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experts comment on study suggesting Alzheimer’s drugs double the risk of death, to be published in Lancet Neurology

Researchers at Kings College London found an elevated risk of premature death among Alzheimer’s patients given anti-psychotic drugs to control their symptoms.

Prof Clive Ballard, Wolfson Centre for Age-Related Diseases, King’s College London and Director of Research at the Alzheimer’s Society, said:

“The study clearly highlights the serious risks associated with the long term use of antipsychotics in people with Alzheimer’s disease. It is essential to reduce the widespread long term prescription of these drugs by using more non-drug treatments such as psychological therapies, and more research is urgently needed to establish more effective and safer drug treatments.”

Prof Ballard is lead author on the paper.

Dr Mark Baxter, Senior Research Fellow, University of Oxford, said:

“Antipsychotic drugs can be effective in controlling unpleasant and disturbing behavioural symptoms of Alzheimer’s disease, including severe aggression, delusions, and agitation. But this study shows, conclusively, that these drugs have a severe and serious cost in terms of increased mortality. The study follows the gold-standard double-blind, placebo-controlled method for clinical trials, and is unique in examining long-term effects of antipsychotic treatment on mortality in patients with Alzheimer’s disease.

“Antipsychotics do not have any effects on the underlying disease processes of Alzheimer’s disease. What is needed is not only an increased application of non-drug methods to improve behavioural health in patients with dementia — including cognitive-behavioural therapy and environmental design — as well as a better understanding of how Alzheimer’s neuropathology causes behavioural disturbances in addition to its effects on memory, so that rational drug therapies can be developed that do not have the liabilities of currently-available antipsychotics.”

Prof David Nutt, Head of Psychopharmacology at the School of Medical Sciences, University of Bristol, said:

“This confirms the earlier descriptive studies. It means that the use of anti-psychotics should be confined to patients for whom other approaches have not been successful and for as short a period as possible.”

Neil Hunt, Chief Executive of Alzheimer’s Society, said:

“This distressing new evidence highlights the desperate need to stop people with dementia being over-prescribed antipsychotics. These drugs also triple risk of stroke, heavily sedate and accelerate cognitive decline in people with dementia.

“Too often these dangerous drugs are used as a substitute for good quality dementia care. Alzheimer’s Society research shows that specialist dementia training for care staff can reduce antipsychotic use by 50%. The forthcoming National Dementia Strategy must seize the opportunity and ensure antipsychotic are always a last resort.”

Prof Peter Roberts, Professor of Pharmacology at the School of Medical Sciences, University of Bristol, said:

“The reported increased risk of death associated with atypical antipsychotic drugs (e.g. clozapine, olanzepine, risperidone) was first announced in a meta-analysis paper in 2005 (JAMA, vol. 294, no. 15, October 2005). The FDA subsequently required these drugs to carry its strongest “black box” warning on its labels regarding dementia patients. Subsequent evidence has shown that older antipsychotics also seem to increase the risk of death in dementia patients. This study is not therefore reporting completely new observations. As far as I am aware, the underlying mechanisms are not at all clear.

“The effects reported are clearly profound and should be of considerable concern to clinicians and carers in terms of the application of these drugs. While the enhanced risk of mortality in patients is not a contraindication per se, the use of these drugs SHORT-TERM remains a judgement for informed clinicians, who can way up the pros and cons. Antipsychotics may have a useful role to play in patients who suffer delusions or hallucinations and consequently exhibit agitation and violent behaviours.”

Dr Richard Perry, Consultant Neurologist Imperial College Healthcare, NHS Trust, said:

“Firstly that it is possible to conduct high quality research studies with patients who are living in care facilities and given that around 100,000 people with dementia are routinely prescribed antipsychotics in UK care homes this is a vitally important aspect of dementia care.

“The fact that so many people with dementia have been prescribed antipsychotics and for so long, and it is only now that we are starting to understand the potential downsides to such treatment, highlights the paucity of research into Alzheimer’s disease in this country, not because the expertise does not exist but because of the drastic underfunding of such research.

“This work highlights the pressing need to develop and evaluate alternative pharmacological and non-pharmacological treatments for behavioural symptoms in dementia.”

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