Is pregabalin a safe and effective treatment for patients with fibromyalgia?
Spaeth M - Pregabalin is safe and effective for the treatment of fibromyalgia, but further studies are needed to determine whether other treatments should be considered instead of, or in addition to, pregabalin, in pts who do not show a sufficient response. Methods- 748 pts with fibromyalgia to receive placebo (n=190) or pregabalin to assess the safety and efficacy of drug
- Doses - 300 mg/d, 450 mg/d, or 600 mg/d twice daily for 13 wks
- Pregabalin was initially administered at 150 mg/d then escalated to the fixed dose within 1 wk
- Safety and efficacy of pregabalin dosages for the relief of fibromyalgia pain was assessed
Results- Relief from symptomatic pain was achieved in pts treated with pregabalin 300 mg, 450 mg, and 600 mg/d vs placebo
- Patient Global Impression of Change and sleep scale scores were improved in all treatment groups at the 13-wk end point
- Dizziness and somnolence - the two most common dose-related AEs
- The results support the use of pregabalin in treatment for pain and sleep disturbances in fibromyalgia pts
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