Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.

Milnacipran Reduces the Overall Severity of Fibromyalgia Symptoms in Patients with Fibromyalgia.

Palmer2,  Robert H., Bennett4,  Robert M., Wang3,  Yong, Gendreau1,  R. Michael

Cypress Bioscience, Inc., San Diego, CA
Forest Research Institute, Jersey City, NJ
Forest Research Institute
Oregon Health & Science Univ, Portland, OR


Fibromyalgia (FM) is a disorder characterized by chronic widespread pain, fatigue, and impaired physical and global function. Patients with FM often have a multitude of other symptoms that include stiffness, poor sleep quality, and cognitive dysfunction. The Fibromyalgia Impact Questionnaire (FIQ) is a validated instrument that measures the spectrum of these FM-related symptoms and can identify patient responses to therapy. Milnacipran, approved in the US for the management of FM, has shown efficacy in treating multiple symptoms in FM patients. This post hoc analysis examines the effect of milnacipran on patients' FM severity.


Data from a randomized, double-blind, placebo-controlled trial were analyzed. Patients with FM received milnacipran 100 mg/day (n=516) or placebo (n=509) for 4 to 6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment. The FIQ was administered to patients at baseline and at each study visit. Patients were classified into 3 severity categories based on their FIQ total scores at baseline: <39 (mild impairment); >=39 to <59 (moderate impairment); >=59 (severe impairment). Improvements in FM severity were determined by the percentage of patients at endpoint shifting from the severe to the moderate or mild categories, or from the moderate to the mild category. Odds ratios (OR) for milnacipran were calculated for shifts in each severity category and are expressed relative to placebo treatment. Analysis was based on LOCF.


FM severity based on the total FIQ score at baseline was mild (8.1%), moderate (48.5%), and severe (43.4%). At all study visits, patients treated with milnacipran had significantly larger decreases from baseline in FIQ total scores than placebo (P<.001 vs placebo). Of patients with severe FM at baseline, 61.1% of patients treated with milnacipran improved by at least one category of severity (32.2% to moderate and 28.9% to mild) compared with 46.1% of patients treated with placebo (26.5% to moderate and 19.6% to mild) (OR, 1.8; P=.002; number needed to treat, 7). Of patients with moderate or severe FM at baseline, 52.2% of milnacipran patients improved by at least one category, compared with 42.0% of placebo patients (OR, 1.5; P=.002; number needed to treat, 10).


These results represent an assessment of efficacy that indicate that milnacipran 100 mg/day is effective for treating the overall symptoms of FM, as measured by improvements in FIQ total scores. Patients with moderate or severe impairment at baseline were more likely to improve their FM severity with milnacipran than with placebo.

To cite this abstract, please use the following information:
Palmer, Robert H., Bennett, Robert M., Wang, Yong, Gendreau, R. Michael; Milnacipran Reduces the Overall Severity of Fibromyalgia Symptoms in Patients with Fibromyalgia. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :806
DOI: 10.1002/art.28574

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