Seeking to identify the underlying causative factors for the symptoms in a given individual should be the first step in management. Schneider LS, Dagerman K, Insel PS. Buhr GT, Kuchibhatla M, Clipp EC. Despite the lack of an FDA-approved indication, the largest number of atypical antipsychotic prescriptions in older adults are for behavioral disturbances in persons with dementia (Weiss et al., 2000). Introduction. (6) Studies of mechanism of action for antipsychotic effects on cardio/cerebrovascular systems. Journal of Neurology, Neurosurgery and Psychiatry. (1) Patient-level meta-analyses of existing data from clinical trials so as to identify predictors of efficacy as well as factors related to increased risk of CVAEs and death in subpopulations of patients and with specific aspects of treatment (e.g., lower vs. higher doses). Accessibility We used the following search terms combined with dementia and limited to clinical trials: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, tricyclic, bupropion, duloxetine, mirtazapine, moclobemide, nefazodone, reboxetine, trazodone, venlafaxine, carbamazepine, divalproex, gabapentin, lamotrigine, phenytoin, topirimate, valproic acid, lithium, benzodiazepine, alprazolam, clonazepam, diazepam, lorazepam, oxazepam, buspirone, donepezil, galantamine, rivastigmine, tacrine, memantine, propranolol, and estrogen. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. As with CVAEs, several mechanisms may be postulated for antipsychotic-associated deaths, although they are all speculative. Good clinical care, independently from pharmacotherapy, may be helpful for patients with dementia-related psychosis and/or agitation, and their caregivers, through nonspecific and specific interventions. Atypical antipsychotic drugs and risk of ischaemic stroke: population based retrospective cohort study. Jeste DV, Lacro JP, Bailey A, Rockwell E, Harris MJ, Caliguiri MP. Rosen J, Zubenko GS. Additional medical evaluations may be needed for patients with specific risk factors. Among US adults over age 65, prevalence estimates of dementia range from 5% to 15%, with Alzheimer Disease (AD) being the most common type of dementia (Kaplan and Sadock, 1998; Evans et al., 1989; Losonczy et al., 1998). Only severe symptoms that are persistent or recurrent and cause clinically significant functional disruption would generally be considered appropriate for ongoing pharamcologic management. Pharmacologic treatment of psychosis and agitation in elderly patients with dementia: Four decades of experience. Street JS, Clark WS, Gannon KS, Cummings JL, Bymaster FP, Tamura RN, et al. Neither atypical nor conventional antipsychotics increase mortality or hospital admissions among elderly patients with dementia: a two-year prospective study. However, unlabeled (or off-label) use of pharmacotherapy, especially antipsychotics, is common practice. The appropriate starting dose of an antipsychotic in older individuals is 25% of the usual adult dose; total daily maintenance doses ranges from 25-50% of the adult dose. In the United States of America (USA), analysis by the federal based Centers for Medicare and Medicaid Services (CMS) databases of over 75,000 patients aged65 from 2001-2005 in nursing homes showed a direct dose-response relationship for all-cause mortality with all . (1990) demonstrated that behavioral disturbances in general (relative risk 1.5, 95% CI 1.02.5), and wandering combined with falls in particular (relative risk 3.1, 95% CI 1.46.6) were associated with decreased survival over 6+ years of follow-up, although on multivariate analysis these relative risks failed to reach significance. Such information should be tailored to the educational/intellectual level of the recipient, and also respect the individual's desire for autonomy in medical decisions. Sink KM, Holden KF, Yaffe K. Pharmacological treatment of neuropsychiatric symptoms of dementia: A review of the evidence. Tariot PN, Schneider L, Katz IR, Mintzer JE, Street J, Copnehaver M, et al. Cohen-Mansfield J. Nonpharmacologic interventions for inappropriate behaviors in dementia: A review and critique. (10) Investigations with a focus on delaying or preventing the emergence of psychosis and agitation in persons with dementia. Additionally, assessments of adverse outcomes in many such trials were not as systematically conducted as in pharmaceutical trials. As such, specifically targeted pharmacotherapies for psychosis and agitation in dementia are unavailable; current treatments are primarily an extrapolation of treatments for related but somewhat different syndromes (e.g., schizophrenia). Reducing antipsychotic drug use in nursing homes. In a meta-analysis of large-scale RCTs of atypical antipsychotics in dementia, the NNT ranged from 5 to 14, depending on the outcome measure, the criterion for improvement, and methodology used (2006a). Walsh et al. Lanctot KL, Herrmann N, van Reekum R, Eryavec G, Naranjo CA. Risk of death associated with the use of conventional versus atypical antipsychotic drugs among elderly patients. That increased risk of . Some evidence suggests that agitation and/or psychosis in dementia might be associated with increased mortality, though this finding has been inconsistent. Livingston G, Johnston K, Katona C, Paton J, Lyketsos CG. Nonspecific therapeutic factors such as improved attention and care for patients enrolled in clinical trials likely account for a substantial portion of this improvement. Atypical antipsychotics and glucose dysregulation: A systematic review. In the five olanzapine trials, the relative risk of CVAEs was 1.8 (95% CI 0.5, 6.3), which was not statistically significant (p = 0.36). light therapy, electroconvulsive therapy, transcranial magnetic stimulation). Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. It is important to identify target signs and symptoms, and to establish a time frame in which to expect and evaluate an intervention's effectiveness and in which to decide on continuing or altering treatment. Hypotheses could include: orthostatic hypotension (1-receptor blockade); tachycardia (1- and M2-receptor blockade); metabolic derangements due to atypical antipsychotics such as insulin resistance, weight gain, dyslipidemia (possibly due to H1-, M3-, 5HT2-receptor blockade); sedation (e.g. Global prevalence of dementia: a Delphi consensus study. Comparison of citalopram, perphenazine, and placebo for the acute treatment of psychosis and behavioral disturbances in hospitalized, demented patients. Importance: Antipsychotic medications are associated with increased mortality in older adults with dementia, yet their absolute effect on risk relative to no treatment or an alternative psychotropic is unclear. Risperidone (0.5-2.0 mg/day) was first line followed by quetiapine (50-150 mg/day) and olanzapine (5.0-7.5 mg/day) as high second-line options. Several recent reviews have summarized the relative strengths and weaknesses of scales designed to measure such outcomes in studies of dementia (Rockwood, 2007; Ready and Ott, 2003; De Deyn and Wirshing, 2001). Predictors of mortality in patients diagnosed with probable Alzheimer's disease. Comorbidity of psychopathological domains in community-dwelling persons with Alzheimer's Disease. Prevalence of Alzheimer's disease in a community population of older persons: Higher than previously reported. Risk of death in elderly users of conventional vs. atypical antipsychotic medications. Katz IR, Jeste DV, Mintzer JE, Clyde C, Napolitano J, Brecher M. Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: A randomized, double-blind trail. The following is a summary of what is known and what is not regarding the use of antipsychotic drugs in dementia-associated psychosis and agitation, based largely on the literature discussed above. Livingston and colleagues (2005) recently reviewed psychosocial treatment trials for neurospychiatric symptoms of dementia and noted several promising treatments (e.g. Objective: To determine the absolute mortality risk increase and number needed to harm (NNH) (ie, number of patients who receive treatment that would be associated with 1 death) of . Combining data from three published placebo-controlled RCTs of risperidone with those from three unpublished trials, Janssen reported the rates of risperidone- versus placebo-associated serious CVAEs were not significantly different (15/1009=1.5% for risperidone vs. 4/712=0.6% for placebo, p=0.27). De Deyn P, Rabheru K, Rasmussen A, Bocksberger JP, Dautzenberg PLJ, Eriksson S, et al. Yet, most trials of psychosis did not exclude agitation, and vice versa, resulting in many trials including persons with elevated symptom scores for both psychosis and agitation (Schneider et al., 2006a). Although the design of CATIE-AD might have led to elevated rates of treatment discontinuation (e.g., through relatively quick decisions to stop therapy and move on to phase 2 of the study), this may also reflect real-world clinical decision-making as it was more of an effectiveness than an efficacy study. 4 Potential harms anticipated with use of these medications include known adverse effects such as metabolic changes and . Hallucinations, cognitive decline, and death in Alzheimer's disease. Evans DA, Funkenstein H, Albert MS, Scherr PA, Cook NR, Chown MJ, et al. The trials used a variety of outcome measures, and when primary outcomes measures were reported, they often represented a global measure of neuropsychiatric symptoms. Schneeweiss S, Setoguchi S, Brookhart A, Dormuth C, Wang PS. The efficacy and safety of pharmacological and psychosocial/behavioral treatment alternatives to antipsychotics for managing patients with dementia complicated by psychosis and/or agitation remain unclear. Yet, these patients had relatively modest levels of behavioral symptoms. Lonergan E, Luxenberg J, Colford J. Haloperidol for agitation in dementia. Trinh NH, Hoblyn J, Mohanty S, Yaffe K. Efficacy of cholinesterase inhibitors in the treatment of neuropsychiatric symptoms and functional impairment in Alzheimer disease: a meta-analysis. Similarly, Ayalon and colleagues (2006) recently published a systematic review of nonpharmacological treatments for neuropsychiatric symptoms of dementia, and using strict inclusion criteria suggested by the American Psychological Association, found only three RCTs that met these criteria. Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli m, et al. Testad I, Aasland AM, Aarsland D. Prevalence and correlates of disruptive behavior in patients in Norwegian nursing homes. Treatment approaches should, therefore, be frequently reassessed. Nonetheless, there is some limited evidence that certain psychosocial interventions can be successfully implemented. Combining data from all the 3 published large-scale double-blind placebo-controlled trials of risperidone, (De Deyn et al., 1999; Katz et al., 1999; Brodaty et al., 2003) 12 out of 744 patients on risperidone compared to 4 out of 562 on placebo developed serious cerebrovascular events. (2) Establishing clinically significant treatment outcomes and goals from the perspectives of patients and caregiverse.g. Clinicians, patients, and caregivers are left with unclear choices of treatment for dementia patients with psychosis and/or severe agitation. However, serious consequences are generally associated with persistent or severe psychosis and agitation in persons with dementia that may make non-specific treatment impractical and even dangerous in certain cases. These drugs are not approved for the treatment of patients with dementia-related psychosis.. A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia. Samson WN, van Duijin CM, Hop WC, Hofman A. Not always. However, there have been only four RCTs comparing these two classes of antipsychotics in persons with dementia: three comparing risperidone with haloperidol (Chan et al., 2001; De Deyn et al., 1999; Suh et al., 2004), and one comparing quetiapine and haloperidol (Tariot et al., 2006). Tariot P, Erb R, Podgorski CA, Cox C, Patel S, Jakimovich L, et al. Quetiapine (100-300 mg/day), olanzapine (7.5-15 mg/day), and aripiprazole (15-30 mg . Atypical antipsychotics demonstrated significantly lower risks of motor side effects and somewhat better overall tolerability compared to the typical agents (Glazer, 2000; Jeste et al., 1999a; Ritsner et al., 2004; Stanniland and Taylor, 2000). Several factors contribute to this dearth of clinical trials in older adults e.g., pharmaceutical companies tend to shy away from studying older adults because of their increased medical comorbidity, polypharmacy, cognitive deficits, and a greater risk for most side effects (Roose and Sackeim, 2002; Ownby, 2001; Schneider et al., 2003). There have been no large-scale published studies of antipsychotic-associated diabetes, obesity, and dyslipidemia among elderly dementia patients. However, based primarily on studies conducted in younger adult populations, the newer agents eventually proved to have their own liabilities, mainly in terms of metabolic side effects (e.g. Review the current studies evaluating the use of atypical antipsychotics in older adults with various dementias and implementing treatment strategies to optimize atypical antipsychotic therapy. It is true there would be obstacles to widespread implementation of even evidence-based psychosocial and psychotherapeutic treatments, including a lack of financial resources, the increased training and time necessary to implement them, and a lack of reimbursement for providing them. (2005) in a retrospective cohort study reported that, after adjustment for potential confounders, participants receiving atypical antipsychotics showed no significant increase in the risk of ischemic stroke compared with those receiving typical antipsychotics (adjusted hazard ratio 1.0, 95% CI 0.8, 1.3). The same is true regarding possible mediators/moderators of therapeutic effects. Elderly people show variable responses and increased sensitivity to medications in general (Reference Avron, Gurwitz, Cassel, Reisenberg and Sorenson Avron & Gurwitz, 1990) and to antipsychotics in particular.Age-related bodily changes affect the pharmacokinetics and pharmacodynamics of anti-psychotic drugs, which have numerous side-effects that can be . Alzheimer Disease and Associated Disorders. Zuidema SU, Derksen E, Verhey FR, Koopmans RT. Placebo-controlled study of divalproex sodium for agitation in dementia. Finkel SI, Mintzer JE, Dysken M, Krishnan KRR, Burt T, McRae T. A randomized, placebo-controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer's disease in outpatients treated with donepezil. In addition, studies have called into question the degree to which atypical antipsychotics (excluding clozapine) represent a significant advance in therapeutic effectiveness compared to the typical agents in schizophrenia (Lieberman et al., 2005; Jones et al., 2006). Ownby RL. Conventional versus newer antipsychotics in elderly patients. Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials. Nasrallah HA, White T, Nasrallah AT. The overall average treatment effect was about 18%, a figure remarkably similar to that found in a meta-analysis of studies of conventional antipsychotics in this population (Schneider et al., 1990). Holmes C, Wilkinson D, Dean C, Vethanayagam S, Olivieri S, Langley A, et al. These risks in addition to acute and subacute adverse effects such as excessive sedation, postural hypotension, and falls should be taken into account when considering treatment. Lyketsos CG, Steinberg M, Tschanz JT, Norton MC, Steffens DC, Breitner JC. In placebo-controlled trials, there was a significantly higher incidence of CVAEs in patients treated with risperidone compared to those treated with placebo. This may include medication tapering or discontinuation in patients who have symptomatic remission. A controlled trial of provider education. Nonspecific interventions such as empathy and attention to interpersonal and social issues may be particularly helpful, as evidenced in several studies and by the improvements in the placebo groups in nearly all clinical trials. Before Federal government websites often end in .gov or .mil. Jones PB, Barnes TR, Davies L, Dunn G, Lloyd H, Hayhurst KP, et al. (2006a) reviewed 15 RCTs of atypical antipsychotics for agitation and/or psychosis of dementia that pre-dated the CATIE-AD trial (3 with aripiprazole, 4 with olanzapine, 4 with risperidone, 1 comparing olanzapine and risperidone, and 3 with quetiapine). The incidence of mortality is significantly higher with atypical antipsychotics as a group (and that of CVAEs with several agents in this class) than with placebo in patients with dementia, based on large-scale RCTs. Rates of physical aggression among community-dwelling dementia patients range from 11% to 46%, whereas rates from institutional settings range from 31% to 42% (Brodaty and Low, 2003). Pollock BG, Mulsant BH, Rosen J, Sweet RA, Mazumdar S, Bharucha A, et al. This leaves open a possibility that adverse effects might not have been adequately evaluated and reported. b) The category of serious CVAEs was broad and not operationally defined while designing the trials. A prospective trial of donepezil for neuropsychiatric symptoms in outpatients with mild-moderate AD showed improvement in global neuropsychiatric symptoms during open-label treatment for 3 months, followed by symptomatic worsening only in placebo-treated patients during the subsequent randomized discontinuation phase of the trial (Holmes et al., 2004). Roose SP, Sackeim HA. Hermann N, Rabheru K, Wang J, Binder C. Galantamine treatment of problematic behavior in Alzheimer disease: post-hoc analysis of pooled data from three large trials. Ritsner M, Gibel A, Perelroyzen G, Kurs R, Jabarin M, Ratner Y. The site is secure. Jeste DV, Finkel SI. Cummings JL. 1. The clinician should regularly monitor relevant adverse effects of antipsychotics, including EPS, tardive dyskinesia, blood pressure, body weight, and blood glucose and lipid levels. Am J Geriatr Psychiatry 15 : 416-424. 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Mj, Caliguiri MP approaches should, therefore, be frequently reassessed Erb! The evidence Setoguchi S, Brookhart A, et al A randomized controlled trial, Patel S Olivieri... Study of divalproex sodium for agitation in elderly users of conventional vs. atypical antipsychotic medications not operationally while... Colford J. Haloperidol for agitation in dementia Cook NR, Chown MJ Caliguiri! Livingston G, Johnston K, Katona C, Brodaty H, Hayhurst,. Of randomized, placebo-controlled trials deaths, although they are all speculative population of older persons: than... Increase mortality or hospital admissions among elderly patients with specific risk factors, Rosen J, J....
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