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News > Medscape Medical News




DULOXETINE ANTIDEPRESSANT ACTION BEGINS IN ONE WEEK

Laurie Barclay, MD

November 12, 2002





Nov. 12, 2002 — Two studies presented at the recent 15th Annual U.S. Psychiatric
and Mental Health Congress in Las Vegas, Nevada, showed that duloxetine
(Cymbalta), a new serotonin/norepinephrine inhibitor similar to venlafaxine, is
safe and effective for long-term use. More importantly, its efficacy begins in
one week, faster than the usual two- to four-week time to onset for most other
antidepressants.



"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," presenter Stephen K. Brannan, MD, from Eli Lilly and
Company in Indianapolis, Indiana, says in a news release.

The investigators analyzed pooled data from two nine-week, double-blind,
randomized studies in 512 patients who met criteria for major depressive
disorder (MDD). After one week of therapy, depressed patients taking duloxetine,
60 mg once daily, had significantly greater improvement in mood and anxiety
measures than did patients treated with placebo. These improvements were
sustained throughout treatment.

By week one, duloxetine-treated patients had a significant improvement in score
on Item 1 (depressed mood) of the Hamilton Depression Rating Scale, HAMD-17.
Overall depressive symptoms on this scale significantly improved by week two. By
the first week, significantly more patients treated with duloxetine than with
placebo had improvement of depressive symptoms on the Clinical Global Impression
Scale of Severity (CGI-S Scale) and on the Patient Global Impression of
Improvement Scale (PGI-I Scale).





Compared with the placebo group, more patients in the duloxetine group improved
by week one on Item 10 (psychic anxiety) of the HAMD-17, which measures anxiety
associated with depression. By week two, duloxetine-treated patients had a
significantly greater improvement in anxiety associated with depression, as
reflected in the HAMD-17 Anxiety Sub-Scale.

SUGGESTED for you



In an open-label, multinational trial, 79% of 1,279 patients with MDD achieved
response and 69% achieved symptom remission after one year of treatment with
duloxetine, 80 mg or 120 mg daily. The drug was relatively well tolerated and
safe over the one-year treatment period.

Most adverse events occurred early in the study period and were mild to
moderate. Discontinuation due to adverse events occurred in 17% of subjects.
Adverse events occurring in more than 1% of subjects and resulting in
discontinuation were nausea in 1.5% of patients and somnolence in 1.4%. Sexual
adverse events leading to discontinuation included erectile dysfunction in 0.2%
and abnormal orgasm in 0.2%. After one year of treatment, mean change in weight
from baseline was a gain of 1.1 kg. When treatment was abruptly discontinued at
study termination, dizziness occurred in 8.3%, anxiety in 4.3%, and nausea in
4.2%.

Rapid, sustained improvement in depressive symptoms could allow earlier
restoration of functional well-being and greater cost savings, the investigators
conclude.



Eli Lilly and Company received conditional U.S. Food and Drug Administration
approval for Cymbalta in September, with final approval contingent on labeling
discussions and resolution of outstanding manufacturing issues. Lilly is also
studying duloxetine in stress urinary incontinence, which is also mediated by
serotonin and norepinephrine.

U.S. Psychiatric and Mental Health 15th Annual Congress. October 28-31, 2002.

Reviewed by Gary D. Vogin, MD

 * 
   



Medscape Medical News © 2002 


Cite this: Laurie Barclay. Duloxetine Antidepressant Action Begins in One
Week - Medscape - Nov 12, 2002.

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AUTHORS AND DISCLOSURES


AUTHOR(S)

LAURIE BARCLAY, MD



Laurie Barclay, MD is a freelance reviewer and writer for Medscape.




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