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A multicenter, double-blind, randomized, placebo- and active-controlled, 24-month study of the effects of bazedoxifene/conjugated estrogens combinations on endometrial hyperplasia and prevention of osteoporosis in postmenopausal women with a uterus. Women were aged 40-75 years (mean 56 years) and postmenopausal was defined as having last menstrual cycle at least 12 months before screening, serum FSH at least 30 mIU/mL and 17β-estradiol <50 pg/mL. The primary endpoint was the incidence of endometrial hyperplasia at year 1. Bone mineral density (BMD) change at the lumbar spine at year 2 was the key secondary endpoint assessed in two substudies. Substudy I included women more than 5 years postmenopausal with lumbar spine or total hip T-score of -1 to -2.5, and at least one additional risk factor for osteoporosis. Substudy II included women 1-5 years postmenopausal with at least one additional risk factor for osteoporosis. BMD change at the total hip at year 2 was also assessed as a secondary endpoint. In both substudies, women took calcium (600-1200 mg) and vitamin D (200-400 IU) daily. Another secondary endpoint was cumulative amenorrhea as recorded by daily diary. The study enrolled a total of 3397 women: Duavee, n=433; placebo, n=427; other bazedoxifene/conjugated estrogens doses, n=2114; and active comparator, n=423.
A multicenter, double-blind, randomized, placebo- and active-controlled, 12-month study of the effects of bazedoxifene/conjugated estrogens combinations on endometrial hyperplasia and prevention of osteoporosis in postmenopausal women with a uterus. Women were aged 41-64 years (mean 54 years) and postmenopausal was defined as at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH level >40 mIU/mL. The primary endpoint was the incidence of endometrial hyperplasia at year 1. Bone mineral density (BMD) change at the lumbar spine at 12 months was the key secondary endpoint assessed in a substudy of women who were less than 5 years postmenopausal. BMD change at the total hip at 12 months was also assessed as a secondary endpoint. Women in the substudy took calcium (600-1200 mg) and vitamin D (200-400 IU) daily. Another secondary endpoint was cumulative amenorrhea as recorded by daily diary. The study enrolled a total of 1843 women: Duavee, n=445; placebo, n=474; other bazedoxifene/conjugated estrogens dose, n=474; bazedoxifene alone, n=230; and active comparator, n=220.
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Women taking Duavee® (conjugated estrogens/bazedoxifene) should not be taking progestins, additional estrogens, or additional estrogen agonist/antagonists.
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Duavee contains bazedoxifene, an estrogen agonist/antagonist, to reduce the risk of endometrial hyperplasia that can occur with estrogens, and which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia.
The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT). Should any of these occur or be suspected, Duavee should be discontinued immediately.
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.
Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.
Estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Duavee should not be used in women with undiagnosed abnormal uterine bleeding; known, suspected, or past history of breast cancer or estrogen-dependent neoplasia; active or past history of venous or arterial thromboembolism; hypersensitivity to estrogens, bazedoxifene, or any ingredients; known hepatic impairment or disease; known thrombophilic disorders. Women who are pregnant should not use Duavee.
Estrogen agonist/antagonists, including bazedoxifene, and estrogens individually are known to increase the risk of VTE.
The use of estrogen alone has been reported to result in an increase in abnormal mammograms requiring further evaluation. The effect of treatment with Duavee on the risk of breast cancer is unknown.
A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown. The effect of treatment with Duavee on the risk of ovarian cancer is unknown.
Estrogens increase the risk of gallbladder disease. Discontinue estrogen if loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs. Monitor thyroid function in women on thyroid replacement therapy, because estrogens may be associated with increased thyroid binding globulin (TBG) levels.
Duavee is not recommended for use in patients with renal impairment.
Most common adverse reactions (≥ 5 percent) are muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain.