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Drugs for Dementia May Be Associated with Small
Increased Risk of Death
Atypical antipsychotic drugs common to treat
aggression, delusions
Oct. 19, 2005 - Patients with dementia who took
atypical antipsychotic drugs had a slightly increased risk of death
compared to patients who took placebo, according to a meta-analysis
published in todays issue of JAMA.
A majority of elderly patients with dementia
develop aggression, delusions, and other neuropsychiatric symptoms
during their illness, according to background information in the
article.
Antipsychotic medications are commonly used to
treat these behaviors, along with psychosocial and environmental
interventions. During the last decade, newer atypical antipsychotic
drugs (i.e., risperidone, olanzapine, quetiapine, and aripiprazole, in
order of introduction) have largely replaced the older conventional or
first generation antipsychotic drugs (e.g., haloperidol and thioridazine)
and have been considered preferred treatments for these behavioral
disturbances associated with dementia.
However, concerns have arisen about possibly
increased risks for cerebrovascular adverse events, rapid cognitive
decline, and death with their use.
Lon S. Schneider, M.D., M.S., and colleagues at the
University of Southern California, Los Angeles, conducted a
meta-analysis of atypical antipsychotic drug trials to assess the
evidence for death associated with their use in elderly patients with
dementia. After a search of databases and meeting presentations, the
researchers selected 15 trials (9 unpublished) that met criteria,
generally 10 to 12 weeks in duration, including 16 contrasts of atypical
antipsychotic drugs with placebo (aripiprazole [n=3], olanzapine [n=5],
quetiapine [n=3], risperidone [n=5]). A total of 3,353 patients were
randomized to study drug and 1,757 were randomized to placebo. Outcomes
were assessed using standard methods to calculate odds ratios (ORs) and
risk differences based on patients randomized and relative risks based
on total exposure to treatment. There were no differences in dropouts.
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Editorial: Antipsychotic Drugs in Dementia - What
Should Be Made of the Risks? |
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In an accompanying editorial, Peter V. Rabins,
M.D., M.P.H., and Constantine G. Lyketsos, M.D., M.H.S., of Johns
Hopkins Medical Institutions, Baltimore, examine the results of the
meta-analysis by Schneider et al.
So what should a clinician do when caring for a
patient with dementia who develops psychotic symptoms or aggression?
First, etiologies other than dementia need to be
considered. Delirium, untreated or undertreated medical illnesses,
overmedication, environmental triggers, lack of engaging activities, and
misinterpretation of disease symptoms are among the potential etiologies
of such behaviors and symptoms. Because all have specific therapies,
they should be considered when such symptoms first develop.
Second, clinicians should consider the risk/benefit
ratio for each patient. For example, patients with hallucinations and
delusions that are neither distressing nor placing them or others at
risk or harm should not be treated with antipsychotic drugs.
Third, once antipsychotic drugs have been
prescribed, careful assessment and documentation of the need for
continued care is necessary. The Omnibus Budget Reconciliation Act (OBRA)
regulations of 1987 require such a reassessment in long-term care, but
the need for medication continuation should be regularly reassessed and
justified for all individuals. Given the high rates of dementia in
assisted living homes, similar practices should be instituted in those
settings as well.
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The researchers found that death occurred more
often among patients randomized to drugs (118 [3.5 percent] vs. 40 [2.3
percent]; OR, 1.54), indicating a significantly increased risk.
Sensitivity analyses did not show evidence for differential risks for
individual drugs, severity, sample selection, or diagnosis.
These findings emphasize the need to consider
certain changes in some clinical practices, the authors say.
Antipsychotic drugs have been dispensed fairly
frequently to patients with dementia and used for long periods. The
established risks for cerebrovascular adverse events together with the
present observations suggest that antipsychotic drugs should be used
with care in these patients.
The fact that excess deaths and cerebrovascular
adverse events can be observed within 10 to 12 weeks of initiating
medication, coupled with observations from individual clinical trials
results that there is substantial improvement in both drug and placebo
groups during the first 1 to 4 weeks of treatment, lead to the
consideration that antipsychotic drugs should be prescribed and dosage
adjusted with the expectation of clinical improvement within that time.
If improvement is not observed, the medication could be discontinued,
the authors write.
As a meta-analysis, our results should be taken as
hypothesis-generating for an increased risk for deaths in patients with
dementia receiving atypical antipsychotic drugs.
No drug is
individually responsible for the effect, but rather each contributes to
the overall effect. This effect may not be limited to atypical drugs as
a class and may be associated with haloperidol and other drugs that have
not been subjected to efficacy trials in elderly patients with
dementia, the researchers conclude.
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