Presentation: Pregabalin Monotherapy for Management of Fibromyalgia: Analysis of Two Double-blind, Randomized, Placebo-Controlled Trials (2007)

1524 Pregabalin Monotherapy for Management of Fibromyalgia: Analysis of Two Double-blind, Randomized, Placebo-Controlled Trials

Objectives: This pooled analysis of 2 similarly designed RCTs was undertaken to provide additional insight into the efficacy of monotherapy with pregabalin (BID) as treatment of Fibromyalgia (FM) pain and associated symptoms.
Methods: The 2 trials employed a similar double-blind, placebo-controlled, design. Patients meeting 1990 ACR criteria for FM (widespread pain for ≥3 months and pain in ≥11 of 18 tender points) with mean pain score ≥4 (0-10 numeric rating scale) and pain VAS score ≥40 mm (0-100-mm scale) and were eligible for randomization to pregabalin 300, 450, or 600 mg/d (BID) or placebo for 13 or 14 weeks (1- or 2-week dosage-escalation). Primary efficacy parameter was endpoint mean pain score. Fibromyalgia Impact Questionnaire (FIQ) score and Patient Global Impression of Change (PGIC) were additional efficacy measurements. Supplementary analyses included ≥30% or ≥50% response in weekly mean pain score from baseline to endpoint.
Results: 1493 patients were randomized: 368 to pregabalin 300 mg/d, 373 to 450 mg/d, 378 to 600 mg/d, and 374 to placebo. 91% were white, 94% were women, mean age was 49 years, median FM duration was 9.7years, and baseline mean pain score was 6.9. Pregabalin significantly improved pain scores; differences from placebo in mean change from baseline to endpoint in pain score were: 300 mg/d, -0.55 (P=.0003); 450 mg/d, -0.71; 600 mg/d, -0.82 (each P<.0001). Pregabalin 450 and 600 mg/d were associated with significant improvements in FIQ total score: mean differences from placebo at endpoint were: 450 mg/d, -3.43 (P=.0116); 600 mg/d -3.05 (P=.0243). Mean treatment difference for 300 mg/d was -2.47 (P=.0707). PGIC results were significant in all pregabalin treatment groups (P ≤ .0002). The proportion of responders generally increased with increasing pregabalin (≥30% response, placebo, 32.6%; pregabalin 300 mg/d, 450 mg/d, and 600 mg/d; 42.1%; 46.4% and 45.8% respectively; ≥50% response placebo, 17.4%, pregabalin 300, 450, and 600 mg/d; 24.5%, 26.3% and 28.6% respectively). Pregabalin was generally well tolerated, and most adverse events (AEs) were mild to moderate in severity and tended to resolve with continued treatment. The most common treatment-emergent AEs among pregabalin-treated patients were dizziness (300 mg/d, 31%; 450 mg/d, 41%; 600 mg/d, 45%; placebo, 8%), somnolence (16%; 21%; 22%; 4%), and weight gain (11%; 11%; 14%; 2%).
Conclusions: Treatment with pregabalin 300, 450, and 600 mg/d (BID) was associated with robust efficacy for the management of FM. Pregabalin treatment was also associated with significant improvement in FIQ total score (450 and 600 mg/d) and in patients’ self ratings of their global improvement on the PGIC (all dosages).
Studies and analysis funded by Pfizer, Inc.

  R. Duan, Pfizer Empolyee, 3; H. Florian, Pfizer Employee, 3; J.P. Young, Pfizer Employee, 3; S. Martin, Pfizer Employee, 3; G. Haig, Pfizer Employee, 3; J. Barrett, Pfizer Employee, 3.