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Rotigotine in the Long-Term Treatment of Severe RLS with Augmentation: A Series of 28 Cases

DOI: 10.1155/2011/468952

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Abstract:

This structured clinical observation includes 28 patients with severe RLS, severe augmentation, and previously frustrating changes of dopaminergic treatment. All were switched from their current dopaminergic regimen to an individually adjusted rotigotine monotherapy; dosages were kept stable for 12 months. Follow-up exams were performed after 1, 3, 6, and 12 months. Severity of RLS symptoms (IRLS), augmentation (ASRS), depressive symptoms (BDI), and daytime sleepiness (ESS) were assessed at all visits. Median rotigotine dose was 4?mg. 27 of the 28 patients showed a major to complete reduction of RLS symptoms. IRLS and BDI scores (both ), but not ESS scores, were significantly reduced. IRLS and BDI amelioration remained stable over the 12-month follow-up period. Augmentation occurred in only one patient. 71.4% suffered at least one mostly mild side effect; most common were increased appetite with compulsive eating (42.9%), application site reaction (28.6%), and nausea (14.3%). In the clinical setting, rotigotine seems to be valuable for the long-term treatment of patients with severe RLS and augmentation. 1. Introduction Restless legs syndrome (RLS) with a prevalence of about 10% is one of the most common neurological disorders. It is characterized by an irresistible urge to move the legs and sometimes other body parts, which is accompanied by sensory leg discomfort, that occurs at rest and may be relieved by moving and follows a circadian rhythm with most pronounced symptoms at night [1, 2]. RLS symptoms may be effectively controlled using dopaminergic drugs. A number of studies suggest that regular (rr) and sustained release (sr) levodopa [3–5], pramipexole [6–9], ropinirole [10–13], and cabergoline [14–17] are useful for the short- and long-term treatment of RLS symptoms. All of these drugs share common side effects, including nausea, edema, and orthostatic hypotension, but are generally well tolerated. Another important side effect of dopaminergic medication is augmentation, which is defined as gain of symptoms regarding localization, time course and severeness while treatment may still be effective, leading to a gradual increase of daily dosages. Treatment is provided by either dose reduction or switch to another dopaminergic agent [1, 18]. Different studies have shown that augmentation occurs in up to 80% of patients treated with levodopa [1, 19] and in about 30% of patients treated with pramipexole [20, 21]. Usually, augmentation manifests within the first year of treatment, but also later in the treatment course augmentation may occur [22]. The

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