Yoshio Tsuboi1, Nobutaka Hattori2, Akihiko Yamamoto3, Yuji Sasagawa4, Masahiro Nomoto5. 1. Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp. 2. Department of Neurology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan. Electronic address: nhattori@juntendo.ac.jp. 3. Meiji Seika Pharma Co., Ltd, 2-4-16 Kyobashi, Chuo-ku, Tokyo 104-8002, Japan. Electronic address: akihiko.yamamoto@meiji.com. 4. Meiji Seika Pharma Co., Ltd, 2-4-16 Kyobashi, Chuo-ku, Tokyo 104-8002, Japan. Electronic address: yuuji.sasagawa@meiji.com. 5. Department of Neurology and Clinical Pharmacology, Graduate School of Medicine, Ehime University, Shitsukawa, Toon, Ehime 791-0295, Japan; Saiseikai Imabari Center for Health and Welfare, 7-6-1 Kitamura, Imabari, Ehime 799-1592, Japan. Electronic address: nomoto@m.ehime-u.ac.jp.
Abstract
INTRODUCTION: Safinamide, a selective, reversible monoamine oxidase B inhibitor with a sodium channel inhibitory effect, improves symptoms in advanced Parkinson's disease (PD). This study aimed to confirm the long-term safety and efficacy of safinamide in Japanese PD patients with wearing-off. METHODS: Japanese PD patients aged ≥30 years with wearing-off were eligible. The primary efficacy endpoint was change from baseline in the mean daily ON-time without troublesome dyskinesias at 52 weeks of treatment. Other efficacy endpoints included changes from baseline in mean daily OFF-time and unified Parkinson's disease rating scale (UPDRS) and PDQ-39 scores. RESULTS: In total, 203 patients entered the study, and 142 completed the 52-week treatment. Adverse events (AEs) occurred in 78.3% of patients, with nasopharyngitis (20.7%) and dyskinesias (17.7%) as the most common; serious AEs occurred in 17.2%, causing discontinuation in 10.8%. At Week 52, the mean daily ON-time without troublesome dyskinesias increased from baseline by 1.42 h. Change from baseline in mean daily OFF-time was -1.40 h, and that in the UPDRS Part III score in the ON-phase was -6.20. CONCLUSIONS: As adjunctive treatment with levodopa, safinamide was safe, well tolerated, and effective in improving ON-time and other PD symptoms at 52 weeks.
INTRODUCTION:Safinamide, a selective, reversible monoamine oxidase B inhibitor with a sodium channel inhibitory effect, improves symptoms in advanced Parkinson's disease (PD). This study aimed to confirm the long-term safety and efficacy of safinamide in Japanese PDpatients with wearing-off. METHODS: Japanese PDpatients aged ≥30 years with wearing-off were eligible. The primary efficacy endpoint was change from baseline in the mean daily ON-time without troublesome dyskinesias at 52 weeks of treatment. Other efficacy endpoints included changes from baseline in mean daily OFF-time and unified Parkinson's disease rating scale (UPDRS) and PDQ-39 scores. RESULTS: In total, 203 patients entered the study, and 142 completed the 52-week treatment. Adverse events (AEs) occurred in 78.3% of patients, with nasopharyngitis (20.7%) and dyskinesias (17.7%) as the most common; serious AEs occurred in 17.2%, causing discontinuation in 10.8%. At Week 52, the mean daily ON-time without troublesome dyskinesias increased from baseline by 1.42 h. Change from baseline in mean daily OFF-time was -1.40 h, and that in the UPDRS Part III score in the ON-phase was -6.20. CONCLUSIONS: As adjunctive treatment with levodopa, safinamide was safe, well tolerated, and effective in improving ON-time and other PD symptoms at 52 weeks.
Authors: Diego Santos García; Carmen Labandeira Guerra; Rosa Yáñez Baña; Maria Icíar Cimas Hernando; Iria Cabo López; Jose Manuel Paz Gonález; Maria Gemma Alonso Losada; María José González Palmás; Cristina Martínez Miró Journal: Brain Sci Date: 2021-03-02