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 Improves Pain and Global Status Independent of Changes in Depressive Symptoms in Patients with Fibromyalgia.

Arnold5,  Lesley M., Gendreau1,  R. Michael, Gendreau2,  Judy, Spera3,  Allan, Chen4,  Wei

Cypress Bioscience, Inc., San Diego, CA
Cypress Bioscience, Inc.
Forest Research Institute, Jersey City, NJ
Forest Research Institute
University of Cincinnati, Cincinnati, OH

Purpose:

Milnacipran is effective in improving multiple symptom domains in fibromyalgia (FM), including pain, physical function, and depressive symptomatology. This post hoc analysis was conducted to elucidate the relationship between changes in pain and patient global status and changes in depressive symptomatology.

Method:

In this phase 3 trial, FM patients were randomized to milnacipran 100 mg/day (n=516) or placebo (n=509) for 12 weeks of stable-dose treatment. Patients with current major depressive episodes (assessed by MINI) or Beck Depression Inventory (BDI) scores >25 were excluded from the trial; however, 30% of patients had a history of depression at screening and in many cases had some evidence of depressive symptomatology. Outcome measures included a pain responder assessment (>=30% improvement from baseline in pain VAS scores), Patient Global Impression of Change (PGIC) responder analysis (rating of "very much improved" or "much improved"), and a 2-measure composite responder analysis (individual patients were required to meet both pain and PGIC responder criteria) at the end of the 12-week stable-dose treatment period. Changes in depressive symptoms were assessed with the BDI. Path analysis was used to describe the association between improvements in depressive symptoms and pain relief. The analysis was based on a regression model that partitioned the overall treatment effect into direct and indirect components.

Results:

Patients treated with milnacipran had a small but statistically significant decrease in BDI scores relative to placebo (-2.12 vs -1.24; P=.008); these changes were significantly correlated with improvements in pain VAS (r=0.210) and PGIC (r=0.309) scores (both P<.001). Pain, PGIC, and 2-measure composite responder rates were the highest in patients with the largest improvements in BDI scores and the lowest in patients with no improvement or worsening of BDI scores. However, even in patients with no improvement or worsening in BDI scores, milnacipran treatment resulted in significantly higher responder rates than placebo on pain, PGIC, and 2-measure composite responder analyses (P<.05, all measures). Path analysis demonstrated that 12.8% (90% CI: 4.8%, 23.5%) of the milnacipran treatment effect on pain relief at endpoint can be explained by improvements in depressive symptoms, and the remaining 87.2% (90% CI: 76.3%, 95.2%) was unexplained by improvements in depressive symptomatology.

Conclusion:

In patients with FM, treatment with milnacipran 100 mg/day significantly improves multiple domains, including pain, global status, and depressive symptoms. Much of the improvement in pain and global status with milnacipran is independent of improvements in depressive symptoms.

To cite this abstract, please use the following information:
Arnold, Lesley M., Gendreau, R. Michael, Gendreau, Judy, Spera, Allan, Chen, Wei; Milnacipran Improves Pain and Global Status Independent of Changes in Depressive Symptoms in Patients with Fibromyalgia. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :805
DOI: 10.1002/art.28573

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