What is the use of Raloxifene (Selective Estrogen Receptor Modulator)?

From the Guidelines

Raloxifene is recommended for the prevention and treatment of osteoporosis in postmenopausal women, as well as for the reduction of invasive breast cancer risk in postmenopausal women with osteoporosis or at increased risk of breast cancer, due to its dual action as an estrogen agonist in bone tissue and antagonist in breast and uterine tissues. The standard dosage of raloxifene is 60 mg taken orally once daily, with or without food 1. Raloxifene has been shown to decrease the incidence of vertebral fracture, although it has not been found to have a significant benefit against non-vertebral or hip fractures 1. Common side effects of raloxifene include hot flashes, leg cramps, and an increased risk of blood clots, such as deep venous thromboses and pulmonary emboli 1. Raloxifene should not be used by women who are pregnant, nursing, or have a history of venous thromboembolism. For optimal bone health, patients should also ensure adequate calcium (1000-1200 mg daily) and vitamin D (800-1000 IU daily) intake while taking raloxifene. Some key points to consider when prescribing raloxifene include:

• Raloxifene is FDA approved for the treatment and prevention of osteoporosis in postmenopausal women, as well as for the reduction of invasive breast cancer risk in postmenopausal women with osteoporosis or at increased risk of breast cancer 1
• The medication is typically continued for several years to achieve maximum benefit for osteoporosis prevention and treatment
• Raloxifene does not relieve menopausal symptoms such as hot flashes and may actually worsen them
• Patients should be monitored for signs of blood clots and other side effects while taking raloxifene.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Raloxifene Overview

• Raloxifene is a selective estrogen receptor modulator (SERM) that has been shown to be effective in increasing bone mineral density (BMD) and reducing the risk of vertebral fractures in postmenopausal women with osteoporosis 2, 3, 4, 5.
• It has also been found to reduce the risk of invasive breast cancer in postmenopausal women 2, 3, 4, 5, 6.

Efficacy in Osteoporosis

• Raloxifene has been shown to increase BMD in the lumbar spine, femoral neck, and total hip in postmenopausal women with osteoporosis 2, 5.
• It has also been found to reduce the risk of vertebral fractures by 30-50% in women with prevalent fractures or osteoporosis 2, 5.

Efficacy in Breast Cancer Prevention

• Raloxifene has been shown to reduce the risk of invasive breast cancer by 76% in postmenopausal women with osteoporosis and no history of breast cancer 2.
• It has also been found to be as effective as tamoxifen in reducing the risk of invasive breast cancer, with a lower risk of thromboembolic events and cataracts 6.

Safety Profile

• Raloxifene has been found to be generally well tolerated, with common adverse events including hot flushes and leg cramps 2, 5.
• It has also been found to increase the risk of venous thromboembolism, with a relative risk of 3.1 compared to placebo 2.
• Raloxifene has not been found to have stimulatory effects on the endometrium, and has been found to reduce the risk of vaginal bleeding compared to estrogen or hormone replacement therapy 2.