Cymbalta 60mg
Duloxetine (sold under the brand names Cymbalta, Ariclaim, Xeristar, Yentreve, Duzela, Dulane) is a serotonin-norepinephrine reuptake inhibitor (SNRI) manufactured and marketed by Eli Lilly. It is effective for major
depressive disorder and generalized
anxiety disorder (GAD).
Duloxetine has approval for use in osteoarthiritis and musculoskeletal pain.
Duloxetine failed the US approval for stress
urinary incontinence amidst
concerns over liver toxicity and suicidal events; however, it was approved for
this indication in Europe, where it is recommended as an add-on medication in stress urinary incontinence instead of surgery.[1] It can also relieve the symptoms of
painful peripheral
neuropathy, particularly diabetic neuropathy,[2][3] and it is used to control the symptoms
of fibromyalgia.
Medical
uses
The main uses of duloxetine are in major depressive disorder, general anxiety disorder, stress urinary incontinence,
painful peripheral neuropathy, fibromyalgia,
and chronic musculoskeletal pain associated with osteoarthritis and chronic lower back pain. It is being studied for various
other indications.
Major depressive disorder
Duloxetine has
demonstrated efficacy for the treatment of major depressive disorder.[citation needed] In a small, clinical study supported
by the manufacturer, duloxetine was also shown to be effective in elderly
patients with recurrent major depressive disorder where it improved cognition,
depression, and some pain measures.[4]
Stress urinary incontinence
Duloxetine was first reported to improve
outcomes in stress urinary incontinence (SUI) in 1998.[5] Systematic
reviews with
meta-analysis, conducted in 2005 by Cochrane Collaboration[6] and in 2008 by University of Minnesota,[7] concluded that duloxetine failed to
cure SUI better than placebo. According to the Cochrane review, some studies
showed that episodes of incontinence were reduced by about 50%. This was
associated with an improvement in quality
of life measurements.[6]
According to the University of Minnesota
review, duloxetine performed worse than oxybutynin (Ditropan) or tolterodine (Detrol) that cured 18% of the cases,
or than pelvic
floor muscle training +
bladder training, which cured 13% of the cases. In terms of
"improvement", that is incomplete cure, duloxetine showed improvement
in 11% of patients while pelvic
floor muscle training
+ bladder training showed improvement in 36% of the cases.[7] Significant side effects were common
with duloxetine; they were reported as acceptable and about a fifth had to
discontinue the medication because of poor tolerance.[6]
In addition, the full report prepared by
Minnesota Evidence-based Practice Center for the U.S. government, on which the
University of Minnesota review is based, notes that weight reduction would
result in improved SUI in 990 adults per 1,000 treated.[8] In the light of the cited data, the
report does not mention duloxetine in its policy recommendations. The only
recommended interventions are early behavioral changes in weight, physical
activity, and pelvic floor muscle training.[8]
The only clinical trial, which directly compared
duloxetine with the gold standard of the SUI treatment pelvic floor muscle
training (PFMT) was conducted by Eli Lilly and gave mixed results. The
incontinence episode frequency in duloxetine group decreased by 57% vs. 35% in
the PFMT group. However, the differences in the pad use and quality of life
were not statistically significant. To the contrary, 65% patients doing PFMT
reported feeling better vs 54% of the patients on duloxetine. 31% of the
patients on duloxetine discontinued the trial due to the side effects during
the first 12 weeks.[9] In the continuation of this trial more
than 91% of the patients on duloxetine experienced side effects.[10]
Summing up the existing evidence, a review in
Prescrire International recommends pelvic floor exercises, which are
"risk-free and effective in two-thirds to three-quarters of cases",
as the first line treatment of SUI. Duloxetine use reduced the frequency of
stress incontinence by one episode a day as compared with placebo. "The
tangible effect of duloxetine on the quality of life is doubtful, with a
maximum gain of five points on a 100-point scale." The review notes that,
at best, duloxetine efficacy is "modest and transient, while its adverse
effects are numerous and potentially severe."[11]
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