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 .
Effects of bazedoxifene/conjugated estrogens on endometrial safety and bone in postmenopausal women
ABSTRACT Objectives Bazedoxifene/conjugated estrogens ( BZA/CE ) has demonstrated efficacy in improving vasomotor and vulvar/vaginal atrophy symptoms in postmenopausal women . This study evaluated the endometrial safety of BZA/CE and effects on bone mineral density ( BMD ) compared with CE/medroxyprogesterone acetate ( MPA ) and placebo . Methods The Selective estrogens , Menopause , And Response to Therapy (SMART)-4 trial was a 1-year , multicenter , double-blind , r and omized , placebo– and active-controlled , phase-3 study in non-hysterectomized , postmenopausal women ( n = 1061 ; aged 40 − < 65 years ) . Subjects received BZA 20 mg/CE 0.45 or 0.625 mg , CE 0.45 mg/MPA 1.5 mg , or placebo daily . Primary endpoints were the incidence of endometrial hyperplasia and the change in lumbar spine BMD at 1 year . Secondary endpoints included the change in total hip BMD and rates of amenorrhea and breast pain . Results At 1 year , no cases of endometrial hyperplasia were identified in the BZA 20-mg/CE 0.45-mg group , while three cases ( 1.1 % ) were confirmed for the BZA 20-mg/CE 0.625-mg group ( 95 % one-sided confidence interval upper limit < 4 % ) . Both BZA/CE doses significantly increased lumbar spine and total hip BMD versus placebo ( p ≤ 0.001 ) and showed low incidences of bleeding and breast tenderness , similar to placebo and significantly lower than for CE 0.45 mg/MPA 1.5 mg ( p < 0.05 ) . BZA/CE treatment was generally safe and well tolerated . Conclusions BZA 20 mg/CE 0.45 and 0.625 mg significantly improved BMD while maintaining endometrial safety and showed a favorable safety/tolerability profile over 1 year . BZA/CE may be a promising therapy for treating menopausal symptoms and preventing osteoporosis in non-hysterectomized , postmenopausal women
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 .