Safinamide Improves Non-Motor Symptoms Burden in Parkinson's Disease: An Open-Label Prospective Study

被引:26
|
作者
Santos Garcia, Diego [1 ]
Labandeira Guerra, Carmen [2 ]
Yanez Bana, Rosa [3 ]
Cimas Hernando, Maria Iciar [4 ]
Cabo Lopez, Iria [5 ]
Paz Gonalez, Jose Manuel [1 ]
Alonso Losada, Maria Gemma [2 ]
Gonzalez Palmas, Maria Jose [5 ]
Martinez Miro, Cristina [1 ]
机构
[1] Complejo Hosp Univ A Coruna, CHUAC, Dept Neurol, La Coruna 15006, Spain
[2] Complejo Hosp Univ Vigo, CHUVI, Dept Neurol, Vigo 36213, Spain
[3] Complejo Hosp Univ Ourense, CHUO, Dept Neurol, Orense 32005, Spain
[4] Hosp Povisa, Dept Neurol, Vigo 36211, Spain
[5] Complejo Hosp Univ Pontevedra, CHOP, Dept Neurol, Pontevedra 36002, Spain
关键词
effectiveness; non-motor symptoms; open-label study; Parkinson's disease; safinamide; ADD-ON THERAPY; DOUBLE-BLIND; LEVODOPA; SAFETY; EFFICACY; SCALE; MOTOR; QUESTIONNAIRE; FLUCTUATIONS; INDEX;
D O I
10.3390/brainsci11030316
中图分类号
Q189 [神经科学];
学科分类号
071006 ;
摘要
Some studies observed a benefit of Parkinson's disease (PD) patients after treatment with safinamide in some non-motor symptoms (NMSs). The aim of this study was to analyze the effectiveness of safinamide on NMS burden in PD. SAFINONMOTOR (an open-label study of the effectiveness of safinamide on non-motor symptoms in Parkinson's disease patients) is a prospective open-label single-arm study conducted in five centers from Spain. The primary efficacy outcome was the change from baseline (V1) to the end of the observational period (6 months) (V4) in the non-motor symptoms scale (NMSS) total score. Between May/2019 and February/2020 50 patients were included (age 68.5 +/- 9.12 years; 58% females; 6.4 +/- 5.1 years from diagnosis). At 6 months, 44 patients completed the follow-up (88%). The NMSS total score was reduced by 38.5% (from 97.5 +/- 43.7 in V1 to 59.9 +/- 35.5 in V4; p < 0.0001). By domains, improvement was observed in sleep/fatigue (-35.8%; p = 0.002), mood/apathy (-57.9%; p < 0.0001), attention/memory (-23.9%; p = 0.026), gastrointestinal symptoms (-33%; p = 0.010), urinary symptoms (-28.3%; p = 0.003), and pain/miscellaneous (-43%; p < 0.0001). Quality of life (QoL) also improved with a 29.4% reduction in the PDQ-39SI (from 30.1 +/- 17.6 in V1 to 21.2 +/- 13.5 in V4; p < 0.0001). A total of 21 adverse events in 16 patients (32%) were reported, 5 of which were severe (not related to safinamide). Dyskinesias and nausea were the most frequent (6%). Safinamide is well tolerated and improves NMS burden and QoL in PD patients with severe or very severe NMS burden at 6 months.
引用
收藏
页码:1 / 15
页数:13
相关论文
共 50 条
  • [1] Safinamide Improves Non-Motor Symptoms Burden in Parkinson's Disease: An Open-label Prospective Study
    Santos Garcia, D.
    Labandeira, C.
    Yanez, R.
    Cimas Hernando, I.
    Cabo Lopez, I.
    Paz Gonzalez, J.
    Alonso Losada, G.
    Gonzalez Palmas, M.
    EUROPEAN JOURNAL OF NEUROLOGY, 2021, 28 : 163 - 163
  • [2] Opicapone improves global non-motor symptoms burden in Parkinson's disease: an open-label prospective study
    Santos Garcia, D.
    Fernandez Pajarin, G.
    Oropesa Ruiz, J.
    Escamilla Sevilla, F.
    Rahim Lopez, R.
    Munoz Enriquez, G.
    MOVEMENT DISORDERS, 2022, 37 : S350 - S351
  • [3] Opicapone Improves Global Non-Motor Symptoms Burden in Parkinson's Disease: An Open-Label Prospective Study
    Santos Garcia, Diego
    Fernandez Pajarin, Gustavo
    Manuel Oropesa-Ruiz, Juan
    Escamilla Sevilla, Francisco
    Rahim Lopez, Raul Rashid Abdul
    Munoz Enriquez, Jose Guillermo
    BRAIN SCIENCES, 2022, 12 (03)
  • [4] Safinamide improves motor and non-motor symptoms in fluctuating Parkinson's Disease patients.
    Cattaneo, C.
    EUROPEAN JOURNAL OF NEUROLOGY, 2023, 30 : 507 - 507
  • [6] Cannabis (Medical Marijuana) Treatment for Motor and Non-Motor Symptoms of Parkinson Disease: An Open-Label Observational Study
    Lotan, Itay
    Treves, Therese A.
    Roditi, Yaniv
    Djaldetti, Ruth
    CLINICAL NEUROPHARMACOLOGY, 2014, 37 (02) : 41 - 44
  • [7] The burden of non-motor symptoms in Parkinson's disease
    Prakash, K. M.
    Yong, M. H.
    Allen, J. C.
    Tan, E. K.
    JOURNAL OF NEUROLOGY, 2012, 259 : S91 - S91
  • [8] The effects of zonisamide on motor and non-motor symptoms in patients with Parkinson's disease: a 3-month open-label study
    Suzuki, K.
    Fujita, H.
    Matsubara, T.
    Kadowaki, T.
    Funakoshi, K.
    Watanabe, Y.
    Shiina, T.
    Sakuramoto, H.
    Hamaguchi, M.
    Hirata, K.
    MOVEMENT DISORDERS, 2019, 34
  • [9] Efficacy of safinamide on motor and non-motor symptoms in fluctuating Parkinson's disease patients
    Cattaneo, C.
    Bonizzoni, E.
    Sardina, M.
    EUROPEAN JOURNAL OF NEUROLOGY, 2016, 23 : 296 - 296
  • [10] Effects of Safinamide on Motor and Non-Motor Symptoms in Patients with Parkinson's Disease and Motor Fluctuations
    Kulisevsky, Jaime
    Ferraz, Henrique B.
    Suppa, Antonio
    Reichmann, Heinz
    EUROPEAN NEUROLOGY, 2024, 87 (5-6) : 291 - 305