Patients Taking Cymbalta(R) Reported Reduced Pain Severity Of Osteoarthritis Of The Knee In New Study

New data suggest that
patients with osteoarthritis pain of the knee treated with 60 mg and 120 mg
Cymbalta (duloxetine HCl) once daily experienced significant pain
reduction. Patients taking duloxetine reported significant pain improvement
compared to placebo within the first week of treatment that lasted
throughout the 13-week trial.(1) Results from the study of 231 patients
were presented today at the annual congress of the European League Against
Rheumatism (EULAR) in Paris, France.


Duloxetine showed statistically significant improvement in pain
associated with osteoarthritis of the knee according to the primary
efficacy measure of mean 24-hour average pain scores. Fifty-nine percent of
duloxetine-treated patients experienced a 30 percent improvement in pain
compared with 45 percent of patients taking placebo. Forty-seven percent of
duloxetine-treated patients experienced a 50 percent improvement in pain
compared with 29 percent of placebo-treated patients.



Treatment with duloxetine also was associated with improved patient
outcomes compared with placebo as measured by the Patient Global
Impressions of Improvement (PGI-I) and physical functioning as measured by
the Western Ontario and McMaster Universities (WOMAC) physical functioning
subscale.



In this study, the most common adverse events (occurred at a rate of
greater than or equal to 3 percent and at least twice the rate of placebo)
were nausea, fatigue, somnolence, dizziness, hypertension, constipation and
decreased libido.



"These data are important because it's the first time duloxetine has
been studied in a large, placebo-controlled trial in what's classified as
an inflammatory disease state," said Amy Chappell, M.D., lead study author
and medical fellow II, Eli Lilly and Company. "Although the exact mechanism
of action is unknown, this study may provide important insights into the
treatment of pain in the central nervous system."



It is estimated that 27 million adults in the United States have
osteoarthritis and the prevalence increases with age.(2) Osteoarthritis of
the knee is a common type of this disorder, impacting the lives of
approximately 10 million Americans.(2) Other symptoms of osteoarthritis in
addition to pain include aching, stiffness and limited range of motion of
the joint.(3)



Additional Study Highlights:



- Compared with patients receiving placebo, patients receiving duloxetine
experienced significant improvement in symptom severity associated with
osteoarthritis pain of the knee, including:
















Significantly greater reduction in Brief Pain Inventory (BPI)
average pain severity (p