Pregabalin: an alpha2-delta (alpha2-delta) ligand for the management of fibromyalgia.
OBJECTIVE
To review the efficacy and safety of pregabalin, an alpha(2)-delta (alpha(2)-delta) ligand, for the management of fibromyalgia (FM).


METHODS
Review of 2 pivotal phase 3 trials that evaluated the efficacy and safety of pregabalin for the management of FM.


RESULTS
FM is a chronic condition that is characterized by widespread musculoskeletal pain and has a greater prevalence in women than in men. In a 14-week, randomized, double-blind trial, pregabalin at all 3 doses (300, 450, and 600 mg daily) resulted in significantly greater improvements in pain and function relative to placebo. Parallel with these improvements, greater proportions of patients in the pregabalin groups reported improvement in global disease status compared with placebo. In a second study designed to evaluate the durability of response, patients were randomized to up to 6 months of treatment with pregabalin or placebo after a 6-week, open-label, dose-optimization treatment phase. Based on predefined criteria for loss of therapeutic response, patients treated with pregabalin were observed to maintain a therapeutic response for a significantly longer duration than patients treated with placebo. Pregabalin was tolerated by most patients in both trials; the incidence of the most commonly reported adverse events (dizziness, somnolence, weight gain, headache, dry mouth) appeared to be dose-related.


CONCLUSIONS
Pregabalin has been demonstrated to be efficacious and well-tolerated for the management of FM.
Arnold
Lesley
L
University of Cincinnati College of Medicine, Cincinnati, OH, USA. lesley.arnold@uc.edu
Mease
Philip
P
Silverman
Stuart
S
D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D004305:Dose-Response Relationship, Drug; D005356:Fibromyalgia / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D000069583:Pregabalin; D016032:Randomized Controlled Trials as Topic; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid