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

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.

► Rotigotine shows good efficacy and safety in patients with restless legs syndrome.
► Rotigotine at up to 3 mg/24 h 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.