Alzheimer's sufferers on antipsychotics have higher death risk
Provided by: Canadian Press
Written by: ANNE-MARIE TOBIN Jun. 4, 2007
TORONTO (CP) - Older adults who suffer dementia and are given antipsychotic drugs have a slightly higher risk of death than those who aren't prescribed these medications, a large Canadian study suggests.
And the older variety of antipsychotics - known as conventional agents - seems to be associated with a higher risk of death than newer atypical antipsychotics, researchers said in the study of Ontario patients, published Tuesday in the journal Annals of Internal Medicine.
The study builds on previous research that led to warnings in the spring of 2005 from Health Canada and the U.S. Food and Drug Administration on atypical antipsychotics and dementia.
Conventional antipsychotic drugs include chlorpromazine (brand names Largactil and Thorazine) and haloperidol (brand name Haldol). Examples of atypical antipsychotics are olanzapine, risperidone and quetiapine (brand names Zyprexa, Risperdal and Seroquel, respectively).
Lead author Dr. Sudeep Gill, a geriatric specialist and adjunct scientist for the Institute for Clinical Evaluative Sciences, said behavioural symptoms in people with dementia can run a full spectrum. Some people have hallucinations and are very suspicious and paranoid, and those symptoms are "well targeted" by antipsychotics.
But sometimes patients with dementia seem agitated and may articulate that they feel restless.
"Paradoxically these drugs may actually worsen that particular symptom," said Gill, an assistant professor of medicine at Queen's University in Kingston, Ont.
He said it's significant that conventional antipsychotics were associated with an even higher mortality risk than atypicals.
After the warnings of two years ago, he noted that some physicians had switched their patients over from the atypical to conventional drugs.
"We were hoping that at a policy level there might be some interest from the drug regulatory agencies, Health Canada, and its comparative agencies in other countries, to look at maybe expanding the warning labels that they apply to atypical antipsychotics to the older conventional antipsychotics," he said.
A statement from Health Canada noted that there are no placebo-controlled clinical trial data on relative risks for illness and death in elderly dementia patients treated with conventional antipsychotics.
"Nevertheless, the data do suggest that the risks associated with treating elderly dementia patients with conventional antipsychotics may be similar to those associated with atypical antipsychotics," Renee Bergeron, a spokeswoman for Health Canada, said in an e-mail Monday.
"Health Canada is currently updating the Product Monographs for all conventional antispychotics to reflect findings from the available data."
The study was based on anonymous patient data, and the researchers did not have access to causes of death. So they could not determine why it was that people taking the drugs were more likely to die.
But they did find that the risk of death associated with these drugs, either atypicals or conventional agents, emerges quickly.
"Within a month the risk is evident," Gill said, adding that the risk persisted for at least six months.
A recent study by Dr. Paula Rochon, who was also senior author on this study, found that 32 per cent of residents in Ontario nursing homes were given anti-psychotic drugs during one sample month in 2003.
For this new study, the investigators used several databases to track Ontario residents aged 66 and older with dementia from April 1997 to March 2002. More than 27,000 matched pairs were identified.
The report looked at people both in the community and in long-term care homes, and Gill said the higher risk of death was comparable in both settings.
"It's a small risk, but it's one that's definitely statistically significant," he said in an interview Monday. "And I would argue it's clinically important."
Antipsychotics are often prescribed to people with schizophrenia, and their use on people with dementia is very common and, for the most part, what's known as "off-label" prescribing, Gill said.
"Our hope is that the individual clinician level and at the level of individual patients, that the patients, their caregivers and physicians really try and think critically about the potential benefits and risks before prescribing these drugs, and think of alternatives, in particular, non-drug treatments."
Non-drug treatments that might help include recollection of pleasant events, physical activity, music therapy and behavioural analysis to find out what's going on, said Gill.
"For example if there's a behaviour that seems to be occurring predictably when the patient's going for a bath - trying to figure out if it's something with the temperature of the water, or the attendant at the bath," he said.
"If it's, say, a male attendant and the patient is female, maybe the behaviour, the disturbance or the lashing out, might be their articulation of some level of discomfort with that situation."
Dr. Michael Borrie, chair of the division of geriatric medicine at the University of Western Ontario, said this study has "real findings" that are consistent with the medical literature in the field of antipsychotics.
He suggested that caregivers may need more training on dealing with the behaviour of someone who might become aggressive because the person doesn't want a bath, for instance.
"So if a person is aggressive at that time, you don't carry on with what you're doing. You back off, let them go, and maybe having the bath at that particular time that day is not important," said Borrie, who is medical director of a dementia special care unit at Parkwood Hospital, in London, Ont.
Dr. David Conn, co-chair of the Canadian Coalition for Seniors' Mental Health, said the organization released guidelines more than a year ago that focus on treating depression and behaviour in long-term care facilities.
"In our guidelines we say you should only use atypical antipsychotics if there's a risk of harm or if there's great suffering or disability caused by the symptoms," he said.
Written by: ANNE-MARIE TOBIN Jun. 4, 2007
TORONTO (CP) - Older adults who suffer dementia and are given antipsychotic drugs have a slightly higher risk of death than those who aren't prescribed these medications, a large Canadian study suggests.
And the older variety of antipsychotics - known as conventional agents - seems to be associated with a higher risk of death than newer atypical antipsychotics, researchers said in the study of Ontario patients, published Tuesday in the journal Annals of Internal Medicine.
The study builds on previous research that led to warnings in the spring of 2005 from Health Canada and the U.S. Food and Drug Administration on atypical antipsychotics and dementia.
Conventional antipsychotic drugs include chlorpromazine (brand names Largactil and Thorazine) and haloperidol (brand name Haldol). Examples of atypical antipsychotics are olanzapine, risperidone and quetiapine (brand names Zyprexa, Risperdal and Seroquel, respectively).
Lead author Dr. Sudeep Gill, a geriatric specialist and adjunct scientist for the Institute for Clinical Evaluative Sciences, said behavioural symptoms in people with dementia can run a full spectrum. Some people have hallucinations and are very suspicious and paranoid, and those symptoms are "well targeted" by antipsychotics.
But sometimes patients with dementia seem agitated and may articulate that they feel restless.
"Paradoxically these drugs may actually worsen that particular symptom," said Gill, an assistant professor of medicine at Queen's University in Kingston, Ont.
He said it's significant that conventional antipsychotics were associated with an even higher mortality risk than atypicals.
After the warnings of two years ago, he noted that some physicians had switched their patients over from the atypical to conventional drugs.
"We were hoping that at a policy level there might be some interest from the drug regulatory agencies, Health Canada, and its comparative agencies in other countries, to look at maybe expanding the warning labels that they apply to atypical antipsychotics to the older conventional antipsychotics," he said.
A statement from Health Canada noted that there are no placebo-controlled clinical trial data on relative risks for illness and death in elderly dementia patients treated with conventional antipsychotics.
"Nevertheless, the data do suggest that the risks associated with treating elderly dementia patients with conventional antipsychotics may be similar to those associated with atypical antipsychotics," Renee Bergeron, a spokeswoman for Health Canada, said in an e-mail Monday.
"Health Canada is currently updating the Product Monographs for all conventional antispychotics to reflect findings from the available data."
The study was based on anonymous patient data, and the researchers did not have access to causes of death. So they could not determine why it was that people taking the drugs were more likely to die.
But they did find that the risk of death associated with these drugs, either atypicals or conventional agents, emerges quickly.
"Within a month the risk is evident," Gill said, adding that the risk persisted for at least six months.
A recent study by Dr. Paula Rochon, who was also senior author on this study, found that 32 per cent of residents in Ontario nursing homes were given anti-psychotic drugs during one sample month in 2003.
For this new study, the investigators used several databases to track Ontario residents aged 66 and older with dementia from April 1997 to March 2002. More than 27,000 matched pairs were identified.
The report looked at people both in the community and in long-term care homes, and Gill said the higher risk of death was comparable in both settings.
"It's a small risk, but it's one that's definitely statistically significant," he said in an interview Monday. "And I would argue it's clinically important."
Antipsychotics are often prescribed to people with schizophrenia, and their use on people with dementia is very common and, for the most part, what's known as "off-label" prescribing, Gill said.
"Our hope is that the individual clinician level and at the level of individual patients, that the patients, their caregivers and physicians really try and think critically about the potential benefits and risks before prescribing these drugs, and think of alternatives, in particular, non-drug treatments."
Non-drug treatments that might help include recollection of pleasant events, physical activity, music therapy and behavioural analysis to find out what's going on, said Gill.
"For example if there's a behaviour that seems to be occurring predictably when the patient's going for a bath - trying to figure out if it's something with the temperature of the water, or the attendant at the bath," he said.
"If it's, say, a male attendant and the patient is female, maybe the behaviour, the disturbance or the lashing out, might be their articulation of some level of discomfort with that situation."
Dr. Michael Borrie, chair of the division of geriatric medicine at the University of Western Ontario, said this study has "real findings" that are consistent with the medical literature in the field of antipsychotics.
He suggested that caregivers may need more training on dealing with the behaviour of someone who might become aggressive because the person doesn't want a bath, for instance.
"So if a person is aggressive at that time, you don't carry on with what you're doing. You back off, let them go, and maybe having the bath at that particular time that day is not important," said Borrie, who is medical director of a dementia special care unit at Parkwood Hospital, in London, Ont.
Dr. David Conn, co-chair of the Canadian Coalition for Seniors' Mental Health, said the organization released guidelines more than a year ago that focus on treating depression and behaviour in long-term care facilities.
"In our guidelines we say you should only use atypical antipsychotics if there's a risk of harm or if there's great suffering or disability caused by the symptoms," he said.
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