AN EVAULATION OF THE SAFETY AND EFFICACY OF DULOXETINE IN THE TREATMENT OF WOMEN WITH FIBROMYLGIA SYNDROME: RESULTS FROM TWO CLINICAL STUDIES

L. Arnold , Y. Pritchett , D.D. D'Souza , D.K. Kajdasz , S. Iyengar , J.F. Wernicke Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Abbott Laboratories, Abbott Laboratories, Abbott Park, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, United StatesObjectives: Assess the efficacy and safety of duloxetine, a serotonin and norepinephrine reuptake inhibitor, in female patients with fibromyalgia.Methods: Pool efficacy data from 2 placebo-controlled clinical trials of similar design (randomized, 12-week and double-blind) comparing duloxetine 60 mg a day (QD) or 60 mg twice daily (BID) (N=326) with placebo (N=212), in women who met the American College of Rheumatology criteria for primary fibromyalgia.Results: Compared with the patients receiving placebo, duloxetine-treated female patients demonstrated a significantly greater improvement in the Brief Pain Inventory average pain severity score, and in the Fibromyalgia Impact Questionnaire total score, beginning 1 week after initiation of therapy and continuing through 12 weeks of acute therapy (P<.001 at each study visit). Duloxetine was superior to placebo on all efficacy measures including mean tender point threshold, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and BPI average interference scores. The duloxetine group was superior to placebo on all quality of life measures including each domain of the SF-36. A direct treatment effect of duloxetine on pain reduction was demonstrated and shown to be independent of secondary improvement in mood (based on BPI average pain score). Significantly more duloxetine-treated patients reported treatment-emergent adverse events (296 [90.8%] duloxetine- and 165 [77.8%] placebo-treated; P<.001). The most common treatment-emergent adverse events reported by duloxetine-treated patients were nausea (duloxetine [35.0%], placebo [12.3%], P<.001), insomnia (duloxetine [24.2%], placebo [14.6%], P=.008), and headache (duloxetine [21.5%], placebo [13.2%], P=.024). Rates of serious adverse events were similar between duloxetine- (2 [0.6%]) and placebo- (0%) treated patients.Conclusion: The results of these studies demonstrate that duloxetine is a safe and efficacious treatment for pain associated with fibromyalgia in female patients. Duloxetine also significantly improved function and quality of life in these patients.Citation: Ann Rheum Dis, volume 66, supplement II, year 2007, page 422Session: Fibromyalgia