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Dopamine agonists such as pramipexole and ropinirole reduce symptoms in patients with restless legs syndrome (RLS). However, some patients don't tolerate these drugs, and their long-term use can be associated paradoxically with worsened symptoms (so-called “augmentation”). Gabapentin and pregabalin also attenuate RLS symptoms, and gabapentin enacarbil (a long-acting form of gabapentin) is FDA-approved for RLS.
In this trial, researchers randomized 719 patients with moderate-to-severe RLS to receive pregabalin (300 mg daily), pramipexole (0.25 mg or 0.5 mg daily), or placebo. At 12 weeks, placebo recipients were randomized to one of the other three treatment groups for the rest of the 1-year study. The trial was sponsored by the manufacturer …