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An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia
The Journal of Rheumatology, 10/03/2011
Clinical Article
Pauer L et al. – Pregabalin demonstrated modest efficacy in pain, global assessment, and function in FM at 450 mg/day, and improved sleep across all dose levels, but it did not provide consistent evidence of benefit at 300 and 600 mg/day in this study. Pregabalin was generally well tolerated for the treatment of FM.
Methods- International, multicenter, double-blind, placebo-controlled trial randomly assigned 747 patients with FM to placebo or 300, 450, or 600 mg/day pregabalin twice daily for 14 weeks
- Primary efficacy measures were endpoint mean pain scores and Patient Global Impression of Change (PGIC)
- Secondary outcomes included assessments of sleep and function
- Patients in 450 mg/day pregabalin group showed significant improvements versus placebo in endpoint mean pain score (–0.56; p = 0.0132), PGIC (73% improved vs 56% placebo; p = 0.0017), and function [Fibromyalgia Impact Questionnaire (FIQ) total score –5.85; p = 0.0012]. PGIC was also significant for 600 mg/day pregabalin (69% improved; p = 0.0227)
- Results for these endpoints were nonsignificant for pregabalin at 300 mg/day and for pain and FIQ score at 600 mg/day
- Early onset of pain relief was seen, with separation from placebo detected by Week 1 in all pregabalin groups
- All pregabalin doses demonstrated superiority to placebo on Medical Outcomes Study-Sleep Scale Sleep Disturbance subscale and Sleep Quality diary
- Dizziness and somnolence were most frequently reported adverse events
