RESEARCH - Duloxetine for the treatment of fibromyalgia in women

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J Womens Health (Larchmt). 2007 Oct;16(8):1145-56.

Duloxetine for the treatment of fibromyalgia in women: pooled results

from two randomized, placebo-controlled clinical trials.

Arnold LM, Pritchett YL, D'Souza DN, Kajdasz DK, Iyengar S, Wernicke JF.

Women's Health Research Program, Department of Psychiatry, University

of Cincinnati College of Medicine, Cincinnati, OH 45219, USA.

BACKGROUND: To assess the efficacy (in particular, in pain, functional

impairment, and quality of life) and safety and tolerability

(incidence of adverse events, discontinuation rates, changes in

laboratory findings, and vital signs) of duloxetine in female patients

with fibromyalgia. METHODS: Data were pooled from two

placebo-controlled clinical trials of similar design (randomized,

12-week, and double-blind), comparing duloxetine 60 mg a day (q.d.) or

60 mg twice daily (b.i.d.) (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 (BPI) average pain

severity score and in the Fibromyalgia Impact Questionnaire (FIQ)

total score, beginning at week 1 and continuing through week 12 (p <

0.001). 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 average

interference from pain scores. The duloxetine-treated group was

superior to placebo on all quality of life and functional measures,

including each domain of the Medical Outcomes Study Short Form-36

(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-treated and 165 [77.8%] placebo-treated, p <

0.001). Rates of serious adverse events were similar between

duloxetine-treated and placebo-treated patients.

CONCLUSIONS: The pooled results of these studies demonstrate that

duloxetine is a safe and efficacious treatment for both the pain and

functional impairment associated with fibromyalgia in female patients,

while significantly improving quality of life.

PMID: 17937567

http://www.ncbi.nlm.nih.gov/pubmed/17937567

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