Raloxifene - RCP evidence grades in osteoporosis

Spine: A Non-vertebral: not demonstrated Hip: not demonstrated

In a randomised trial of 7,705 postmenopausal osteoporotic women receiving calcium and vitamin D, 3 years treatment with raloxifene 60mg daily improved the risk of vertebral fracture (rr 0.7). Treatment groups also experienced an improvement in the spine and femur of 2-3%.

The risk of oestrogen receptor positive breast cancer after 40 months follow up was significantly reduced (rr 0.24). There was no increase inthe risk of vaginal bleeding or endometrial cancer. Raloxifene has favourable effects on cardiovascular markers but its effects on coronary artery disease have not been established.

Raloxifene increases the frequency of hot flushes, leg cramps and peripheral oedema and also increases the risk of venous thromboembolism.