Objective: In this study we compared the effects of risperidone and melperone on BPSD and other symptoms in patients with dementia.
Design: Naturalistic, open-label prospective multicenter study
Materials and Methods: 302 out-patients with dementia requiring antipsychotic therapy were assigned to either risperidone or melperone. Patients had not received antipsychotics on a regular basis during the last 4 weeks. BPSD, such as social withdrawal, mistrust, aggressiveness, delusions and hallucinations, were rated categorially on five stages (not present=0 to extreme=4) by the treating neurologist or psychiatrist at days 1, 15, 22 and 28. Patients and caregivers were interviewed weekly about symptoms like dizziness, daytime sleep, falls and abnormal gait. At endpoint, caregivers and physicians rated overall treatment effects (1=much improved to 4=worsened). Data were analyzed based on Intention To Treat population (ITT) using the Last Observation Carried Forward method (LOCF). Results were tested for significance (two-sided, a=0.05) using Chi-Square-, Mann-Whitney-U- or Wilcoxon-Test where appropriate.
Results: There were 194 patients in the risperidone group and 108 in the melperone group. Patients were diagnosed with Alzheimer, vascular or mixed dementia. At baseline, there were no significant differences between groups with regard to demographics, vital signs, diagnoses, comorbidity, comedication, severity of cognitive impairment, BPSD, and other symptoms. At day 1, only delusions were more severe in the risperidone group (p=.006). Mean daily doses of risperidone and melperone at endpoint were 1.3 ± 0.7 mg and 60.7 ± 29.1 mg, respectively. Mistrust (p=.003), delusions (p<.001) and hallucinations (p=.007) improved significantly more in the risperidone than in the melperone group. The patients' rating of therapy with risperidone was significantly superior to melperone with regard to reduction of dizziness (p=.008), abnormal gait (p=.046) and daytime sleep (p=.037). Caregivers rated treatment with risperidone significantly superior to melperone in reducing dizziness (p<.001), abnormal gait (p<.001), frequency of falls (p=.027), frequency (p<.001) and duration (p=.005) of daytime sleep. Daytime somnolence was significantly lower in risperidone treated patients (p<.001, at least mild to moderate daytime somnolence at baseline. Adverse events were less frequently reported with risperidone (7.2%) compared to melperone (14.8%, p=.055). There were n=3 falls associated with fractures in the melperone group. Extrapyramidal symptoms did not differ between the two treatment groups. Overall ratings showed that significantly more patients improved with risperidone compared to melperone.
Conclusion: In patients with dementia, risperidone led to a significantly better improvement of BPSD and other symptoms compared to melperone. Therefore, risperidone may be regarded as a drug of choice in these patients.
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