Clinical utility, safety, and efficacy of pregabalin in the treatment of fibromyalgia.

Significant improvements in FIQ were noted with pregabalin at the doses of 450 and 600 mg/day compared to placebo in a randomized trial 36 (baseline FIQ scores: 58.7, 61.1, 59.6, and 59.5 for placebo and pregabalin 300, 450, and 650 mg/day, respectively; FIQ scores at week 14: 51.99, 49.03, 46.75, and 46.65 for placebo and pregabalin 300, 450, and 600 mg/day, respectively; mean change from baseline: −7.74 for placebo, −12.98 for pregabalin 450 mg/day [ P =0.0041] and −13.08 for pregabalin 600 mg/day [ P =0.0034]); the difference did not reach statistical significance in patients taking the dose of 300 mg/day (FIQ score at baseline: 61.1 and at week 13: 49.03; mean change: −10.70 vs −7.74 for placebo [ P =0.1]).

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A third randomized trial with a similar sample size, 37 however, failed to show a statistically significant response in FIQ although there was an overall trend toward improvement (baseline FIQ scores: 64.3 for all groups; FIQ at week 13: 50.66, 48.18, 48.62, and 49.45 for placebo and pregabalin 300, 450, and 600 mg/day, respectively; mean change: −13.66, −16.15, −15.71, and −14.88 for placebo, pregabalin 300, 450, and 600 mg/day, respectively: all P -values >0.2).

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