title: Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome.
abstract: 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 3 mg/24 h 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.
authors.affiliation: Department of Somnology, Tokyo Medical University, 6-1-1 Shinjuku, Tokyo 160-8402, Japan. inoue@somnology.com
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Inoue
authors.forename: Koichi
authors.initials: K
authors.lastname: Hirata
authors.forename: Kenichi
authors.initials: K
authors.lastname: Hayashida
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Hattori
authors.forename: Takayuki
authors.initials: T
authors.lastname: Tomida
authors.forename: Diego
authors.initials: D
authors.lastname: Garcia-Borreguero
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D018491:Dopamine Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D012720:Severity of Illness Index; D013764:Tetrahydronaphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine