Patients Taking Cymbalta(R) Reported Reduced Pain Severity of Osteoarthritis of the Knee in New Study
13 June 2008 - 10:00PM
PR Newswire (US)
Patients on Treatment Also Experienced Improved Physical
Functioning INDIANAPOLIS, June 13 /PRNewswire-FirstCall/ -- 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