From the American Academy of Neurology 59th Annual Meeting: Pregabalin provides relief from fibromyalgia-related pain

Key Points

Patients with pain related to fibromyalgia syndrome (FMS) can experience a ≥50% reduction in pain if they are treated with pregabalin, according to the results of a 14-week study in which 745 patients were randomized to either pregabalin (300, 450, or 600 mg twice daily) or placebo. The results were presented at the American Academy of Neurology 59th Annual Meeting.

"About 30 percent of patients achieve 50% improvement with 450 or 600 mg/d of pregabalin treatment, and about 50% of patients get 30% improvement. A 30% improvement represents a clinically relevant change in the severity of their discomfort," said I. Jon Russell, MD, associate professor in the clinical immunology and rheumatology division at the University of Texas Health Science Center at San Antonio.

Pregabalin is not approved by FDA for the treatment of fibromyalgia.

Patients rated their pain on a scale of 0 to 10. The mean baseline score was 6.7. At the conclusion of the study, pregabalin was associated with significant reductions in pain scores from baseline compared with placebo (600 mg/d, 2.05 point reduction; P<.0001; 450 mg/d, 2.03 point reduction; P<.0001; 300 mg/d, 1.75 point reduction; P=.0009). Patients taking placebo reported a mean 1.04 point reduction from baseline. Overall, 30%, 27%, and 24% of patients in the 3 pregabalin groups, respectively, experienced a ≥50% reduction in their pain compared with 15% of placebo recipients.

Patients in all 3 pregabalin groups reported improvements in overall status and function compared with placebo as measured by the Patient Global Impression of Change (PGIC) scale. Compared with placebo-treated patients, 20% more patients taking pregabalin 300 mg/d (P=.003), 30% more patients taking pregabalin 450 mg/d (P<.0001), and 18% more patients taking pregabalin 600 mg/d (P=.0005) reported at least minimal improvement on the PGIC.

In addition, patients in the 2 higher-dose groups had significant improvements in function, progress, and outcomes when these parameters were evaluated using the Fibromyalgia Impact Questionnaire.

The most common side effects associated with pregabalin were dizziness (36%), somnolence (18%), weight gain (13%), headache (9%), and peripheral edema (8%).