Baseline characteristics that influence “off” time improvement in levodopa-carbidopa intestinal gel-treated advanced Parkinson’s disease patients in the GLORIA registry

2017 ◽  
Vol 381 ◽  
pp. 187
Author(s):  
W. Poewe ◽  
L. Bergmann ◽  
A. Yegin ◽  
W. Robieson ◽  
A. Antonini
2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Cindy Zadikoff ◽  
Werner Poewe ◽  
James T. Boyd ◽  
Lars Bergmann ◽  
Horia Ijacu ◽  
...  

Background. Levodopa-carbidopa intestinal gel (LCIG) provides continuous levodopa administration and clinical benefits to patients with advanced Parkinson’s disease (PD). This report evaluates long-term safety and efficacy of high-dose LCIG in PD patients. Methods. Data were collected from several prospective, phase III clinical studies and an observational registry. The phase III program (N = 412) included four multicenter studies: a 12-week, randomized, double-blind study and three open-label studies extending ≥12 months. GLORIA (N = 375) was a 24-month, multicountry, observational registry. LCIG safety (adverse effects (AEs)/adverse drug reactions (ADRs)) and efficacy (modified Unified Parkinson’s Disease Rating Scale (UPDRS) part IV item 32 and 39 scores for “On” time with dyskinesia and “Off” time) were assessed in patients who received ≥2000 mg/day vs <2000 mg/day LCIG. Results. A total of 72 of 412 (17.5%) patients required dosages ≥2000 mg/day LCIG in the phase III program and 47 of 375 (12.5%) patients in GLORIA. Baseline demographics and disease severity were similar between dosage groups with more men in the high-dosage group. Compared with the <2000 mg/day dosage group, patients requiring ≥2000 mg/day LCIG had higher rates of AEs/ADRs including polyneuropathy; improvements in “Off” time and discontinuations due to AEs were similar between dosage groups and lower for discontinuations due to ADRs reported in GLORIA. Conclusions. Patients who require ≥2000 mg/day LCIG exhibited a safety profile comparable to the established safety/tolerability of LCIG with similar clinical improvements. Higher AEs were noted but within what is accepted for LCIG. Continuous administration of LCIG is beneficial to advanced PD patients who require very high doses of levodopa.


BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Guiying He ◽  
Chun-Feng Liu ◽  
Qinyong Ye ◽  
Zhenguo Liu ◽  
Miao Jin ◽  
...  

Abstract Background The impact of nocturnal disturbance (ND) in Parkinson’s disease on quality of life of patients in Western Countries is increasingly understood. Our study aimed to investigate ND prevalence and its quality of life impact in patients with advanced Parkinson’s disease in China. Methods In a multicenter, tertiary-care hospital, outpatient-based, cross-sectional study, patients with advanced Parkinson’s disease (Modified Hoehn & Yahr [H&Y] Stage II–IV with ≥3 h awake “off” time/day) from 10 tertiary hospitals throughout China completed the Parkinson’s Disease Sleep Scale-2 (PDSS-2) and Parkinson’s Disease Questionnaire-39 (PDQ-39). The primary endpoint was the percentage of patients with significant ND (PDSS-2 total score ≥ 15). Additional endpoints were demographic and clinical characteristics, PDSS-2 and PDQ-39 total and subscale scores, correlation between PDSS-2 and PDQ-39, and risk factors for ND and higher PDSS-2 or PDQ-39 scores. Results Of 448 patients analyzed (mean age 63.5 years, 47.3% female), 70.92% (95% confidence interval: 66.71, 75.13) had significant ND. Presence of ND and higher PDSS-2 scores were associated with longer disease duration and higher H&Y stage. Presence of ND was also associated with more awake “off” time/day and female sex. PDQ-39 scores were significantly worse for patients with ND versus those without ND; worse scores were associated with more awake “off” time/day, female sex, and higher H&Y stage. PDSS-2 and PDQ-39 total scores were associated: Pearson correlation coefficient 0.62 (p < 0.001). Conclusions In China, ND was highly prevalent in patients with advanced Parkinson’s disease and adversely impacted quality of life. This study highlights the importance of early diagnosis and optimized management of ND in patients with Parkinson’s disease in China.


2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Yuka Hayashi ◽  
Ryoko Nakagawa ◽  
Miwako Ishido ◽  
Yoko Yoshinaga ◽  
Jun Watanabe ◽  
...  

Introduction. Parkinson’s disease (PD) is characterized by a triad of motor symptoms and several nonmotor symptoms (NMS). Identifying the most appropriate treatment is essential for improving patient quality of life (QoL). However, it is still not known which PD symptoms more commonly affect patients with advanced PD (APD) versus non-APD. This study examined the factors that most affected the QoL of patients with APD (defined using the 5-2-1 criteria: ≥5 oral levodopa doses a day, off time ≥2 hours a day, or troublesome dyskinesia ≥1 hour a day) versus non-APD in a large Japanese population using the Japanese Quality-of-Life Survey of Parkinson’s Disease (JAQPAD) study. Methods. Participants in this self-reported survey-based study included all members of the Japan Parkinson’s Disease Association. Questionnaires assessing NMS and QoL (e.g., the 8-item PD Questionnaire [PDQ-8]) were included. Univariate and multivariate regression analyses were conducted to identify clinical factors impacting QoL using the PDQ-8 Summary Index (PDQ-8 SI). Results. Of the 3022 eligible patients, 864 were classified as having non-APD and 1599 as having APD. QoL as assessed by the PDQ-8 SI was notably worse in patients with APD versus non-APD (39.2 vs. 26.9, p < 0.0001 ). Although off time affected QoL only in patients with APD, PD duration and the NMS Questionnaire score significantly contributed to the QoL in both patients with APD and non-APD. Conclusions. This study identified the factors more commonly associated with worse QoL in patients with APD versus non-APD. Our findings offer new insights for providing optimal treatment and improving treatment satisfaction in patients with PD.


2014 ◽  
Vol 4 (3) ◽  
pp. 361-373 ◽  
Author(s):  
Anthony P. Nicholas ◽  
Rupam Borgohain ◽  
Pedro Chaná ◽  
Erwin Surmann ◽  
Emily L. Thompson ◽  
...  

2004 ◽  
Vol 31 (S 1) ◽  
Author(s):  
F Sixel-Döring ◽  
M Rausch-Hertel ◽  
H Klinke ◽  
C Trenkwalder

2021 ◽  
Author(s):  
Frouke A.P. Nijhuis ◽  
Rianne Esselink ◽  
Rob M.A. Bie ◽  
Hans Groenewoud ◽  
Bastiaan R. Bloem ◽  
...  

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