By Jill Stein
BOSTON, MA -- May 2, 2007 -- Pregabalin (Lyrica) is highly effective for the management of pain related to fibromyalgia syndrome (FMS), according to data released here at the American Academy of Neurology (AAN) 59th Annual Meeting.
Researchers say that significantly more pregabalin-treated patients than placebo-treated patients had a pain reduction of at least 50%, and patients said they had improved significantly in overall status and health outcomes.
Investigator I. Jon Russell, MD, associate professor, division of clinical immunology and rheumatology, University of Texas Health Science Center at San Antonio, Texas, presented results in 745 patients who had undergone 14 weeks of treatment with pregabalin at daily doses of 300, 450, or 600 mg twice daily, or placebo.
All subjects satisfied the American College of Rheumatology criteria for FMS, including widespread pain for at least 3 months, pain Visual Analog Scale (VAS) score of at least 40 mm, and a decrease in VAS score of at least 30% during the placebo run-in phase.
The primary efficacy parameter was endpoint mean pain score.
Results showed that the overall pregabalin group had significant improvement in pain compared with the placebo group. At 14 weeks, the mean decreases in pain scores were 2.05 in the 600-mg group (P <.0001), 2.03 in the 450-mg group (P <.0001), 1.75 in the 300-mg group (P =.0009), and 1.04 in the placebo group.
In addition, 30% of patients receiving 600 mg, 27% of patients on the 450-mg dose, and 24% of those on 300 mg reported that their pain was reduced by at least 50%. In the placebo group, 15% of patients reported this level of pain relief.
All pregabalin groups showed statistically significant improvements in Patient Global Impression of Change scores. In addition, the 450-mg and 600-mg groups achieved statistically significant improvements in function, progress, and outcomes according to scores on the Fibromyalgia Impact Questionnaire.
Most treatment-related adverse effects were mild or moderate and of limited duration, and tended to be dose-related, according to the researchers.
Fibromyalgia is the most common chronic, generalized pain condition in the US. Studies indicate that at least 6 million Americans are affected; however, some investigators believe that the figure could be as high as 12 million.
There is no treatment that is specifically approved for fibromyalgia syndrome. The condition is treated by neurologists, rheumatologists, primary care physicians, psychiatrists, physiatrists, pain specialists, and nurse practitioners, among others.
Pregabalin is approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, and in epilepsy for the adjunctive treatment of partial-onset seizures in adults.
The study was sponsored by Pfizer, Inc.
[Presentation title: Pregabalin for Management of Fibromyalgia Syndrome (FMS): A 14-Week, Randomized, Double-Blind, Placebo-Controlled Monotherapy Trial. Abstract P03.075]
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