Key result
Amisulpride and risperidone were both well tolerated in elderly patients with schizophrenia, with adverse events occurring in 40% and 38.5% of patients, respectively.
Why the study?
Does amisulpride compared to risperidone improve tolerability and efficacy in elderly patients with schizophrenia?
RCT (n=38)
Double-blind
Parallel group
Does amisulpride compared to risperidone improve tolerability and efficacy in elderly patients with schizophrenia?
Absolute Event Rate: 40% vs 38.5%
Amisulpride and risperidone are both generally well tolerated and efficacious in elderly patients with schizophrenia, though the small sample size limits comparative conclusions.
Either agent may be considered in elderly schizophrenia; extends tolerability data but leaves direct comparisons open due to sample size.
OBJECTIVE: The primary objective of this randomised, active-controlled, parallel group, double-blind study was to evaluate the tolerability of treatment with either amisulpride or risperidone in elderly patients with schizophrenia aged over 65 years; evaluation of efficacy was a secondary objective. METHODS: The study included patients of either sex aged 65 years or older fulfilling DSM IV-diagnostic criteria for psychotic disorders and who presented psychotic symptoms severe enough to require antipsychotic medication. Subjects were randomly allocated to a flexible dose of either amisulpride (100-400mg/day) or risperidone (1-4 mg/day) for six weeks following a three- to six-day placebo wash-out period. Safety assessment involved adverse event reporting, physical examination, blood pressure, heart rate and ECG monitoring, and laboratory tests. Extrapyramidal symptoms were evaluated with the Simpson-Angus Scale, Barnes Akathisia Scale and the AIMS. Efficacy parameters were changes in score on the PANSS, BPRS, CDS and MMSE scores. RESULTS: Thirty-eight patients were randomised, 25 to amisulpride and 13 to risperidone. A total of 26 adverse events were experienced by 10 patients in the amisulpride group and five patients in the risperidone group. One patient in each group discontinued the study due to the emergence of a movement disorder. Changes in scores on the three measures of extrapyramidal symptoms were similar in the two groups. The PANSS total score decreased by 27.8% in the amisulpride group and by 29% in the risperidone group between inclusion and study end. CONCLUSION: Amisulpride and risperidone are generally well tolerated in elderly patients with schizophrenia. Both drugs appeared to be efficacious in this study population, with no differences in efficacy being observed. However, the sample size was too low to reveal potential inter-group differences. Both these atypical antipsychotics thus appear to be suitable for the treatment of schizophrenia in the elderly.
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Riedel et al. (2008) conducted an RCT in Schizophrenia / Psychotic disorders (n=38). Amisulpride vs. Risperidone (1-4 mg/day) was evaluated on Tolerability (adverse events). Amisulpride and risperidone were both well tolerated in elderly patients with schizophrenia, with adverse events occurring in 40% and 38.5% of patients, respectively.
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