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The Emerging Science abstracts were originally presented at the 2012 AAN Annual Meeting. Abstracts qualify for Emerging Science presentations by having key aspects of research conducted after the October 24th abstract submission deadline and must be new and of sufficient scientific importance to warrant expedited presentation and publication.
Long-Term Efficacy and Augmentation Assessment of a Dopamine Agonist (Pramipexole) Compared with an Alpha-2-Delta Ligand (Pregabalin) in Restless Legs Syndrome: Results of a Randomized, Double-Blinded, Placebo-Controlled Trial
Diego Garcia-Borreguero, MD, Crystal Chen, MD, Richard Allen, PhD, John Winkelman, Sarah Dubrava, MS, Jeffrey Miceli, PhD, Lloyd Knapp, PharmD
OBJECTIVE: To assess pregabalin efficacy vs placebo and pramipexole, and augmentation vs pramipexole, in restless legs syndrome (RLS). BACKGROUND: Dopamine agonists (e.g. pramipexole) are currently first-line treatment for RLS; however long-term use is limited by augmentation and they only partly improve sleep. Pregabalin has shown efficacy in improving RLS symptoms and sleep and, with its non-dopaminergic mechanism-of-action, might induce less augmentation. METHODS: This was a 12-week placebo-controlled, 52-week active-comparator, randomized, double-blinded, multicenter trial. Participants with moderate-to-severe RLS received pregabalin 300mg/day, pramipexole 0.25mg/day or pramipexole 0.5mg/day for 52 weeks, or placebo for the first 12 weeks followed by randomization to one of the 3 active treatments for 40 weeks. Co-primary endpoints were efficacy of pregabalin vs placebo in reducing RLS symptoms over 12 weeks and augmentation with pregabalin vs pramipexole over 40 or 52 weeks. RESULTS: 719 participants received treatment: 182 pregabalin, 178 pramipexole 0.25mg/day, 180 pramipexole 0.5mg/day, and 179 placebo. RLS symptoms were significantly improved with pregabalin vs placebo, as measured by International RLS Study Group Rating Scale (IRLS) score (change from baseline vs placebo, −4.5; p<0.0001) and Clinical Global Impression-Improvement (CGI-I) scale (71.4% vs 46.8% with symptoms “very much” or “much” improved; p<0.0001). Pregabalin also demonstrated superior short- and long-term efficacy to pramipexole in reducing RLS symptoms (IRLS). Incidence of augmentation over 40/52 weeks was significantly lower with pregabalin vs pramipexole 0.5mg/day (2.1% vs 8.3%;p=0.0012) and numerically lower vs pramipexole 0.25mg/day …
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