Objective: Previous studies have shown that risperidone is effective in treating behavioral and psychological symptoms of dementia in elderly nursing-home residents. Objective: To assess whether the efficacy of risperidone in treating aggression and agitation in elderly patients with dementia is direct and not secondary to its antipsychotic effect or to sedation.
Materials and Methods: Data from three, 12-week, double-blind, placebo-controlled, clinical trials were pooled (426 placebo, 713 risperidone). The mean risperidone dose in this patient population was 1.0 mg/day. Efficacy was evaluated at baseline and endpoint, using the total aggression subscale scores of the Cohen-Mansfield Agitation Inventory (CMAI). The analyses were performed in psychotic and non-psychotic patients (defined at baseline as a score of ³2 or <2, respectively, on any delusion or hallucination item of the Behavioral Pathology in Alzheimer’s Disease scale). A subanalysis was made comparing patients who reported somnolence as an adverse event with those who did not experience somnolence.
Results: A significantly greater improvement in CMAI total aggression subscale scores was observed from baseline to endpoint for risperidone compared with placebo in both non-psychotic patients [-4.7 ± 0.63 (n = 282) vs. -2.4 ± 0.91 (n = 174), respectively; P<0.001] and psychotic patients [-5.2 ± 0.56 (n = 431) vs. -1.4 ± 0.35 (n = 252), respectively; P<0.001]. There is no indication that the difference between risperidone and placebo varies with psychotic status of the patient (P=0.99). The reductions in the CMAI total aggression subscale scores were also significantly greater for risperidone compared with placebo in patients with somnolence [-6.4 ± 0.82 (n = 161) vs. -3.0 ± 1.44 (n = 59), respectively; P=0.002] and those without somnolence (-4.6 ± 0.49 (n = 552) vs. -1.7 ± 0.66 (n = 367), respectively; P<0.001). There appears to be no indication that the observed difference between risperidone and placebo differs between patients with or without somnolence (P=0.18).
Conclusion: In elderly patients with dementia, risperidone at low doses is effective in reducing symptoms of aggression, and this efficacy appears to be direct and is not secondary to its antipsychotic effect or induction of somnolence.
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