New Drug Reviews
Conjugated Estrogens/Bazedoxifene (Duavee) for Menopausal Symptoms
Am Fam Physician. 2016 Feb 15;93(4):307-314.
Conjugated estrogens/bazedoxifene (Duavee) combines conjugated estrogen with bazedoxifene, a selective estrogen receptor modulator. Bazedoxifene stimulates estrogen receptors in bone and has antagonistic effects in the breast and uterus.1 Conjugated estrogens/bazedoxifene is labeled for the treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis.2
Conjugated estrogens/bazedoxifene (Duavee)
0.45 mg/20 mg once daily
Conjugated estrogens/bazedoxifene (Duavee)
0.45 mg/20 mg once daily
As with other estrogen therapies, conjugated estrogens/bazedoxifene includes a boxed warning of increased risk of dementia in women older than 65 years, endometrial cancer, stroke, and deep venous thrombosis.2 However, in studies of 7,487 patients, there was no increase in endometrial hyperplasia. There is not enough research to directly evaluate the effect of conjugated estrogens/bazedoxifene on thrombotic or cardiovascular events.1,3,4 Because of established risks of estrogen agonists/antagonists, conjugated estrogens/bazedoxifene should not be used with other estrogen preparations or in patients with abnormal uterine bleeding, breast cancer, estrogen-dependent neoplasia, venous or arterial thromboembolism, liver disease, or thrombophilic disorders. It has not been studied in patients with renal impairment, obesity (body mass index greater than 34 kg per m2), or in women older than 75 years. Conjugated estrogens/bazedoxifene is a U.S. Food and Drug Administration pregnancy category X drug and should not be used by lactating women.2
Conjugated estrogens/bazedoxifene is generally well tolerated. About one in 12 patients (8%) will stop taking the medication in the first year because of adverse effects.4,5 When compared with conjugated estrogens/medroxyprogesterone, conjugated estrogens/bazedoxifene results in less vaginal bleeding, and in head-to-head trials it has lower dropout rates due to adverse effects (8% vs. 13%; P < .05).4,5
Conjugated estrogens/bazedoxifene reduces the number and severity of hot flashes, decreases pain with intercourse, and reduces vaginal dryness vs. placebo.1,3,6 Also, use of conjugated estrogens/bazedoxifene results in statistically significant improvements in sexual functioning, menopause-related quality of life, sleep quality, and satisfaction with treatment.7–9 Improvements in sleep quality and quality of life are similar to those seen with conjugated estrogens/medroxyprogesterone.9
For the prevention of postmenopausal osteoporosis, conjugated estrogens/bazedoxifene will maintain or slightly increase bone mineral density in the lumbar spine and hip. Its effect on vertebral, hip, or overall fracture rate is not known.4,5,10 Although conjugated estrogens/bazedoxifene does not affect breast density, studies have not examined its use for the prevention of breast cancer.11
A one-month supply of conjugated estrogens/bazedoxifene costs approximately $145. In comparison, a one-month supply of conjugated estrogens/medroxyprogesterone costs approximately $148. Cyclical combined hormone replacement with separate tablets of estradiol and medroxyprogesterone costs about $10 per month.
Conjugated estrogens/bazedoxifene is taken once daily without regard to meals.
Conjugated estrogens/bazedoxifene is effective for the treatment of menopausal symptoms and may be better tolerated than conjugated estrogens/medroxyprogesterone. It will maintain bone mineral density in the lumbar spine and hip, but its effect on fractures is not known. Cardiovascular safety beyond two years is not known.
REFERENCESshow all references
1. Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril. 2009;92(3):1025–1038....
2. Daily Med. Drug label information: Duavee—estrogens, conjugated and bazedoxifene acetate tablet, film coated. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdd5d5b-7569-4848-afa2-e820fbe3c8fb. Accessed April 1, 2015.
3. Pinkerton JV, Utian WH, Constantine GD, Olivier S, Pickar JH. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial [published correction appears in Menopause. 2015;22(2):245]. Menopause. 2009;16(6):1116–1124.
4. Pinkerton JV, Harvey JA, Lindsay R, et al.; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. J Clin Endocrinol Metab. 2014;99(2):E189–198.
5. Mirkin S, Komm BS, Pan K, Chines AA. Effects of bazedoxifene/conjugated estrogens on endometrial safety and bone in postmenopausal women. Climacteric. 2013;16(3):338–346.
6. Kagan R, Williams RS, Pan K, Mirkin S, Pickar JH. A randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. Menopause. 2010;17(2):281–289.
7. Utian W, Yu H, Bobula J, Mirkin S, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens and quality of life in postmenopausal women. Maturitas. 2009;63(4):329–335.
8. Bachmann G, Bobula J, Mirkin S. Effects of bazedoxifene/conjugated estrogens on quality of life in postmenopausal women with symptoms of vulvar/vaginal atrophy. Climacteric. 2010;13(2):132–140.
9. Pinkerton JV, Pan K, Abraham L, et al. Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial. Menopause. 2014;21(3):252–259.
10. Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril. 2009;92(3):1045–1052.
11. Harvey JA, Pinkerton JV, Baracat EC, Shi H, Chines AA, Mirkin S. Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens. Menopause. 2013;20(2):138–145.
STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.
This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.
A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.
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