Abstract
Background and PurposeNeuropsychiatric symptoms in Parkinson's disease (PD) have been shown to significantly affect quality of life (QOL). We investigated the impact of safinamide on depression and apathy when administered as an adjunct to levodopa in Japanese patients with PD.MethodsThis was a post-hoc analysis of data from a phase 2/3 clinical study of safinamide in Japanese patients with PD experiencing wearing-off (JapicCTI-153056; https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-153056). Patients received placebo, safinamide 50 mg, or safinamide 100 mg as an adjunct therapy. The endpoints for this analysis were changes from baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I item 3 (depression) and item 4 (apathy) scores and the Parkinson's Disease Questionnaire (PDQ-39) “emotional well-being” domain score. Subgroup analyses investigated the relationship between neuropsychologic symptoms and improvements in motor fluctuation and assessed which patient populations might be expected to obtain neuropsychologic benefit from safinamide.ResultsCompared with placebo, safinamide (both doses) significantly improved UPDRS Part I item 3 scores in the overall analysis population, and the 100-mg dose improved UPDRS Part I item 4 scores in the population with apathy at baseline. Changes in the PDQ-39 “emotional well-being” score showed numerical, but not significant, dose-related improvements. Notable reductions in depression were associated with a change in daily ON-time ≥1 h, pain during OFF-time at baseline, and female sex.ConclusionsThe results from this post-hoc analysis of the Japanese phase 2/3 study suggest that safinamide could bring benefits to patients with PD who have mild depression, pain during the OFF phase. In addition, safinamide might provide particular benefits for patients with PD who have mild apathy and female.
Highlights
According to the most recent estimates, Parkinson’s disease (PD) affects more than 6 million people worldwide, and the incidence is expected to double within a generation [1]
In a recent survey undertaken in a large population of patients with PD in Japan, a strong correlation was found between mood and quality of life (QOL) [11]; improving mood is considered to be an important treatment goal for Japanese patients with PD
ON-time notably improved in the subgroup using concomitant dopamine agonists compared with the subgroup without these drugs. In this post-hoc analysis of a placebo-controlled phase 2/3 study in Japanese patients with PD [33], we investigated the impact of adjunct safinamide 50 and 100 mg on depression and apathy, two neuropsychiatric symptoms which are known to significantly affect the QOL of patients with PD [10, 14, 34]
Summary
According to the most recent estimates, Parkinson’s disease (PD) affects more than 6 million people worldwide, and the incidence is expected to double within a generation [1]. Neuropsychiatric symptoms in PD can include depression [5], anxiety [6], and apathy [7], and they are known to increase in prevalence [8] and worsen with the severity of PD [9] These symptoms have been shown to significantly affect the quality of life (QOL) of patients with PD [10]. In addition to the general risk factors for developing depression in the overall population [15], specific risk factors for depression in PD have been reported These include being female, having cognitive impairment, and having episodes of psychiatric disease, anxiety, and sleep disorders [16].
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