[Raloxifene (Celvista, Evista)].
The prevention of osteoporotic fractures in post-menopausal women must be viewed in the framework of the treatment of menopause. SERMs ("Selective Estrogen Receptor Modulators") derivative from steroid hormones have estrogenic and antiestrogenic properties according to the substance and the target tissue. Raloxifene is a second generation SERM. It increases bone mass by 1 to 3% according to the measured site and, after 3 years of therapy at the dose of 60 mg per day, it reduces the incidence of vertebral fractures by 30 to 50% if patients have or do not have vertebral fractures before therapy. This drug is approved for the prevention of vertebral fractures in post-menopausal women at increased risk of fractures. A significant reduction in the incidence of hip fractures has not been demonstrated. Raloxifene exerts favorable effects on cardiovascular risk factors but one has to wait for the results of controlled prospective trials before concluding that raloxifene reduces the risk of atherogeniec disease. Preliminary results indicate a substantial reduction of the risk of invasive breast cancer, still to be confirmed. The incidence of vaginal bleeding does not differ from placebo as raloxifene does not stimulate endometrial proliferation. The most serious adverse event, although infrequent, consists in an increase of the relative risk of thromboembolic disease by 3.1 as compared to placebo. Longer term studies are necessary to compare raloxifene with the estrogen replacement therapy and to determine the extra-bone effects.
Body
J J
JJ
Clinique des Soins Supportifs, Institut J. Bordet, U.L.B.
Sternon
J
J
D001161:Arteriosclerosis / Q000517:prevention & control; D001842:Bone and Bones / Q000187:drug effects; D001943:Breast Neoplasms / Q000517:prevention & control; D018849:Controlled Clinical Trials as Topic; D004717:Endometrium / Q000187:drug effects; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control; D006331:Heart Diseases / Q000517:prevention & control; D006620:Hip Fractures / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications; D010919:Placebos; D011446:Prospective Studies; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016103:Spinal Fractures / Q000517:prevention & control; D013923:Thromboembolism / Q000139:chemically induced; D014592:Uterine Hemorrhage / Q000517:prevention & control
D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride