Effect of raloxifene on the incidence of elevated low density lipoprotein (LDL) and achievement of LDL target goals in postmenopausal women

Objective: To determine the extent to which raloxifene can maintain low density lipoprotein cholesterol (LDL-C) levels below 160 mg/dL or reduce elevated LDL-C levels to below lipid-lowering goals in postmenopausal women. Patients and methods: The Multiple Outcomes of Raloxifene Evaluation (MORE) osteoporosis treatment trial randomized 7705 postmenopausal women to placebo or raloxifene (60 mg or 120 mg) daily for a core treatment phase of 3 years. Changes in LDL-C and other serum lipids in a subset of women was a predefined secondary objective. This post-hoc analysis included the 2413 women who did not take lipid-lowering medications at any time during the trial and for whom LDL-C measurements were available. The threshold for high LDL-C (greater than or equal to 160 mg/dL) and LDL-C lipid-lowering goals were defined according to National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guidelines. Results: The percent of women with LDL-C < 160 mg/dL was comparable between treatment groups at baseline (placebo, 57.5%; raloxifene 60 mg, 56.4%; raloxifene 120 mg, 56.8%). At 3 years, the percent of these women whose LDL-C had increased to above 160 mg/dL was significantly less in the raloxifene 60 mg and 120 mg groups compared with placebo by 65% (95% CI, 44%-78%) and 64% (95% CI, 43%-77%), respectively. Among women with elevated (defined for these analyses as greater than or equal to 160 mg/dL) LDL-C at baseline, the proportion having elevated LDL-C at 3 years was significantly less in the raloxifene 60 mg and 120 mg groups compared with placebo by 32% (95% CI, 24%-40%) and 40% (95% CI, 32%-48%), respectively. Fifty percent and 13% of these women achieved LDL-C goals of < 160 mg/dL and < 130 mg/dL, respectively (P < 0.001 vs. placebo for both) in the raloxifene 60 mg group, with similar results for the raloxifene 120 mg group. Conclusions: In postmenopausal women with osteoporosis not taking concurrent lipid-lowering therapy, raloxifene significantly reduced the incidence of LDL-C greater than or equal to 160 mg/dL and significantly increased the proportion achieving LDL-C goals for lipid-lowering compared with placebo. Whether these and other effects of raloxifene on cardiovascular risk markers will improve cardiovascular outcomes requires further study.