Aggressive versus moderate lipid-lowering therapy in hypercholesterolemic postmenopausal women - beyond endorsed lipid lowering with EBT scanning (BELLES)

Background - Women have been underrepresented in statin trials, and few data exist on the effectiveness and safety of statins in this gender. We used sequential electron-beam tomography (EBT) scanning to quantify changes in coronary artery calcium (CAC) as a measure of atherosclerosis burden in patients treated with statins. Methods and Results - In a double-blind, multicenter trial, we randomized 615 hyperlipidemic, postmenopausal women to intensive (atorvastatin 80 mg/d) and moderate (pravastatin 40 mg/d) lipid-lowering therapy. Patients also submitted to 2 EBT scans at a 12-month interval (mean interval 344 +/- 55 days) to measure percent change in total and single-artery calcium volume score (CVS) from baseline. Of the 615 randomized women, 475 completed the study. Mean +/- SD percent LDL reductions were 46.6% +/- 19.9% and 24.5% +/- 18.5 in the intensive and moderate treatment arms, respectively (P < 0.0001), and National Cholesterol Education Program Adult Treatment Panel III LDL goal was reached in 85.3% and 58.8% of women, respectively (P < 0.0001). The total CVS% change was similar in the 2 treatment groups (median 15.1% and 14.3%, respectively; P = NS), and single-artery CVS% changes and absolute changes were also similar (P = NS). In both arms, there was a trend toward a greater CVS progression in patients with prior cardiovascular disease, diabetes mellitus, and hypertension, whereas hormone replacement therapy had no effect on progression. Conclusions - In postmenopausal women, intensive statin therapy for 1 year caused a greater LDL reduction than moderate therapy but did not result in less progression of coronary calcification. The limitations of this study ( too short a follow-up period and the absence of a placebo group) precluded determination of whether progression of CVS was slowed in both arms or neither arm compared with the natural history of the disease.