The long search for an effective fibromyalgia pain treatment has finally yielded results. In a double-blind, controlled trial of 745 patients who had the frustrating ailment for a median of eight years, pregabalin (Lyrica) relieved pain and improved the quality of life.
The drug, manufactured by Pfizer, is indicated for diabetic peripheral neuropathic pain and postherpetic neuralgia. To date, no therapy has been specifically approved for fibromyalgia, and the American Pain Society’s most recent guidelines recommend only an antidepressant as the initial medication.
In the new study, investigators randomized the patients (95% women; mean age 50 years) to either placebo or one of three dosages of pregabalin for 14 weeks. Patients measured pain severity on a scale of 0-10; their baseline score averaged 6.7. After treatment, pain severity dropped by 2.05 points in the 600-mg/day group, 2.03 in the 450-mg/day group, 1.75 in the 300-mg/day group, and 1.04 in placebo patients.
Pain relief of at least 50% was reported by 24%-27% of those on Lyrica, depending on the dosages, compared with 15% of those on placebo. The Lyrica-treated patients also reported improved physical function and better overall health status. The most common side effects were dizziness and somnolence.
The researchers, who presented the study at the American Academy of Neurology’s annual meeting last month in Boston, called the findings “robust” and “clinically relevant.” The study was sponsored by Pfizer, which has applied for a fibromyalgia indication for Lyrica.