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 .
Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial
Objective : The aim of this study was to assess the safety and efficacy of bazedoxifene (BZA)/conjugated estrogens ( CE ) treating moderate to severe vasomotor symptoms in the Selective Estrogen Menopause and Response to Therapy 2 trial . Methods : This was an outpatient , multicenter , double-blind , r and omized , placebo-controlled , phase 3 study conducted in the United States . Healthy postmenopausal women ( N = 332 ; aged 40 - 65 y ) with moderate to severe hot flushes ( ≥7/d or 50/wk ) were r and omized to BZA 20 mg/CE 0.45 mg , BZA 20 mg/CE 0.625 mg , or placebo once daily for 12 weeks . Changes from baseline in the average daily number of moderate and severe hot flushes and daily severity score were assessed at weeks 4 and 12 ; adverse events were recorded . Results : BZA/CE significantly reduced the number and severity of hot flushes at weeks 4 and 12 ( P < 0.001 ) . At week 12 , BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg reduced hot flushes from baseline by 74 % ( 10.3 hot flushes [ baseline ] vs 2.8 [ week 12 ] ) and 80 % ( 10.4 vs 2.4 ) , respectively , compared with 51 % ( 10.5 vs 5.4 ) for placebo . More participants at week 12 had at least a 75 % decrease in hot flushes with BZA 20 mg/CE 0.45 mg ( 61 % ) and BZA 20 mg/CE 0.625 mg ( 73 % ) versus placebo ( 27 % ; P < 0.001 ) . The safety profile was similar between BZA/CE and placebo , and no unexpected safety findings were reported . Conclusions : BZA 20 mg paired with CE 0.45 or 0.625 mg is effective , with short-term safety , for treating vasomotor symptoms in 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 .