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New Data Show Patients With Chronic Low Back Pain Maintained Pain Reduction on Cymbalta(R)
Date:9/11/2009

ding to the International Association for the Study of Pain (IASP), the pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.(3) Chronic pain is defined as pain that persists beyond acute pain or beyond the expected time for an injury to heal.(4) Men and women are equally affected by chronic low back pain, and it occurs most often between the ages of 30 and 50.(5)

Study Methods

Patients (N=181) with chronic low back pain (defined as low back pain present on most days for the preceding six months or longer) entered the study's 41-week extension phase and received duloxetine 60 mg or 120 mg once daily after completing a 13-week, placebo-controlled acute phase. Patients completing the acute phase on duloxetine remained on the same dose while those on placebo were switched to duloxetine. Maintenance of effect was assessed in 58 duloxetine patients who were responders [greater than or equal to 30 percent reduction in Brief Pain Inventory (BPI) average pain] at the end of the acute phase. If the upper bound of the 97.5 percent Confidence Interval (CI) of the mean change from the end of the acute phase for the BPI average pain was less than the pre-specified margin of 1.5, then maintenance of effect was established.

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on preclinical studies, Cymbalta is a balanced and potent reuptake inhibitor of serotonin and norepinephrine that is believed to potentiate the activity of these chemicals in the central nervous system (brain and spinal cord). While the mechanism of action of Cymbalta is not known in humans, scientists believe its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity o
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SOURCE Eli Lilly and Company
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