Donepezil, rivastigmine, galantamine and memantine for ...

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viii List of abbreviations List of abbreviations continued IHQL Index of Health Related Quality of Life ITT intention-to-treat LOCF last observation carried forward MENFIS Mental Function Impairment Scale MID multiple-infarct dementia mMMSE modified MMSE MMSE mini-mental state examination MDS Minimum Data Set MRI magnetic resonance imaging NADES National Dementia Economic Study NHS CRD NHS Centre for Reviews and Dissemination NICE National Institute for Health and Clinical Excellence NINCDS- National Institute of Neurological ADRDA and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association NMDA N-methyl-D-aspartate NNT number-needed-to-treat NOSGER Nurses’ Observation Scale for Geriatric Patients NPI Neuropsychiatric Inventory NPI-D Neuropsychiatric Inventory, distress subscale ns not significant NYU New York University oc observed case OPCS Office of Population Census and Surveys OR odds ratio PCA prescription cost analysis PCT primary care trust P&CSQ Physician’s and Caregiver’s Satisfaction Questionnaire PDS Progressive Deterioration Scale PGA Patient Global Assessment Scale PSMS Physical Self-Maintenance Scale PSS Personal Social Services PSSRU Personal Social Services Research Unit QALY quality-adjusted life-year QoL quality of life QoL-C caregiver-rated quality of life QoL-P patient-rated quality of life QWB Quality of Well-being Scale RCT randomised controlled trial SD standard deviation SDAT senile dementia of the Alzheimer’s type SEM standard error of the mean SEVINT OPCS measure of intellectual functioning SHTAC Southampton Health Technology Assessment Centre SIB Severe Impairment Battery sMMSE severe MMSE SMR standardised mortality ratio SSD Social Services Department TESS Treatment Emergent Signs and Symptoms TMT trail making test TTO time trade-off UPDRS Unified Parkinson’s Disease Rating Scale VAD vascular dementia VAS visual analogue scale WIHRD Wessex Institute for Health Research and Development WMD weighted mean difference All abbreviations that have been used in this report are listed here unless the abbreviation is well known (e.g. NHS), or it has been used only once, or it is a non-standard abbreviation used only in figures/tables/appendices in which case the abbreviation is defined in the figure legend or at the end of the table.
Epidemiology and background Alzheimer’s disease (AD) is the most common cause of dementia and is characterised by an insidious onset and slow deterioration in cognition, functional ability (e.g. activities of daily living) and behaviour and mood. AD prevalence rises with increasing age and the estimated prevalence of AD for a standard primary care trust with a population of 200,000 is approximately 1100. Current service involves a wide range of agencies. In 2001, the National Institute for Health and Clinical Excellence (NICE) recommended that cholinesterase inhibitors (donepezil, rivastigmine, galantamine) should be offered to patients with mild to moderate AD under a number of conditions. Patients with more severe AD may benefit from memantine but there is currently no guidance on its use. Aim of the review The aim of this review was to provide an update review of the best quality evidence for the clinical effectiveness and cost-effectiveness of donepezil, rivastigmine, and galantamine for mild to moderately severe AD. It also aimed to provide a review of the best quality evidence for the clinical effectiveness and cost-effectiveness of memantine for moderately severe to severe AD. Methods A systematic review of the literature and an economic evaluation were undertaken. Data sources Electronic databases were searched from inception to July 2004. Bibliographies of included studies and related papers were checked for relevant studies and experts were contacted for advice and peer review and to identify additional published and unpublished studies. Manufacturer submissions to NICE were reviewed. Executive summary © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 1 Study selection Studies were included if they met the following criteria. ● Interventions: donepezil, rivastigmine, galantamine or memantine. ● Participants: people diagnosed with Alzheimer’s disease who met the criteria for treatment with donepezil, rivastigmine, galantamine or memantine. ● Design: systematic reviews of randomised controlled trials (RCTs) and RCTs comparing the different drugs with placebo or each other or non-drug comparators were included in the review of effectiveness. Economic evaluations including a comparator (or placebo) and both the costs and consequences (outcomes) of treatment were included. ● Primary outcomes: measures of global functioning, cognition, function, behaviour and mood, and health-related quality of life. Studies in non-English languages were excluded. Studies published only as abstracts or conference presentations were included if sufficient detail was presented. Titles and abstracts were screened for eligibility by one reviewer and checked by a second reviewer. Inclusion criteria were applied to the full text of selected papers by two reviewers. Any differences in opinion were resolved though discussion or consultation with a third reviewer. Data extraction and quality assessment Data extraction and quality assessment were undertaken by one reviewer and checked by a second reviewer, with any differences in opinion resolved through discussion. The quality of included RCTs was assessed using criteria developed by the NHS Centre for Reviews and Dissemination. An outline assessment of economic evaluations was undertaken using a standard checklist. ix
Page 1 and 2: Health Technology Assessment 2006;
Page 3 and 4: The clinical and cost-effectiveness
Page 5 and 6: Objectives: To provide an update re
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Page 9: AChEI acetylcholinesterase inhibito
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48 Clinical effectiveness differenc
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52 Clinical effectiveness This appe
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78 Clinical effectiveness donepezil
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80 Evidence from systematic reviews
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82 Economic analysis TABLE 48 Chara
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84 TABLE 49 Economic analysis Outli
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86 Economic analysis The UK study r
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92 Economic analysis published econ
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94 Economic analysis Fenn and Gray
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96 Economic analysis one another. W
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100 Economic analysis respond to ga
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102 Economic analysis donepezil, ri
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104 Economic analysis of this study
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106 Economic analysis independent,
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108 Economic analysis classificatio
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110 Economic analysis survey studie
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112 Economic analysis vascular deme
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114 Economic analysis Livingston an
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120 Economic analysis The model str
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122 Economic analysis CEA, given th
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124 Economic analysis TABLE 70 Key
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128 Economic analysis Probability o
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130 Economic analysis Results are s
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136 Economic analysis indicating th
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Ongoing research, with relevance to
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The increasing numbers of the very
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1. Clegg A, Bryant J, Nicholson T,
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placebo-controlled study of donepez
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94. Brooks E, Deal L. The effect of
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of memantine in patients with moder
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This version of HTA monograph volum
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376 Health Technology Assessment Pr
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378 Health Technology Assessment Pr
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