Treatment Effects on Changes in Pain and Changes in Sleep: Pregabalin (Lyrica®) in Fibromyalgia (FM) Patients

Chronic pain and related sleep disturbance is prominent in patients with FM. Previous trials found pregabalin to be effective for treating pain and symptoms of disturbed sleep associated with FM. Here we explore the relationship between changes in pain and changes in sleep quality as measured on an 11 point numeric rating scale (NRS) and recorded in a daily sleep diary. These trials evaluated the relationship between pain and sleep quality in patients with chronic pain from FM. Patients meeting ACR criteria for FM for ≥3 months and who had pain VAS score ≥40 mm were followed for 8-14 weeks in 3 randomized, double-blind, placebo-controlled trials. A total of 2022 patients received either 150, 300, 450 or 600 mg/d pregabalin, or placebo after a 1-week baseline phase. The primary efficacy parameter was Endpoint Mean Pain Score (MPS) compared to baseline. Pearson correlations were used to explore relationships between changes in pain and changes in sleep. Pregabalin treatment at 300, 450 and 600 mg/d showed significant improvement in Endpoint MPS. Likewise, significant improvement was demonstrated for endpoint mean sleep quality across the pregabalin treatment groups. Correlations by treatment between changes in pain and sleep were as follows: 0.71 (placebo), 0.65 (150 mg/d), 0.73 (300 mg/d), 0.66 (450 mg/d) and 0.67 (600 mg/d). Adverse events were consistent with known side effects of pregabalin; dizziness and somnolence were the most frequently reported AEs for patients who received pregabalin and tended to resolve with treatment. Changes in pain correlated with changes in sleep quality across all treatments (including placebo) for patients with FM.

Study funded by Pfizer, Inc