532
Views
71
CrossRef citations to date
0
Altmetric
Review

A fixed-dose combination of memantine extended-release and donepezil in the treatment of moderate-to-severe Alzheimer’s disease

&
Pages 3267-3279 | Published online: 03 Oct 2016

References

  • Alzheimer’s Association2016 Alzheimer’s disease facts and figuresAlzheimers Dement201612445950927570871
  • Alzheimer’s Disease InternationalWorld Alzheimer report 2015: the global impact of dementia2015 Available from: https://www.alz.co.uk/research/WorldAlzheimerReport2015.pdfAccessed Aug 13, 2016
  • HurdMDMartorellPDelavandeAMullenKJLangaKMMonetary costs of dementia in the United StatesN Engl J Med2013368141326133423550670
  • GauthierSMolinuevoJLBenefits of combined cholinesterase inhibitor and memantine treatment in moderate-severe Alzheimer’s diseaseAlzheimers Dement20139332633123110864
  • AtriAMolinuevoJLLemmingOWirthYPulteIWilkinsonDMemantine in patients with Alzheimer’s disease receiving donepezil: new analyses of efficacy and safety for combination therapyAlzheimers Res Ther201351623336974
  • MatsunagaSKishiTIwataNCombination therapy with cholinesterase inhibitors and memantine for Alzheimer’s disease: a systematic review and meta-analysisInt J Neuropsychopharmacol2015185
  • FarrimondLERobertsEMcShaneRMemantine and cholinesterase inhibitor combination therapy for Alzheimer’s disease: a systematic reviewBMJ Open201223
  • National Institute for Health and Clinical ExcellenceDonepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s diseaseNICE Technology Appraisal Guidance 2172011
  • SchmidtRHoferEBouwmanFHEFNS-ENS/EAN guideline on concomitant use of cholinesterase inhibitors and memantine in moderate to severe Alzheimer’s diseaseEur J Neurol201522688989825808982
  • Namenda XR (memantine hydrochloride) drug approval packageUS Food and Drug Administration2010 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525s000_namenda_xr_toc.cfmAccessed May 17, 2016
  • Namzaric (memantine hydrochloride extended-release/donepezil hydrochloride) capsulesUS Food and Drug Administration2014 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206439Orig1s000TOC.cfmAccessed May 17, 2016
  • KrsticDKnueselIDeciphering the mechanism underlying late-onset Alzheimer diseaseNat Rev Neurol201391253423183882
  • ParsonsCGDanyszWDekundyAPulteIMemantine and cholinesterase inhibitors: complementary mechanisms in the treatment of Alzheimer’s diseaseNeurotox Res201324335836923657927
  • DanyszWParsonsCGAlzheimer’s disease, beta-amyloid, glutamate, NMDA receptors and memantine – searching for the connectionsBr J Pharmacol2012167232435222646481
  • NeumeisterKLRiepeMWSynergistic effects of antidementia drugs on spatial learning and recall in the APP23 transgenic mouse model of Alzheimer’s diseaseJ Alzheimers Dis201230224525122414570
  • Martinez-CoriaHGreenKNBillingsLMMemantine improves cognition and reduces Alzheimer’s-like neuropathology in transgenic miceAm J Pathol2010176287088020042680
  • BoinpallyRChenLZukinSRMcClureNHofbauerRKPericlouAA novel once-daily fixed-dose combination of memantine extended release and donepezil for the treatment of moderate to severe Alzheimer’s disease: two phase I studies in healthy volunteersClin Drug Investig2015357427435
  • PericlouAPVenturaDShermanTRaoNAbramowitzWTLack of pharmacokinetic or pharmacodynamic interaction between memantine and donepezilAnn Pharmacother20043891389139415266045
  • Namzaric (memantine hydrochloride extended-release and donepezil hydrochloride) [package insert]Cincinnati, OHForest Pharmaceuticals, Inc2016
  • LamSSmithCGomolinIHMemantine standard tablet and extended-release dosing considerations: a pharmacokinetic analysisJ Am Geriatr Soc201563238338425688611
  • GrossbergGTManesFAllegriRFThe safety, tolerability, and efficacy of once-daily memantine (28 mg): a multinational, randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe Alzheimer’s disease taking cholinesterase inhibitorsCNS Drugs201327646947823733403
  • SchmittFAAshfordWErnestoCThe severe impairment battery: concurrent validity and the assessment of longitudinal change in Alzheimer’s disease. The Alzheimer’s Disease Cooperative StudyAlzheimer Dis Assoc Disord199711Suppl 2S51S569236953
  • Center for Drug Evaluation and ResearchReview and evaluation of clinical data (Medical review)US Food and Drug Administration2010 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525Orig1s000MedR.pdfAccessed Aug 13, 2016
  • GrossbergGAlvaGHendrixSHofbauerRPejovicVGrahamSMEfficacy and tolerability of memantine extended release added to stable donepezil regimen in individuals with moderate to severe Alzheimer’s disease: subset analysis of a randomized clinical trialAlzheimers Dement201410Suppl 4P450
  • Center for Drug Evaluation and ResearchReview and evaluation of clinical data (statistical review and evaluation)US Food and Drug Administration2010 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525Orig1s000StatR.pdfAccessed Aug 13, 2016
  • Center for Drug Evaluation and ResearchSummary reviewUS Food and Drug Administration2010 Available from: https://www.access-data.fda.gov/drugsatfda_docs/nda/2010/022525Orig1s000SumR.pdfAccessed Aug 13, 2016
  • ToccoMHendrixSMillerMPejovicVGrahamSEffects of extended-release memantine (28 mg, once daily) on language and communication abilities in a randomized trial of patients with moderate-to-severe Alzheimer’s diseaseAlzheimers Dement20128Suppl 4P589
  • ToccoMHendrixSMillerMPejovicVGrahamSEffects of extended-release memantine (28 mg/day) on cognitive domains in patients with moderate to severe Alzheimer’s disease: post hoc analysis of a randomized trialAlzheimers Dement20117Suppl 4S784S785
  • ToccoMHendrixSMillerMPejovicVGrahamSEffects of extended-release memantine (28 mg/day) on activities of daily living in patients with moderate to severe alzheimer’s disease: post hoc factor analysis of a randomized trialAlzheimers Dement20117Suppl 4S790S791
  • GrahamSHendrixSMillerMResponse across multiple outcome measures in a randomized trial of extended-release memantine (28 mg, once daily) in patients with moderate-to-severe Alzheimer’s diseaseAlzheimers Dement20128Suppl 4S591
  • KauferDICummingsJLChristineDAssessing the impact of neuropsychiatric symptoms in Alzheimer’s disease: the Neuropsychiatric Inventory Caregiver Distress ScaleJ Am Geriatr Soc19984622102159475452
  • AtriAHendrixSEllisonNPejovićVOtcheretkoVCaregiver distress related to neuropsychiatric symptoms is reduced with extended-release memantine-cholinesterase inhibitor combination in patients with moderate to severe Alzheimer’s diseaseAlzheimers Dement201511Suppl 7P749P750
  • Withdrawal assessment report: memantine FGKEuropean Medicines Agency2012 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/human/002687/WC500141943.pdfAccessed May 17, 2016
  • TariotPNFarlowMRGrossbergGTMemantine treatment in patients with moderate to severe Alzheimer disease already receiving donepezil: a randomized controlled trialJAMA2004291331732414734594
  • PorsteinssonAPGrossbergGTMintzerJOlinJTMemantine MEMMDSGMemantine treatment in patients with mild to moderate Alzheimer’s disease already receiving a cholinesterase inhibitor: a randomized, double-blind, placebo-controlled trialCurr Alzheimer Res200851838918288936
  • AtriAMolinuevoJLLemmingOWirthYPulteIWilkinsonDMemantine in patients with Alzheimer’s disease receiving donepezil: new analyses of efficacy and safety for combination therapyAlzheimers Res Ther201351623336974
  • MolinuevoJLLemmingOEffects of memantine in patients with moderate Alzheimer’s disease receiving stable doses of donepezilAlzheimers Dement20128Suppl 4P601
  • AtriAHendrixSBPejovicVCumulative, additive benefits of memantine-donepezil combination over component monotherapies in moderate to severe Alzheimer’s dementia: a pooled area under the curve analysisAlzheimers Res Ther2015712825991927
  • HowardRMcShaneRLindesayJDonepezil and memantine for moderate-to-severe Alzheimer’s diseaseN Engl J Med20123661089390322397651
  • ShawGTwo drugs are not better than one for treating moderate to severe Alzheimer Disease, British investigators report: why some US neurologists don’t agreeNeurology Today [serial on the Internet]20121281213 Available from: http://journals.lww.com/neurotodayonline/Fulltext/2012/04190/Two_Drugs_Are_Not_Better_Than_One_for_Treating.10.aspxAccessed May 17, 2016
  • HendrixSEllisonNStanworthSOtcheretkoVTariotPNPost hoc evidence for an additive effect of memantine and donepezil: consistent findings from DOMINO-AD study and memantine clinical trial programJ Prev Alzheimers Dis201523165171
  • HowardRMcShaneRLindesayJNursing home placement in the Donepezil and Memantine in Moderate to Severe Alzheimer’s Disease (DOMINO-AD) trial: secondary and post-hoc analysesLancet Neurol201514121171118126515660
  • RountreeSDAtriALopezOLDoodyRSEffectiveness of antidementia drugs in delaying Alzheimer’s disease progressionAlzheimers Dement20139333834523102979
  • AtriAShaughnessyLWLocascioJJGrowdonJHLong-term course and effectiveness of combination therapy in Alzheimer diseaseAlzheimer Dis Assoc Disord200822320922118580597
  • LopezOLBeckerJTWahedASLong-term effects of the concomitant use of memantine with cholinesterase inhibition in Alzheimer diseaseJ Neurol Neurosurg Psychiatry200980660060719204022
  • BirksJHarveyRJDonepezil for dementia due to Alzheimer’s diseaseCochrane Database Syst Rev20061CD00119016437430
  • WinbladBJonesRWWirthYStofflerAMobiusHJMemantine in moderate to severe Alzheimer’s disease: a meta-analysis of randomised clinical trialsDement Geriatr Cogn Disord2007241202717496417
  • GillSSAndersonGMFischerHDSyncope and its consequences in patients with dementia receiving cholinesterase inhibitors: a population-based cohort studyArch Intern Med2009169986787319433698
  • Park-WyllieLYMamdaniMMLiPGillSSLaupacisAJuurlinkDNCholinesterase inhibitors and hospitalization for bradycardia: a population-based studyPLoS Med200969e100015719787032
  • SheffrinMMiaoYBoscardinWJSteinmanMAWeight loss associated with cholinesterase inhibitors in individuals with dementia in a national healthcare systemJ Am Geriatr Soc20156381512151826234945
  • KimDHBrownRTDingELKielDPBerrySDDementia medications and risk of falls, syncope, and related adverse events: meta-analysis of randomized controlled trialsJ Am Geriatr Soc20115961019103121649634
  • MayerMPulteIHow safe is combination memantine/donepezil treatment in people with Alzheimer’s disease? Safety evaluations based on 23 clinical studiesAlzheimers Dement20139Suppl 4P282
  • PerhachJGrahamSA long-term, open-label extension study evaluating the safety of extended-release memantine (28 mg) in patients with moderate to severe Alzheimer’s diseaseAlzheimers Dement20117Suppl 4e70
  • Saint-Laurent ThibaultCOzer StillmanIChenSCost-utility analysis of memantine extended release added to cholinesterase inhibitors compared to cholinesterase inhibitor monotherapy for the treatment of moderate-to-severe dementia of the Alzheimer’s type in the USJ Med Econ2015181193094326086535
  • WeyckerDTanejaCEdelsbergJCost-effectiveness of memantine in moderate-to-severe Alzheimer’s disease patients receiving donepezilCurr Med Res Opin20072351187119717519086
  • TouchonJLachaineJBeaucheminCGranghaudARiveBBineauSThe impact of memantine in combination with acetylcholinesterase inhibitors on admission of patients with Alzheimer’s disease to nursing homes: cost-effectiveness analysis in FranceEur J Health Econ201415879180023928827
  • LachaineJBeaucheminCLegaultMBineauSEconomic evaluation of the impact of memantine on time to nursing home admission in the treatment of Alzheimer diseaseCan J Psychiatry2011561059660422014692
  • RountreeSDChanWPavlikVNDarbyEJSiddiquiSDoodyRSPersistent treatment with cholinesterase inhibitors and/or memantine slows clinical progression of Alzheimer diseaseAlzheimers Res Ther200912719845950
  • BangaloreSKamalakkannanGParkarSMesserliFHFixed-dose combinations improve medication compliance: a meta-analysisAm J Med2007120871371917679131
  • ThomSPoulterNFieldJEffects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: the UMPIRE randomized clinical trialJAMA2013310991892924002278
  • MaxwellCJStockKSeitzDHerrmannNPersistence and adherence with dementia pharmacotherapy: relevance of patient, provider, and system factorsCan J Psychiatry2014591262463125702361
  • HerrmannNBinderCDalzielWSmythSCamachoFPersistence with cholinesterase inhibitor therapy for dementia: an observational administrative health database studyDrugs Aging200926540340719552492
  • BorahBSaccoPZarotskyVPredictors of adherence among Alzheimer’s disease patients receiving oral therapyCurr Med Res Opin20102681957196520569067
  • TianHAbouzaidSChenWKahlerKHKimEPatient adherence to transdermal rivastigmine after switching from oral donepezil: a retrospective claims database studyAlzheimer Dis Assoc Disord201327218218622892648
  • BrewerLBennettKMcGreevyCWilliamsDA population-based study of dosing and persistence with anti-dementia medicationsEur J Clin Pharmacol20136971467147523443628
  • OlazaranJNavarroERojoJMPersistence of cholinesterase inhibitor treatment in dementia: insights from a naturalistic studyDement Geriatr Cogn Dis Extra201331485923637699
  • ParienteAPinetMMorideYMerliereYMooreNFourrier-ReglatAFactors associated with persistence of cholinesterase inhibitor treatments in the elderlyPharmacoepidemiol Drug Saf201019768068620583209
  • AlagiakrishnanKBhanjiRAKurianMEvaluation and management of oropharyngeal dysphagia in different types of dementia: a systematic reviewArch Gerontol Geriatr20135611922608838
  • StrachanIGreenerMMedication related swallowing difficulties may be more common than we realizePharm Pract2005159411414
  • MarquisJSchneiderMPPayotVSwallowing difficulties with oral drugs among polypharmacy patients attending community pharmaciesInt J Clin Pharm20133561130113623963541
  • HawCStubbsJDickensGAn observational study of medication administration errors in old-age psychiatric inpatientsInt J Qual Health Care200719421021617562662
  • StegemannSGoschMBreitkreutzJSwallowing dysfunction and dysphagia is an unrecognized challenge for oral drug therapyInt J Pharm20124301–219720622525080
  • HauberABGnanasakthyASnyderEHBalaMVRichterAMauskopfJAPotential savings in the cost of caring for Alzheimer’s disease. Treatment with rivastigminePharmacoeconomics200017435136010947490
  • NeumannPJHermannRCKuntzKMCost-effectiveness of donepezil in the treatment of mild or moderate Alzheimer’s diseaseNeurology19995261138114510214734
  • JelicVWinbladBAlzheimer disease. Donepezil and nursing home placement–benefits and costsNat Rev Neurol2016121111326714658
  • KarlawishJHKlocinskiJLMerzJClarkCMAschDACaregivers’ preferences for the treatment of patients with Alzheimer’s diseaseNeurology20005571008101411061260
  • YaffeKFoxPNewcomerRPatient and caregiver characteristics and nursing home placement in patients with dementiaJAMA2002287162090209711966383
  • HatoumHTThomasSKLinSJLaneRBullockRPredicting time to nursing home placement based on activities of daily living scores – a modelling analysis using data on Alzheimer’s disease patients receiving rivastigmine or donepezilJ Med Econ20091229810319492974
  • AlvaGEllisonNDassBHendrixSDaily functioning benefits of adding memantine to stable cholinesterase treatment in patients with moderate to severe Alzheimer’s disease: a post hoc pooled factor analysis (P2.218)Neurology201686Suppl 16
  • New York Schneiderman v. Actavis PLC LLCFindLaw2015 Available from: http://caselaw.findlaw.com/us-2nd-circuit/1702157.htmlAccessed May 17, 2016
  • Upsher-Smith receives FDA approval for generic version of Namenda® (Memantine HCl) tabletsPRNewswire2015 Available from: http://www.prnewswire.com/news-releases/upsher-smith-receives-fda-approval-for-generic-version-of-namenda-memantine-hcl-tablets-300125957.htmlAccessed May 17, 2016