Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Jan;40(1):147-55.
doi: 10.1161/STROKEAHA.108.518621. Epub 2008 Oct 23.

Effect of raloxifene on stroke and venous thromboembolism according to subgroups in postmenopausal women at increased risk of coronary heart disease

Lori Mosca  1 , Deborah Grady, Elizabeth Barrett-Connor, Peter Collins, Nanette Wenger, Beth L Abramson, Annlia Paganini-Hill, Mary Jane Geiger, Sherie A Dowsett, Messan Amewou-Atisso, Marcel Kornitzer
Affiliations
Randomized Controlled Trial

Effect of raloxifene on stroke and venous thromboembolism according to subgroups in postmenopausal women at increased risk of coronary heart disease

Lori Mosca et al. Stroke. 2009 Jan.

Abstract

Background and purpose: Raloxifene, a selective estrogen receptor modulator, reduces risk of invasive breast cancer and osteoporosis, but the effect on risk for stroke and venous thromboembolism in different patient subgroups is not established. The purpose of this analysis was to evaluate the effect of raloxifene on the incidence of all strokes, stroke deaths, and venous thromboembolic events according to participant subgroups.

Methods: This was a secondary end point analysis of an international, randomized, placebo-controlled clinical trial of 10 101 postmenopausal women with or at increased risk of coronary heart disease followed a median of 5.6 years. Strokes, venous thromboembolic events, and deaths were adjudicated by expert centralized committees. Strokes were categorized as ischemic, hemorrhagic, or undetermined and venous thromboembolic events were subclassified.

Results: The incidences of all strokes did not differ between raloxifene (incidence rate per 100 woman-years=0.95) and placebo (incidence rate=0.86) treatment groups (P=0.30). In women assigned raloxifene versus placebo, there was a higher incidence of fatal strokes (incidence rates=0.22 and 0.15, respectively, P=0.0499) and venous thromboembolic events (incidence rates=0.39 and 0.27, respectively, P=0.02). No significant subgroup interactions were found except that there was a higher incidence of stroke associated with raloxifene use among current smokers.

Conclusions: In postmenopausal women at increased risk for coronary events, the incidences of venous thromboembolism and fatal stroke but not all strokes were higher in those assigned raloxifene versus placebo. Raloxifene's effect did not differ across subgroups, except that the risk of stroke differed by smoking status. Treatment decisions about raloxifene should be based on a balance of projected absolute risks and benefits.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Cumulative incidence rates for strokes, fatal strokes, and venous thromboembolic events.
Figure 2
Figure 2
Prespecified subgroup analyses for all strokes.
Figure 3
Figure 3
Post hoc subgroup analyses for fatal strokes.
Figure 4
Figure 4
Stroke distribution by baseline comorbidity.
Figure 5
Figure 5
Post hoc subgroup analyses for venous thromboembolic events.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Barrett-Connor E, Mosca L, Collins P, Geiger MJ, Grady G, Kornitzer M, McNabb MA, Wenger NK. Raloxifene Use for The Heart (RUTH) Trial Investigators. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2006;355:125–237. - PubMed
    1. Stefanick ML. Risk–benefit profiles of raloxifene for women. N Engl J Med. 2006;355:190–192. - PubMed
    1. Grady D, Wenger NK, Herrington D, Khan S, Furberg C, Hunninghake D, Vittinghoff E, Hulley S. Postmenopausal hormone therapy increases risk for venous thromboembolic disease: the Heart and Estrogen/progestin Replacement Study. Ann Intern Med. 2000;132:689–696. - PubMed
    1. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J, Writing Group for the Women's Health Initiative Investigators Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321–333. - PubMed
    1. Grady D, Ettinger B, Moscarelli E, Plouffe L, Jr, Sarkar S, Ciaccia A, Cummings S, Multiple Outcomes of Raloxifene Evaluation Investigators Safety and adverse effects associated with raloxifene: Multiple outcomes of raloxifene evaluation. Obstet Gynecol. 2004;104:837–844. - PubMed

Publication types

Substances