Effects of fluvastatin on cardiac events in renal transplant patients: ALERT (Assessment of Lescol (R) in Renal Transplantation) study design and baseline data

Background Recent clinical trials of primary and secondary prevention of ca rdiovascular disease have demonstrated that lowering plasma cholesterol wit h 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors ('st atins') reduces morbidity and mortality from coronary heart disease in dive rse patient populations. Study aims The aim of the present ALERT (Assessment of Lescol (R) in Renal Transplantation) study is to determine whether renal transplant recipients would also benefit from statin therapy. ALERT is a multicentre, randomized, double-blind, placebo-controlled trial to assess the effect of fluvastatin in renal transplant recipients with mild-to-moderate hypercholesterolaemia . The primary objective is to investigate the effects of fluvastatin on maj or adverse cardiac events (MACE). In addition, the effects on cardiovascula r and all-cause mortality, as well as renal function, will be addressed. Study population The study population contains patients with functioning re nal allografts of more than 6 months' duration, recruited from 75 centres i n Northern Europe and Canada. Patients of both sexes, aged 30-75 years, wit h a total cholesterol level of 4.0-9.0mmol/l (155-348 mg/dl) were included, except for those with a history of myocardial infarction, where the upper limit for inclusion was 7.0 mmol/l (270 mg/dl). Study design A total of 2100 patients were recruited by the end of October 1997 and will be followed for up to 6 years. This report presents the desig n features of the study (recruitment, follow-up, sample size, data analysis and study organization), along with baseline results. ALERT is the first l arge-scale prospective, randomized, double-blind study to address the preve ntion of cardiovascular mortality in renal transplant patients receiving an HMGCoA reductase inhibitor.