The efficacy and tolerability of rotigotine on patients with periodic limb movement in sleep: A systematic review and meta-analysis.

OBJECTIVE: There is still no consensus on the treatment for periodic limb movement in sleep (PLMS). This study aimed to determine the efficacy and tolerability of rotigotine in patients suffering from PLMS.

METHODS: Publications listed in PubMed, ScienceDirect, The Cochrane Library, and ClinicalTrials.gov were reviewed to assess the efficacy of rotigotine on PLMS. Analyses of PLMS frequency before and after rotigotine treatments (pre- and post-intervention studies) and PLMS frequency between placebo and rotigotine treatments (placebo-controlled trial studies) were included in our study. A systematic review and meta-analysis was conducted.

RESULTS: Five publications involving 197 participants were included in this study. Among these articles, pre- and post-intervention data involving 55 participants were available from three articles, while placebo-controlled trial data from 107 participants receiving rotigotine and 70 participants receiving a placebo were available from an additional three articles. In the pre- and post-intervention studies, the periodic limb movement index was significantly decreased after therapy with rotigotine with a difference in means of -5.866/h (95% CI, -10.570 to -1.162, p = 0.015). In comparison with the placebo, the use of rotigotine significantly lowered the periodic limb movement index, with a difference in means of -32.105/h (95% CI, -42.539 to -21.671, p < 0.001), reduced the PLMS with arousal index, with a difference in means of -7.160/h (95% CI, -9.310 to -5.010, p < 0.001), and increased the withdrawal rate, with an odds ratio of 3.421 (95% CI, 1.230 to 9.512, p = 0.018).

CONCLUSIONS: This meta-analysis revealed the considerable efficacy of rotigotine in alleviating the frequency of PLMS. However, the high withdrawal rate should be taken into account.