EFFICACY AND SAFETY OF NEUROLEPTICS IN BEHAVIORAL-DISORDERS ASSOCIATED WITH DEMENTIA

Background: Neuroleptics are commonly used to treat behavioral disorde rs associated with dementia. However, their safety and efficacy have n ot been well established in these patients. Method: A meta-analysis of randomized, controlled (either placebo or active drug), double-blind trials published since 1966 (N = 16; 499 treated, 112 active controls, and 123 placebo) was conducted. Data were collected on proportion of patients with clinically significant improvement, significant side eff ects, and dropout rates. Results: Pooled mean percentages of patients who improved (95% CI): all neuroleptics, 64% (54% to 74%); low potency , 63% (54% to 72%); moderate potency, 70% (56% to 85%); moderate-high potency, 62% (49% to 75%); and high potency, 69% (49% to 90%). Thus, n o differences in efficacy existed between different potencies of neuro leptics, Therapeutic effect (neuroleptic minus placebo) was only 26% ( 14% to 38%). Treatment-emergent side effects were more common for neur oleptics vs. placebo (mean difference = 25%, 13% to 37%), but pooled m ean dropout rates were not different (mean difference = 4%, -7% to 14% ). Neither weighting by clinical trial quality (3 raters; weighted agr eement, 83% to 92%) nor exclusion of poor quality trials changed the r esults. Conclusion: Neuroleptics have small but significant efficacy o ver placebo in this population, and the efficacy rate is equivalent to the side effect rate. Comparing different neuroleptics shows they hav e similar efficacy, side effects, and dropout rates. Further study to determine more specific drug-responsive behaviors is needed to maximiz e benefits of these drugs.