The EMEA has reported that, as with newer (atypical) antipsychotics, conventional (typical) antipsychotics are likely to be associated with increased mortality when used in elderly people with dementia.
Prescribers should continue to follow the NICE-SCIE guideline on dementia and avoid using any antipsychotics (atypical or conventional) for non-cognitive symptoms or challenging behaviour of dementia unless the patient is severely distressed or there is an immediate risk of harm to them or others. Any use of antipsychotics should include a full discussion with the patient and/or carers about the possible benefits and risks of treatment.
Safety concerns over the use of both typical and atypical antipsychotics in elderly patients with dementia have been well documented. In 2004, the Committee on Safety of Medicines (CSM) advised that the atypical antipsychotics, olanzapine and risperidone, should not be used for treatment of behavioural symptoms of dementia due to evidence of an increased risk of stroke in elderly patients with such symptoms. Other more recent evidence has emerged suggesting that all antipsychotics, regardless of their type, are associated with an increased risk of serious adverse reactions (see previous MeReC Rapid Review blogs here and here).
What was this report about?
The EMEA opinion was based on a CHMP review of the safety of conventional (typical) antipsychotics in elderly patients with dementia and concluded that, as with atypical antipsychotics, they are likely to be associated with increased mortality when used in such patients. From the evidence available, it was not possible to confirm whether the risk differs between individual conventional antipsychotics and a class effect cannot be excluded. Also, although some studies suggested that this excess mortality might be greater than that seen with atypical antipsychotics, this could not be confirmed because of methodological limitations of the studies. The mechanism of this increased mortality is unclear. As a result, the EMEA have recommended that the product information for the conventional antipsychotics is updated to include information on the increased risk of mortality when used in elderly patients with dementia. Further information on the 12 studies that were included in this review is available from the full CHMP assessment report.
This EMEA report adds to the ever-growing evidence suggesting that all antipsychotics, regardless of their type are associated with an increased risk of serious adverse reactions. It seems prudent to continue to follow NICE-SCIE guidance on dementia and only use antipsychotics in exceptional circumstances in such patients (see below). As we reported in a MeReC Stop Press blog, a Department of Health review of antipsychotic prescribing is being conducted as part of the National Dementia Strategy to investigate and suggest actions to reduce the inappropriate prescribing of antipsychotics to people with dementia. The review is due for publication shortly.
The NICE-SCIE guideline on dementia recommends that people with dementia who develop non-cognitive symptoms or behaviours that challenge should only be offered a pharmacological intervention in the first instance if they are severely distressed or there is an immediate risk of harm to the person or others. Antipsychotics should only be offered after a full discussion with the patient and/or their carers about the risks and benefits, especially the risk of stroke or transient ischaemic attack (TIA) and possible adverse effects on cognition. The dose of antipsychotic should be low initially and titrated upwards. It should be treatment time-limited and regularly reviewed (every three months or according to need). Antipsychotics should not be prescribed to people with mild-to-moderate dementia with Lewy bodies, as these people are particularly at risk of serious adverse effects.
You can find further information on the treatment of dementia on the CNS and mental health section of NPC