Published online before print July 11, 2005, doi: 10.1161/CIRCULATIONAHA.104.512681
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(Circulation. 2005;112:563-571.)
© 2005 American Heart Association, Inc.
Imaging |
Aggressive Versus Moderate Lipid-Lowering Therapy in Hypercholesterolemic Postmenopausal Women
Beyond Endorsed Lipid Lowering With EBT Scanning (BELLES)
From Tulane University School of Medicine (P.R.), New Orleans, La; Rush-Presbyterian-St. Luke’s Medical Center (M.D.), Chicago, Ill; EBT Research Foundation (T.Q.C.), Hendersonville, Tenn; Harvard Medical School (F.K.W.), Boston, Mass; University of Medicine and Dentistry of New Jersey (G.A.B.), Robert Wood Johnson Medical School, New Brunswick, NJ; Beth Israel Medical Center and Continuum Heart Institute (H.H.), New York, NY; and The Ohio State University (J.A.R.), Columbus, Ohio.
Correspondence to Paolo Raggi, MD, Section of Cardiology, Tulane University Health Sciences Center, 1430 Tulane Ave, SL-48, New Orleans, LA 70112-2699. E-mail praggi{at}tulane.edu
Received October 6, 2004; revision received April 9, 2005; accepted April 13, 2005.
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.
Key Words: calcium • imaging • lipids • women
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