A Multicenter, Randomized, Double-Blind Study of the Effects of Aripiprazole in Overweight Subjects With Schizophrenia or Schizoaffective Disorder Switched From Olanzapine
J Clin Psychiatry 2008;69(7):1046-1056
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: Major mental disorders are
associated with an increased risk for obesity-related
cardiovascular mortality, leading to interest in risk-reduction
approaches that target weight and risk-related plasma
lipids, including use of antipsychotic agents with low
metabolic risk. This multicenter, randomized,
double-blind study compared the metabolic effects of
aripiprazole versus olanzapine in overweight persons with
schizophrenia or schizoaffective disorder who were
previously on olanzapine treatment.
Method: In total, 173 subjects with
DSM-IV-TR-defined schizophrenia or schizoaffective disorder
were randomly assigned to receive aripiprazole (N = 88)
or olanzapine (N = 85) for 16 weeks in a study
conducted from March 30, 2004, to August 8, 2006. Primary
and secondary endpoints were mean weight change
from baseline and percentage change from baseline in
fasting triglyceride levels, respectively.
Results: At week 16, weight decreased
significantly with aripiprazole versus olanzapine (-1.8 vs. +1.41 kg;
p < .001). Significant differences in percentage change
in triglyceride levels were observed with aripiprazole
(decreases) versus olanzapine (increases) at all
timepoints. In addition, significantly more subjects receiving
aripiprazole had clinically relevant (>= 7%) weight
loss versus olanzapine (11.1% vs. 2.6%; p = .038), and
a lower percentage of subjects receiving aripiprazole
had clinically relevant weight gain (2.5% vs. 9.1%; p
= .082). Mean percentage changes in fasting total
cholesterol and high-density lipoprotein cholesterol at week
16 were significantly different with aripiprazole
versus olanzapine, with no significant effects on glycemic
laboratory measures. Mean Clinical Global
Impressions-Improvement (CGI-I) scores for both groups were in
the range of "no change" to "minimal improvement."
CGI-I endpoint scores were statistically significantly
better with olanzapine (mean ± SE = 3.09 ± 0.16) versus
aripiprazole (mean ± SE = 3.74 ± 0.15; p < .001), and
more subjects discontinued aripiprazole (N = 32/88;
36%) than olanzapine (N = 22/85; 26%).
Conclusion: Significant improvements in weight
and lipids observed during discontinuation of
olanzapine and switch to aripiprazole treatment occurred with
limited evidence of negative psychiatric effects, relative
to uninterrupted continuation of olanzapine treatment.
The results suggest that the potential value of
therapeutic substitutions involving specific antipsychotic
medications should be considered in overall efforts to
reduce cardiovascular risk in this population.
Trial Registration: clinicaltrials.gov Identifier: NCT00095524