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Title: Pregabalin Therapy for Fibromyalgia Eases Pain and Improves Sleep Patterns: Presented at NAMS

"Pregabalin Therapy for Fibromyalgia Eases Pain and Improves Sleep Patterns: Presented at NAMS"

By Carole Bullock DALLAS, TX -- October 9, 2007 -- A pooling of two major trials of fibromyalgia syndrome (FMS) patients treated with pregabalin found that the drug improved sleep and lowered pain scores, investigators reported here at the North American Menopause Society (NAMS) 18th annual meeting. "Pregabalin therapy was associated with robust efficacy as demonstrated by endpoint mean pain score. The drug was also well-tolerated at the 600-mg/d dose," reported S. Martin, PhD, Pfizer Inc., Ann Arbor, Michigan, and New York, New York, who presented data from enrollees of the LIFT and RELIEF Trials, which compared 12-week fixed dose of pregabalin with placebo for improving sleep outcomes related to FMS. "Sleep disturbance is widely recognized as a key symptom, affecting about 74% of FMS patients, so the objective of this pooled analysis was to evaluate the efficacy of pregabalin for sleep-related outcomes," Dr. Martin said in a presentation on October 4. Researchers randomized 1,493 patients having FMS diagnosis to pregabalin 300, 450, or 600 mg/d for 13 to 4 weeks. Baseline and endpoint mean pain score and safety and frequency of adverse events were reported. Most of the population was female (93.2%), aged 49.4 years, with a mean duration of FMS of 9.7 years. Differences in placebo mean change from baseline to endpoint in pain score according to dosage were 300 mg/d, 0.55 ([P =.0003); 450 mg/d, 0.71 and 600 mg/d, 0.82 (each P <.0001).

All doses were associated with significant improvement in Patient Global Impression Change scores. For Medical Outcomes Scale, which included sleep disturbance, all pregabalin treatment groups improved compared to placebo.

Additionally, improvements were reported in sleep quality and sleep problem item index.

Up to 50% reported problems with dizziness; however, only 6.4% of patients discontinued the drug for that reason. Another 10% to 20% reported somnolence, weight gain, and headache.

"Incidence of treatment-emergent adverse events tended to increase with dosage," Dr. Martin added.

[Presentation title: Pregabalin Treatment Improves Sleep Outcomes in Fibromyalgia Patients (LIFT and RELIEF Trials). Abstract P-50.]

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