Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome

• Published in: Progress in neuro-psychopharmacology & biological psychiatry Vol. 40; pp. 326 - 333
• Main Authors: Inoue, Yuichi, Hirata, Koichi, Hayashida, Kenichi, Hattori, Nobutaka, Tomida, Takayuki, Garcia-Borreguero, Diego
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier Inc 10.01.2013; Elsevier
• Subjects: Adult; Aged; Application site reactions; Asian Continental Ancestry Group; Augmentation; Biological and medical sciences; Dopamine Agonists - adverse effects; Dopamine Agonists - therapeutic use; Female; Humans; Male; Medical sciences; Middle Aged; Nervous system (semeiology, syndromes); Nervous system as a whole; Neurology; Neuropharmacology; Pharmacology. Drug treatments; Quality of life; Responder rate; Restless legs syndrome; Restless Legs Syndrome - drug therapy; Rotigotine; Severity of Illness Index; Tetrahydronaphthalenes - adverse effects; Tetrahydronaphthalenes - therapeutic use; Thiophenes - adverse effects; Thiophenes - therapeutic use; Treatment Outcome; Application site reactions; SAS; LOCF; MedDRA; MPI; ECG; NIH; ASRS; QOL; SF-36; Quality of life; Augmentation; SD; Restless legs syndrome; IRLS; RLS; Rotigotine; FAS; JESS; Responder rate; IRLSSG; PSQI; Sensitivity disorder; Agonist; Nervous system diseases; Dopamine receptor; Toxicity; D1 Dopamine receptor; Antiparkinson agent; D3 Dopamine receptor; D2 Dopamine receptor; Efficiency; Dopamine agonist; Risk factor; Safety; Neurological disorder
• ISSN: 0278-5846; 1878-4216; 1878-4216
• DOI: 10.1016/j.pnpbp.2012.10.012

The present study aimed to examine the long-term efficacy and safety of rotigotine treatment for restless legs syndrome (RLS), as well as the rate of clinically significant augmentation, in a 1-year open-label study of Japanese subjects. Japanese patients with RLS who had been treated with rotigotine or placebo in a double-blind trial were enrolled in a 1-year, open-label, uncontrolled extension study and treated with rotigotine at a dose of up to 3mg/24h after an 8-week titration phase. Outcomes included International Restless Legs Syndrome Study Group rating scale (IRLS scale), Pittsburgh Sleep Quality Index (PSQI), safety, and investigator-/expert panel-assessed augmentation (including Augmentation Severity Rating Scale). Overall, 185 patients entered the open-label study and 133 completed the study. IRLS and PSQI total scores improved throughout the 52-week treatment period (IRLS, from 23.2±5.1 to 7.8±7.6 and PSQI, from 8.0±3.1 to 5.0±2.9). Treatment-emergent adverse events were mild to moderate in severity, and included application site reactions (52.4%) and nausea (28.6%). Clinically significant augmentation occurred in five patients (2.7%). These results indicate a good long-term efficacy of rotigotine for treating RLS, with a relatively low risk of clinically significant augmentation. ► Rotigotine shows good efficacy and safety in patients with restless legs syndrome. ► Rotigotine at up to 3mg/24h significantly improved IRLS, PSQI and SF-36 scores. ► Mean IRLS scores decreased from 23.2 to 7.8 during the 52-week study period. ► Clinically significant augmentation occurred in five patients (2.7%). ► Rotigotine was well tolerated with adverse events of only mild to moderate severity.