Meta-analysis of the efficacy and safety of pramipexole in treating restless legs syndrome to different races

Abstract

Objective To analyze the efficacy and safety of pramipexole in treating restless legs syndrome (RLS) to different races. Methods A search for randomized, double-blind, and placebo-controlled clinical trials of pramipexole in treating RLS using Pubmed was carried out. A meta-analysis of included clinical trials was performed with Revman 5.2. The efficacy was calculated based on the change of the weighted mean difference (WMD) with International Restless Legs Syndrome Study Group rating scale (IRLS) and the relative risk (RR) of response with Clinical Global Impression-Improvement (CGI-I) scale. Safety was assessed with RR of the adverse event (AE). Subgroup analysis was conducted in the white race subgroup and the yellow race subgroup, separately. Results A total of 6 clinical trials were included in this meta-analysis. The records of patients were pooled. Overall, WMD of the change in IRLS score was -4.72 (Z=6.57, P<0.01), which was -4.33 in white race subgroup (Z=3.90, P<0.01) and -4.52 (Z=42.28, P<0.01) in yellow race subgroup. Overall RR of response based on CGI-I was 1.64 (Z=10.39, P<0.01), which was 1.60 (Z=4.66, P<0.01) in white race subgroup, and 1.51 (Z=4.42, P<0.01) in yellow race subgroup. Overall RR for AE was 1.26 (Z=5.11, P<0.01), which was 1.26 (Z=2.27, P=0.02) in white race subgroup and 1.36 (Z=2.98, P=0.003) in yellow race subgroup. Conclusion To treat RLS, pramipexole is an effective and safe drug. The results are similar for both the white race and the yellow race. Key words: Restless legs syndrome; Benzothiazoles; Reproducibility of results; Meta-analysis