Autor: |
Santos García, Diego, Cabo López, Iria, Labandeira Guerra, Carmen, Yáñez Baña, Rosa, Cimas Hernando, Maria I., Paz González, Jose M., Alonso Losada, Maria G., Gonzalez Palmás, Maria J., Cores Bartolomé, Carlos, Martínez Miró, Cristina |
Zdroj: |
Neurological Sciences; Apr2022, Vol. 43 Issue 4, p2537-2544, 8p, 2 Charts, 2 Graphs |
Abstrakt: |
Background and objective: Some studies observed a benefit of PD patients after treatment with safinamide in some non-motor symptoms. Our aim was to analyze the effectiveness of safinamide on sleep and daytime sleepiness in Parkinson's disease (PD) patients. Material and methods: SAFINONMOTOR is a prospective open-label single-arm study conducted in 5 centers from Spain. In this analysis, a secondary objective of the study, the score in the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS) at V1 (baseline) and V4 (6 months ± 1 month) were compared. Results: Fifty patients were included between May/2019 and February/2020 (age 68.5 ± 9.12 years; 58% women; 6.4 ± 5.1 years from diagnosis). At 6 months, 44 patients completed the follow-up (88%). The PSQI total score was reduced by 19.8% (from 10.43 ± 4.02 at V1 to 8.36 ± 4.41 at V4; p = 0.001). By domains, improvement was observed in subjective sleep quality (PSQI-C1; − 23.9%; p = 0.009), sleep latency (PSQI-C2; − 25%; p = 0.025), sleep duration (PSQI-C3; − 40%; p = 0.001), and habitual sleep efficiency (PSQI-C4; − 25.9%; p = 0.023). A significant reduction (− 24.7%) in the ESS total score from V1 to V4 was observed as well (from 9.20 ± 5.64 to 6.93 ± 5.11; p = 0.012). Specifically, the improvement in daytime sleepiness was observed in sitting and reading (p = 0.024) and sitting inactive in a public space (p = 0.027). A total of 21 adverse events in 11 patients (22%) were reported, 5 of which were severe (not related to safinamide). Conclusion: Safinamide was well-tolerated and improved sleep and daytime sleepiness in PD patients at 6 months. [ABSTRACT FROM AUTHOR] |
Databáze: |
Complementary Index |
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