is the new drug for the treatment of postmenopausal osteoporosis
It is a selective estrogen receptor modulator (SERM) indicated in the treatment of postmenopausal osteoporosis in women at increased risk of fractures. With this treatment, bone resorption decreases, reducing biochemical markers of bone turnover and increasing bone mineral density. A single clinical trial has been published comparing its efficacy with placebo and raloxifene in reducing the incidence of vertebral fractures (diagnosed by radiological methods). In this study, it had a similar efficacy and safety profile to raloxifene. At the moment, it is not clear what are the real benefits in clinical practice, presenting an efficacy similar to that of raloxifene, of very low magnitude in absolute terms on a variable (morphometric radiological vertebral fractures) of uncertain clinical significance, measured with doubtful diagnostic precision; and with no differences between them in the safety profile, treatment regimen or cost, the experience available with raloxifene being greater.
The use of this drug is not recommended in women at increased risk of venous thromboembolic events (advanced age, obesity, immobilization, surgery, major trauma and malignancy); Its administration should be suspended before and during prolonged immobilization (post-surgical recovery, prolonged bed rest), resuming only after the patient is fully wandering. Also, during long trips, women treated with it are advised to move from time to time. It should not be used in premenopausal women, or in patients with breast cancer or treated concomitantly with agents used in this disease, either in the initial or advanced stages, as it has not been studied in this population. Also, as the commercial formulation contains lactose, It should not be used in cases of hereditary intolerance to galactose, lactase deficiency or glucose or galactose malabsorption. It should be used with caution in women with known hypertriglyceridaemia (> 300 mg / dl) since it has not been studied in this population and may increase serum triglyceride levels. It is contraindicated in patients: with hypersensitivity to the active substance or to any of the excipients ( contains lactose); with the presence or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolism and retinal vein thrombosis); of childbearing age; who have unexplained uterine bleeding; and, with signs or symptoms of endometrial cancer. It should not be used during pregnancy, lactation, pediatrics and liver failure; It should be used with caution in severe renal failure, as it has not been evaluated in these patients, although in mild or moderate renal failure, no dose adjustment is required. In elderly patients, no dose adjustment is required either.