Pregabalin: an alpha2-delta (alpha2-delta) ligand for the management of
Author(s): Arnold L, Mease P, Silverman S.
Affiliation(s): University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Publication date & source: 2010, Am J Manag Care. , 16(5 Suppl):S138-43
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
CONCLUSION: Pregabalin has been demonstrated to be efficacious and well-tolerated
for the management of FM.