Mortality in elderly dementia patients treated with risperidone

Area of Science:

• Geriatric Medicine
• Psychopharmacology
• Clinical Trials

Background:

• Behavioral and psychological symptoms of dementia (BPSD), including agitation and psychosis, significantly impact patient and caregiver well-being.
• Atypical antipsychotics are commonly used for BPSD, but concerns exist regarding increased mortality.
• A US FDA warning followed a meta-analysis showing increased mortality with atypical antipsychotics in dementia patients.

Purpose of the Study:

• To specifically evaluate the mortality risk associated with risperidone in dementia patients.
• To analyze data from placebo-controlled trials to compare risperidone's safety profile.

Main Methods:

• A meta-analysis of 6 phase-2/3 double-blind trials comparing risperidone and placebo in 1721 dementia patients.
• Calculation of hazard ratios and 95% confidence intervals to assess relative mortality risk.
• Data sourced from Johnson & Johnson Pharmaceutical Research and Development.

Main Results:

• Mortality was 4.0% with risperidone versus 3.1% with placebo (relative risk: 1.21; 95% CI: 0.71-2.06).
• The increase in mortality was not statistically significant.
• Common causes of death included pneumonia, cardiac events, and cerebrovascular disorders; no dose-mortality relationship was observed.

Conclusions:

• This meta-analysis indicates a nonsignificant increase in mortality during risperidone treatment for dementia patients.
• Larger studies are needed to definitively rule out a small mortality risk.
• Prescribing risperidone for BPSD requires careful consideration of potential benefits versus risks.