What is the recommended use of Evista (raloxifene) in postmenopausal women?

Recommended Use of Raloxifene (Evista) in Postmenopausal Women

Raloxifene (60 mg daily) is recommended for postmenopausal women in two primary scenarios: for treatment and prevention of osteoporosis, and for reduction of invasive breast cancer risk in those with osteoporosis or at high risk of breast cancer. 1

FDA-Approved Indications

Raloxifene is FDA-approved for:

1. Treatment and prevention of osteoporosis in postmenopausal women
2. Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis
3. Reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer 1

Dosage and Administration

• The recommended dosage is 60 mg orally once daily
• May be taken any time of day without regard to meals
• Standard duration is 5 years for breast cancer risk reduction 2
• May be used longer than 5 years in women with osteoporosis, where breast cancer risk reduction becomes a secondary benefit 2, 3

Patient Selection

Ideal Candidates

Raloxifene should be considered for postmenopausal women who are:

• ≥35 years of age with a 5-year projected absolute breast cancer risk ≥1.66% (according to the NCI Breast Cancer Risk Assessment Tool) 2
• Diagnosed with lobular carcinoma in situ (LCIS) 2
• Diagnosed with osteoporosis or low bone mass requiring treatment 2
• At high risk for breast cancer, defined as having at least one breast biopsy showing LCIS or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥1.66% 1

Contraindications

Raloxifene should not be used in:

• Premenopausal women 2
• Women with history of deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack 2
• During periods of prolonged immobilization 2
• Women with active venous thromboembolic disease 1

Clinical Benefits

Osteoporosis Prevention and Treatment

• Increases bone mineral density by 2.1-2.6% at the femoral neck and spine compared to placebo 4
• Reduces the risk of vertebral fractures by 30-55% in postmenopausal women with osteoporosis 4
• First-line therapy option for younger postmenopausal women with osteoporosis 2

Breast Cancer Risk Reduction

• Reduces the risk of invasive breast cancer by 76% during a median follow-up of 40 months 5
• Particularly effective for estrogen receptor-positive invasive breast cancers (90% risk reduction) 5
• Does not reduce the risk of estrogen receptor-negative cancers 2
• Not effective for reducing the risk of noninvasive breast cancer 2

Adverse Effects and Monitoring

Common Side Effects

• Hot flashes (more pronounced in early menopause) 3
• Leg cramps 2, 3
• Peripheral edema 2
• Influenza-like symptoms 2

Serious Adverse Events

• Increased risk of venous thromboembolism (relative risk of 3.1 compared to placebo) 4, 5
• Increased risk of fatal stroke in women at high risk of coronary events 6

Monitoring Recommendations

• Baseline bone mineral density testing before initiating therapy 3
• Regular breast exams and mammograms before and during treatment 1
• Vigilance for symptoms of venous thromboembolism 3
• Calcium (1,200 mg daily) and vitamin D (600-800 IU daily) supplementation 2, 3

Clinical Decision Algorithm

1. Assess menopausal status: Confirm patient is postmenopausal
2. Screen for contraindications: Rule out history of thromboembolic events
3. Determine primary indication:
   • For osteoporosis: Confirm diagnosis with DEXA scan (T-score ≤-2.5 or low bone mass with risk factors)
   • For breast cancer risk reduction: Calculate 5-year breast cancer risk (≥1.66%)
4. Consider patient age and comorbidities: Especially suitable for younger postmenopausal women
5. Discuss benefits vs. risks: Weigh fracture prevention and breast cancer risk reduction against potential for thromboembolic events
6. Determine treatment duration:
   • Standard: 5 years for breast cancer risk reduction
   • Extended: >5 years if treating osteoporosis

Important Clinical Considerations

• Raloxifene does not stimulate endometrial tissue, unlike estrogen or tamoxifen 5
• It has favorable effects on lipid profile, reducing total and LDL cholesterol 5
• Women at increased risk of both fracture and invasive breast cancer are most likely to receive dual benefits 6
• Raloxifene is not recommended after tamoxifen therapy due to potential cross-resistance 2
• It does not eliminate the risk of breast cancer, so continued screening is essential 1