Safety and efficacy of statins in patients with end-stage renal disease.

Objective: To review statins in the prevention of cardiovascular disease (CVD) events and their associated safety in patients with end-stage renal disease (ESRD).

Data Sources: Peer-reviewed clinical trials, review articles, and treatment guidelines were identified from MEDLINE (1966-July 2013) using the following search terms: end stage renal disease, statin, HMG-CoA (hydroxymethylglutaryl-coenzyme A) reductase inhibitor, chronic kidney disease, cardiovascular outcomes, and cardiovascular disease. Results were limited to human trials published in English. Citations from articles were reviewed for additional references.

Study Selection And Data Extraction: Only clinical trials evaluating cardiovascular end points of statins used in patients with ESRD were included.

Data Synthesis: In patients with ESRD, CVD is the leading cause of death. Statin therapy has been evaluated in 3 clinical trials in patients with ESRD. The 4D and AURORA trials failed to show a benefit with statin therapy, and the SHARP trial, although positive, also included patients with earlier stages of chronic kidney disease. Despite the lack of efficacy, statin therapy was well tolerated. The cause of cardiovascular death in this patient population may not be a result of atherosclerotic events and possibly dependent on the type of renal replacement therapy. For patients on hemodialysis, lipid profiles may not be amenable to statin therapy.

Conclusions: Statin therapy has failed to significantly alter the course of CVD events in patients with ESRD. Evidence supports avoiding the routine use of statins in this patient population and instead reserving them for patients with elevated cholesterol levels or those with recent CVD events.