The CHORUS (Cerivastatin in heart outcomes in renal disease Understanding survival) protocol: A double-blind, placebo-controlled trial in patients with ESRD

The 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)-medi ated lowering of serum cholesterol has been associated with a significant r eduction in cardiovascular morbidity and mortality. Recent studies suggest that additional non-lipid lowering effects (eg, endothelial stabilization, anti-inflammatory, antithrombogenic) may be important in modulating their e ffectiveness. Dyslipidemia is common in end-stage renal disease (ESRD), and hemodialysis patients have increased cardiovascular morbidity and mortalit y. Cerivastatin, a new statin with powerful low-density lipoprotein-cholest erol (LDL-C) lowering capabilities, possesses some unique non-LDL-C-mediate d properties that may contribute to a reduction of coronary events in the p atient with ESRD, The primary objective of this multicenter multinational s tudy of 1,054 hemodialysis patients is to compare 2 years of treatment with cerivastatin (0.4 mg/d) versus placebo on the composite clinical event rat e of myocardial infarction, sudden cardiac death, ischemic stroke, and the need for coronary arterial bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) procedures in these patients. Changes in lipid s, inflammatory proteins including heat stable C-reactive protein (hsCRP), interleukin-6 (IL-6), oncostatin-M, intracellular adhesion molecule-1 (ICAM -1) and monocyte-chemoattractant protein-1 (MCP-1), as well as markers of c ardiac muscle pathology, such as troponin I and troponin T, will be assesse d in a subset of patients. This study is the first of its kind to assess th e effect of a statin on the reduction of cardiovascular morbidity and morta lity in an incident hemodialysis population. It will determine whether trea tment with cerivastatin can effectively reduce the significant cardiovascul ar morbidity and mortality. (C) 2001 by the National Kidney Foundation, Inc .