Is pregabalin a safe and effective treatment for patients with fibromyalgia?

Abstract

The concept of fibromyalgia being one of several 'central sensitivity syndromes' has led to the use of centrally acting drugs in the treatment of this disorder. One such drug, pregabalin, has recently been approved by the US FDA for the treatment of fibromyalgia. In a study by Mease and colleagues, significant relief from symptomatic pain was achieved in patients treated with pregabalin 300 mg/day, 450 mg/day and 600 mg/day compared with placebo. In addition, Patient Global Impression of Change and sleep scale scores were significantly improved in all treatment groups at the 13-week end point. Dizziness and somnolence were the two most common dose-related adverse events, but led to few withdrawals from the study. The results support the use of pregabalin as a mechanism-based treatment for pain and sleep disturbances in patients with fibromyalgia. Further studies with a longer observation period and randomized trials comparing different medications are needed.