Effects of Raloxifene on Cardiovascular Events and Breast Cancer in Postmenopausal Women
Open accessAbstract
BACKGROUND: The effect of raloxifene, a selective estrogen-receptor modulator, on coronary heart disease (CHD) and breast cancer is not established. METHODS: We randomly assigned 10,101 postmenopausal women (mean age, 67.5 years) with CHD or multiple risk factors for CHD to 60 mg of raloxifene daily or placebo and followed them for a median of 5.6 years. The two primary outcomes were coronary events (i.e., death from coronary causes, myocardial infarction, or hospitalization for an acute coronary syndrome) and invasive breast cancer. RESULTS: As compared with placebo, raloxifene had no significant effect on the risk of primary coronary events (533 vs. 553 events; hazard ratio, 0.95; 95 percent confidence interval, 0.84 to 1.07), and it reduced the risk of invasive breast cancer (40 vs. 70 events; hazard ratio, 0.56; 95 percent confidence interval, 0.38 to 0.83; absolute risk reduction, 1.2 invasive breast cancers per 1000 women treated for one year); the benefit was primarily due to a reduced risk of estrogen-receptor-positive invasive breast cancers. There was no significant difference in the rates of death from any cause or total stroke according to group assignment, but raloxifene was associated with an increased risk of fatal stroke (59 vs. 39 events; hazard ratio, 1.49; 95 percent confidence interval, 1.00 to 2.24; absolute risk increase, 0.7 per 1000 woman-years) and venous thromboembolism (103 vs. 71 events; hazard ratio, 1.44; 95 percent confidence interval, 1.06 to 1.95; absolute risk increase, 1.2 per 1000 woman-years). Raloxifene reduced the risk of clinical vertebral fractures (64 vs. 97 events; hazard ratio, 0.65; 95 percent confidence interval, 0.47 to 0.89; absolute risk reduction, 1.3 per 1000). CONCLUSIONS: Raloxifene did not significantly affect the risk of CHD. The benefits of raloxifene in reducing the risks of invasive breast cancer and vertebral fracture should be weighed against the increased risks of venous thromboembolism and fatal stroke. (ClinicalTrials.gov number, NCT00190593 [ClinicalTrials.gov].).
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Raloxifene is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.
“Raloxifene is also indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [83–86].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [86]
The Primary Outcomes (p. 5) report that raloxifene reduced invasive breast cancer in the RUTH trial, and the introductory text (p. 2) reports a similar finding from MORE, an osteoporosis-treatment trial. The paper does not state that breast-cancer risk reduction is an approved indication for postmenopausal women with osteoporosis; RUTH enrolled women with or at increased risk for coronary heart disease. (LLM, conf=0.84)
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- Authors
- Barrett-Connor, E., Mosca, L., Collins, P., Geiger, M. J., Grady, D., Kornitzer, M., McNabb, M. A., & Wenger, N. K.
- Affiliations
- University of California, San Francisco (US)
- Eli Lilly (United States) (US)
- San Francisco VA Medical Center (US)
- Université Libre de Bruxelles (BE)
- Emory University (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2006-07-13
- Volume
- 355
- Issue
- 2
- Pages
- 125-137
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2048257551
- Cited by
- 1,048
- References
- 31
- Citations by year
- 2026: 18 · 2025: 23 · 2024: 24 · 2023: 34 · 2022: 26 · 2021: 32 · 2020: 40 · 2019: 32 · 2018: 26 · 2017: 34 · 2016: 41 · 2015: 43 · 2014: 59 · 2013: 63 · 2012: 52
- FWCI
- 74.94
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, other-oa)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
- Health Sciences › Medicine › Pathology and Forensic Medicine › Phytoestrogen effects and research
- Keywords
- raloxifene, selective estrogen receptor modulators, coronary artery disease, invasive breast cancer, estrogen receptor-positive breast cancer, postmenopausal women, cardiovascular events, stroke, venous thromboembolism, vertebral fractures, osteoporosis, cardiovascular risk factors, myocardial infarction, acute coronary syndrome, mortality, fracture risk reduction, breast cancer risk reduction
- MeSH terms
- Aged, Breast Neoplasms, Coronary Disease, Double-Blind Method, Female, Humans, Middle Aged, Risk, Thromboembolism, Spinal Fractures, Postmenopause, Stroke, Selective Estrogen Receptor Modulators, Raloxifene Hydrochloride
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