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Volume 337:1641-1647 December 4, 1997 Number 23 Next

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ABSTRACT

Background Long-term estrogen therapy can reduce the risk of osteoporotic fracture and cardiovascular disease in postmenopausal women. At present, however, these beneficial effects are not separable from undesirable stimulation of breast and endometrial tissues.

Methods We studied the effect of raloxifene, a nonsteroidal benzothiophene, on bone mineral density, serum lipid concentrations, and endometrial thickness in 601 postmenopausal women. The women were randomly assigned to receive 30, 60, or 150 mg of raloxifene or placebo daily for 24 months.

Results The women receiving each dose of raloxifene had significant increases from base-line values in bone mineral density of the lumbar spine, hip, and total body, whereas those receiving placebo had decreases in bone mineral density. For example, at 24 months, the mean (±SE) difference in the change in bone mineral density between the women receiving 60 mg of raloxifene per day and those receiving placebo was 2.4±0.4 percent for the lumbar spine, 2.4±0.4 percent for the total hip, and 2.0±0.4 percent for the total body (P<0.001 for all comparisons). Serum concentrations of total cholesterol and low-density lipoprotein cholesterol decreased in all the raloxifene groups, whereas serum concentrations of high-density lipoprotein cholesterol and triglycerides did not change. Endometrial thickness was similar in the raloxifene and placebo groups at all times during the study. The proportion of women receiving raloxifene who reported hot flashes or vaginal bleeding was not different from that of the women receiving placebo.

Conclusions Daily therapy with raloxifene increases bone mineral density, lowers serum concentrations of total and low-density lipoprotein cholesterol, and does not stimulate the endometrium.

Source Information

From Hôpital Edouard Herriot and INSERM Research Unit 403, Lyons, France (P.D.D., A.-C.R.); the Center for Clinical and Basic Research, Ballerup, Denmark (N.H.B., C.C.); and Lilly Research Laboratories, Lilly Corporate Center, Indianapolis (B.H.M., A.S.S., W.J.H., M.D.).

Address reprint requests to Dr. Delmas at Hôpital Edouard Herriot, Pavillon F, 69437 Lyons, CEDEX 03, France.

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Effects of Raloxifene in Postmenopausal Women
Cole R. C., Flaws J. A., Bush T. L., Friedman M. N., Delmas P. D., Mitlak B. H., Christiansen C.
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N Engl J Med 1998; 338:1313-1314, Apr 30, 1998. Correspondence

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• FRIEDLANDER, A. H. (2002). The physiology, medical management and oral implications of menopause. Journal of the American Dental Association 133: 73-81 [Abstract] [Full Text]  
• McDonnell, D. P., Connor, C. E., Wijayaratne, A., Chang, C.-y., Norris, J. D. (2002). Definition of the Molecular and Cellular Mechanisms Underlying the Tissue-selective Agonist/Antagonist Activities of Selective Estrogen Receptor Modulators. Recent Prog Horm Res 57: 295-316 [Abstract] [Full Text]  
• Hisamoto, K., Ohmichi, M., Kanda, Y., Adachi, K., Nishio, Y., Hayakawa, J., Mabuchi, S., Takahashi, K., Tasaka, K., Miyamoto, Y., Taniguchi, N., Murata, Y. (2001). Induction of Endothelial Nitric-oxide Synthase Phosphorylation by the Raloxifene Analog LY117018 Is Differentially Mediated by Akt and Extracellular Signal-regulated Protein Kinase in Vascular Endothelial Cells. J. Biol. Chem. 276: 47642-47649 [Abstract] [Full Text]  
• Dardes, R. C., Bentrem, D., O'Regan, R. M., Schafer, J. M., Jordan, V. C. (2001). Effects of the New Selective Estrogen Receptor Modulator LY353381.HCl (Arzoxifene) on Human Endometrial Cancer Growth in Athymic Mice. Clin. Cancer Res. 7: 4149-4155 [Abstract] [Full Text]  
• Grossman, J. M., MacLean, C. H. (2001). Quality Indicators for the Management of Osteoporosis in Vulnerable Elders. ANN INTERN MED 135: 722-730 [Full Text]  
• Jordan, V. C., Gapstur, S., Morrow, M. (2001). Selective Estrogen Receptor Modulation and Reduction in Risk of Breast Cancer, Osteoporosis, and Coronary Heart Disease. JNCI J Natl Cancer Inst 93: 1449-1457 [Abstract] [Full Text]  
• Gallagher, J. C., Baylink, D. J., Freeman, R., McClung, M. (2001). Prevention of Bone Loss with Tibolone in Postmenopausal Women: Results of Two Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Studies. J. Clin. Endocrinol. Metab. 86: 4717-4726 [Abstract] [Full Text]  
• Fitts, J. M., Klein, R. M., Powers, C. A. (2001). Estrogen and Tamoxifen Interplay with T3 in Male Rats: Pharmacologically Distinct Classes of Estrogen Responses Affecting Growth, Bone, and Lipid Metabolism, and Their Relation to Serum GH and IGF-I. Endocrinology 142: 4223-4235 [Abstract] [Full Text]  
• Dowsett, M., Bundred, N. J., Decensi, A., Sainsbury, R. C., Lu, Y., Hills, M. J., Cohen, F. J., Veronesi, P., O'Brien, M. E. R., Scott, T., Muchmore, D. B. (2001). Effect of Raloxifene on Breast Cancer Cell Ki67 and Apoptosis: A Double-Blind, Placebo-controlled, Randomized Clinical Trial in Postmenopausal Patients. Cancer Epidemiol. Biomarkers Prev. 10: 961-966 [Abstract] [Full Text]