P0285 - Pregabalin monotherapy for relief of pain associated with fibromyalgia: Durability of pain results of a 14-week, double-blind, placebo-controlled trial

Abstract

Background and Aims:

Evaluate durability of pregabalin's effect on pain associated with fibromyalgia (FM).

Methods:

Randomized, double-blind, placebo-controlled trial with 1-week single-blind placebo run-in. Patients meeting ACR diagnostic criteria were randomized to pregabalin 300, 450, or 600 mg/d (BID) or placebo for 14 weeks (2-week dosage escalation; 12-week fixed-dosage). Pain was assessed with a daily pain diary using an 11-point numeric scale. Primary efficacy parameter was the LOCF endpoint mean pain score (MPS). Sensitivity analyses were assessed using the Duration Adjusted Average Change (DAAC) and a Mixed Model Repeated Measurements (MMRM).

Results:

745 randomized patients: 95% female, mean age=50 years, median FM duration=10 years, baseline MPS=6.7. Placebo-corrected differences in mean change from baseline to endpoint in MPS: 300mg/d, -0.71 (P=0.0009); 450mg/d, -0.98 (P<0.0001); 600mg/d, -1.00 (P<0.0001). Mean differences from placebo at endpoint (adjusted for treatment duration) over the entire treatment period (DAAC): 300mg/d, -.38, P=0.0200; 450mg/d, -.62; P=0.0001 and 600mg/d,-.57 P<0.0001. In the MMRM analysis, all 3 pregabalin treatment groups demonstrated pain relief by Week 1, and every weekly assessment thereafter, with the exception of 300mg/d treatment group at Week 11. Most common AEs: dizziness (all pregabalin, 35.8% vs placebo, 7.6%); somnolence (18.0% vs 3.8%). Most AEs were mild to moderate and resolved with continued treatment.

Conclusions:

Pregabalin demonstrated significant reduction in endpoint MPS in FM patients. The DAAC sensitivity analysis confirmed the robustness of this effect. MMRM analyses demonstrated significant pain relief by Week 1 that was maintained throughout pregabalin treatment.

Study funded by Pfizer, Inc.