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SERM

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

  • first selective oestrogen receptor modulator to be launched for the prevention of vertebral fractures in postmenopausal women
  • short term studies suggest a beneficial effect with treatment on the surrogate endpoints for bone and cardiovascular disease
  • raloxifene is an additional therapeutic option for postmenopausal women at risk of osteoporosis but not wanting to have a restoration of monthly cyclical bleeding
  • raloxifene will not alter the symptoms of the menopause and should not be given to women before the menopause
  • raloxifene may be more acceptable than HRT if breast tenderness or pain is a problem (1)
  • raloxifene reduces the risk of oestrogen receptor positive breast tumours
    • the MORE trial showed a reduction in vertebral fracture risk and breast cancer risk in women treated with raloxifene
    • a more recent study has provided evidence that, whatever the prior self-reported HRT of the women involved, raloxifene reduced vertebral fractures and breast cancer in postmenopausal women with osteoporosis (2)
    • in comparison to tamoxifen (3)
      • raloxifene is as effective as tamoxifen in reducing the risk of invasive breast cancer and has a lower risk of thromboembolic events and cataracts but a nonstatistically significant higher risk of noninvasive breast cancer
      • risk of other cancers, fractures, ischemic heart disease, and stroke is similar for both drugs
  • there is no data currently available on the long term efficacy and safety of raloxifene
  • raloxifene in osteoporosis
    • raloxifene inhibits bone resorption
      • it is approved for the treatment and prevention of osteoporosis in postmenopausal women, at a dose of 60 mg daily
      • has been shown to reduce vertebral fracture risk but reduction in non-vertebral and hip fractures has not been demonstrated
      • raloxifene is taken as a single daily dose (60 mg) and may be taken at any time without regard to meals
    • NICE state that (5)
      • raloxifene (along with strontium ranelate) is recommended as alternative treatment options for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:
      • recommended as an alternative treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:
        • who are unable to comply with the special instructions for the administration of alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate and
        • who also have a combination of T-score, age and number of independent clinical risk factors for fracture

          • T-scores (SD) at (or below) which strontium ranelate and raloxifene is recommended when alendronate and either risedronate or etidronate cannot be taken

Age (years)

0 independent clinical risk factors for fracture

1 independent clinical risk factors for fracture

2 independent clinical risk factors for fracture

50-54

Treatment strontium ranelate or raloxifene is not recommended

-3.5

-3.5

55-59

-4.0

-3.5

-3.5

60-64

-4.0

-3.5

-3.5

65-69

-4.0

-3.5

-3.0

70-74

-3.0

-3.0

-2.5

75 or older

-3.0

-2.5

-2.5

  • with respect to use of raloxifene in patients at increased cardiovascular disease risk (6):
    • raloxifene did not significantly affect the risk of coronary heart disease. There was an increased risk of venous thromboembolism and fatal stroke associated with use of raloxifene

Reference:


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