Results of systematic review s and meta-analyses of r and omized controlled trials have shown that both systemic estrogen therapy or hormone therapy ( estrogen combined with a progestin ) are useful to prevent bone loss , and they are the most effective treatment for such climacteric symptoms as hot flushes , sweating , vaginal dryness , and dyspareunia .
The combination of a SERM with estrogen as a tissue selective estrogen complex ( TSEC ) is a new strategy for the prevention of bone loss and the treatment of climacteric symptoms .
This combination is particularly interesting from a clinical point of view , taking into account that estrogen alone did not increase breast cancer risk by the Women 's Health Initiative .
TSEC is hypothesized to provide the benefits of estrogen-alone therapy , with an improved tolerability profile because the SERM component can make possible the elimination of progestin .
The conclusion is that effectively , the combination of bazedoxifene and conjugated estrogens may be a promising alternative to hormone therapy for the prevention of osteoporosis and the treatment of postmenopausal symptoms in non-hysterectomized postmenopausal women
Decreasing levels of estrogens during menopause are associated with reduced bone density and an increased risk of osteoporosis .
Many women also experience bothersome vasomotor and vaginal symptoms during the menopausal transition .
Unfortunately , estrogen therapy and hormone therapy increase the risk of endometrial and breast cancer , respectively .
The selective estrogen receptor modulators ( SERMs ) result in positive estrogenic effects on bone , with no negative effects on the endometrium and breast but do not provide relief from postmenopausal symptoms .
The objective of this review was to critically evaluate the evidence from the reports published to date on the use of bazedoxifene ( a third-generation SERM ) in combination with conjugated estrogens in postmenopausal women .
Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy.
OBJECTIVE To evaluate the endometrial safety of a tissue selective estrogen complex ( TSEC ; pairing of a selective estrogen receptor modulator [ SERM ] with estrogens ) composed of bazedoxifene/conjugated estrogens ( BZA/CE ) in postmenopausal women . DESIGN R and omized , double-blind , multicenter , placebo- and active-controlled , phase 3 study ( Selective estrogen Menopause And Response to Therapy [SMART]-1 ) . SETTING Outpatient clinical . PATIENT(S ) Healthy , postmenopausal women ( n = 3,397 ) age 40 - 75 with an intact uterus . INTERVENTION(S ) Single tablets of BZA ( 10 , 20 , or 40 mg ) combined with CE ( 0.625 or 0.45 mg ) ; raloxifene ( 60 mg ) ; or placebo daily for 2 years . MAIN OUTCOME MEASURE(S ) Incidence of endometrial hyperplasia at 12 months in the efficacy evaluable population . RESULT ( S ) Treatment with BZA ( 20 or 40 mg)/CE ( 0.625 or 0.45 mg ) was associated with low rates ( < 1 % ) of endometrial hyperplasia that were not significantly different from those reported with placebo over 24 months . Endometrial thickness with BZA ( 20 or 40 mg)/CE ( 0.625 or 0.45 mg ) was not significantly different from that with placebo . CONCLUSION ( S ) When combined with CE ( 0.625 mg or 0.45 mg ) , BZA ( 20 mg ) was the lowest effective dose that prevented endometrial hyperplasia over 2 years of study , creating the possibility for a new , progestin-free menopausal therapy
Results of systematic review s and meta-analyses of r and omized controlled trials have shown that both systemic estrogen therapy or hormone therapy ( estrogen combined with a progestin ) are useful to prevent bone loss , and they are the most effective treatment for such climacteric symptoms as hot flushes , sweating , vaginal dryness , and dyspareunia .
The combination of a SERM with estrogen as a tissue selective estrogen complex ( TSEC ) is a new strategy for the prevention of bone loss and the treatment of climacteric symptoms .
This combination is particularly interesting from a clinical point of view , taking into account that estrogen alone did not increase breast cancer risk by the Women 's Health Initiative .
TSEC is hypothesized to provide the benefits of estrogen-alone therapy , with an improved tolerability profile because the SERM component can make possible the elimination of progestin .
The conclusion is that effectively , the combination of bazedoxifene and conjugated estrogens may be a promising alternative to hormone therapy for the prevention of osteoporosis and the treatment of postmenopausal symptoms in non-hysterectomized postmenopausal women
Decreasing levels of estrogens during menopause are associated with reduced bone density and an increased risk of osteoporosis .
Many women also experience bothersome vasomotor and vaginal symptoms during the menopausal transition .
Unfortunately , estrogen therapy and hormone therapy increase the risk of endometrial and breast cancer , respectively .
The selective estrogen receptor modulators ( SERMs ) result in positive estrogenic effects on bone , with no negative effects on the endometrium and breast but do not provide relief from postmenopausal symptoms .
The objective of this review was to critically evaluate the evidence from the reports published to date on the use of bazedoxifene ( a third-generation SERM ) in combination with conjugated estrogens in postmenopausal women .