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Raloxifene

Raloxifene is a selective oestrogen receptor modulator (SERM), which is a selective agonist or antagonist acting on some oestrogen receptive tissues. It is an agonist on bone, thus reducing the bone resorption which would occur with falling oestrogen levels after the menopause. It has a partial effect on cholesterol metabolism (reducing total and LDL-cholesterol), but does not effect the hypothalamus, uterine or breast tissues.1

Osteoporosis diagnosis

Osteoporosis is a disease characterised by low bone mass and deterioration of bone tissue, leading to enhanced bone fragility and an increase in fracture risk. The World Health Organization defines osteoporosis on the basis of bone mineral density (BMD).2

  • BMD is usually reported as a T score. This is the number of standard deviations by which the patients BMD differs from the mean peak BMD for young adults of the same gender.
  • For every standard deviation below the mean, the risk of fracture is approximately doubled.
  • A T score of minus 2.5 or less indicates osteoporosis.
  • A T score of between minus 1 and minus 2.5 indicates osteopaenia.

Raloxifene is used in the prophylaxis and treatment of osteoporosis. It is licensed for use in the post-menopausal woman.

Available treatments for osteoporosis3

First-line treatment

  • Use alendronate or risedronate

Second-line treatment

  • Postmenopausal women with diagnosed osteoporosis: consider raloxifene, intranasal calcitonin (salmon), or cyclical etidronate. Consider using hormone replacement therapy if the benefits of treatment outweigh the risks.
  • Elderly women with diagnosed osteoporosis, consider cyclical etidronate or raloxifene (off-licence use).
  • Calcium 1.2 g with 800 iu vitamin D is also an option for the elderly (age 80 ), frail, or housebound.

Adjunctive treatment with calcium and vitamin D.

  • Give calcium supplements with vitamin D as an adjunct to bisphosphonates, or raloxifene if dietary intake is suboptimal (in the absence of conditions associated with hypercalcaemia).
  • Consider prescribing calcium 1.2 g with 800 iu vitamin D daily to prevent osteoporosis in people who are frail or housebound e.g. those in residential and nursing homes.4

Indications for use

NICE recommends that raloxifene should be given to any of the following women:5

  • Women who are currently taking other medicines that may be affected by the bisphosphonates or have another medical condition that means bisphosphonates cannot be used.
  • Women who are unable to physically manage the way a bisphosphonate has to be taken. For example, taking it with a certain amount of water, having to avoid eating for certain periods before or after taking it, and having to remain upright for certain periods after taking it.
  • Women who have already been treated for a year with a bisphosphonate but it has not been effective. For instance, another fracture has occurred and bone density has decreased to a level lower than when treatment started.
  • Women who are unable to take bisphosphonate because of the side effects. Side effects can include inflammation or ulceration of the oesophagus, and diarrhoea.

It may be useful to bear in mind that:

  • Raloxifene has also been found to decrease the relative risk of invasive breast cancer by 72%, predominately due to a reduction in oestrogen receptor-positive tumours.6
  • Raloxifene has not been found to cause endometrial proliferation, and available data suggest that there is no increase in the risk of developing endometrial cancer after 3 years of treatment.
Cautions and contraindications
  • Raloxifene increases the risk of venous thromboembolism (VTE) by about 2.5 times. This is similar to the risk associated with HRT use.7 People who have a personal or family history of deep vein thrombosis or pulmonary embolism should not take raloxifene.
  • Raloxifene should also be avoided in people at increased risk of VTE e.g. with severe varicose veins, obesity, recent surgery or trauma, or prolonged bed rest.
  • Although the risks of breast cancer or endometrial cancer seem to be low with raloxifene, it has not been studied in women with active disease. Avoid raloxifene in women with current breast cancer, endometrial cancer, or unexplained uterine bleeding.
  • It should also be avoided where there is a history of oestrogen-induced hypertriglyceridaemia. Monitoring serum triglycerides is recommended.
  • Use with caution where there is hepatic impairment or cholestasis.
  • Use with caution where there is severe renal impairment.
  • Avoid in pregnancy and breast-feeding.
Adverse effects
  • Raloxifene does not relieve vasomotor symptoms - it may increase them
  • Venous thromboembolism, thrombophlebitis
  • Leg cramps, peripheral oedema
  • Influenza-like symptoms
  • Rarely rashes, gastro-intestinal disturbances, hypertension, headache (including migraine), breast discomfort

Document references
  1. Summary of Product Characteristics - Evista® 60mg film-coated tablets (Raloxifene); Eli Lilly and Company Limited, Updated May 2007, electronic Medicines Compendium.
  2. Osteoporosis - treatment (and prevention of fragility fractures), Clinical Knowledge Summaries. 2006.
  3. Management of osteoporosis, SIGN (2004)
  4. Chapuy MC, Arlot ME, Delmas PD, et al; Effect of calcium and cholecalciferol treatment for three years on hip fractures in elderly women.; BMJ. 1994 Apr 23;308(6936):1081-2.
  5. Osteoporosis - secondary prevention, NICE 2005; The clinical effectiveness and cost effectiveness of technologies for the secondary prevention of osteoporotic fractures in postmenopausal women.
  6. Cauley JA, Norton L, Lippman ME, et al; Continued breast cancer risk reduction in postmenopausal women treated with raloxifene: 4-year results from the MORE trial. Multiple outcomes of raloxifene evaluation. Breast Cancer Res Treat. 2001 Jan;65(2):125-34. [abstract]
  7. No authors listed; Raloxifene to prevent postmenopausal osteoporosis. Drug Ther Bull. 1999 May;37(5):33-6. [abstract]
Internet and further reading AcknowledgementsEMIS is grateful to Dr Hayley Willacy for writing this article. The final copy has passed scrutiny by the independent Mentor GP reviewing team. ©EMIS 2008.
DocID: 404
Document Version: 3
DocRef: bgp25166
Last Updated: 2 Feb 2008
Review Date: 1 Feb 2009

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PS - Health and Poverty

Perhaps the biggest cause of ill health in the world is poverty. Help to Make Poverty History. For example, why not lend some of your money to disadvantaged communities to enable them to trade their way out of poverty through schemes such as Shared Interest.

See also MAKEPOVERTYHISTORY North East for details and links to campaigns against poverty.

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