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Cymbalta(R) Significantly Reduced Osteoarthritis Knee Pain in New Study
Date:1/30/2009

pain of the knee, including:

-- Decreased interference from pain in general activity and normal work, as measured by the BPI Pain Interference (BPI-I) scales.

-- Duloxetine-treated patients did not show statistically significant improvements compared with placebo-treated patients according to BPI-I measures of mood, walking ability, relations with other people, sleep, enjoyment of life and average interference.

-- Weekly mean of the 24-hour average pain severity and worst pain severity.

-- PGI-Improvement (PGI-I).

-- Duloxetine-treated patients showed statistically significant improvements compared with placebo as measured by PGI-I at each office visit, but not at study endpoint.

-- CGI-Severity.

-- A total of 31 patients in the study discontinued due to adverse events - seven in the placebo-treated group and 24 in the duloxetine-treated group.

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 subtype of this disorder, impacting the lives of approximately 10 million Americans.(2) In addition to pain, other symptoms of osteoarthritis include aching, stiffness and limited range of motion of the joint.(3) Duloxetine is being studied to manage the pain associated with this disorder.

Methods

In this 13-week double-blind trial, patients were at least 40 years of age without a current diagnosis of major depressive disorder; with no confounding painful conditions or diagnosis of inflammatory arthritis or autoimmune disorders; and with no invasive therapy of the knee in the past three months, knee arthroscopy within the past year or joint replacement of the index knee at anytime. Patients were randomized to duloxetine (n=128) or placebo (n=128) and stratified by whether or not
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SOURCE Eli Lilly and Company
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