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Is there any role for atypical antipsychotics in dementia care?

GPs have been left with a difficult dilemma by last month's Committee on Safety of Medicines ruling that risperidone and olanzapine should not be used to treat behavioural problems in elderly patients with dementia – Dr Andy Barker and Professor Susan Benbow offer advice

How the issue hit the headlines

lLast month the CSM issued a warning that risperidone and olanzapine should not be used to treat behavioural problems in patients with dementia because of a three-fold increase in the risk of stroke

lAround 30,000 patients aged 65 and over were last year prescribed risperidone and 9,000 received olanzapine for the treatment of dementia; the CSM urged GPs to review their treatment within weeks

lThe CSM also said GPs should 'carefully consider' the risk of cerebrovascular events before prescribing the drugs to any patient with a history of stroke or TIA

Up to 75 per cent of care home residents suffer from dementia and concern about potential overprescribing of sedative medication predates the CSM ruling. The CSM advice could have a big effect on clinical practice and it leaves doctors with some difficult dilemmas for which there are no simple solutions.

An uneasy collusion exists between clinicians and care home managers, involving the use of mild sedatives – theoretically to help care staff cope and help distressed agitated people to feel calmer and more content. After excluding exacerbating medical disorders, GPs have normally found it simplest to prescribe one of the newer, better-tolerated antipsychotics, which are regularly used by specialist colleagues.

The scale of the increased stroke risk

The CSM advice that risperidone and olanzapine should not be used to treat behavioural problems in older people with dementia was based on an analysis of four randomised placebo-controlled trials lasting between eight and 12 weeks and involving almost 1,800 patients in total. Although most people had Alzheimer's disease, some had mixed/vascular dementia. Cerebrovascular events, including cerebrovascular accidents and transient ischaemic events, occurred in 34 of 979 patients receiving risperidone, compared with eight out of 685 controls – a three-fold increase.

There was no relation to dose or duration of treatment, and these events occurred irrespective of past history of cerebrovascular disease. The CSM's best estimate was that for every six people treated for a year with risperidone, one would have a treatment-related cerebrovascular event. The risk data was similar for olanzapine.

As a result of the CSM advice, the olanzapine summary of product characteristics has been amended to make clear it is not recommended for dementia-related psychosis, and the risperidone SPC now advises the treatment of acute psychoses in patients with a history of dementia should be limited to short-term use under specialist supervision.

Future management options

Joint guidelines on management of behavioural and psychiatric symptoms in dementia, in the wake of the CSM advice, have been drawn up by an inter-collegiate working group on behalf of the Royal College of Psychiatrists' faculty of old age psychiatry, the RCGP, the British Geriatrics Society and the Alzheimer's Society

Management of older patients already taking olanzapine or risperidone

People with a psychotic illness in the absence of dementia, for example schizophrenia and psychotic depression

l If there is no history of stroke or TIA no change in medication is indicated.

l If there is a history of stroke or TIA, continue on current medication but consider referral for psychiatric review.

People who have dementia and psychosis, for example paranoid delusions

l If there are no current psychotic symptoms, withdraw medication gradually over two to four weeks and review for re-emergence of psychosis. If psychotic symptoms recur, and especially if the patient is distressed by them, treat as below.

l If the person is currently exhibiting psychotic symptoms, switch to an alternative atypical antipsychotic, such as sulpiride (starting at 100mg twice daily to a maximum 300mg twice daily) or amisulpride (starting at 50mg daily to a maximum 200mg daily in divided doses). If symptoms persist refer to the local old age psychiatry service.

People who have dementia and behavioural symptoms, for example agitation, restlessness

l Consider if non-pharmacological care is adequate.

l Withdraw the drug gradually over two to four weeks and review for re-emergence of symptoms.

lIf symptoms recur that are distressing to patient or present risk, follow the guidance below.

Management of newly presenting elderly patients with psychiatric symptoms or behavioural signs associated with dementia

Don't be too ready to prescribe sedative medications

lConsider whether the person might be medically ill: worsened behaviour is often the result of inter-current illness. Check for subtle disorders such as asymptomatic infection, constipation or dehydration.

lDelay prescribing if possible: often people with confusion will have brief periods of saying odd things, or being distressed for no apparent reason. Individual care staff will vary in their tolerance levels and some will request that 'something must be done' rather then trying alternative management strategies. Ask care staff to wait and see if things improve over a few days: explain that medication may cause more problems than it solves, since all medications have potential side-effects.

lConsider if medication is really indicated: it is worthwhile prescribing for the treatment of psychosis, severe emotional distress or

behaviour that is dangerous to the individual or others.

If medication is indicated, be clear what it is you are treating

lIf there may be depression, use an antidepressant.

lIf there is insomnia, use a short-acting hypnotic.

lIf there are sustained delusional beliefs or true hallucinations, use an antipsychotic. The intercollegiate working group stated that on balance newer antipsychotics are still felt to have a favourable side-effect profile compared with older antipsychotics, but in view of the CSM recommendations it is difficult to justify risperidone and olanzapine as first-line drugs.

Review the need for medication regularly

lIt is worth trying to withdraw medication intermittently. Psychiatric symptoms and behavioural signs in dementia are often shortlived. Several randomised controlled trials of drug withdrawal have shown that in approximately two-thirds of people, antipsychotics can be stopped without significant deterioration and often with improvements.

Consider referral in the following cases

lPeople with continuing moderate to severe symptoms despite medication.

lPeople with a history of serious risk to self or others.

lWhere medication withdrawal may prove problematic for other reasons.

Do other atypical antipsychotics carry the same risk?

The mechanism causing the increased risk of stroke is unknown, and it is uncertain how far the findings extrapolate to other drugs. The CSM considered a third atypical antipsychotic, quetiapine, but lacked sufficient RCT data to reach conclusions on this drug, other atypicals and older antipsychotics.

Is it therefore possible that the two restricted medications are safer than alternatives? The General Practice Research Database is currently being examined to try to determine the likelihood of other antipsychotics carrying similar risks.

No medication is licensed for the treatment of psychiatric and behavioural symptoms in dementia, leaving clinicians with little choice than to manage their patients according to their best professional judgment.

Conclusion

The new restrictions on the use of olanzapine and risperidone have the potential to change clinical practice.

This could be a change for the better if it leads to increasing reluctance to prescribe, greater appreciation of the risks of using drugs for behavioural challenges associated with dementia, more frequent review of treatment, and more understanding of the effects of environment and social circumstances on people with dementia.

Perhaps this is an opportunity to improve

the care of this group of highly vulnerable

people.

Andy Barker is consultant in old age psychiatry, Hampshire Partnership NHS Trust

Susan Benbow is consultant in old age psychiatry at Wolverhampton City PCT, professor of mental health and ageing at the University of Wolverhampton and chair of the Royal

College of Psychiatrists faculty of old age psychiatry

Useful websites

Olanzapine:

www.emea.eu.int/pdfs/human/press/pus/085604en.pdf

CSM advice:

www.medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/antipsystroke_9304.htm

Intercollegiate advice:

www.rcpsych.ac.uk/college/faculty/oap/professional/

guidance_summary.htm

Alzheimers Society information for people with dementia and their carers:

www.alzheimers.org.uk/Caring_for_someone_with_dementia/

PDF/CMSInfo1_neurolepticsrestrictions.pdf

Alzheimers Society information for care staff:

www.alzheimers.org.uk/Working_with_people_with_dementia/

PDF/CSMInfo2_neurolepticrestrictions.pdf

A GP's view

Review your patients urgently

GPs need to react quickly to the

CSM warning on risperidone and olanzapine, says Dr Chris Dunstan

The recent CSM advice about the use of atypical antipsychotics in patients with dementia means GPs will need to review the medication of such patients with some urgency.

We have become used to carrying out medication reviews, especially for older people, so the mechanisms for dealing with this latest advice are well established in most practices.

The issue for GPs is what alternative strategies or medications can be used in patients with dementia and behavioural symptoms.

We must start with assessment of the 'problem' and advice about this is spelt out in the Royal College of Psychiatrists' guidance.

To whom is it a problem and why? What risks are associated with it? To what extent might improved carer-interactions lessen the difficulty?

Care home staff are not the only group who may need advice from GPs to avoid over-reliance on drugs – family carers will need support too.

To provide this support GPs must work with community mental health teams for older people to take advantage of the full range of professional skills.

As for drug treatment, the inter-collegiate guidance stresses that any drug used should be started at the lowest dose possible, monitored regularly, aimed at short-term use and for the treatment of severe psychosis, severe emotional distress or behaviour that is

dangerous.

As a practice, we will certainly be following this advice and using the drugs recommended.

Chris Dunstan is a GP in West Byfleet,

Surrey, and was a member of the external

reference group for the national service

framework for older people

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