Mortality in elderly dementia patients treated with risperidone.
ABSTRACT Agitation, aggression, and psychosis are among the most troublesome behavioral and psychological symptoms of dementia (BPSD) and impair the lives of dementia patients and their caregivers. Atypical antipsychotics have been widely prescribed to improve these BPSD. However, in a number of trials with atypical antipsychotics, a consistent increase in overall mortality has been observed. The US Food and Drug Administration issued a warning for all atypical antipsychotics as a result of a meta-analysis of 17 placebo-controlled clinical trials using various atypical antipsychotics for the treatment of BSPD. To evaluate this mortality risk specifically for risperidone, 6 phase-2/3 double-blind trials comparing risperidone with placebo were analyzed. Data were obtained from Johnson & Johnson Pharmaceutical Research and Development. Hazard ratios with 95% confidence intervals were calculated to compare the relative mortality risk between patients treated with risperidone and those treated with placebo. In this meta-analysis, 1721 patients were included. In the pooled sample, the mortality was 4.0% with risperidone versus 3.1% with placebo (relative risk, 1.21; 95% confidence interval, 0.71-2.06) during treatment or within 30 days after treatment discontinuation. The most common adverse events associated with death were pneumonia, cardiac failure or arrest, or cerebrovascular disorder. No relationship was found between risperidone dose and mortality. In conclusion, this meta-analysis found a nonsignificant increase in mortality during treatment with risperidone in dementia patients. Larger studies would be needed to rule out a small increase in mortality in these patients. Careful assessments of potential benefits and risks should be made before prescribing risperidone for the treatment of BPSD.
- SourceAvailable from: Esther Mm van de Glind[Show abstract] [Hide abstract]
ABSTRACT: Representation of hospitalized patients with pre-existing cognitive impairment in pharmaceutical delirium trials is important because these patients are at high risk for developing delirium. The aim of this systematic review is to investigate whether patients with cognitive impairment were included in studies on pharmacological prophylaxis or treatment of delirium and to explore the motivations for their exclusion (if they were excluded). This study was a systematic review. A MEDLINE search was performed for publications dated from 1 January 1985 to 15 November 2012. Randomized and non-randomized controlled trials that investigated medication to prevent or treat delirium were included. The number of patients with cognitive impairment was counted, and if they were excluded, motivations were noted. The search yielded 4293 hits, ultimately resulting in 31 studies that met the inclusion criteria. Of these, five studies explicitly mentioned the percentage of patients with cognitive impairment that were included. These patients comprised a total of 8% (n=279 patients) of the 3476 patients included in all 31 studies. Ten studies might have included cognitively impaired patients but did not mention the exact percentage, and sixteen studies excluded all patients with cognitive impairment. The motivations for exclusion varied, but most were related to the influence of dementia on delirium. The exclusion of patients with pre-existing cognitive impairment hampers the generalizability of the results of these trials and leaves clinicians with limited evidence about the pharmacological treatment of this group of vulnerable patients who have an increased risk of side effects.Journal of psychosomatic research 03/2014; 76(3):193-199. DOI:10.1016/j.jpsychores.2013.12.007 · 2.84 Impact Factor
- Essential Notes in Psychiatry, 03/2012; , ISBN: 978-953-51-0574-9
- International Psychogeriatrics 03/2009; 21(4):616-21. DOI:10.1017/S1041610209008485 · 1.89 Impact Factor