STEPS

New Drug Reviews

Conjugated Estrogens/Bazedoxifene (Duavee) for Menopausal Symptoms

 


FREE PREVIEW. AAFP members and paid subscribers: Log in to get free access. All others: Purchase online access.


FREE PREVIEW. Purchase online access to read the full version of this article.

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

View/Print Table

DrugDosageDose formCost*

Conjugated estrogens/bazedoxifene (Duavee)

0.45 mg/20 mg once daily

0.45-mg/20-mg tablet

$145


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed December 14, 2015).

DrugDosageDose formCost*

Conjugated estrogens/bazedoxifene (Duavee)

0.45 mg/20 mg once daily

0.45-mg/20-mg tablet

$145


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed December 14, 2015).

SAFETY

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

TOLERABILITY

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

Address correspondence to Kristina Johnson, MD, at kgj2e@virginia.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

REFERENCES

show 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.



 

Copyright © 2016 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.

Want to use this article elsewhere? Get Permissions

CME Quiz

More in AFP


Editor's Collections


Related Content


More in Pubmed

MOST RECENT ISSUE


Dec 1, 2016

Access the latest issue of American Family Physician

Read the Issue


Email Alerts

Don't miss a single issue. Sign up for the free AFP email table of contents.

Sign Up Now

Navigate this Article