Pregabalin (Lyrica) slightly outperformed pramipexole (Mirapex) for the treatment of restless legs syndrome (RLS) in a recent industry-sponsored trial. In a 52-week, randomized, double-blind trial, 719 patients were randomized to pregabalin 300 mg per day, pramipexole 0.25 mg or 0.5 mg per day, or 12 weeks of placebo followed by 40 weeks of randomly assigned active treatment. Over the first 12 weeks, the improvement in a standardized RLS scale was significantly greater among participants receiving pregabalin and the higher dose of pramipexole than those receiving placebo (P < 0.001). A drawback of dopaminergic drugs such as pramipexole is the development of iatrogenic worsening of RLS symptoms over time (augmentation), and this was seen significantly less frequently with pregabalin than with higher doses of pramipexole. Suicidal ideation was higher in the pregabalin group. The authors conclude that pregabalin provided significantly improved treatment outcomes as compared to placebo, and augmentation rates were lower with pregabalin than with higher doses of pramipexole for the treatment of RLS (N Engl J Med 2014;370:621-631).
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