Raloxifene (Evista®) in the treatment of postmenopausal osteoporosis - the profile of the patient

Osteoporoza je uz bolesti dojke i srčanožilnog sustava, jedan od vodećih zdravstvenih problema žena u postmenopauzi. Nekoliko različitih terapijskih opcija, uključujući hormonsko nadomjesno liječenje (HNL), bisfosfonate, kalcitonin i selektivne modulatore estrogenih receptora, omogućuje uspješno liječenje ove bolesti. Ipak, budući da je dugotrajna primjena HNL povezana s neželjenim učincima kao što su vaginalno krvarenje i rak dojke, a bisfosfonati, osim na kost, nemaju učinak na druge sustave, raloksifen, kao prvi SERM druge generacije, predstavlja značajan napredak u liječenju postmenopauzalnih žena. Ovisno o tkivu, SERM-ovi djeluju agonistički (kost) odnosno antagonistički (dojka) estrogenu. Primjena raloksifena prevenira gubitak kosti, smanjuje učestalost vertebralnih prijeloma u žena s ili bez prethodnog prijeloma, smanjuje učestalost invazivnog, estrogen-receptor pozitivnog, raka dojke, a čini se da smanjuje i učestalost kardiovaskularnih događaja u žena s povišenim rizikom. Nedavno su objavljeni rezultati studije CORE koji su potvrdili rezultate prethodnih studija u pogledu učinka raloksifena na rak dojke, dok se podaci o učinku na koštani sustav nakon 8 godina primjene raloksifena očekuju u najskorijoj budućnosti. Dodatne informacije o učinkovitosti i sigurnosnom profilu raloksifena pružiti će studije RUTH i STAR.Osteoporosis, breast cancer and cardiovascular diseases are major health problems among postmenopausal women. Several pharmacologic options for treatment of osteoporosis are available, including hormone replacement therapy (HRT), bisphosphonates, calcitonin and selective estrogen receptor modulators. However, long-term HRT is associated with unwanted side effects such as vaginal bleeding and breast cancer and bisphosphonates, besides bone, have no other benefits. Therefore, raloxifene, the first of the second-generation of SERMs represents a significant improvement in the treatment of postmenopausal women. It could have either estrogen agonist (bone) or antagonist (breast) activity according to the type of estrogen-responsive tissue. Raloxifene prevents bone loss, reduces the number of vertebral fractures in women with and without prevalent vertebral fractures, induces reduction of estrogen-receptor positive invasive breast cancer and has potential beneficial effect on cardiovascular diseases in women with high risk. CORE study, that was recently published, confirmed previously observed reduction of invasive breast cancer in women treated with raloxifene (MORE study), while the data on skeletal effects after 8-years treatment with raloxifene will be published in the near future. Further studies (RUTH, STAR) will provide additional information on efficacy and safety of raloxifene