A Review of Treatment-Emergent Adverse Events During Olanzapine Clinical Trials in Elderly Patients With Dementia.
J Clin Psychiatry 2006;67(6):933-945
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: Olanzapine and other
antipsychotics are not approved by the U.S. Food and Drug
Administration to treat behavioral disturbances
associated with dementia, but they are often prescribed
to these patients. Although antipsychotics may be
efficacious in this population, elderly patients with
dementia may be particularly vulnerable to adverse events. This article reviews the safety of olanzapine in elderly patients with dementia.
Data Sources: Data from 6 studies
comparing olanzapine to placebo, risperidone, or
conventional antipsychotics in elderly patients with
dementia were analyzed for mortality, cerebrovascular
adverse events (CVAEs), and other adverse events. These trials represent all Lilly
olanzapine-comparator trials in this population. The data included
integration of 5 double-blind, placebo-controlled
studies (olanzapine, N = 1184; placebo, N = 478;
median age = 79 years; 1 study also compared olanzapine with risperidone, N = 196) and an open-label
study comparing olanzapine (N = 150) with
conventional antipsychotics (N = 143).
Synthesis: Incidence of mortality was
significantly higher in olanzapine- (3.5%) than in
placebo-treated patients (1.5%; p = .024). There were
no significant differences in the crude incidence
of mortality between olanzapine- (2.9%) and
risperidone- (2.0%) or olanzapine- (14.8%) and
conventional antipsychotic-treated patients
(16.1%; p = .871). Risk factors associated with mortality
in olanzapine-treated patients included age > = 80,
concurrent benzodiazepine use, treatment-emergent sedation, or treatment-emergent pulmonary
conditions. Incidence of CVAEs was approximately 3 times higher in olanzapine- (1.3%) than in
placebo-treated patients (0.4%). There were no
significant differences in the incidence of CVAEs
between olanzapine- (2.5%) and risperidone- (2.0%;
p = 1.0) or olanzapine- (3.4%) and conventional
antipsychotic-treated patients (4.3%; p = .765).
Conclusion: These findings should be
considered if prescribers elect to treat behavioral
disturbances associated with dementia in the elderly
with olanzapine or other antipsychotics.