Lyrica and fibromyalgia
Researchers at the University of Michigan evaluated the efficacy and safety of pregabalin for the treatment of fibromyalgia (FM) in an eight-week, placebo-controlled, phase II trial. The patients were treated with pregabalin doses of 150mg, 300mg, or 450mg per day or with a placebo. The total dosage was divided into three doses a day and taken for eight weeks, after a one-week baseline observation period. The primary measure of efficacy was the pain score at the end of the eight weeks. This information was derived from daily pain diaries. Patients treated with pregabalin had statistically significant improvement in their mean pain score compared with the placebo. Of patients treated with pregabalin, 28.9 percent had a statistically significant (greater than 50 percent) reduction in pain from baseline compared to 13.2 percent of patients treated with the placebo. Forty-eight percent of patients in the pregabalin 450mg per day group had at least a 30 percent statistically significant reduction in pain from baseline compared to 27 percent on the placebo. The significant improvement in pain occurred as early as week one. There were significant improvements in functional measures such as sleep, fatigue, and quality of life. The most common treatment events were sleepiness and dizziness and were considered to be dose related. Discontinuation rates due to side effects were less than 10 percent. FM practitioners have used Lyrica in practice and more clinical information regarding its effect on FM is forthcoming.
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