A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder

Abstract

This was a 12-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, in 354 female patients with primary fibromyalgia, with or without current major depressive disorder. Patients (90% Caucasian; mean age, 49.6 years; 26% with current major depressive disorder) received duloxetine 60 mg once daily (QD) (N=118), duloxetine 60 mg twice daily (BID) (N=116), or placebo (N=120). The primary outcome was the Brief Pain Inventory average pain severity score. Response to treatment was defined as >or=30% reduction in this score. Compared with placebo, both duloxetine-treated groups improved significantly more (P<0.001) on the Brief Pain Inventory average pain severity score. A significantly higher percentage of duloxetine-treated patients had a decrease of >or=30% in this score (duloxetine 60 mg QD (55%; P<0.001); duloxetine 60 mg BID (54%; P=0.002); placebo (33%)). The treatment effect of duloxetine on pain reduction was independent of the effect on mood and the presence of major depressive disorder. Compared with patients on placebo, patients treated with duloxetine 60 mg QD or duloxetine 60 mg BID had significantly greater improvement in remaining Brief Pain Inventory pain severity and interference scores, Fibromyalgia Impact Questionnaire, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and several quality-of-life measures. Both doses of duloxetine were safely administered and well tolerated. In conclusion, both duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in the treatment of fibromyalgia in female patients with or without major depressive disorder.

A Framework for Fibromyalgia Management for Primary Care Providers

“…As noted earlier in this article, patients and their families should have their expectations managed on initiation of any therapy, with PCPs reiterating that although medications cannot cure the underlying disease, medications can improve symptoms and function. [31][32][33][34] Pregabalin is an alpha 2 delta calcium channel ligand; duloxetine and milnacipran are serotonin and norepinephrine reuptake inhibitors (Table). Alpha 2 delta calcium channel ligands are thought to act in part by reducing the activity of excitatory neurotransmitters (eg, glutamate), whereas serotonin and norepinephrine reuptake inhibitors act largely by increasing norepinephrine and serotonin and thereby increasing activity in the descending inhibitory pain pathways.…”

A Comparison of Reboxetine and Amitryptilline in the Treatment of Fibromyalgia Syndrome with Co-morbid Depressive Symptoms: An Open-label Preliminary Study

“…But one should consider that the selective action of an antidepressant on the central nervous system does not necessarily resulting a selective response (42). Similarly, several studies have suggested that mirtazapine, venlafaxine, duloxetine , milnacipran also act to enhance the activity of central NA and 5-HT neurones and might be useful in the treatment of pain in both humans and/ or animals (43)(44)(45)(46)(47)(48)(49)(50)(51)18,10).…”

Pharmacotherapy of Fibromyalgia: Focus on Duloxetine

“…46 Three trials concerning Duloxetine in FMS were involved. 28,29,31 The response rate was defined as a 50% reduction in the average pain score from baseline to endpoint. The Number Need to Treat (NNT) compared with the placebo was 6.4 (4.7 to 9.9).…”