskinesia (hereafter referred to as ON-time) according to baseline clinical variables. Subgroup analyses by baseline Unified Parkinson's Disease Rating Scale (UPDRS) part III score were also conducted. We evaluated cardinal motor symptoms using the UPDRS. RESULTS: In the multiple regression analysis, changes in ON-time were related to baseline non-motor symptoms (UPDRS part I score) and ON-time in the 50-mg group, but no relationships with non-motor symptoms were observed in the 100-mg group. Additionally, in the subgroup analysis of patients with more severe motor symptoms (UPDRS part III score > 20), a significant improvement in ON-time was observed only with 100 mg/day (p = 0.01). At both doses, safinamide significantly improved cardinal motor symptom scores (bradykinesia, rigidity, tremor, axial symptoms, and gait disturbances). CONCLUSIONS: The observed response profile to the 50-mg/day dose may be related to baseline non-motor symptoms, but this was not true for the 100-mg/day dose. Both safinamide doses improved major motor symptoms in levodopa-treated patients with PD.
INTRODUCTION: Patients with Parkinson's disease (PD) experience various motor and non-motor symptoms. We conducted a post hoc analysis of a Japanese phase 2/3 study of safinamide (50 or 100 mg/day) in patients with Parkinson's disease and wearing-off to evaluate response according to background factors. Safinamide efficacy against major motor symptoms was also assessed. METHODS: Multiple regression analyses in safinamide-treated patients (50 or 100 mg/day) assessed changes in daily ON-time without troublesome dyskinesia (hereafter referred to as ON-time) according to baseline clinical variables. Subgroup analyses by baseline Unified Parkinson's Disease Rating Scale (UPDRS) part III score were also conducted. We evaluated cardinal motor symptoms using the UPDRS. RESULTS: In the multiple regression analysis, changes in ON-time were related to baseline non-motor symptoms (UPDRS part I score) and ON-time in the 50-mg group, but no relationships with non-motor symptoms were observed in the 100-mg group. Additionally, in the subgroup analysis of patients with more severe motor symptoms (UPDRS part III score > 20), a significant improvement in ON-time was observed only with 100 mg/day (p = 0.01). At both doses, safinamide significantly improved cardinal motor symptom scores (bradykinesia, rigidity, tremor, axial symptoms, and gait disturbances). CONCLUSIONS: The observed response profile to the 50-mg/day dose may be related to baseline non-motor symptoms, but this was not true for the 100-mg/day dose. Both safinamide doses improved major motor symptoms in levodopa-treated patients with PD.