THURSDAY, June 17 (HealthDay News) -- Duloxetine appears to significantly reduce pain and improve functioning in nondepressed individuals with non-neuropathic chronic low back pain (CLBP), according to a study published in the June 1 issue of Spine, though during the study, more subjects on duloxetine discontinued treatment because of adverse events than those on placebo.
Vladimir Skljarevski, M.D., of Lilly Research Laboratories in Indianapolis, and colleagues randomized nondepressed individuals with non-neuropathic CLBP and a weekly mean of the 24-hour average pain score of four or higher at baseline (zero to 10 scale) to duloxetine or placebo for 13 weeks. During the first seven weeks of treatment, individuals received 60 mg of duloxetine once daily, with dosing increasing to 120 mg at week seven among patients who reported less than 30 percent pain reduction.
The researchers found that patients undergoing treatment with duloxetine had a significantly greater reduction in the Brief Pain Inventory (BPI) 24-hour average pain rating than those receiving placebo (least-squares mean change of −2.32 versus −1.50). In addition, those receiving duloxetine experienced significant improvements in secondary outcome measures, including Patient's Global Impressions of Improvement, Roland-Morris Disability Questionnaire-24, BPI-Severity and average BPI-Interference, weekly mean of the 24-hour average pain, night pain, and worst pain. However, 13.9 percent of patients receiving duloxetine discontinued treatment due to adverse events, compared with 5.8 percent of placebo-treated patients.
"Duloxetine significantly reduced pain and improved functioning in patients with CLBP," the authors write. "The safety and tolerability were similar to those reported in earlier studies."
The study was sponsored by Eli Lilly and Company, of which several study authors are employees and stockholders. One author disclosed financial ties to several other pharmaceutical and medical device companies.
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