Effect of amlodipine on the progression of atherosclerosis and the occurrence of clinical events

Background-The results of angiographic studies have suggested that calcium channel-blocking agents may prevent new coronary lesion formation, the prog ression of minimal lesions, or both. Methods and Results-The Prospective Randomized Evaluation of the Vascular E ffects of Norvasc Trial (PREVENT) was a multicenter, randomized, placebo-co ntrolled, double-masked clinical trial designed to test whether amlodipine would slow the progression of early coronary atherosclerosis in 825 patient s with angiographically documented coronary artery disease. The primary out come was the average 36-month angiographic change in mean minimal diameters of segments with a baseline diameter stenosis of 30%. A secondary hypothes is was whether amlodipine would reduce the rate of atherosclerosis in the c arotid arteries as assessed with B-mode ultrasonography, which measured int imal-medial thicknesses (IMT). The rates of clinical events were also monit ored. The placebo and amlodipine groups had nearly identical average 36-mon th reductions in the minimal diameter: 0.084 versus 0.095 mm, respectively (P=0.38). In contrast, amlodipine had a significant effect in slowing the 3 6-month progression of carotid artery atherosclerosis: the placebo group ex perienced a 0.033-mm increase in IMT, whereas there was a 0.0126-mm decreas e in the amlodipine group (P=0.007). There was no treatment difference in t he rates of all-cause mortality or major cardiovascular events, although am lodipine use was associated with fewer cases of unstable angina and coronar y revascularization. Conclusions-Amlodipine has no demonstrable effect on angiographic progressi on of coronary atherosclerosis or the risk of major cardiovascular events b ut is associated with fewer hospitalizations for unstable angina and revasc ularization.