Saturday, November 19, 2011

Duloxetine 30 mg once daily not effective in Patients with Fibromyalgia

Lesley M. Arnold and colleagues were interested in the question, whether duloxetine 30 mg QD dose in adult patients with fibromyalgia with or without major depressive disorder was effective in statistically significant pain reduction. The background lies in previous fibromyalgia trials, which showed a reduction of pain in one week trials at a dosage of 30 mg daily. 30 mg duloxetine daily did not reduce pain significantly compared to placebo. Though there “were no new safety issues identified”, which wasn’t to be expected as other studies with higher a dosage had been done already, but verum-treated patients had at least twice the incidence of nausea, dry mouth, somnolence, and insomnia.

[TUE] 1916
A Randomized, Double-Blind Comparison of Duloxetine 30 Mg Once Daily (QD) and Placebo in Adult Patients with Fibromyalgia.
Lesley M. Arnold1, Shuyu Zhang2 and Beth Pangallo3. 1University of Cincinnati College of Medicine, Cincinnati, OH, 2Eli Lilly and Company, Indianapolis, IN, 3ELi Lilly and Company, Indianapolis, IN
Conclusion: The primary result of the study did not demonstrate the
analgesic effect of the duloxetine 30 mg QD in the treatment of fibromyalgia with or without MDD. Duloxetine 30 mg QD was generally well tolerated, and there were no new safety issues identified.

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