Objective: To evaluate in an open-label clinical series the occurrence of restless legs syndrome (RLS) augmentation in 60 consecutive RLS patients treated with pramipexole (PPX) for at least 6 months.
Background: In patients with restless legs syndrome (RLS), augmentation is most commonly seen with long-term use of levodopa and pergolide.
Method: Open-label clinical series in 60 consecutive RLS patients treated with PPX for at least 6 months.
Results: Augmentation was observed in five patients (8.3%) after 4-15 weeks of treatment. Augmentation occurred more frequently in patients with secondary RLS (4/21) than in those with idiopathic RLS (1/39).
Conclusions: Augmentation is unrelated to either severity of RLS or doses of PPX. There is a very low optimal therapeutic dose of PPX (0.25 mg/day) in most RLS patients (66%).