Design and rationale of the ARBITER trial (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol) - A randomized trial comparing the effects of atorvastatin and pravastatin on carotid arteryintima-media thickness

Background As a class, statins ore remarkably effective in reducing low-den sity lipoprotein (LDL) cholesterol, and several of these drugs have now bee n shown to reduce coronary heart disease morbidity and mortality. However, several important controversies in the use of statins remain to be answered by clinical trials. For example, it is controversial whether marked choles terol reduction to levels below 100 mg/dL would further reduce the incidenc e of coronary heart disease. Furthermore, concerns about differences among statins for nonlipid effects has raised the concern that the assumption of: a class effect is premature until head-to-heed clinical trials are complet ed. Methods Arterial Biology for the investigation for the Treatment Effects of Reducing Cholesterol (ARBITER) is a single-center, randomized, active-cont rolled study comparing the efficacy of high-dose atorvastatin (80 mg/d) and pravastatin (40 mg/d) in patients being treated for either the primary or secondary prevention of coronary heart disease. This trial will enroll up t o 200 patients For the primary end point of the mean change in intima-media thickness of the common carotid artery. This effect will be evaluated over a treatment duration of 12 months. Secondary end points include the effect s of statin therapy on inflammatory and hemostatic markers (C-reactive prot ein and fibrinogen). Conclusion ARBITER will provide important date on the role of marked LDL re duction and the "class effect" theory of statin therapy in cardiovascular m edicine.