Safety and tolerability

The safety and tolerability of DUAVEE were evaluated in 4 phase III trials ranging from 12 weeks to 24 months in duration2

Adverse events (AEs)

Adverse reactions (incidence ≥5%) more common in the DUAVEE® (conjugated estrogens/bazedoxifene) treatment group in placebo-controlled trials2

Serious AEs

Incidence of serious AEs was 3.5% in the DUAVEE group vs 4.8% in the placebo group2

Discontinuations due to AEs

Discontinuations due to AEs similar to placebo2

The most common AEs leading to discontinuations were hot flash (DUAVEE 0.7%; placebo 1.8%), abdominal pain upper (DUAVEE 0.5%; placebo 0.5%), and nausea (DUAVEE 0.5%; placebo 0.7%)2,5

Cumulative amenorrhea

8 of 10 patients reported NO BLEEDING OR SPOTTING from the start of treatment through the course of 1 year, comparable to placebo2

*The number of women included in the analysis of cumulative amenorrhea were as follows: Study 1: DUAVEE n=429; placebo n=421. Study 2: DUAVEE n=355; placebo n=379.5

Studies 1 and 2 descriptions
VTE

Venous thromboembolism (VTE) and clinical trial data2

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.

Estrogen agonist/antagonists, including bazedoxifene, and estrogens individually are known to increase the risk of VTE.

In the clinical studies with DUAVEE, the reporting rates for VTE were low in all treatment groups. Adverse reactions of VTE were reported in 0.0% of patients treated with DUAVEE (n=1224) and 0.1% of patients treated with placebo (n=1069).

Due to the low rate of events in both groups, it is not possible to conclude that the risk of VTE with DUAVEE is different from that seen with other estrogen therapies.

Study Descriptions

Study 1: 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.

Study 277彩票网址: 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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Dosing