What is Raloxifene used for in postmenopausal women?

Raloxifene Uses in Postmenopausal Women

Raloxifene is primarily used in postmenopausal women for the treatment and prevention of osteoporosis and for reducing the risk of invasive breast cancer in those with osteoporosis or at high risk for breast cancer. 1, 2

Primary Indications

Osteoporosis Management

• FDA-approved for both treatment and prevention of osteoporosis in postmenopausal women 1
• Increases bone mineral density (BMD) by 2.1-2.6% at the femoral neck and spine compared to placebo 3
• Reduces the risk of vertebral fractures by 30-55% in postmenopausal women with osteoporosis 3
• Does not significantly reduce the risk of non-vertebral fractures (except ankle fractures in some studies) 4

Breast Cancer Risk Reduction

• Reduces the risk of invasive breast cancer in:
  • Postmenopausal women with osteoporosis 1
  • Postmenopausal women at high risk of invasive breast cancer 1, 2
• Provides approximately 65-76% reduction in invasive breast cancer risk 3, 4
• Particularly effective for estrogen receptor-positive invasive breast cancers (90% risk reduction) 2, 4
• Not effective for estrogen receptor-negative cancers or noninvasive breast cancer 2, 1

Patient Selection Criteria

Appropriate Candidates

• Postmenopausal women ≥35 years of age with:
  • 5-year projected absolute breast cancer risk ≥1.66% (per NCI Breast Cancer Risk Assessment Tool) 2
  • Diagnosis of lobular carcinoma in situ (LCIS) 2
  • Osteoporosis requiring treatment 2
  • At least one breast biopsy showing LCIS or atypical hyperplasia 1
  • One or more first-degree relatives with breast cancer 1

Contraindications

• Premenopausal women 2, 1
• History of venous thromboembolism (deep vein thrombosis, pulmonary embolism) 2, 1
• History of stroke or transient ischemic attack 2, 1
• Women at high risk for stroke 1

Additional Benefits

• Improves lipid profile by reducing total and LDL cholesterol 4, 2
• Does not stimulate endometrial tissue (unlike estrogen) 4
• First-line therapy option for younger postmenopausal women with osteoporosis 2

Common Side Effects and Risks

• Venous thromboembolism (3.1 times increased risk compared to placebo) 3, 5
• Hot flushes (may be accentuated in early menopause) 2, 6
• Leg cramps 2, 4
• Peripheral edema 2, 7
• Influenza-like symptoms 2
• Increased risk of fatal stroke in women with documented coronary heart disease or at high risk for major coronary events 1, 7

Dosing and Duration

• Standard dose: 60 mg daily, taken orally without regard to meals 1
• Standard duration for breast cancer risk reduction: 5 years 2
• May be used longer than 5 years in women with osteoporosis 6, 2
• Should be supplemented with calcium (1,200 mg daily) and vitamin D (600-800 IU daily) 2

Important Limitations

• Not indicated for treatment of invasive breast cancer or reduction of recurrence risk 1
• Not indicated for reduction of noninvasive breast cancer risk 1
• No data available on effectiveness in women with BRCA1/BRCA2 mutations 1
• Should not be used with systemic estrogens 1
• Not recommended for use in premenopausal women at high risk for breast cancer (may decrease BMD) 6

Raloxifene represents an important therapeutic option for postmenopausal women, offering dual benefits of osteoporosis management and breast cancer risk reduction with an acceptable safety profile when used in appropriate patients.