scholarly journals Long-Term Safety and Efficacy of Donepezil in Patients with Dementia with Lewy Bodies: Results from a 52-Week, Open-Label, Multicenter Extension Study

2013 ◽  
Vol 36 (3-4) ◽  
pp. 229-241 ◽  
Author(s):  
Manabu Ikeda ◽  
Etsuro Mori ◽  
Kenji Kosaka ◽  
Eizo Iseki ◽  
Mamoru Hashimoto ◽  
...  
Keyword(s):  
Dementia With Lewy Bodies ◽  
Lewy Bodies ◽  
Extension Study ◽  
Open Label ◽  
Safety And Efficacy

scholarly journals Effects of Donepezil on Extrapyramidal Symptoms in Patients with Dementia with Lewy Bodies: A Secondary Pooled Analysis of Two Randomized-Controlled and Two Open-Label Long-Term Extension Studies

2015 ◽  
Vol 40 (3-4) ◽  
pp. 186-198 ◽  
Author(s):  
Etsuro Mori ◽  
Manabu Ikeda ◽  
Masaki Nakagawa ◽  
Hideaki Miyagishi ◽  
Hideo Yamaguchi ◽  
...  
Keyword(s):  
Dementia With Lewy Bodies ◽  
Rating Scale ◽  
Multivariate Logistic Regression Analysis ◽  
Lewy Bodies ◽  
Pooled Analysis ◽  
Extrapyramidal Symptoms ◽  
Open Label ◽  
Predisposing Factor ◽  
Baseline Severity

Background/Aims: The aim of this study was to clarify the effects of donepezil on extrapyramidal symptoms in patients with dementia with Lewy bodies (DLB). Methods: Using pooled datasets from phase 2 and 3, 12-week randomized, placebo-controlled trials (RCT, n = 281) and 52-week open-label long-term extension trials (OLE, n = 241) of donepezil in DLB, the effects of donepezil on the incidence of extrapyramidal adverse events (AEs) and on the Unified Parkinson's Disease Rating Scale (UPDRS) part III were assessed, and potential baseline factors affecting the AEs were explored. Results: The RCT analysis did not show significant differences between the placebo and active (3, 5, and 10 mg donepezil) groups in extrapyramidal AE incidence (3.8 and 6.5%, p = 0.569) and change in the UPDRS (mean ± SD: -0.2 ± 4.3 and -0.6 ± 6.5, p = 0.562). In the OLE analysis (5 and 10 mg donepezil), the incidence did not increase chronologically; all AEs leading to a dose reduction or discontinuation except one were relieved. The UPDRS was unchanged for 52 weeks. An exploratory multivariate logistic regression analysis of the RCTs revealed that donepezil treatment was not a significant factor affecting the AEs. Baseline severity of parkinsonism was a predisposing factor for worsening of parkinsonism without significant interactions between donepezil and baseline severity. Conclusion: DLB can safely be treated with donepezil without relevant worsening of extrapyramidal symptoms, but treatment requires careful attention to symptom progression when administered to patients with relatively severe parkinsonism.

MP31-01 LONG-TERM SAFETY AND EFFICACY OF SER120 1.5 MCG IN PATIENTS WITH NOCTURIA: RESULTS FROM A 2-YEAR OPEN-LABEL EXTENSION STUDY

2017 ◽  
Vol 197 (4S) ◽  
Author(s):  
Scott MacDiarmid ◽  
J.P. Nicandro ◽  
Maria Cheng ◽  
Steven Abrams ◽  
Seymour Fein ◽  
...  
Keyword(s):  
Extension Study ◽  
Open Label ◽  
Safety And Efficacy ◽  
Open Label Extension
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