Cardiovascular events reported in randomized controlled trials in restless legs syndrome

Abstract

Objective: Evaluate the frequency of cardiovascular adverse events reported in randomized controlled trials (RCT) in Restless Leg Syndrome (RLS).

Methods: Databases were searched up to October 2015. Randomized, double-blind, placebo-controlled trials of patients with RLS were included if quantitative data were extractable. The primary outcome was cardiovascular adverse events defined as cardiac diseases, blood pressure abnormalities, syncope, cerebrovascular diseases, thromboembolic events, and sudden death. The pooled estimated prevalence of cardiovascular (CV) adverse events (AE) and respective 95% confidence interval (CI) was determined by using a meta-analysis.

Results: In sum, 28 RCT (2515 participants in the placebo arm and 4223 participants in the intervention arm) reported CV AE. The pooled estimated prevalence of CV AE was 0.61% (95% CI 0.31 to 0.91; I² = 0%) in the placebo arm and 0.68% (95%CI 0.40 to 0.96; I² = 18.25%) in the intervention arm. The frequency of major CV events (myocardial infarction, stroke and peripheral artery disease) was 0.49% (95%CI 0.22 to 0.77; I² = 0%) and 0.33% (95% CI 0.16 to 0.50; I² = 0%) in the placebo and intervention arm, respectively.

Conclusions: The frequency of major cardiovascular events in the RLS trials is not negligible, particularly when considering the young age of these patients.

Keywords: Cardiovascular diseases; Myocardial infarction; Peripheral artery disease; Randomized controlled trials; Restless leg syndrome; Stroke.