Patients Taking Cymbalta(R) Reported Reduced Pain Severity of Osteoarthritis of the Knee in...(ide important insights into thetreatment...),Health

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<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. Pa
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