Bazedoxifene + conjugated estrogens in HT for the prevention of osteoporosis and treatment of vasomotor symptoms associated with the menopause

Tella, Sri Harsha; Gallagher, J. Christopher

doi:10.1517/14656566.2013.844790

Cited by 13 publications

(12 citation statements)

References 56 publications

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“…This product may prove useful in women with progestogen intolerance, as it avoids the addition of progesterone whilst providing endometrial protection. 42 However, this product is not yet available in the UK.…”

Section: Estradiolmentioning

confidence: 99%

Clinical epidemiology of premenstrual disorder: informing optimized patient outcomes

Robinson¹,

Ismail²

2015

IJWH

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Premenstrual disorders encompass a spectrum that ranges from mild cyclical psychological and somatic symptoms to the rarer but much-more-severe premenstrual dysphoric disorder. This condition is serious and the etiology is unclear, but possible causes include genetic factors, hormonal fluctuations, and neurotransmitter dysfunctions. Differentiation from other affective disorders can be difficult but is key to providing appropriate management. This comprehensive review will discuss the most-recent classification of premenstrual disorders, etiology, diagnosis, and potential current management strategies.

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Section: Estradiolmentioning

confidence: 99%

Clinical epidemiology of premenstrual disorder: informing optimized patient outcomes

Robinson¹,

Ismail²

2015

IJWH

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“…In terms of tolerability, breast pain, a common side effect of HRT associated with discontinuation of treatment, did not appear at a greater frequency in treatment arms. As mentioned earlier, uterine bleeding appeared with lower frequency in the BZA/CE as opposed to HRT, suggesting a better side effect profile [ 47 , 48 ].…”

Section: Breast Density Changesmentioning

confidence: 86%

The Tissue-Selective Estrogen Complex: A Review of Current Evidence

2015

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The tissue-selective estrogen complex (TSEC) has recently entered the market for the treatment of postmenopausal osteoporosis, and is particularly targeted to women with significant vasomotor symptoms. This review appraises the evidence behind the only approved TSEC to-date, a combination of bazedoxifene and conjugated estrogens, with regards to its efficacy and relevant safety concerns. The majority of evidence that has led to its approval is derived from the SMART study. This large phase III trial with several substudies was aimed at discerning the effects of the TSEC on various estrogen-responsive tissues in comparison to raloxifene and placebo. Overall, the evidence thus far suggests a superior improvement in lumbar bone mineral density of 1.01% ± 0.28% as well as decrease in the frequency of hot flushes. Regarding safety concerns, endometrial thickness did not change over the treatment course, and investigators also identified a modest reduction in breast density. While there was no difference in rates of venous thromboembolism between treatment and placebo groups in a 2-year follow-up period, the effects of the drug on coagulation profiles are similar to those seen with hormone replacement therapy. Thus, the drug’s effects on venous thromboembolism risk over a longer treatment course remain unclear. In conclusion, the actual efficacy of the TSEC for postmenopausal osteoporosis remains as yet undefined, given the lack of fracture prevention data. The evidence thus far does seem to suggest a beneficial effect on vasomotor symptoms and a generally favorable side effect profile. However, it should be noted that only one study has addressed this question thus far, and so the repeatability of the findings is still in question.Electronic supplementary materialThe online version of this article (doi:10.1007/s40744-015-0013-z) contains supplementary material, which is available to authorized users.

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“…The mean annual percentage change in BMD from baseline was modest for all CE/BZA groups and ranged from 0.51 to 1.59% in late menopause and 0.55 to 1.60% in early menopause groups. Mean percent increases in TH BMD were significantly higher from baseline to month 24 with BZA (10 mg)/CE (0.625 or 0.45 mg) and BZA (20 mg)/CE (0.625 mg) when compared with raloxifene and even better versus placebo with all BZA/CE doses in the femoral inter-trochanteric, neck, and trochanteric regions [46,47].…”

Section: B Combination Of Estrogens/selective Estrogen Receptor Modumentioning

confidence: 93%

“…Specifically, in a 2-year randomized trial (SMART-1) among postmenopausal women, the effects of various doses of BZA and CE on BMD were compared with placebo and raloxifene after 12 and 24 months [46]. The adjusted mean annual percent change from baseline in the BMD of the LS for all BZA/CE doses was positive and significantly greater than that with placebo and tended to be larger with higher doses of CE and lower doses of BZA [46,47]. The mean annual percentage change in BMD from baseline was modest for all CE/BZA groups and ranged from 0.51 to 1.59% in late menopause and 0.55 to 1.60% in early menopause groups.…”

Section: B Combination Of Estrogens/selective Estrogen Receptor Modumentioning

confidence: 99%

“…Apart from preserving bone mass, BZA/CE also relieves vasomotor and vaginal symptoms; phase III clinical trials indicate 20 mg BZA with CE 0.45 and 0.625 mg daily as the optimum dose combination [47]. Additionally, the effect on the endometrium is comparable with standard hormonal therapy (estrogen and progestin)…”

Section: B Combination Of Estrogens/selective Estrogen Receptor Modumentioning

confidence: 99%

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Novel therapies for osteoporosis

2015

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Bazedoxifene + conjugated estrogens in HT for the prevention of osteoporosis and treatment of vasomotor symptoms associated with the menopause

Cited by 13 publications

References 56 publications

Clinical epidemiology of premenstrual disorder: informing optimized patient outcomes

Clinical epidemiology of premenstrual disorder: informing optimized patient outcomes

The Tissue-Selective Estrogen Complex: A Review of Current Evidence

Novel therapies for osteoporosis

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