Dual
reuptake inhibitor duloxetine produces rapid and sustained improvement
in depression
Use of duloxetine,
a reuptake inhibitor of serotonin and norepinephrine, produced rapid
and sustained improvement in the symptoms of depression, according
to study findings presented at the U.S. Psychiatric and Mental Health
Congress.
Data indicate that patients treated with duloxetine 60 mg daily had
significantly greater improvement in measures of mood and anxiety
than placebo-treated patients by the end of the first week of therapy,
with improvements sustained through the end of the nine-week, double-blind
trial of patients with major depressive disorder.
In addition, data from a one-year open-label study indicate that 79
percent of patients achieved response and 69 percent of patients achieved
remission with doses of either 80 mg daily or 120 mg daily. The drug
appears to be relatively well tolerated and safe for long-term treatment
over the range of doses studied.
Researchers, who were supported by the drug manufacturer, used several
measures for symptoms of depression such as mood and anxiety, including
the Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Sub-Scale,
Clinical Global Impression Scale of Severity, and Patient Global Impression
of Improvement Scale. "Rapid
response to treatment helps doctors recognize that a therapy may
be the right one for the patient, but even more importantly if the
patient is able to feel improvement quickly, the more likely that
patient will stick with treatment and ultimately get well,"
said Stephen K. Brannan, M.D., presenter.
Many experts believe treatment of the complete
spectrum of depression symptoms is intrinsic to a lasting recovery.
Combined action through serotonin and norepinephrine may provide
a more rapid and sustained clinical effect. Duloxetine is a dual
reuptake inhibitor of both serotonin and norepinephrine.
Additional data from the one-year study reflected a low level of
adverse drug effects. For instance, discontinuation due to adverse
events was relatively low, at 17 percent over the course of the
study. Most adverse events occurred early in treatment and were
mild to moderate. The only adverse events that occurred at a rate
higher than 1.0 percent and led to discontinuation were nausea (1.5%)
and somnolence (1.4%). At the end of the year, the mean change in
weight from baseline was an increase of 1.1 kg.
Adverse events that occurred at a rate of 3.0 percent or greater
upon abrupt discontinuation of drug at the end of the study were
dizziness (8.3%), anxiety (4.3%), and nausea (4.2%).
The researchers used pooled analysis for patient data from two nine-week,
double-blind, placebo-controlled studies in patients diagnosed with
major depressive disorder: A total of 512 patients were randomized
to placebo (n=261) or duloxetine 60 mg daily (n=251). Results were
evaluated using the Hamilton Depression Rating Scale, as well as
the Clinical Global Impression and Patient Global Impression scales.
Additional data were obtained from an open-label,
52-week, international clinical trial involving 1,279 patients who
met the criteria for major depressive disorder. These patients received
either duloxetine 80 mg/day or 120 mg/day. Efficacy was measured
with the use of the same three scales.
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