II. Indications

  1. Osteoporosis Prevention in postmenopausal women
  2. Hormone Replacement in postmenopausal women
    1. Beyond hot flash stage
    2. Estrogen Replacement contraindicated (Breast Cancer)
  3. Breast Cancer Prevention in post-menopausal women
    1. Breast Cancer risk >1.66% in 5 years

III. Contraindications

  1. Venous Thromboembolism
  2. Perioperative period
  3. Prolonged immobilization
  4. History of Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA)

IV. Mechanism

  1. Positive Estrogen effects
    1. Stimulates bone mineralization
    2. Improves lipid profile
  2. Anti-Estrogenic effects
    1. No Breast stimulation
    2. No uterine stimulation

V. Efficacy

  1. Lower efficacy than Tamoxifen for breast Cancer Prevention (but lower Venous Thromboembolism, Endometrial Cancer Risks)

VI. Advantages

  1. No Uterine endometrial stimulation (unlike Estrogen)
    1. Does not require concurrent Progestin use
  2. Does not stimulate Breast tissue (unlike Estrogen)
    1. No Breast swelling, tenderness, or pain
    2. No data yet on Breast Cancer
  3. Increases Bone Mineral Density
    1. Modest effect (1-2%) at hip, spine, and long bones
    2. Not as effective as Estrogen Replacement
  4. Positive lipid effects
    1. Lowers LDL 10-12%
    2. Lowers Total Cholesterol 6-7%
  5. Helps stabilize pelvic floor
    1. Protects against Uterine Prolapse
    2. Decreases Incidence of Urinary Incontinence
    3. Reduces pelvic surgery rate by 50%
    4. Goldstein (2001) Obstet Gynecol 98:91-6 [PubMed]

VII. Precautions

  1. DVT, PE and Cardiovascular Risk is an FDA black box warning

VIII. Disadvantages

  1. Expensive: $65/month (Premarin is $20/month)
  2. Anti-Estrogen effects (Hot Flashes)

IX. Adverse Effects

  1. Hot Flashes (24.6%)
  2. Leg Cramps (5.9%)
  3. Increased Deep Vein Thrombosis and Thromboembolism risk
    1. More likely to occur in first 4 months of treatment
    2. Similar to risk with Estrogen Replacement

X. Dosing

  1. Raloxifene 60 mg PO daily
    1. Course of 5 years if used for breast Cancer Prevention

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Related Studies

Cost: Medications

raloxifene (on 12/21/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
RALOXIFENE HCL 60 MG TABLET Generic $0.28 each