Pregabalin vs. Pramipexole for Restless Legs Syndrome

February 12, 2014

Pregabalin vs. Pramipexole for Restless Legs Syndrome

  1. Allan S. Brett, MD

Efficacy is roughly equivalent; side-effect profiles are somewhat different.

  1. Allan S. Brett, MD

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 of pregabalin.

At baseline, the mean score on a 40-point standardized RLS symptom scale was 22. At 12 weeks, reductions in mean symptom scores were significantly greater in the pregabalin and the 0.5-mg pramipexole groups (−11 and −10 points) than in the placebo group (−7 points). No benefit was noted with lower-dose pramipexole. Between 12 weeks and 1 year (after placebo recipients were randomized to active treatments), pregabalin and higher-dose pramipexole remained more effective than lower-dose pramipexole. At 1 year, incidence of augmentation was significantly lower with pregabalin than with 0.5-mg pramipexole (2.1% vs. 7.7%). Dizziness and somnolence were more common with pregabalin than with pramipexole; nausea and headache were more common with pramipexole.


These results suggest that pregabalin and pramipexole (0.5 mg) are equally effective for managing restless legs syndrome. The drugs' side-effect profiles are somewhat different, and pregabalin therapy might be less likely to result in symptom augmentation. If pregabalin eventually is approved for use in RLS, it will provide one more alternative to dopamine agonists.

Editor Disclosures at Time of Publication

  • Disclosures for Allan S. Brett, MD at time of publication Nothing to disclose


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