Risperidone & Stroke Risk in Dementia: UK Study Finds No Safe Group

A recent study of over 165,000 people living with dementia reveals a concerning link between the commonly prescribed antipsychotic drug risperidone and an increased risk of stroke, regardless of a patient’s prior cardiovascular health. Published in the British Journal of Psychiatry, the findings challenge previous assumptions about which dementia patients might be safer candidates for the medication and underscore the need for careful consideration of risks and benefits.

Risperidone is frequently used to manage severe agitation and aggressive behaviors in dementia patients, particularly in care settings where non-pharmacological approaches have proven insufficient. It’s currently the only drug of its kind licensed for this purpose in the UK. But, this large-scale study suggests that even individuals without a history of heart disease or stroke face a heightened risk while taking the medication.

Understanding the Study and Its Findings

Researchers from Brunel University London and other institutions analyzed anonymized health records from the UK’s Clinical Practice Research Datalink, spanning from 2004 to 2023. They compared outcomes for 28,403 dementia patients who initiated risperidone treatment with a matched control group of 136,324 patients who did not receive the drug. The analysis revealed an overall increased risk of stroke among risperidone users (adjusted hazard ratio: 1.28; 95% CI: 1.20-1.37). The study, detailed in the British Journal of Psychiatry, found this elevated risk consistent across all subgroups, including those with and without pre-existing cardiovascular disease (CVD) or a history of stroke.

“We knew Risperidone causes stroke, but we didn’t know whether some groups of people might be more at risk than others,” explained Dr. Byron Creese of Brunel University London. “We thought if we might identify characteristics that make people more at risk, doctors could avoid prescribing to patients with those characteristics.” The consistent risk across groups suggests that identifying such characteristics may be more difficult than previously thought.

What Does This Mean for Patients and Caregivers?

Dementia is often accompanied by agitation, affecting approximately half of all individuals living with the condition. This can cause significant distress for both patients and their caregivers. When behavioral interventions and other non-drug strategies are ineffective, risperidone may be considered as a last resort. However, this study highlights the difficult balancing act clinicians and families face: weighing the potential benefits of calming severe agitation against the risk of a serious adverse event like stroke.

The research team found that among patients with a prior stroke, the annual stroke rate per 1000 person-years was 22.2% for those taking risperidone, compared to 17.7% for those not on the drug. Even in patients with no prior stroke history, the risk was still elevated, with rates of 2.9% for risperidone users versus 2.2% for non-users. Notably, the study as well indicated a higher stroke risk among patients using the medication for shorter durations (12 weeks).

Current Guidance and Monitoring Practices

Risperidone is known to increase stroke risk in older adults generally, but specific guidance for dementia patients has been lacking. Current NHS guidance recommends limiting risperidone treatment to six weeks for severe symptoms. However, in practice, many patients continue the medication for longer periods. Monitoring practices also vary across the country, creating inconsistencies in patient care.

Dr. Creese emphasizes the limited availability of alternative medications. “You’ll see currently no licensed alternative drugs in the UK for treating severe agitation in dementia patients,” he stated. This lack of options underscores the need for doctors to thoroughly explain the risks and benefits of risperidone before prescribing it. The Cambridge University Press article details the study’s methodology and findings.

Beyond Risperidone: A Broader Context of Stroke Risk

It’s vital to remember that individuals with a history of stroke are already at increased risk of experiencing another one. If a stroke occurs in a patient taking risperidone, it may not always be directly attributable to the medication. Doctors typically reserve risperidone for cases where other interventions have failed, acknowledging the inherent risks.

“These findings supply clearer information about who is most at risk, which helps everyone make more informed choices,” Dr. Creese added. “Every decision should be based on what is right for each person, through honest conversations between doctors, patients, and families.”

What’s Next: Refining Guidance and Improving Patient Care

The researchers hope their findings will inform updated clinical guidance that is more person-centered and takes into account individual patient characteristics. A review in the New England Journal of Medicine highlights the importance of this research for clinical practice. Further research is needed to explore alternative treatments for severe agitation in dementia and to develop more effective strategies for monitoring patients on risperidone. The study’s authors suggest a need for more detailed data collection on risperidone employ and stroke incidence to better understand the long-term risks and benefits of the medication. Ongoing surveillance of stroke rates among dementia patients prescribed risperidone will be crucial for evaluating the impact of any changes in clinical practice.

the goal is to ensure that patients with dementia receive the most appropriate and safest care possible, balancing the need to manage distressing symptoms with the potential risks of medication.