Treatment of vascular dementia - Dementia e Neuropsychologia [PDF]

demência vascular: atividade física, álcool, tabagismo, dieta e suplementos, hipertensão arterial, diabetes mellitus

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Dement Neuropsychol 2011 December;5(4):275-287

Treatment of vascular dementia Recommendations of the Scientific Department of Cognitive Neurology and Aging of the Brazilian Academy of Neurology

Sonia Maria Dozzi Brucki1,2, Ana Cláudia Ferraz2, Gabriel R. de Freitas3, Ayrton Roberto Massaro4, Márcia Radanovic5, Rodrigo Rizek Schultz6 and Working Group on Alzheimer’s Disease and Vascular Dementia of the Brazilian Academy of Neurology Abstract  –  Scientific Department of Cognitive Neurology and Aging of ABN had a consensus meeting to write recommendations on treatment of vascular dementia, there was no previous issue. This disease has numerous particularities and can be considered a preventable dementia. Prevention treatment is primary care of vascular risk factors or a secondary prevention of factors that could cause recurrence of ischemic or hemorrhagic brain modifications. In these guidelines we suggested only symptomatic treatment, pharmacologic or nonpharmacologic. We have reviewed current publications on MEDLINE (PubMed), LILACS e Cochrane Library databases. Recommendations are concern to the following factors and their prevention evidences, association, or treatment of vascular dementia: physical activity, tobacco use, diet and food supplements, arterial hypertension, diabetes mellitus, obesity, statins, cardiac failure, atrial fibrillation, antithrombotics, sleep apnea, carotid revascularization, symptomatic pharmacological treatment. Key words: vascular dementia, pharmacological treatment, prevention, cholinesterase. Tratamento da demência vascular. Recomendações do Departamento Científico de Neurologia Cognitiva e do Envelhecimento da Academia Brasileira de Neurologia Resumo  –  O DC de Neurologia Cognitiva e do Envelhecimento da ABN reuniu-se para escrever recomendações para o tratamento da demência vascular, uma vez que não havia nenhuma recomendação neste sentido. Esta doença tem inúmeras particularidades e pode ser considerada uma das demências que pode ser prevenida. O tratamento para sua prevenção é o de cuidados primários para os fatores de risco vasculares, ou a prevenção secundária dos fatores que levam a recorrência de alterações isquêmicas ou hemorrágicas cerebrais. Nestas recomendações sugerimos apenas o tratamento sintomático, medicamentoso ou não. Baseamo-nos nas evidências disponíveis, através da revisão das publicações nas bases MEDLINE (PubMed), LILACS e Cochrane Library. As recomendações dizem respeito aos seguintes fatores e suas evidências na prevenção, associação ou tratamento da demência vascular: atividade física, álcool, tabagismo, dieta e suplementos, hipertensão arterial, diabetes mellitus, obesidade, estatinas, insuficiência cardíaca, fibrilação atrial, antiagregantes, apneia do sono, revascularização carotídea e tratamento farmacológico sintomático. Palavras-chave: demência vascular, tratamento farmacológico, prevenção, inibidores das colinesterases, memantina, diretrizes, consenso, Brasil. Neurology Service, Hospital Santa Marcelina, Cognitive and Behavioral Neurology Group of Clínicas Hospital of the University of São Paulo School of Medicine (FMUSP), Referral Center for Cognitive Disorders (CEREDIC) of the FMUSP, São Paulo SP, Brazil; 2D’Or Institute of Research and Teaching, University Federal Fluminense, Rio de Janeiro RJ, Brazil; 3Institute of Rehabilitation Lucy Montoro. 4Medical Investigation Laboratory 27 (LIM 27), Institute of Psychiatry, School of Medicine, University of Sao Paulo, São Paulo SP, Brazil; 5Sector of Behavioral Neurology of the Department of Neurology and Neurosurgery of the Federal University of São Paulo (UNIFESP), Center for Brain Aging (NUDEC) - Institute of Memory (UNIFESP), São Paulo SP, Brazil. 1

Sonia Maria Dozzi Brucki  –  Rua Rio Grande, 180/61 - 04018-000 São Paulo SP - Brazil. E-mail: [email protected] Disclosure: The authors report no conflits of interest. Received September 15, 2011. Accepted in final form November 20, 2011.

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Dement Neuropsychol 2011 December;5(4):275-287

The diagnosis of vascular cognitive impairment (VCI) and vascular dementia (VD) remains controversial. Since a number of criteria are available in the literature, this discussion is of primary importance to Brazil in furthering knowledge, improving diagnosis and gleaning greater understanding of the mechanisms involved in the emergence of cognitive decline due to vascular causes in the Brazilian population. Thus, VCI has recently been proposed as a term encompassing VD and all other forms of mild to severe cognitive impairment secondary to cerebrovascular disease. The term encompasses three conditions: VCI no dementia, vascular dementia, and AD with a vascular component. VCI no dementia constitutes the most prevalent VCI subgroup in persons younger than 85 years of age. VD denotes dementia caused by all types of vascular pathology. The current classification of VD includes cortical vascular dementia, subcortical ischemic VD, dementia due to strategic infarct, dementia due to hypoperfusion, and dementia due to hemorrhagic lesions. Therefore, this subject was extensively addressed and a consensus on its diagnostic criteria by this group can be found in an earlier publication. Given the array of (often imprecise) criteria used to diagnose VCI and VD among studies on the treatment of vascular risk factors, the task of defining recommendations for treating these diseases, particularly in the prevention of cognitive decline, does not have robust levels of evidence to draw on. The heterogeneity of the physiopathology, location and magnitude of lesions, diagnostic criteria, and cognitive assessment all vary among studies on cognition, precluding, in the majority of cases, generalization of results for all types of impairment.

Methods A search of the electronic PubMed and Scielo databases for articles published up to May 2011 was carried out. Studies containing an abstract that addressed the association among VCI and VD, symptomatic treatment of risk factors for vascular diseases and cognition, or specific treatment of cognition-related symptoms in patients with VCI or VD, were included. Review type articles and metaanalyses on the theme were also included. The themes chosen were divided by members of the consensus group into: physical activity; diet and food supplementation; alcohol, obesity, smoking, treatment of arterial hypertension, diabetes, dyslipidemia, cardiac insufficiency, atrial fibrillation;sleep apnea and antiaggregants. Regarding specific symptomatic treatment, trials with cholinesterase inhibitors and glutamate antagonist,

276     Vascular dementia: treatment     Brucki SMD, et al.

cytocholine, calcium channel blockers, cerebrolysin and pentoxifylline were assessed. After selection of articles, these were classified into Classes I, II and III, while recommendations were qualified according to levels of evidence with A, B, C and U ratings. The criteria employed are summarized in Tables 1 and 2, and were based on the recommendations of the American Academy of Neurology published in 2008.

Physical activity Animal studies have shown that physical activity stimulates angiogenesis, synaptogenesis and neurogenesis. Rats subjected to treadmill running had more astrocytes and neuroblasts able to proliferate in the subgranular zone of the dentate gyrus of the hippocampus, as well as a greater number of neurons in the transient stage, compared to control animals.1 Physical exercise also reduces risk factors for vascular diseases and can release hormonal factors which enhance neuronal functioning, lending support to the theory of potential benefits. Such benefits have also been confirmed in clinical trials. In a recent 8-year follow-up study involving 3075 elderly between 70 and 79 years of age in 1997, 30% of the group presented cognitive decline at the end of the followup period. Multivariate analysis of the initial variables associated good evolution with younger age, white ethnicity, higher level of education and literacy, moderate to vigorous exercise, and non-smoking status.2 Some evidence indicates that physical activity plays a role in preventing dementia and conversion from mild cognitive impairment (MCI) to dementia in the form of Alzheimer’s disease (AD) or VD.3-6 A recent meta-analysis of prospective studies involving 33816 non-demented individuals at base line, followed up for one to 12 years, found that a high level of physical activity was associated to a 38% reduction in risk of cognitive decline, whereas light to moderate physical activity was also associated to a 35% reduction in risk of decline.7 In the randomized clinical trial by Lautenschlager et al., physical activity was associated to lower risk of developing MCI and dementia among adults with subjective memory complaints.3 Volunteers were 50 years of age or older and randomly assigned to an educational program or to a domiciliary physical exercise program lasting a period of 24 weeks. A statistically significant difference, albeit modest, was seen in the cognitive performance of the group that performed the physical activity, a difference which persisted after an 18-month period.3 Studies in the literature show a statistically significant benefit from physical activity. However, preventive effects

Dement Neuropsychol 2011 December;5(4):275-287

Table 1. Classification of studies. Class I.

A randomized, controlled clinical trial of the intervention of interest with masked or objective outcome assessment, in a representative population. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences. The following are also required: a.

Primary outcome(s) clearly defined.

b.

Concealed allocation clearly defined.

c.

Exclusion/inclusion criteria clearly defined.

d.

Adequate accounting for drop-outs (with at least 80% of enrolled subjects completing the study) and cross-overs with numbers sufficiently low to have minimal potential for bias.

e.

For non-inferiority or equivalence trials claiming to prove efficacy for one or both drugs, the following are also required*: 1.

The standard treatment used in the study is substantially similar to that used in previous studies establishing efficacy of the standard treatment. (e.g. for a drug, the mode of administration, dose and dosage adjustments are similar to those previously shown to be effective).

2.

The inclusion and exclusion criteria for patient selection and the outcomes of patients on the standard treatment are comparable to those of previous studies establishing efficacy of the standard treatment.

3.

The interpretation of the results of the study is based upon an analysis of cases observed.

Class II.

A randomized controlled clinical trial of the intervention of interest in a representative population with masked or objective outcome assessment that lacks one criteria a-e above or a prospective matched cohort study with masked or objective outcome assessment in a representative population that meets b-e above. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.

Class III.

All other trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement.

Class IV.

Studies not meeting Class I, II or III criteria including consensus or expert opinion.

*Note that numbers 1-3 in Class Ie are required for Class II in equivalence trials. If any one of the three are missing, the class is automatically downgraded to Class III.

Table 2. Levels of evidence. A. Established as effective, ineffective or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population (Level A rating requires at least two consistent Class I studies)*. B.

Probably effective, ineffective or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population (Level B rating requires at least one Class I study or two consistent Class II studies).

C. Possibly effective, ineffective or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population (Level C rating requires at least one Class II study or two consistent Class III studies). U. Data inadequate or conflicting;given current knowledge, treatment (test, predictor) is unproven. *In exceptional cases, one convincing Class I study may suffice for an “A” recommendation if 1) all criteria are met, 2) the magnitude of effect is large (relative rate improved outcome > 5 and the lower limit of the confidence interval is > 2).

seem to be weaker in VD than AD.8 Studies investigating cognitive performance and physical activity have tended to involve a smaller number of VD patients, yet all showed a reduced risk of dementia.9,10 In post-stroke patients, there is an increased risk for reduced physical activity, predominantly among those with cognitive impairment, especially executive function disorders.11 A meta-analysis revealed lower VD in patients that per-

formed physical activity (odds ratio 0.62 – CI: 0.42-0.92).12 In an observational study in community-dwelling elderly, physical activity proved preventive for the development of VCI in women.13 An Italian prospective study assessing the efficacy of physical activity in reducing the risk of developing AD or VD in elderly individuals found physical activity to be associated to a lower risk of VD, but not of AD.14 A prospective long-term (up to 21 years) follow-up study of 401 community-dwelling older adults, found that taking

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Dement Neuropsychol 2011 December;5(4):275-287

part in cognitive activities, but not in physical activities, was associated to a lower risk of VCI with or without dementia.15 Several controlled trials are underway assessing the effect of physical activity on patients with VCI and AD.16,17 Recommendations  –  Regular physical activity should be recommended to healthy individuals, patients with cerebrovascular disease, and to patients with cognitive decline (Level of evidence B)

Diet and supplements A balanced diet, specifically a Mediterranean diet characterized by high consumption of fruit, vegetables, legumes, grains and unsaturated fatty acids (olive oil);low intake of milk and milk-derived products, meat and saturated fatty acids plus moderate consumption of alcohol, have been associated to a lower risk for dementia as well as reduced conversion of MCI to AD.18-20 The vascular factors can be linked to a Mediterranean diet, but other nonvascular biological mechanisms (oxidative and inflammatory) may be responsible for explaining the complex epidemiological association between a Mediterranean diet and cognitive decline.21 In a population-based cohort study, high adherence to a Mediterranean diet was associated, during follow up, with lower decline in scores on the Mini-Mental State Exam, although this did not translate to a similarly reduced risk for dementia. Differences can occur depending on the study venue and on previous diet, whereby the cited study was run in France, whilst the others were done in North America.22 Randomized trials have failed to show any effect of food supplementation with various substances on cognitive decline prevention. Substances supplemented have included omega 3;23,24 vitamin C, E and beta carotene,25 vitamin B12, folic acid and vitamin B6.26 Recommendations  –  Adapting the diet and effecting changes in eating habits are important by promoting consumption of healthy foods predominantly vegetables, unsaturated fatty acids, grains and fish (Level of evidence B).

Alcohol The majority of studies on alcohol and cognition have shown that consumption of low amounts of alcohol has a preventive effect on the development of VD, AD and other types of dementia.27 There is compelling evidence that consumption of alcohol in moderation is associated to a lower risk of coronary diseases, ischemic strokes and dementia. The underlying

278     Vascular dementia: treatment     Brucki SMD, et al.

protective mechanisms involved include reduced LDL and increased HDL;decreased resistance to insulin; lowering of blood pressure; reduced platelet aggregation and fibrinogen levels and lower serum homocysteine and inflammatory markers. In addition, anti-amyloidogenic activity promoted by resveratrol (present in red wine) also seems to occur.28-35 Although studies show a positive correlation between alcohol consumption and dementia prevention, with some benefit associated to wine consumption, there is a deleterious effect of alcohol when consumed at high doses. The consumption of two daily drinks (

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