title: Aggressive versus moderate lipid-lowering therapy in hypercholesterolemic postmenopausal women: Beyond Endorsed Lipid Lowering with EBT Scanning (BELLES).
abstract: 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.
  
  
  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.
authors: Tulane University Health Sciences Center, New Orleans, LA 70112-2699, USA. praggi@tulane.edu
authors: Paolo
authors: P
authors: Raggi
authors: Michael
authors: M
authors: Davidson
authors: Tracy Q
authors: TQ
authors: Callister
authors: Francine K
authors: FK
authors: Welty
authors: Gloria A
authors: GA
authors: Bachmann
authors: Harvey
authors: H
authors: Hecht
authors: John A
authors: JA
authors: Rumberger
mesh_terms: D000368:Aged; D002114:Calcinosis / Q000517:prevention & control*; D002118:Calcium / Q000032:analysis*; D008078:Cholesterol, LDL / Q000097:blood; D003327:Coronary Disease / Q000517:prevention & control*; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D017698:Postmenopause; D014057:Tomography, X-Ray Computed
chemical_list: D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D002118:Calcium