Rotigotine in the treatment of primary restless legs syndrome: A meta-analysis of randomized placebo-controlled trials.
10.1007/s11596-015-1406-5
- Author:
Jun DING
1
;
Wei FAN
;
Hong-hui CHEN
;
Peng YAN
;
Sheng-gang SUN
;
Jin ZHENG
Author Information
1. Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China, dingding803@126.com.
- Publication Type:Journal Article
- MeSH:
Humans;
Placebos;
Randomized Controlled Trials as Topic;
Restless Legs Syndrome;
drug therapy;
Tetrahydronaphthalenes;
therapeutic use;
Thiophenes;
therapeutic use
- From:
Journal of Huazhong University of Science and Technology (Medical Sciences)
2015;35(2):169-175
- CountryChina
- Language:English
-
Abstract:
The aim of this study was to summarize the efficacy and tolerability of rotigotine in the treatment of primary restless legs syndrome (RLS). PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for English-language randomized controlled trials (RCTs) that assessed the effectiveness of rotigotine for RLS. The pooled mean change from baseline in International RLS (IRLS) Study Group Rating Scalescore and relative risk (RR) of response based on the Clinical Global Impression-Improvement (CGI-I) scale score were applied to evaluate the outcomes. The pooled proportions of adverse events (AEs) were also estimated. Six RCTs were included. The meta-analysis showed a favorable effectiveness of rotigotine versus placebo on RLS [mean change on IRLS score: mean difference (MD)=-4.80; 95% confidence interval (CI): -5.90 to -3.70; P<0.00001 and RR of response on CGI-I was 2.19; 95% CI: 1.86 to 2.58, P<0.00001]. The most common AEs were application site reactions, nausea, headache and fatigue. In general, rotigotine was well-tolerated in patients with primary RLS. Based on the findings from the meta-analysis, rotigotine was more significantly efficacious in the treatment of RLS than placebo. Nevertheless, long-term studies and more evidence of comparisons of rotigotine with other dopamine agonists are needed.