By Liz Meszaros
PHILADELPHIA -- October 21, 2009 -- Milnacipran improves pain, global status, physical and mental function, and symptoms of fatigue in patients with fibromyalgia, according to research presented here at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).
Previous trials have shown the efficacy of milnacipran in the treatment of fibromyalgia with doses of up to 200 mg/day. For the current phase 3 trial, researchers evaluated the efficacy and tolerability of milnacipran 100 mg/day for the management of fibromyalgia.
"Patients are having a very good response to milnacipran," said Allan Spera, MD, Forest Research Institute, Jersey City, New Jersey. "Composite scores from our trials showed that they experienced decreases in pain and increases in global physical function. So they have not only a relief of pain, but improvements in functionality as well."
The double-blind, placebo-controlled trial included 1,025 patients with fibromyalgia who were randomised to milnacipran 100 mg/day or placebo. After 4 to 6 weeks of flexible dose escalation, patients had 12 weeks of stable-dose treatment, followed by a 2-week randomised, double-blind discontinuation phase.
At 3 months, significantly more of the patients treated with milnacipran met 2-measure composite responder criteria, which was defined as an individual achieving >=30% improvement from baseline in pain and a rating of "very much improved" or "much improved" on the Patient Global Impression of Change (PGIC; P < .001, baseline observation carried forward [BOCF]).
The results were the same for the 3-measure composite responder, which included the 2-measure composite responder achievements as well as a >=6-point improvement from baseline in physical function (P < .001, BOCF).
Patients treated with milnacipran had significantly greater improvements from baseline than placebo in a number of endpoints, including patient experience diary 24-hour recall pain, PGIC, Short Form-36 physical and mental component summaries, Brief Pain Inventory average pain severity, Fibromyalgia Impact Questionnaire total (all measures, P < .001), and Multidimensional Fatigue Inventory total (P = .036).
"Within 1 week, we saw a significant effect on pain relief with milnacipran in relief of pain," added Dr. Spera.
Indeed, significant improvements were seen in mean pain scores after 1 week of double-blind treatment and these were sustained through the stable-dose period (P < .001 vs placebo, all visits after 1 week).
Milnacipran was well tolerated by most patients, with the most common adverse event being nausea, which occurred in 36.6% of patients vs 20.8% in placebo.
"The side-effect profile was unremarkable, with some patients experiencing nausea. This subsided, however, after several weeks," he said.
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 1408]
E-Mail this DGDispatch to a colleague
