What is Evista (Raloxifene), a trade name for?

What is Evista (Raloxifene)?

Evista is the brand name for raloxifene hydrochloride, a selective estrogen receptor modulator (SERM) that acts as an estrogen agonist in bone and an estrogen antagonist in breast and uterine tissue. 1

FDA-Approved Indications

Raloxifene is FDA-approved for three specific uses in postmenopausal women:

• Treatment and prevention of osteoporosis in postmenopausal women 2, 1
• Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis 2
• Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer 2

The FDA expanded these indications in 2007 to include breast cancer risk reduction 2

Mechanism of Action

Raloxifene is a second-generation SERM that is chemically different from tamoxifen and belongs to the benzothiophene class of compounds 2, 1. It functions through selective tissue effects:

• Acts as an estrogen agonist in bone, decreasing bone resorption and turnover while increasing bone mineral density 1
• Acts as an estrogen antagonist in breast and uterine tissues, providing considerably less endometrial stimulation compared to tamoxifen 2

Dosing and Formulation

• Standard dose: 60 mg orally once daily 2, 1
• Each tablet contains 60 mg of raloxifene hydrochloride, equivalent to 55.71 mg of free base 1
• Duration for breast cancer risk reduction: 5 years 2
• May be used longer than 5 years in women with osteoporosis, where breast cancer risk reduction becomes a secondary benefit 2

Clinical Efficacy

Breast Cancer Risk Reduction

• Reduces invasive breast cancer risk by 76% in postmenopausal women with osteoporosis over a median 40-month follow-up 3
• Reduces estrogen receptor-positive breast cancer risk by 66-90% but has no effect on estrogen receptor-negative cancers 2, 3
• In the MORE trial, the relative risk of developing invasive breast cancer was 0.24 (95% CI, 0.13-0.44) compared to placebo 2

Osteoporosis Treatment

• Reduces vertebral fracture risk by 30-55% in postmenopausal women with osteoporosis 4, 5
• Increases bone mineral density by 2.1-2.6% at the femoral neck and 2.6-2.7% at the spine after 36 months 4
• Does not reduce hip fracture or non-vertebral fracture risk (except ankle fractures) 3, 5

Important Safety Considerations

Contraindications

Raloxifene should not be used in:

• Women with history of deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack 2, 6
• Premenopausal women 2
• Women during prolonged immobilization 2, 6
• Pregnant women, women who may become pregnant, or nursing mothers 2

Common Adverse Effects

• Hot flashes 2, 7
• Leg cramps 2, 7
• Influenza-like syndromes 2
• Peripheral edema 2

Serious Adverse Effects

• Increased risk of venous thromboembolism: 0.7% with raloxifene 60 mg/day versus 0.2% with placebo (relative risk 3.1) 2, 7
• Increased risk of pulmonary embolism: 0.3% with raloxifene 120 mg/day versus 0.1% with placebo 2, 7
• No increased risk of endometrial cancer, unlike tamoxifen 2

Comparison to Tamoxifen

• Raloxifene and tamoxifen are equally effective at reducing invasive breast cancer risk in postmenopausal women 8
• Raloxifene has a more favorable side effect profile with lower risk of thromboembolic disease, benign uterine complaints, and cataracts compared to tamoxifen 6
• Raloxifene and tamoxifen should never be used together as they are alternative options, not complementary therapies 6

Special Populations

• Use with caution in moderate or severe renal impairment 1
• Use with caution in hepatic impairment 1
• No dose adjustment needed for geriatric patients 1