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Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women.
N Engl J Med. 2006 Jul 13; 355(2):125-37.NEJM

Abstract

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].).

Links

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Authors+Show Affiliations

Barrett-Connor E
Department of Family and Preventive Medicine, University of California, San Diego, La Jolla 92093-0607, USA. ebarrettconnor@ucsd.edu
Mosca L
No affiliation info available
Collins P
No affiliation info available
Geiger MJ
No affiliation info available
Grady D
No affiliation info available
Kornitzer M
No affiliation info available
McNabb MA
No affiliation info available
Wenger NK
No affiliation info available
Raloxifene Use for The Heart (RUTH) Trial Investigators
No affiliation info available

MeSH

AgedBreast NeoplasmsCoronary DiseaseDouble-Blind MethodFemaleHumansMiddle AgedPostmenopauseRaloxifene HydrochlorideRiskSelective Estrogen Receptor ModulatorsSpinal FracturesStrokeThromboembolism

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16837676

Clinical Trial Links

Clinical trial which this article describes

Citation

Barrett-Connor, Elizabeth, et al. "Effects of Raloxifene On Cardiovascular Events and Breast Cancer in Postmenopausal Women." The New England Journal of Medicine, vol. 355, no. 2, 2006, pp. 125-37.
Barrett-Connor E, Mosca L, Collins P, et al. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2006;355(2):125-37.
Barrett-Connor, E., Mosca, L., Collins, P., Geiger, M. J., Grady, D., Kornitzer, M., McNabb, M. A., & Wenger, N. K. (2006). Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. The New England Journal of Medicine, 355(2), 125-37.
Barrett-Connor E, et al. Effects of Raloxifene On Cardiovascular Events and Breast Cancer in Postmenopausal Women. N Engl J Med. 2006 Jul 13;355(2):125-37. PubMed PMID: 16837676.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. AU - Barrett-Connor,Elizabeth, AU - Mosca,Lori, AU - Collins,Peter, AU - Geiger,Mary Jane, AU - Grady,Deborah, AU - Kornitzer,Marcel, AU - McNabb,Michelle A, AU - Wenger,Nanette K, AU - ,, PY - 2006/7/14/pubmed PY - 2006/7/19/medline PY - 2006/7/14/entrez SP - 125 EP - 37 JF - The New England journal of medicine JO - N Engl J Med VL - 355 IS - 2 N2 - 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].). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16837676/Effects_of_raloxifene_on_cardiovascular_events_and_breast_cancer_in_postmenopausal_women_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa062462?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -