Istradefylline improves daytime sleepiness in patients with Parkinson's disease: An open-label, 3-month study

Suzuki, Keisuke; Miyamoto, Masayuki; Miyamoto, Tomoyuki; Uchiyama, Tomoyuki; Watanabe, Yuka; Suzuki, Shigeaki; Kadowaki, Tomoko; Matsubara, Takeo; Sakuramoto, Hirotaka; Hirata, Koichi

doi:10.1016/j.jns.2017.07.045

Cited by 46 publications

(41 citation statements)

References 25 publications

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“…However, in our study, we observed a discrepancy between the physician's assessment of motor dysfunction (48.5% of patients were assessed as improved/markedly improved) and the physician's global assessment (61.3% assessed as effective), which suggests that the physician's global assessment may also capture improvements in non-motor symptoms in patients. In addition, several clinical research and animal model studies reported that A 2A antagonists were expected to improve some non-motor symptoms [27][28][29][30].…”

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of istradefylline in patients with Parkinson’s disease: interim analysis of a post-marketing surveillance study in Japan

Takahashi

Fujita

Asai

et al. 2018

Expert Opinion on Pharmacotherapy

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Background: Istradefylline is a first-in-class, non-dopaminergic, selective adenosine A 2A receptor antagonist for the treatment of Parkinson's disease (PD) in patients experiencing the wearing-off phenomenon with levodopa (L-DOPA). The authors present an interim report from a post-marketing surveillance (PMS) evaluating the safety and effectiveness of long-term istradefylline in a real-world setting.Research design and methods: Istradefylline safety was assessed by the incidence of adverse events (AE) and adverse drug reactions (ADRs). Effectiveness was assessed using the physician's assessment of off-time, off-time symptoms and motor dysfunction, unified PD rating scale (UPDRS) Part III score, and the physician's global assessment.Results: This analysis evaluated 476 patients. Istradefylline was generally well tolerated, despite dyskinesia and hallucination being the most common ADRs. Reduction in off-time was observed in 38.2% of patients, off-time symptoms were improved or markedly improved in 44.7%, and motor dysfunction was improved or markedly improved in 48.5%. The mean UPDRS Part III score decreased from 33.7 to 30.3 at the end of the study. The physician's global assessment rated the drug as effective in 61.3% of patients. Conclusions: This PMS provides useful safety and effectiveness data for long-term treatment with istradefylline in a real-world setting for patients with PD exhibiting the wearing-off phenomenon with L-DOPA. ARTICLE HISTORY

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Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of istradefylline in patients with Parkinson’s disease: interim analysis of a post-marketing surveillance study in Japan

Takahashi

Fujita

Asai

et al. 2018

Expert Opinion on Pharmacotherapy

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“…3 . Administration of istradefylline was reported to improve overactive bladder and daytime sleepiness 24 , 25 , however, these were not randomized placebo-controlled trials. Further studies are needed to establish robust evidence of efficacy of istradefylline on non-motor symptoms.…”

Section: Discussionmentioning

confidence: 99%

The effect of istradefylline for Parkinson’s disease: A meta-analysis

Sako

Murakami

Motohama

et al. 2017

Sci Rep

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Adenosine A2A receptor antagonists are an alternative treatment strategy for Parkinson’s disease. Several randomized placebo controlled studies have tested the effect of A2A receptor antagonist istradefylline, and more robust evidence has been acquired. This meta-analysis aimed to provide evidence for its efficacy and safety on patients with Parkinson’s disease. After a systematic literature search, we calculated the pooled standardized mean difference and risk ratio for continuous and dichotomous variables, respectively. Further, sensitivity analyses were performed to confirm the effect estimated by meta-analyses. Publication bias was assessed by funnel plot and deviation of intercept. Six studies satisfied our inclusion criteria. Istradefylline (40 mg/day) decreased off time and improved motor symptoms of Parkinson’s disease in homogeneous studies. Istradefylline at 20 mg/day decreased off time and improved motor symptoms, but heterogeneity was found in the analysis of the former among studies. There was a significant effect of istradefylline on dyskinesia in homogeneous studies. Publication bias, however, was observed in the comparison of dyskinesia. Other adverse events showed no significant difference. The present meta-analysis suggests that istradefylline at 40 mg/day could alleviate off time and motor symptoms derived from Parkinson’s disease. Dyskinesia might be worsened, but publication bias prevents this from being clear.

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“…An open study found that the ESS scores of PD patients significantly decreased after they were treated with istradefylline for 2 and 3 months. [54] Based on the results of the study, there is insufficient evidence for the efficacy of istradefylline in EDS of PD patients.…”

Section: Excessive Daytime Sleepinessmentioning

confidence: 99%

Management Recommendations on Sleep Disturbance of Patients with Parkinson's Disease

Liu

Wang

Zhan

et al. 2018

Chinese Medical Journal

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Istradefylline improves daytime sleepiness in patients with Parkinson's disease: An open-label, 3-month study

Cited by 46 publications

References 25 publications

Safety and effectiveness of istradefylline in patients with Parkinson’s disease: interim analysis of a post-marketing surveillance study in Japan

Safety and effectiveness of istradefylline in patients with Parkinson’s disease: interim analysis of a post-marketing surveillance study in Japan

The effect of istradefylline for Parkinson’s disease: A meta-analysis

Management Recommendations on Sleep Disturbance of Patients with Parkinson's Disease

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