Objective: To determine the efficacy of risperidone versus placebo in the treatment of BPSD in elderly nursing-home residents with different diagnosis and severity of dementia.
Design: Pooled data from three, 12-week, randomized, controlled clinical trials including 1150 elderly patients with BPSD. The mean risperidone dose in this patient population was 1.0 mg/day.
Materials and Methods: 76%, 14% and 10% of patients were diagnosed, respectively, with Alzheimer’s Disease (AD), vascular dementia (VD) or mixed dementia (MD), as defined by DSM-IV. For the severity analysis, patients were dichotomized at baseline, on the basis of a MMSE score of £5 (49.3% and 49.8% of patients receiving placebo and risperidone) or a MMSE score of >5 (50.7% and 50.2%, respectively). BPSD were evaluated from baseline to endpoint using the Behavioral Pathology in Alzheimer’s Disease (BEHAVE-AD) total score and the Cohen-Mansfield Agitation Inventory (CMAI) total and total aggression scores.
Results: Patients diagnosed with AD and VD and receiving risperidone demonstrated a significantly greater improvement compared with placebo on BEHAVE-AD total (AD: mean change from baseline: -6.3 (SE: 0.4) vs. -3.9(0.5); p<0.001 and VD: -5.5(0.7) vs. -3.2(0.9); p=0.02), CMAI total (AD: -12.4(0.9) vs. -6.8(1.3); p<0.001 and VD: -9.8(1.6) vs. -5.4(2.3); p=0.019) and CMAI total aggression (AD: -5.1(0.5) vs. -2.2(0.7); p<0.001 and VD: -4.4(0.9) vs. -1.2(1.3); p=0.003). No significant difference between treatment groups was observed in patients diagnosed with MD (BEHAVE-AD total: -5.3(1.2) vs. -2.7(1.3); p=0.08, CMAI total: -11.6(2.6) vs. -5.8(3.3); p=0.36 and CMAI total aggression: -5.4(1.3) vs. -0.8(1.7); p=0.08), which was probably due to the small sample size (N=46 and N=77, respectively). There is no indication that the difference between risperidone and placebo varies with diagnoses (p>0.50 for all scales). Except for CMAI total aggression (p=0.68), a trial by MMSE interaction was observed,indicated by a significant effect on BEHAVE-AD (p=0.02) and CMAI total (p=0.003). However, the differences between the trials were consistent within each trial but varied in magnitude. Independent of severity of dementia, risperidone-treated patients demonstrated a greater improvement compared with placebo on BEHAVE-AD total (MMSE£5: -6.0(0.5) vs. -3.1(0.6); p<0.001, MMSE>5: -6.3(0.5) vs. -4.0(0.6); p=0.004), CMAI total (MMSE£5: -13.1(1.2) vs. -4.9(1.6); p<0.001, MMSE>5: -11.0(1.0) vs. -7.3(1.5); p=0.004) and CMAI total aggression scores, (MMSE£5: -6.6(0.7) vs. -1.6(0.5); p<0.001, MMSE>5: -3.8(0.5) vs. -1.7(0.8); p<0.001). Overall, there is no difference that the effect size between risperidone and placebo varies with severity of dementia (BEHAVE-AD total: p=0.92, CMAI total: p=0.11). There is, however, an interaction between severity and CMAI total aggression (p<0.05).
Conclusion: In elderly nursing-home residents with dementia,low-dose risperidone is effective in reducing BPSD independent of the type and severity of dementia.
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