Objective: This is an observational study aimed at evaluating the effect of Safinamide and Rasagiline on motor fluctuations, subjective sleep and daytime sleepiness in Parkinson’s Disease (PD) patients.

Background: Sleep disturbances represent one of the main non-motor symptoms (NMS) in PD and progressively increase in frequency as the disease progresses. Thereafter, motor fluctuating PD patients frequently experience sleep problems.

Methods: In this observation, we included idiopathic PD patients starting Rasagiline or Safinamide according to common clinical practice and indications. Patients maintained the other anti-PD treatments stable until the follow-up (FU) visit at 4 months. We assessed the effect of Safinamide and Rasagiline on subjective nocturnal sleep and daytime sleepiness by measuring the changes in total score of validated questionnaires, widely used in PD studies, counting the Parkinson’s Disease Sleep Scale – Second Version (PDSS2), the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Motor effect of both drugs were measured by means of the Unified Parkinson’s Disease Rating Scale (UPDRS) III (motor performances) and IV (motor fluctuations) parts.

Results: Sixty-one mild to moderate motor fluctuating PD patients were enrolled. Among them, Safinamide was prescribed in 46 patients (SAF-PD) and Rasagiline in 15 patients (RAS-PD). Analyzing data achieved at FU we documented the same significant effect of Safinamide and Rasagiline on UPDRS-III scores, but SAF-PD showed a significant lower UPDRS-IV scores compared to RAS-PD. Considering sleep questionnaires, at FU PD SAF-PD showed lowed PDSS-2 and ESS scores compared to RAS-PD, whereas PSQI total score was similar in the two groups, although the item-7 of the PSQI, related to daytime dysfunction, was lower in SAF-PD than RAS-PD.

Conclusions: This observational study, comparing the effect of Rasagiline and Safinamide in mild to moderate fluctuating PD patients showed no significant differences in the improvement of UPDRS-III score. However, UPDRS-IV score was significantly reduced in SAF-PD compared to RAS-PD. The novelty of this study is the beneficial effect of Safinamide compared to Rasagiline on subjective sleep quality and daytime sleepiness of patients, as measured by validated questionnaires. These results, showing a positive effect of safinamide on PD sleep, may suggest future prospective and objective studies focused on safinamide as useful in improving nocturnal sleep and daytime sleepiness in fluctuating PD patients.

« Back to 2018 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-and-rasagiline-effect-on-motor-fluctuation-sleep-quality-and-daytime-sleepiness-in-parkinsons-disease-a-validated-questionnaires-study/