The objective of this study was to evaluate efficacy and safety of low-dose risperidone for treating psychosis of Alzheimer disease (AD).
The authors conducted a randomized, eight-week, double-blind, placebo-controlled, multicenter trial involving nursing home residents diagnosed with AD and psychosis. Four hundred seventy-three patients were randomly assigned to placebo (N = 238) or 1.0 to 1.5 mg risperidone per day (N = 235). Coprimary efficacy end points were: changes in scores on the Behavioral pathology in Alzheimer's Disease (BEHAVE-AD) Psychosis subscale and Clinical Global Impression of Change (CGI-C). Protocol-specified subgroup analyses were performed by demographics and dementia severity.
Efficacy analysis included 416 patients. Both groups improved significantly on the BEHAVE-AD Psychosis subscale and CGI-C with no significant difference between groups. In the subgroups analyses, a statistically significant treatment by Mini-Mental Status Examination (MMSE) interaction on the CGI-C (F([2,381]) = 3.90, p = 0.021) was observed with patients with more severe dementia (MMSE <10) showing significant differences at end point favoring risperidone treatment (chi(2) () = 5.11, p = 0.024). Mean risperidone dose was 1.03 +/- 0.24 mg per day. All-cause discontinuation rates were 25% for both risperidone and placebo. Treatment-emergent adverse events occurred in 74% risperidone versus 64% placebo patients, with somnolence occurring significantly more frequently with risperidone (16.2% versus 4.6%). Nine (3.8%) risperidone- and six (2.5%) placebo patients died during or within 30 days after treatment.
This trial did not confirm earlier findings in this population.
"The median trial duration was 56 days (range = 1–90 days). A variety of outcome measures were reported in studies including composite measures of NPS (Barnes et al., 1982; Cantillon et al., 1996; Tariot et al., 1998; 2001; 2005; 2006; De Deyn et al., 1999; 2004; Katz et al., 1999; Street et al., 2000; Porsteinsson et al., 2001; Fontaine et al., 2003; Peskind et al., 2005; Gehrman et al., 2009; Sommer et al., 2009; Wang et al., 2009), agitation (Gaber et al., 2001; Ballard et al., 2005; Verhey et al., 2006; Holmes et al., 2007; Zhong et al., 2007; Rappaport et al., 2009,), aggression (Kyomen et al., 1999; Brodaty et al., 2003; Hall et al., 2005; Huertas et al., 2007), or psychosis (Mintzer et al., 2006; 2007; Streim et al., 2008). "
[Show abstract][Hide abstract] ABSTRACT: Background: Medications are frequently prescribed for neuropsychiatric symptoms (NPS) associated with dementia, although information on the efficacy and safety of medications for NPS specifically in long-term care (LTC) settings is limited. The objective of this study was to provide a current review of the efficacy and safety of pharmacological treatments for NPS in LTC.
Methods: We searched MEDLINE, EMBASE, PsychINFO, and the Cochrane Library for randomized controlled trials comparing medications with either placebo or other interventions in LTC. Study quality was described using the Cochrane collaboration risk of bias tool. The efficacy of medications was evaluated using NPS symptom rating scales. Safety was evaluated through rates of trial withdrawals, trial withdrawals due to adverse events, and mortality.
Results: A total of 29 studies met inclusion criteria. The most common medications evaluated in studies were atypical antipsychotics (N = 15), typical antipsychotics (N = 7), anticonvulsants (N = 4), and cholinesterase inhibitors (N = 3). Statistically significant improvements in NPS were noted in some studies evaluating risperidone, olanzapine, and single studies of aripiprazole, carbamazepine, estrogen, cyproterone, propranolol, and prazosin. Study quality was difficult to rate in many cases due to incomplete reporting of details. Some studies reported higher rates of trial withdrawals, adverse events, and mortality associated with medications.
Conclusions: We conclude that there is limited evidence to support the use of some atypical antipsychotics and other medications for NPS in LTC populations. However, the generally modest efficacy and risks of adverse events highlight the need for the development of safe and effective pharmacological and non-pharmacological interventions for this population.
International Psychogeriatrics 10/2012; 25(2):1-19. DOI:10.1017/S1041610212001627 · 1.93 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Neuropsychiatric features of dementia are a common and significant burden on patients and their carers. Management usually involves a combination of pharmacological and non-pharmacological approaches. Antipsychotics are the cornerstone of treatment; among the atypical antipsychotics, risperidone is the most studied. Several trials have confirmed the efficacy of risperidone in the treatment of neuropsychiatric features in dementia, especially for agitation and psychosis. Recent concerns over an increased cerebrovascular adverse event profile and overall mortality with use of antipsychotics have emphasised the need for a risk-benefit analysis for individual demented patients being treated for neuropsychiatric features of their disease.
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