Post‐marketing survey of donepezil hydrochloride in Japanese patients with Alzheimer's disease with behavioral and psychological symptoms of dementia (BPSD)

Tanaka, Toshihisa; Kazui, Hiroaki; Morihara, Takeshi; Sadik, Golam; Kudo, Takashi; Takeda, Masatoshi

doi:10.1111/j.1479-8301.2008.00250.x

Cited by 33 publications

(33 citation statements)

References 3 publications

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“…The J-ZBI was arranged by Arai et al in 1997 for use in Japan. 12,13 There are some reports on the impact of donepezil on care burden based on data collected in studies conducted in Japan and abroad that were not clinical trials, 11,[14][15][16][17][18] yet there are no reports on the effects of donepezil in AD patients as determined with the ZBI, except for one regarding dementia with Lewy Bodies (DLB). 18 The J-ZBI scores were determined by asking caregivers to answer questionnaires.…”

Section: Assessmentsmentioning

confidence: 99%

“…To evaluate changes in BPSD that may have considerable impact on the care burden, symptoms were examined at baseline with respect to abulia/apathy, depression, delusion, hallucination, anxiety, dependency, wandering, aggressive behavior, resistance to care and irritability. These behavioral disturbances were derived from previous studies 11,14 and are mostly included in the Neuropsychiatric Inventory (NPI). 22 These symptoms were examined again at Week 12 and the findings were compared with those at baseline and classified as: 1, improved; 2 ,unchanged; or 3, aggravated.…”

Section: Assessmentsmentioning

confidence: 99%

“…To our knowledge, only one post-marketing trial has been conducted to investigate the effects of donepezil on BPSD and caregivers' burden. 11 However, that study focused on only a few BPSD and did not use a formal assessment scale to establish the caregivers' burden. Thus, we conducted the present post-marketing survey in a general clinical practice setting to investigate the impact of donepezil on the care burden with a focus on the QOL of caregivers.…”

Section: Introductionmentioning

confidence: 99%

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Impact of donepezil hydrochloride on the care burden of family caregivers of patients with Alzheimer's disease

et al. 2009

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Background: To evaluate the impact of donepezil hydrochloride on the care burden on family members of patients with Alzheimer's disease (AD). At present, donepezil is the only drug approved for the treatment of AD in Japan. Although the care burden on primary caregivers of AD patients comprises both physical and psychological burdens and donepezil is recognized to improve cognitive dysfunction and associated symptoms, there are few data on the effects of the drug on the care burden. Methods: Of the uninstitutionalized AD patients who visited a dementia clinic between June 2008 and May 2009 with their primary family caregivers, 416 subjects who satisfied the enrollment criteria were registered for the study. All participants provided informed consent. Assessment included changes in scores on the Japanese version of the Zarit Caregiver Burden Interview ( J-ZBI) and the Mini-Mental State Examination (MMSE), as well as the presence of behavioral and psychological symptoms of dementia (BPSD). Caregivers answered the questionnaires at baseline and after 12 weeks treatment with donepezil (starting dose 3 mg, p.o., once daily, followed by 5 mg after 1 or 2 weeks). Results: There were significant changes in mean scores on the J-ZBI (-1.9 1 9.5; P < 0.01) and MMSE (+0.9 1 2.9; P < 0.01) from baseline to Week 12, without significant correlation between these two scores. In patients with BPSD, there was a significant decrease in J-ZBI scores over the 12 weeks (P = 0.013); in contrast, in patients without BPSD, the decrease in the J-ZBI score did not reach statistical significance (P = 0.418). Conclusions:The results indicate that donepezil improves cognitive function and some of the BPSD. As a possible consequence of improvements in BPSD, donepezil may also reduce caregivers' burden.

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Section: Assessmentsmentioning

confidence: 99%

Section: Assessmentsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Impact of donepezil hydrochloride on the care burden of family caregivers of patients with Alzheimer's disease

et al. 2009

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“…Currently, there is no cure for AD; i.e., reducing or halting the deterioration of affected brain cells, however, the U.S. Food and Drug Administration (FDA) has approved drugs that alleviate the cognitive symptoms associated with AD in some patients [2]. Among the approved drugs is donepezil hydrochloride (RS)-2-[(1-benzyl-4-piperidyl) methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one monohydrochloride], also known as E2020 or Aricept ® , a reversible cholinesterase inhibitor (ChEI) with enhanced specificity for acetylcholinesterase over butylcholinesterase and less reported hepatic toxicity [3,4].…”

Section: Introductionmentioning

confidence: 99%

Comparison of Metabolism of Donepezil in Rat, Mini-Pig and Human, Following Oral and Transdermal Administration, and in an In Vitro Model of Human Epidermis

Davis¹,

Murgasova²

2012

J Drug Metab Toxicol

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Donepezil hydrochloride is a centrally acting, reversible acetyl cholinesterase inhibitor approved for Alzheimer's disease therapy. Donepezil is marketed as an oral tablet but a transdermal patch may have advantages as an alternate therapy. To determine whether the transdermal route alters known donepezil metabolism, this study compared plasma metabolites of donepezil hydrochloride with two routes of drug delivery, transdermal and oral, in three species; rat, mini-pig and human. The utility of a reconstituted human epidermis (RHE) in vitro model for transdermal drug biotransformation was also evaluated. In addition to donepezil, structures from three metabolic pathways were detectable in each matrix: 1) O demethylation (M1/M2; 2) N-dealkylation (M4); 3) N-oxidation (M6) utilizing LC/quadrupole-Ion trap MS/MS. In rats and humans, including RHE, the mean concentration levels of the donepezil and metabolites for both routes were found in the following order: donepezil>M4>M6>isomeric M1/M2 whilst in the pig, the order was the following: donepezil>M6>isomeric M1/M2>M4. Overall, there were no substantial differences in the plasma profiles between the rat and human. Donepezil metabolites were detectable in mini-pigs after both oral and transdermal administration, however, the concentrations varied from both rat and human. RHE showed quantitative and qualitative similarities between the metabolites produced in vitro with those found in human plasma after transdermal application. Thus, the data from the present study demonstrate that similar metabolites are found between the three species with rat most closely resembling humans and that the RHE model is a potentially valuable model to predict dermal metabolism.

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“…There are 50 beds in our WED, which proactively accepts patients with behavioral and psychological symptoms of dementia (BPSD) who have not responsed well to either pharmaceutical or non-pharmaceutical treatment. [1][2][3][4] For example, on 1 February 2008, there were 27 men (61%) and 17 women (39%) in our WED. The average age of the patients was 76 years (men 75 years; women 76 years).…”

Section: Introductionmentioning

confidence: 90%

Physical complications for elderly inpatients with senile dementia in the Imaise Branch of Ichinomiya City Hospital

Ukai

Mizuno

2009

Psychogeriatrics

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Background: In the present study, we investigated the physical complications of elderly patients with senile dementia in the Department of Psychogeriatrics, Imaise Branch, Ichinomiya City Hospital. Methods: Physical complications that occurred in our ward in the 12 months from April 2007 to March 2008 were recorded. Our ward has 50 beds and, over the 12 months, the average occupation rate was approximately 90%. We subdivided physical complications into two categories: (i) serious emergencies occurring in the ward with a possible high risk of mortality within a few days (e.g. pneumonia and upper airway obstruction); and (ii) life-threatening complications arising in the ward that required diagnosis and treatment by specialists from other medical departments (e.g. bone fracture and cancer). Results: Serious emergencies with a high risk of mortality occurred 56 times. Six patients died. Life-threatening complications requiring diagnosis and treatment by specialists from other departments occurred 44 times. Both categories of physical complications in occurred at a high rate, with various types of diseases recorded. Conclusions:The present study confirms the high frequency of physical complications that require treatment in facilities for patients with senile dementia. It is necessary to diagnose and treat these various physical complications and to cooperate with specialists from other medical departments.

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Post‐marketing survey of donepezil hydrochloride in Japanese patients with Alzheimer's disease with behavioral and psychological symptoms of dementia (BPSD)

Abstract: Background: To investigate the efficacy and safety of donepezil hydrochloride (Aricept

Cited by 33 publications

References 3 publications

Impact of donepezil hydrochloride on the care burden of family caregivers of patients with Alzheimer's disease

Impact of donepezil hydrochloride on the care burden of family caregivers of patients with Alzheimer's disease

Comparison of Metabolism of Donepezil in Rat, Mini-Pig and Human, Following Oral and Transdermal Administration, and in an In Vitro Model of Human Epidermis

Physical complications for elderly inpatients with senile dementia in the Imaise Branch of Ichinomiya City Hospital

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