Efficacy, Adverse Events, and Treatment Discontinuations in Fluoxetine Clinical Studies of Major Depression: A Meta-Analysis of the 20-mg/day Dose
J Clin Psychiatry 2000;61(10):722-728
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: The efficacy and safety of
fluoxetine in adults with moderate-to-severe major depression are
well established. However, most analyses combined dosages (20-80
mg/day) of the compound. We hypothesized that in patients taking
20 mg/day, efficacy would be maintained but the incidence of
adverse events would be lower. We present a meta-analysis of
efficacy and safety data for fluoxetine, 20 mg/day.
Method: Data were from 3 double-blind studies (N
= 417) that included patients with moderate-to-severe major
depression (DSM-III or DSM-III-R criteria) who received placebo
or fixed-dose 20-mg/day treatment with fluoxetine. Efficacy was
assessed using the Hamilton Rating Scale for Depression (HAM-D;
HAM-D-17 total score and anxiety/somatization, retardation, sleep
disturbance, and cognitive disturbance factors) and response and
remission rates. Safety assessments included treatment-emergent
adverse events, reasons for discontinuation, and adverse events
leading to discontinuation. Adverse events were evaluated to
determine the emergence of activation and/or sedation.
Results: At 20 mg/day, fluoxetine-treated
patients demonstrated significantly greater remission and
response rates and mean changes on HAM-D-17 total score and
anxiety/somatization, retardation, and cognitive disturbance
factor scores than placebo-treated patients (p < .001). The
incidence of specific adverse events leading to discontinuation
and the frequency of study discontinuations due to adverse events
were similar among fluoxetine-treated and placebo-treated
patients (6.1% vs. 5.8%, p = .879). Several adverse events
(insomnia, asthenia, somnolence, gastroenteritis, decreased
libido, chills, and confusion) occurred significantly more
frequently among fluoxetine-treated patients. A significant
change in sedation, but not activation, occurred in patients in
the fluoxetine 20-mg/day group compared with the placebo group.
Conclusion: These data affirm that
fluoxetine at 20 mg/day is efficacious, safe, and of similar
activation potential when compared with placebo in patients with