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 .
Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial.
In this 3-yr , r and omized , double-blind , placebo- and active-controlled study , healthy postmenopausal women with osteoporosis ( 55 - 85 yr of age ) were treated with bazedoxifene 20 or 40 mg/d , raloxifene 60 mg/d , or placebo . The primary endpoint was incidence of new vertebral fractures after 36 mo ; secondary endpoints included nonvertebral fractures , BMD , and bone turnover markers . Among 6847 subjects in the intent-to-treat population , the incidence of new vertebral fractures was significantly lower ( p < 0.05 ) with bazedoxifene 20 mg ( 2.3 % ) , bazedoxifene 40 mg ( 2.5 % ) , and raloxifene 60 mg ( 2.3 % ) compared with placebo ( 4.1 % ) , with relative risk reductions of 42 % , 37 % , and 42 % , respectively . The treatment effect was similar among subjects with or without prevalent vertebral fracture ( p = 0.89 for treatment by baseline fracture status interaction ) . The incidence of nonvertebral fractures with bazedoxifene or raloxifene was not significantly different from placebo . In a posthoc analysis of a subgroup of women at higher fracture risk ( femoral neck T-score < or= -3.0 and /or > or=1 moderate or severe vertebral fracture or multiple mild vertebral fractures ; n = 1772 ) , bazedoxifene 20 mg showed a 50 % and 44 % reduction in nonvertebral fracture risk relative to placebo ( p = 0.02 ) and raloxifene 60 mg ( p = 0.05 ) , respectively . Bazedoxifene significantly improved BMD and reduced bone marker levels ( p < 0.001 versus placebo ) . The incidence of vasodilatation , leg cramps , and venous thromboembolic events was higher with bazedoxifene and raloxifene compared with placebo . In conclusion , bazedoxifene significantly reduced the risk of new vertebral fracture in postmenopausal women with osteoporosis and decreased the risk of nonvertebral fracture in subjects at higher fracture risk
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 .