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Meta-Analysis of Randomized Controlled Trials on the Efficacy and Safety of Donepezil, Galantamine, Rivastigmine, and Memantine for the Treatment of Alzheimer's Disease. To study the impact of donepezil, rivastigmine, galantamine, and memantine on cognitive, functional, behavioral, global changes and adverse effects in patients with mild, moderate and severe Alzheimer's disease (AD), we screened the literature published before September 2017 in the Pubmed, Embase, Cochrane library and Web (...) that there were significant differences between the donepezil, rivastigmine and placebo groups using ADAS-cog, ADCS-ADL, and CIBIC+. Meta-analyses of these placebo-controlled trials showed that there were significant differences between the galantamine and placebo groups using ADAS-cog, ADCS-ADL, NPI, and CIBIC+. These observations suggest that memantine is beneficial for stabilizing or slowing the decline in ADAS-cog and ADCS-ADL19 changes in AD patients. However, there was no significant effect according
Risk of rhabdomyolysis with donepezil compared with rivastigmine or galantamine: a population-based cohort study Donepezil, rivastigmine and galantamine are popular cholinesterase inhibitors used to manage the symptoms of Alzheimer disease and other dementias; regulatory agencies in several countries warn about a possible risk of rhabdomyolysis with donepezil, based on information from case reports. Our goal was to investigate the 30-day risk of admission to hospital with rhabdomyolysis (...) associated with initiating donepezil versus other cholinesterase inhibitors.We conducted a retrospective cohort study in Ontario, Canada, from 2002 to 2017. Participants were adults aged 66 years or older with a newly dispensed prescription for donepezil compared with rivastigmine or galantamine. The primary outcome was hospital admission with rhabdomyolysis (assessed using hospital diagnostic codes) within 30 days of a new prescription of a cholinesterase inhibitor. Odds ratios were estimated using
No synergistic effect of subtherapeutic doses of donepezil and EVP-6124 in healthy elderly subjects in a scopolamine challenge model. Donepezil is a widely used cholinesterase inhibitor in the management of Alzheimer's disease. Despite large-scaled evidence for its efficacy, elevated peripheral ACh levels often lead to side effects and are dose limiting. The present exploratory study is designed to determine the potentiation of the effects of donepezil by cotreatment with EVP-6124, an alpha-7 (...) nicotinic agonist, to reduce scopolamine-induced cognitive deficits in healthy elderly subjects. Secondary objectives are to explore safety and pharmacokinetic and pharmacodynamics effects of EVP-6124 alone and in combination with donepezil compared to placebo.A phase I randomized, single-center, placebo-controlled, double-blind, five-way, partial crossover study was performed with donepezil 2.5, 5 mg or placebo combined with EVP-6124 0.3, 1, 2, 4 mg or placebo in three cohorts of healthy elderly
A systematic review of economic evaluations of the use of memantine alone or combined with donepezil for moderate to severe Alzheimer’s disease A systematic review of economic evaluations of the use of memantine alone or combined with donepezil for moderate to severe Alzheimer’s disease Services on Demand Journal Article text in Indicators Cited by SciELO Related links Similars in SciELO Share Print version ISSN 1809-9823 On-line version ISSN 1981-2256 Rev. bras. geriatr. gerontol. vol.22 no.4 (...) Rio de Janeiro 2019 Epub Nov 25, 2019 http://dx.doi.org/10.1590/1981-22562019022.190002 Review Articles A systematic review of economic evaluations of the use of memantine alone or combined with donepezil for moderate to severe Alzheimer’s disease Ione Ayala Gualandi de Oliveira Rosângela Caetano Ricardo Ewback Steffen Aline Navega Biz 1 Universidade do Estado do Rio de Janeiro (UERJ), Instituto de Medicina Social. Rio de Janeiro, RJ, Brasil. Objective: To synthesize the available evidence
2016 Share Save Guidance on donepezil ( Aricept ), galantamine (Reminyl), rivastigmine (Exelon) and memantine (...) (Ebixa) for treating Alzheimer's disease in adults. This guidance has been partially updated by NICE’s guideline on (CG42) and replaces NICE technology appraisal guidance on donepezil , galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease (TA111). Guidance development process Is this guidance up to date? . We identified nothing new that affects (...) for MCI, and MCI remains a vague term and those so described are a heterogeneous population, consisting of people who may rapidly progress to dementia but also of people (...) with stable cognitive deficits and some who may actually improve. Treatment in the very earliest stages of AD may delay progression to AD. Donepezil ( Aricept , E2020), a cholinesterase inhibitor, has been shown to benefit all severities of AD including mild and it would be reasonable to investigate its efficacy for those
Donepezil for dementia due to Alzheimer's disease. Alzheimer's disease is the most common cause of dementia in older people. One approach to symptomatic treatment of Alzheimer's disease is to enhance cholinergic neurotransmission in the brain by blocking the action of the enzyme responsible for the breakdown of the neurotransmitter acetylcholine. This can be done by a group of drugs known as cholinesterase inhibitors. Donepezil is a cholinesterase inhibitor.This review is an updated version (...) of a review first published in 1998.To assess the clinical efficacy and safety of donepezil in people with mild, moderate or severe dementia due to Alzheimer's disease; to compare the efficacy and safety of different doses of donepezil; and to assess the effect of donepezil on healthcare resource use and costs.We searched Cochrane Dementia and Cognitive Improvement's Specialized Register, MEDLINE, Embase, PsycINFO and a number of other sources on 20 May 2017 to ensure that the search was as comprehensive
Treatment effects between monotherapy of donepezil versus combination with memantine for Alzheimer disease: A meta-analysis. This is the first meta-analysis to compare the treatment effects and safety of administering donepezil alone versus a combination of memantine and donepezil to treat patients with moderate to severe Alzheimer Disease, particularly regarding cognitive functions, behavioral and psychological symptoms in dementia (BPSD), and global functions.PubMed, Medline, Embase, PsycINFO (...) , and Cochrane databases were used to search for English and non-English articles for inclusion in the meta-analysis to evaluate the effect size and incidence of adverse drug reactions of different treatments.Compared with patients who received donepezil alone, those who received donepezil in combination with memantine exhibited limited improvements in cognitive functions (g = 0.378, p < .001), BPSD (g = -0.878, p < .001) and global functions (g = -0.585, p = .004). Gradual titration of memantine plus
Effect of the CYP2D6 and APOE Polymorphisms on the Efficacy of Donepezil in Patients with Alzheimer's Disease: A Systematic Review and Meta-Analysis. Differential responses to donepezil treatment in patients with Alzheimer's disease (AD) have been observed in clinical practice. It remains controversial whether, and to what extent, individual variation in the genes responsible for drug metabolism (CYP2D6) or those associated with AD pathogenesis (APOE) modulate the response to donepezil (...) treatment.The aim of this study was to better understand the potential link between donepezil treatment response and CYP2D6 or APOE polymorphisms.We performed a meta-analysis based on data collected from 1266 donepezil-treated AD patients, and evaluated the association of CYP2D6 or APOE polymorphisms with treatment effectiveness.No significant difference was observed in the responder rate of donepezil treatment between the normal function CYP2D6 alleles group and the decreased/non-functional group [odds
The effectiveness and cost-effectiveness of donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease (review of Technology Appraisal No. 111): a systematic review and economic model. Alzheimer’s disease (AD) is the most commonly occurring form of dementia. It is predominantly a disease of later life, affecting 5% of those over 65 in the UK.Review and update guidance to the NHS in England and Wales on the clinical effectiveness and cost-effectiveness (...) of donepezil, galantamine, rivastigmine [acetylcholinesterase inhibitors (AChEIs)] and memantine within their licensed indications for the treatment of AD, which was issued in November 2006 (amended September 2007 and August 2009).Electronic databases were searched for systematic reviews and/or metaanalyses, randomised controlled trials (RCTs) and ongoing research in November 2009 and updated in March 2010; this updated search revealed no new includable studies. The databases searched included The Cochrane
The effect of funding sources on donepezil randomised controlled trial outcome: a meta-analysis. To investigate whether there is a difference in the treatment effect of donepezil on cognition in Alzheimer disease between industry-funded and independent randomised controlled trials.Fixed effects meta-analysis of standardised effects of donepezil on cognition as measured by the Mini Mental State Examination and the Alzheimer's Disease Assessment Scale-cognitive subscale.Studies included (...) in the meta-analyses reported in the National Institute for Health and Care Excellence (NICE) technical appraisal 217 updated with new studies through a PubMed search.Inclusion criteria were double-blind, placebo-controlled trials of any length comparing patients diagnosed with probable Alzheimer disease (according to the NINCDS-ADRDA/DSM-III/IV criteria) taking any dosage of donepezil. Studies of combination therapies (eg, donepezil and memantine) were excluded, as were studies that enrolled patients
Efficacy and Safety of Donepezil, Galantamine, Rivastigmine, and Memantine for the Treatment of Alzheimer's Disease: A Systematic Review and Meta-Analysis. The role of currently available drugs for Alzheimer's disease (AD) has been controversial, with some national formularies restricting their use, and health economists questioning whether the small clinical effects are economically worthwhile.To estimate the efficacy and safety of donepezil, galantamine, rivastigmine, and memantine (...) observed, except for -2.72 (95% CI -4.92 to -0.52) in the 10 mg daily donepezil group and -1.72 (95% CI -3.12 to -0.33) for 24 mg daily galantamine trial. Only 5 mg daily donepezil had no effect on the function outcome. Compared with placebo, more dropouts and adverse events occurred with the cholinesterase inhibitors, but not with memantine.Cholinesterase inhibitors and memantine are able to stabilize or slow decline in cognition, function, behavior, and global change.
to be bioequivalent to the marketed 20 mg memantine hydrochloride tablets Axura / Ebixa and 10 mg donepezil hydrochloride tablets Aricept. Balaxur finished product is presented as pale yellow to light yellow, oval shaped film-coated tablet with imprint “MEM” on one side and imprint “DON” on the other side. The starting point for the formulation development activities was the existing and successfully marketed drug products Axura / Ebixa 20 mg film coated tablet and their established and validated manufacturing (...) Balaxur (memantine hydrochloride / donepezil hydrochloride) 18 October 2012 EMA/817438/2012 Committee for Medicinal Products for Human Use (CHMP) Assessment report Balaxur International non-proprietary name: memantine hydrochloride / donepezil hydrochloride Procedure No. EMEA/H/C/002708 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European
concern. The proposed re-test period and storage conditions are supported by the overall results. 2.2.4. Finished Medicinal Product Pharmaceutical Development Acrescent fixed dose combination formulation was designed as film tablet to be bioequivalent to the marketed 20 mg memantine hydrochloride tablets Axura / Ebixa and 10 mg donepezil hydrochloride tablets Aricept. Acrescent finished product is presented as pale yellow to light yellow, oval shaped film-coated tablet with imprint “MEM” on one side (...) Acrescent (memantine hydrochloride / donepezil hydrochloride) 18 October 2012 EMA/111381/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Acrescent International non-proprietary name: memantine hydrochloride / donepezil hydrochloride Procedure No. EMEA/H/C/002424 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European
Efficacy of memantine, donepezil, or their association in moderate-severe Alzheimer's disease: a review of clinical trials. Acetylcholinesterase (AChE)/cholinesterase (ChE) inhibitors (Is) and memantine are licensed for symptomatic treatment of mild-moderate and moderate-severe forms of Alzheimer's disease (AD), respectively. High doses of the AChE-I donepezil were licensed in the USA for moderate-severe AD, and the association AChE/ChE-Is plus memantine was proposed for AD at this stage.This (...) paper has reviewed evidence from clinical trials of the effectiveness of memantine, donepezil, or the two drugs in association in managing moderate-severe AD.Double-blind, placebo-controlled randomized trials (RCTs) using memantine or donepezil alone or in association versus placebo in moderate-severe AD were reviewed. Analysis done in January 2013 considered the years 2007-2012.Only 83 of the 941 papers selected were considered relevant, and only 13 met the criterion of "adequacy
A meta-analysis of the efficacy of donepezil, rivastigmine, galantamine, and memantine in relation to severity of Alzheimer's disease. Randomized clinical trials have evaluated the efficacy of acetylcholinesterase inhibitors (AChE-Is) and memantine across a wide range of Alzheimer's disease (AD) severity. However, these drugs are prescribed and reimbursed according to precise upper and lower cut off scores of cognitive tests.To verify whether the efficacy of pharmacological treatment had any
Evaluating the cost effectiveness of donepezil in the treatment of Alzheimer's disease in Germany using discrete event simulation Evaluating the cost effectiveness of donepezil in the treatment of Alzheimer's disease in Germany using discrete event simulation Evaluating the cost effectiveness of donepezil in the treatment of Alzheimer's disease in Germany using discrete event simulation Hartz S, Getsios D, Tao S, Blume S, Maclaine G Record Status This is a critical abstract of an economic (...) evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary The objective was to evaluate the cost-effectiveness of donepezil, for the treatment of Alzheimer’s disease, versus memantine or no treatment, in Germany. The authors concluded that donepezil was highly cost-effective. The methods were appropriate