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OBJECTIVE: 1) Evaluate pregabalin’s efficacy/safety for treating FMS-associated pain: 2) Evaluate pregabalin’s efficacy/safety for management of FMS.
BACKGROUND: Previous trials found pregabalin to be effective for treating pain and other symptoms associated with FMS.
DESIGN/METHODS: Randomized, double-blind, placebo-controlled with 1-week single-blind placebo run-in. Patients meeting ACR criteria for FMS, including widespread pain ≥3 months, who had pain VAS score ≥40 mm (0-100 mm scale), and who did not have ≥30% reduction in VAS score during placebo run-in were randomized to pregabalin 300, 450, or 600 mg/d (BID) or placebo for 14 weeks (2-week dosage escalation; 12-week fixed dosage). Primary efficacy parameter was endpoint mean pain score. If met, additional primary efficacy parameters included endpoint scores on the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ).
RESULTS: 745 patients were randomized: 95% female, mean age=50 years, median FMS duration=8 years, baseline mean pain score=6.7. Differences from placebo in mean change from baseline to endpoint in pain score were 300 mg/d, -0.71 (P=.0009); 450 mg/d, -0.98, 600 mg/d, -1.00 (each P<.0001). On the PGIC, 68% of 300 mg/d, 78% of 450 mg/d, and 66% 600 mg/d patients reported at least minimal improvement vs 48% of placebo patients, representing a statistically significant superiority. Pregabalin 450 and 600 mg/d were associated with statistically significant improvements in total FIQ score: mean differences from placebo at endpoint were: 450 mg/d, -5.24 (P=.0041); 600 mg/d, -5.34 (P=.0034). Incidence of Aes increased with dosage. The most common Aes were dizziness (all pregabalin, 35.8%; placebo, 7.6%) and somnolence (18%, 3.8%).
CONCLUSIONS/RELEVANCE: Pregabalin treatment demonstrated robust efficacy for relief of FMS-associated paiin at all dosages. The clinical relevance of these findings were confirmed by efficacy in the PGIC (all doses) and in total FIQ scores (450 and 600 mg/d).
Abstract presented at
American Academy of Neurology
May 1, 2007
Washington DC
American Pain Society
May 3, 2007
Washington DC
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