Rivastigmine for Alzheimer’s disease.

Birks, Jacqueline S; Chong, Lee-Yee; Grimley Evans, John

doi:10.1002/14651858.cd001191.pub4

Cited by 534Cholinesterase and Neurodegenerative DiseasesDementia and Cognitive Impairment ResearchAlzheimer's disease research and treatments

Rivastigmine for Alzheimer’s disease.

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Birks, Jacqueline S, Chong, Lee-Yee, Grimley Evans, John·2015·Cochrane Database of Systematic Reviews

DOI 10.1002/14651858.cd001191.pub4PMC PMC7050299

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Abstract

BACKGROUND: Alzheimer's disease is the commonest cause of dementia affecting older people. One of the therapeutic strategies aimed at ameliorating the clinical manifestations of Alzheimer's disease is to enhance cholinergic neurotransmission in the brain by the use of cholinesterase inhibitors to delay the breakdown of acetylcholine released into synaptic clefts. Tacrine, the first of the cholinesterase inhibitors to undergo extensive trials for this purpose, was associated with significant adverse effects including hepatotoxicity. Other cholinesterase inhibitors, including rivastigmine, with superior properties in terms of specificity of action and lower risk of adverse effects have since been introduced. Rivastigmine has received approval for use in 60 countries including all member states of the European Union and the USA. OBJECTIVES: To determine the clinical efficacy and safety of rivastigmine for patients with dementia of Alzheimer's type. SEARCH METHODS: We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register, on 2 March 2015 using the terms: Rivastigmine OR exelon OR ENA OR "SDZ ENA 713". ALOIS contains records of clinical trials identified from monthly searches of a number of major healthcare databases (Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, LILACS), numerous trial registries and grey literature sources. SELECTION CRITERIA: We included all unconfounded, double-blind, randomised, controlled trials in which treatment with rivastigmine was administered to patients with dementia of the Alzheimer's type for 12 weeks or more and its effects compared with those of placebo in a parallel group of patients, or where two formulations of rivastigmine were compared. DATA COLLECTION AND ANALYSIS: One review author (JSB) applied the study selection criteria, assessed the quality of studies and extracted data. MAIN RESULTS: A total of 13 trials met the inclusion criteria of the review. The trials had a duration of between 12 and 52 weeks. The older trials tested a capsule form with a dose of up to 12 mg/day. Trials reported since 2007 have tested continuous dose transdermal patch formulations delivering 4.6, 9.5 and 17.7 mg/day.Our main analysis compared the safety and efficacy of rivastigmine 6 to 12 mg/day orally or 9.5 mg/day transdermally with placebo.Seven trials contributed data from 3450 patients to this analysis. Data from another two studies were not included because of a lack of information and methodological concerns. All the included trials were multicentre trials and recruited patients with mild to moderate Alzheimer's disease with a mean age of about 75 years. All had low risk of bias for randomisation and allocation but the risk of bias due to attrition was unclear in four studies, low in one study and high in two studies.After 26 weeks of treatment rivastigmine compared to placebo was associated with better outcomes for cognitive function measured with the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) score (mean difference (MD) -1.79; 95% confidence interval (CI) -2.21 to -1.37, n = 3232, 6 studies) and the Mini-Mental State Examination (MMSE) score (MD 0.74; 95% CI 0.52 to 0.97, n = 3205, 6 studies), activities of daily living (SMD 0.20; 95% CI 0.13 to 0.27, n = 3230, 6 studies) and clinician rated global impression of changes, with a smaller proportion of patients treated with rivastigmine experiencing no change or a deterioration (OR 0.68; 95% CI 0.58 to 0.80, n = 3338, 7 studies).Three studies reported behavioural change, and there were no differences compared to placebo (standardised mean difference (SMD) -0.04; 95% CI -0.14 to 0.06, n = 1529, 3 studies). Only one study measured the impact on caregivers using the Neuropsychiatric Inventory-Caregiver Distress (NPI-D) scale and this found no difference between the groups (MD 0.10; 95% CI -0.91 to 1.11, n = 529, 1 study). Overall, participants who received rivastigmine were about twice as likely to withdraw from the trials (odds ratio (OR) 2.01, 95% CI 1.71 to 2.37, n = 3569, 7 studies) or to experience an adverse event during the trials (OR 2.16, 95% CI 1.82 to 2.57, n = 3587, 7 studies). AUTHORS' CONCLUSIONS: Rivastigmine (6 to 12 mg daily orally or 9.5 mg daily transdermally) appears to be beneficial for people with mild to moderate Alzheimer's disease. In comparisons with placebo, better outcomes were observed for rate of decline of cognitive function and activities of daily living, although the effects were small and of uncertain clinical importance. There was also a benefit from rivastigmine on the outcome of clinician's global assessment. There were no differences between the rivastigmine group and placebo group in behavioural change or impact on carers. At these doses the transdermal patch may have fewer side effects than the capsules but has comparable efficacy. The quality of evidence is only moderate for all of the outcomes reviewed because of a risk of bias due to dropou

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Estimation of the Absolute Bioavailability of Rivastigmine in Patients with Mild to Moderate Dementia of the Alzheimer???s Type
Hossain, M. S., Jhee, S. S., Shiovitz, T. M., McDonald, C., Sedek, G., Pommier, F., & Cutler, N. R. (2002) · Clinical Pharmacokinetics · doi:10.2165/00003088-200241030-00006 · Cited by 60 · see citing works
Long-term effects of rivastigmine treatment on neuropsychiatric and behavioral disturbances in nursing home residents with moderate to severe Alzheimer's disease: results of a 52-week open-label study
Aupperle, P. M., Koumaras, B., Chen, M. J., Rabinowicz, A. L., & Mirski, D. F. (2004) · Current Medical Research and Opinion · doi:10.1185/030079904125004204 · Cited by 56 · see citing works
Preserved cognitive function after 12 months of treatment with rivastigmine in mild Alzheimer's disease in comparison with untreated AD and MCI patients
Almkvist, O., Darreh‐Shori, T., Stefanova, E. D., Spiegel, R., & Nordberg, A. K. (2004) · European Journal of Neurology · doi:10.1046/j.1468-1331.2003.00757.x · Cited by 55 · see citing works
Response to rivastigmine or donepezil in Alzheimer's patients with symptoms suggestive of concomitant Lewy body pathology
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A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease
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A rivastigmine patch for the treatment of Alzheimer’s disease and Parkinson’s disease dementia
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A pilot, randomized, open‐label trial assessing safety and pharmakokinetic parameters of co‐administration of rivastigmine with risperidone in dementia patients with behavioral disturbances
Weiser, M., Rotmensch, H. H., Korczyn, A. D., Hartman, R. D., Cicin-Sain, A., & Anand, R. (2002) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.599 · Cited by 46 · see citing works
RIVASTIGMINE IN PATIENTS WITH ALZHEIMER'S DISEASE AND CONCURRENT HYPERTENSION
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Rivastigmine Transdermal Patch Skin Tolerability
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POTENTIAL LONG‐TERM EFFECTS OF RIVASTIGMINE ON DISEASE PROGRESSION MAY BE LINKED TO DRUG EFFECTS ON VASCULAR CHANGES IN ALZHEIMER BRAINS
Erkinjuntti, T., Skoog, I. G., Lane, R. M., & Andrews, C. (2003) · International Journal of Clinical Practice · doi:10.1111/j.1742-1241.2003.tb10609.x · Cited by 32 · see citing works
The Economic Benefits of Acetylcholinesterase Inhibitors for Patients with Alzheimer Disease and Associated Dementias
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Risperidone and rivastigmine and agitated behaviour in severe Alzheimer's disease: a randomised double blind placebo controlled study
Holmes, C., Wilkinson, D. G., Dean, C., Clare, C., El‐Okl, M., Hensford, C., & Moghul, S. (2007) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.1667 · Cited by 28 · see citing works
The ACTION study: methodology of a trial to evaluate safety and efficacy of a higher dose rivastigmine transdermal patch in severe Alzheimer's disease
Farlow, M. R., Grossberg, G. T., Gauthier, S. G., Meng, X., & Olin, J. T. (2010) · Current Medical Research and Opinion · doi:10.1185/03007995.2010.513849 · Cited by 28 · see citing works
Rivastigmine transdermal patch and capsule in Alzheimer's disease: influence of disease stage on response to therapy
Farlow, M. R., Grossberg, G. T., Meng, X., Olin, J. T., & Somogyi, M. (2010) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.2669 · Cited by 27 · see citing works
Efficacy of rivastigmine transdermal patch on activities of daily living: item responder analyses
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Rivastigmine in outpatient services: experience of 114 neurologists in Austria
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Identification of responders and reactive domains to rivastigmine in Alzheimer's disease
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Cognitive deficits in Alzheimer's disease: Treatment with acetylcholinesterase inhibitor agents
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For Debate: Is the Evidence for the Efficacy of Cholinesterase Inhibitors in the Symptomatic Treatment of Alzheimer's Disease Convincing or Not?
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Effects of Body Weight on Tolerability of Rivastigmine Transdermal Patch
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Efficacy of higher-dose 13.3 mg/24 h (15 cm 2 ) rivastigmine patch on the Alzheimer's Disease Assessment Scale-cognitive subscale: domain and individual item analysis
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Rivastigmine Transdermal Patch 13.3 mg/24 h: A Review of Its Use in the Management of Mild to Moderate Alzheimer’s Dementia
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Self-citation
Comparing treatment effects in a clinical sample of patients with probable Alzheimer's disease treated with two different cholinesterase inhibitors.
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Effects of Rivastigmine Transdermal Patch and Capsule on Aspects of Clinical Global Impression of Change in Alzheimer’s Disease: A Retrospective Analysis
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Evaluation of the convenience of changing the rivastigmine administration route in patients with Alzheimer disease
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No donepezil discontinuation effect in patients with Alzheimer's disease who were switched to rivastigmine after failing to benefit from donepezil treatment
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The Effect of Vascular Risk Factors on the Efficacy of Rivastigmine Patch and Capsule Treatment in Alzheimer’s Disease
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Donepezil compared to rivastigmine in Alzheimer's disease: Similar efficacy but better tolerability and physician and caregiver satisfaction in a multinational randomized trial
Hock, C., Wilkinson, D. G., Passmore, P., Bullock, R. M., Hopker, S. W., Smith, R. A., Potocnik, F. C. V., Maud, C., Englebrecht, I., Mastey, V., et al. (2001) · European Neuropsychopharmacology · doi:10.1016/s0924-977x(01)80453-3 · Cited by 8 · see citing works
P3–299: Infrequent skin reactions at the application site of the rivastigmine patch (4.6, 9.5 or 13.3 mg/24 h): Analysis of two clinical studies revealed most were tolerable and manageable across all doses
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P3–275: Incidence and predictors of response to the 13.3 (15 cm2) and 9.5 mg/24h (10 cm2) rivastigmine patch in the OPtimising Transdermal Exelon In Mild‐to‐moderate Alzheimer's disease (OPTIMA) study
Molinuevo, J. L., Grossberg, G. T., Frölich, L., Galvin, J. E., Krahnke, T., & Strohmaier, C. (2013) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2013.05.1349 · Cited by 5 · see citing works
Early intervention with a cholinesterase inhibitor produces long-term beneficial effects in moderately severe AD patients
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AAGP Annual Meeting 2009
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Managing Functional and Cognitive Decline in Patients with Mild-to-Moderate Alzheimer's Disease: A 48-Week, Randomized, Double-Blind Evaluation of 13.3 mg/24 h (15 cm{superscript 2}) Versus 9.5 mg/24 h (10 cm{superscript 2}) Rivastigmine Patch (P04.193)
Cummings, J. L., Frölich, L., Black, S., Bakchine, S., Bellelli, G., Molinuevo, J. L., Kressig, R. W., Downs, P., Caputo, A., & Strohmaier, C. (2012) · Neurology · doi:10.1212/wnl.78.1_meetingabstracts.p04.193 · Cited by 4 · see citing works
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Farlow, M. R., Grossberg, G. T., Sadowsky, C., Meng, X., & Somogyi, M. (2013) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2013.05.1344 · Cited by 3 · see citing works
P3‐423: Efficacy of the 13.3 mg/24 h rivastigmine patch on instrumental activities of daily living in the OPtimising Transdermal Exelon In Mild‐to‐moderate Alzheimer's disease (OPTIMA) study: Prospective subgroup analysis by disease severity and time‐to‐meet decline
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Molinuevo, J. L., Grossberg, G. T., Frölich, L., Galvin, J. E., Krahnke, T., & Strohmaier, C. (2013) · Journal of the Neurological Sciences · doi:10.1016/j.jns.2013.07.1243 · Cited by 3 · see citing works
High-dose 13.3mg/24h rivastigmine patch efficacy and safety in mild-to-moderate Alzheimer's disease with and without concomitant memantine use
Molinuevo, J. L., Cummings, J. L., Frölich, L., Galvin, J. E., Krahnke, T., & Strohmaier, C. (2013) · Journal of the Neurological Sciences · doi:10.1016/j.jns.2013.07.1280 · Cited by 3 · see citing works
Long-term safety and efficacy of 13.3mg/24h rivastigmine patch in severe Alzheimer's disease: ACTivities of daily living and cognitION (ACTION) study
Farlow, M. R., Grossberg, G. T., Sadowsky, C., Meng, X., & Somgyi, M. (2013) · Journal of the Neurological Sciences · doi:10.1016/j.jns.2013.07.1252 · Cited by 3 · see citing works
Attenuation in the Progression of Cognitive Deterioration in Alzheimer's Disease With Rivastigmine: A Dose-Dependent Effect
Farlow, M. R., Messina, J. C., Anand, R., Hartman, R. D., & Veach, J. (2000) · CNS Spectrums · doi:10.1017/s109285290000701x · Cited by 3 · see citing works
Predictors of Response to 13.3 mg/24 h Rivastigmine Patch in Patients with Severe Alzheimer’s Disease (P1.007)
Farlow, M. R., Sadowsky, C., Velting, D. M., Meng, X., & Islam, Z. (2014) · Neurology · doi:10.1212/wnl.82.10_supplement.p1.007 · Cited by 2 · see citing works
P3–273: Efficacy, safety and tolerability of a higher‐dose 13.3 mg/24 h rivastigmine patch in people with severe Alzheimer's disease with and without concomitant memantine use
Grossberg, G. T., Farlow, M. R., Meng, X., & Somogyi, M. (2013) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2013.05.1347 · Cited by 2 · see citing works
Efficacy and safety of high-dose 13.3mg/24h rivastigmine patch in severe Alzheimer's disease with and without concomitant memantine use
Grossberg, G. T., Farlow, M. R., Meng, X., & Somogyi, M. (2013) · Journal of the Neurological Sciences · doi:10.1016/j.jns.2013.07.1244 · Cited by 2 · see citing works
26 High-dose rivastigmine patch: results from the optima study
Frölich, L. (2012) · Neurobiology of Aging · doi:10.1016/j.neurobiolaging.2012.01.044 · Cited by 2 · see citing works
P3‐422: Comparisons of patient characteristics in subpopulations of the OPtimising Transdermal Exelon In Mild‐to‐moderate Alzheimer's disease (OPTIMA) study
Frölich, L., Monsch, A. U., Kressig, R. W., Downs, P., Caputo, A., & Strohmaier, C. (2012) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2012.05.2096 · Cited by 2 · see citing works
P3‐424: High‐dose 13.3 mg/24 h rivastigmine transdermal patch demonstrates efficacy on instrumental activities of daily living: Individual item analysis
Cummings, J. L., Grossberg, G. T., Alva, G., Caputo, A., Downs, P., & Strohmaier, C. (2012) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2012.05.2098 · Cited by 2 · see citing works
Efficacy of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch on activities of daily living in severe Alzheimer’s disease
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Cognitive Efficacy of 13.3 mg/24 h versus 4.6 mg/24 h Rivastigmine Patch in Severe Alzheimer’s Disease: Severe Impairment Battery Factor Analysis (P1.009)
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Efficacy of 13.3 mg/24 h versus 4.6 mg/24 h Rivastigmine Patch on Activities of Daily Living in Severe Alzheimer’s Disease: A Factor Analysis (P1.008)
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P3–278: The rivastigmine high‐dose, 13 mg/24h (15cm2), transdermal patch provides daily living benefits to people with severe Alzheimer's disease: Retrospective analyses of the OPtimising Transdermal Exelon In Mild‐to‐moderate Alzheimer's disease (OPTIMA) study
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P3–268: Effect of body mass index on the efficacy, safety and tolerability of a higher‐dose 13.3 mg/24 h rivastigmine patch in people with severe Alzheimer's disease
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Flagged first, then by citations

10 of the 147 references couldn’t be matched to a known paper.

Research works printed but not linked: 31

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Novartis. No title. Unpublished. Data provided by Novartis. No year. Novartis Pharmaceuticals. ADENA Programme. Unpublished Data 1998. B352 {published data only} Burns A, Spiegel R, Quarg P. Efficacy of rivastigmine in subjects with moderately severe Alzheimer's disease. International Journal of Geriatric Psychiatry 2004;19(3):243-9.
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Authors: Birks, J. S., Chong, L.-Y., & Grimley Evans, J.
Affiliations: University of Oxford (GB)
Cochrane (GB)
University of Oxford; Division of Clinical Geratology, Nuffield Department of Clinical Medicine; Radcliffe Infirmary Woodstock Road Oxford UK OX2 6HE
ORCID: Birks, Jacqueline S
Venue: Cochrane Database of Systematic Reviews
Publisher: Wiley
Published: 2015-09-22
Volume: 38
Issue: 2
Pages: 15-6
ISSN: 1361-6137 (ISSN-L)
1465-1858
DOI: 10.1002/14651858.cd001191.pub4
PMC: PMC7050299
OpenAlex: W2098999434
Cited by: 534
References: 147
Citations by year: 2026: 10 · 2025: 15 · 2024: 24 · 2023: 25 · 2022: 23 · 2021: 29 · 2020: 28 · 2019: 30 · 2018: 30 · 2017: 21 · 2016: 25 · 2015: 18 · 2014: 24 · 2013: 19 · 2012: 28
FWCI: 3.93
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Cochrane Database of Systematic Reviews (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
Keywords: rivastigmine, Alzheimer's disease, dementia, cholinesterase inhibitors, acetylcholinesterase inhibition, transdermal patch, oral dosage forms, cognitive function, functional status, adverse effects, hepatotoxicity, tacrine, placebo comparison, treatment efficacy and safety, older adults, dose comparison
MeSH terms: Rivastigmine, Alzheimer Disease, Carbamates, Cholinesterase Inhibitors, Humans, Randomized Controlled Trials as Topic, Neuroprotective Agents, Phenylcarbamates

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