"We found that pregabalin was effective and tolerated well as a treatment for pain and associated symptoms in patients with this condition," according to principal investigator Leslie J. Crofford, MD, Director, Women's Health Program, Professor of Internal Medicine and Chief of Rheumatology, University of Kentucky, Lexington, Kentucky, United States.

Patients with fibromyalgia have persistent pain at 11 of 18 trigger points throughout the body. The pain appears to be due to a dysfunction of the pain processing pathways in the central nervous system, rather than to an injury at the pain site, Dr. Crofford explained.

In the study, 529 women who met the American College of Rheumatology's criteria for fibromyalgia completed a 1-week baseline phase, after which they were randomized to receive either placebo or one of three doses of pregabalin (150, 300, or 450 mg daily). The treatment phase lasted for 8 weeks and was double-blinded, with the treatment given on a fixed-dose basis.

The effect of treatment were measured using patients' daily pain diaries, sleep-quality diaries, Patient and Clinical Global Impressions of Change (PGIC and CGIC, respectively), Medical Outcomes Study (MOS)-Sleep Scale, and Multidimensional Assessment of Fatigue (MAF).

Among all pregabalin treatment groups, 48% had a clinically meaningful reduction in pain, compared to 27% of those on placebo, which the investigators reported was a statistically significant difference (P </= .001). The study design defined a clinically meaningful reduction as a reduction in pain of at lease 30%. Among women on the 450 mg daily dose of pregabalin, 29% had a reduction in pain of at least 50% compared to 13% of those on placebo (P = .003).

Average sleep quality, fatigue, PGIC, and CGIC scores at the end of the treatment phase were significantly improved over baseline for women who received the 300 mg and 450 mg doses of pregabalin, the investigators reported. The MOS-Sleep Scale was also significantly improved over baseline in all of pregabalin groups.

The most common adverse events were dizziness and drowsiness. The investigators noted that 9% of patients withdrew due to adverse events, and that these withdrawals occurred at similar rates across the four groups.

Among the patients overall, 78% completed the trial and entered a follow-on safety trial.

The investigators concluded that pregabalin at the 450 mg daily dose was effective and well tolerated as a treatment for several symptoms of fibromyalgia.

The study was funded by Pfizer, the manufacturer of Lyrica.


[Presentation title: Pregabalin Efficaciously Treats Symptoms of Fibromyalgia Syndrome. Abstract NR801]

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