What is the role of raloxifene (Evista) in the treatment of osteoporosis?

Updated: Jan 20, 2021
  • Author: Rachel Elizabeth Whitaker Elam, MD, MSc; Chief Editor: Herbert S Diamond, MD  more...
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Raloxifene (Evista) is a SERM indicated for the treatment and prevention of osteoporosis in postmenopausal women. The usual dose is 60 mg given orally daily. It can also be given in combination with calcium and vitamin D. It is the first SERM studied for breast cancer prevention, and it decreases bone resorption through actions on estrogen receptors.

Raloxifene has been shown to prevent bone loss, and data in women with osteoporosis have demonstrated that this agent causes a 35% reduction in the risk of vertebral fractures. It has also been shown to reduce the prevalence of invasive breast cancer. However, raloxifene is not without risk; it has been shown to increase the incidence of deep vein thrombosis, stroke, and hot flashes.

Raloxifene may be most useful in younger postmenopausal women without severe osteoporosis. In 601 postmenopausal women who had daily therapy with raloxifene, BMD was increased, serum concentrations of total low-density lipoprotein cholesterol were lowered, and the endometrium was not stimulated.

Pooled mortality data from large clinical trials of raloxifene (60 mg/day) were analyzed by Grady et al in 2010. When compared with placebo, all-cause mortality was 10% lower in older postmenopausal women receiving raloxifene. The primary reduction was in noncardiovascular, noncancer deaths. [169]  However, in contrast, the FDA has advised a black box warning on raloxifene for increased risk of venous thromboembolism and death from stroke. Increased risk of deep vein thrombosis, pulmonary embolism, and death due to stroke have been seen in trials with raloxifene and this must be weighed against potential benefit to patient for osteoporosis when considering prescribing raloxifene or other SERMs.

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