(HealthDay News) — For patients with restless legs syndrome (RLS), pregabalin treatment is associated with improved treatment outcomes versus placebo and with lower augmentation than that seen with 0.5mg pramipexole, according to a study published in the February 13 issue of the New England Journal of Medicine.

Richard P. Allen, PhD, from Johns Hopkins University in Baltimore, and colleagues conducted a 52-week randomized trial involving 719 patients with RLS to assess efficacy and augmentation with pregabalin treatment compared with placebo and pramipexole. Participants received daily treatment: 182 with 300mg pregabalin, 178 with 0.25mg pramipexole, 180 with 0.5mg pramipexole, and 179 with placebo.

The researchers found that for patients receiving pregabalin versus placebo there was a greater improvement (reduction) in mean scores on the International RLS Study Group Rating Scale, by 4.5 points, over a 12-week period. Furthermore, a greater proportion of patients receiving pregabalin had symptoms that were very much improved or much improved versus those receiving placebo (71.4 versus 46.8%; P<0.001). Over a period of 40 to 52 weeks, the rate of augmentation was significantly lower with pregabalin than with 0.5 mg pramipexole (2.1 versus 7.7%; P=0.001), but not with 0.25 mg pramipexole (2.1 versus 5.3 percent; P=0.08).

“Pregabalin provided significantly improved treatment outcomes as compared with placebo, and augmentation rates were significantly lower with pregabalin than with 0.5mg of pramipexole,” the authors write.

The study was funded by Pfizer, the manufacturer of pregabalin; several authors are employees of Pfizer.

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