Source: DGNews  |  Posted 2 years ago

By Jennifer Reising

SAN ANTONIO, Tex -- February 5, 2010 -- Milnacipran is effective and well tolerated in treating the multiple symptoms of fibromyalgia, including pain, global status, physical and mental functioning, and fatigue, researchers reported here at the 26th annual meeting of the American Academy of Pain Medicine (AAPM).

“The study demonstrated there was a clinically significant improvement in all 3 composite responder criteria at the same time in individual patients who received milnacipran 100 mg/day,” said Aroon Datta, MD, Forest Research Institute, Jersey City, New Jersey, on February 3. “This is important because fibromyalgia is multi-dimensional, so we don’t want to show that there’s just an improvement in pain, but in all other components of fibromyalgia.”

The randomised, double-blind, placebo-controlled study included 1,025 patients with fibromyalgia with a baseline visual analog scale (VAS) pain score >=40, <=90 (0 to 100 scale) on the patient electronic diary, and a Fibromyalgia Impact Questionnaire (FIQ) Physical Function score >=4.

Patients were randomly assigned to receive either milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients received 12 weeks of stable-dose treatment following a 4- to 6-week flexible dose-escalation phase.

The primary endpoints were a 2-measure composite responder analysis of >=30% improvement in VAS 24-hour recall pain and Patient Global Impression of Change (PGIC) rating of 1 or 2, and a 3-measure composite responder analysis which included the 2-measure composites plus a >=6-point improvement in the Short Form (SF)-36 Physical Component Summary (PCS) score.

Additional outcomes measured included the Multidimensional Fatigue Inventory (MFI), Brief Pain Inventory (BPI), and the FIQ.

Significantly more patients treated with milnacipran met the 2- and 3-measure composite responder criteria at 3 months compared with placebo (P < .001, both measures; baseline observation carried forward).

In addition, compared with the placebo group, patients receiving milnacipran showed significantly greater improvements from baseline on a number of additional endpoints, including VAS 24-hour recall pain, PGIC, SF-36 PCS, BPI average pain severity, FIQ total (P < .001, all measures), and MFI total (P = .036).

Milnacipran was generally well tolerated with the most common adverse event in both groups being nausea (20.8%, placebo; 36.6%, milnacipran). The incidence of serious adverse events was comparable between the milnacipran group and the placebo group (1.6% vs 1.2%, respectively).

Funding for this study was provided by Forest Laboratories, Inc., and Cypress Bioscience, Inc.

[Presentation title: Milnacipran 100 mg/day in the Treatment of Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Trial. Abstract 109]