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A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder
Ist Teil von
Pain (Amsterdam), 2005-12, Vol.119 (1), p.5-15
Ort / Verlag
Amsterdam: Elsevier B.V
Erscheinungsjahr
2005
Quelle
MEDLINE
Beschreibungen/Notizen
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 ≥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 ≥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.