Cymbalta Reduces Pain Severity Of Knee Osteoarthritis

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. 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 the0 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.

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<0.001) and WOMAC scores for pain (p=0.003)

* Overall improved clinical global assessment according to Clinical Global Impressions of Severity (CGI-S) (p=0.001)

- A total of 22 (9.5 percent) patients discontinued due to adverse events - seven (5.8 percent) in the placebo-treated group and 15 (13.5 percent) in the duloxetine-treated group.

Methods

In this study, 111 patients were randomly assigned to receive 60 mg per day of duloxetine; 120 patients received placebo. Patients were stratified by whether or not they used non-steroidal anti-inflammatory drugs (NSAIDs) on a regular basis. At week seven, those receiving active treatment were re- randomized to either 60 mg duloxetine or 120 mg duloxetine per day. The duloxetine groups were combined for overall analyses. The primary endpoint of the study was reduction of pain severity as measured by the weekly mean of the 24-hour average pain scores. Changes from baseline to endpoint were analyzed using a mixed-effects model repeated measures (MMRM) approach. Secondary measures included effects on associated pain and functioning. Pain and functional outcomes were assessed using Patient Global Impressions of Improvement (PGI-I), Western Ontario and McMaster Universities (WOMAC) pain and physical functioning subscales, Clinical Global Impressions of Severity (CGI-S) and Brief Pain Inventory (BPI)-Severity. Patients with a recent diagnosis (within six months) of major depressive disorder were excluded from this study.