A new study sponsored by the UK Alzheimer’s Research Trust concluded that antipsychotic drugs commonly prescribed to Alzheimer’s patients in the UK nearly doubles their risk of death over three years.
The study was led by Professor Clive Ballard of King’s College London and was published in The Lancet Neurology on 9 January.
For the study, Ballard and colleagues recruited 165 residential care home patients with Alzheimer’s disease who were on prescription antipsychotic drugs. 83 of them continued to take the real drugs while 82 continued with placebos.
They found there was a significant increase in the risk of death among the patients who continued to take the antipsychotics compared to the ones who came off them and continued on the placebos. This risk grew with time: patients on the antipsychotics had a 24-month survival rate of 46 per cent compared to 71 per cent for those on the placebos, while the figures for 36 month survival were 30 versus 59 per cent respectively.
In other words less than a third of the patients who continued to take antipsychotics were still alive after three years compared to nearly two thirds of those who took the placebos only.
A report published last year by the MP Paul Burstow suggested that as many as 100,000 residents in care homes in the UK are routinely prescribed antipsychotic drugs. On this basis some 23,500 are dying prematurely, said a statement from the Alzheimer’s Research Trust.
Patients are prescribed antipsychotics to help control symptoms of of agitation, delusions and aggressive behaviour. The UK’s National Institute for Clinical Excellence (NICE) guidelines recommend they are used only for short periods when the symptoms are bad, yet according to a statement from the Alzheimer’s Research Trust, in practice they stay on them for 1 to 2 years on average. The NICE guidelines also state that patients should be monitored when on these drugs.
An earlier study sponsored by the Alzheimer’s Research Trust showed that while there was evidence of “modest” benefit from short term (up to 12 weeks) use of antipsychotics for treating the more serious behavioural symptoms of Alzheimer’s, the benefit disappeared with longer term use.
Ballard said antipsychotics still had a place, although it was small (and perhaps now getting smaller), in the treatment of Alzheimer’s, particularly severe aggression, but these findings show there is an urgent need to find less harmful alternatives.
Chief Executive of the Alzheimer’s Research Trust, Rebecca Wood, said this research was a “real wake-up call” and highlighted the danger of long term use of antipsychotics.
“We must avoid the use of these drugs as a potentially dangerous ‘chemical cosh’ to patients who would be better off without it,” said Wood.
Dr Mark Baxter of the University of Oxford said:
“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.”
He said antipsychotics do the job they were designed for: they are effective at controlling the “unpleasant” and “disturbing” symptoms of Alzheimer’s, but that is not the issue, the issue is their high cost in terms of increased mortality.
“Antipsychotics do not have any effects on the underlying disease processes of Alzheimer’s disease,” said Baxter who called for more use of non-drug methods like cognitive-behavioural therapy and environmental design, as well as better understanding of the neuroscience of Alzheimer’s, so that:
“Rational drug therapies can be developed that do not have the liabilities of currently-available antipsychotics.”
There are about 700,000 people living with dementia in the UK today.
“The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial .”
Clive Ballard, Maria Luisa Hanney, Megan Theodoulou, Simon Douglas, Rupert McShane, Katja Kossakowski, Randeep Gill, Edmund Juszczak, Ly -Mee Yu and Robin Jacoby.
The Lancet Neurology, Early Online Publication, 9 January 2009
doi:10.1016/S1474-4422(08)70295-3
Sources: Alzheimer’s Research Trust.
Written by: Catharine Paddock, PhD