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Recent advances help understand and improve the safety of menopausal therapies

Mirkin, Sebastian MD1; Archer, David F. MD2; Pickar, James H. MD3; Komm, Barry S. PhD1

doi: 10.1097/GME.0000000000000292
Review Article
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Objective Hormone therapy (HT) remains a mainstay of treatment of vasomotor symptoms, which are among the most common and most bothersome of menopausal symptoms. This review provides updates on HT and reviews newer menopausal therapies, focusing on recent safety data.

Methods An interpretative review of recent medical literature was conducted using computerized databases.

Results The latest analyses from the Women’s Health Initiative and other trials suggest that there is a window shortly after the onset of menopause in which HT provides optimal benefit with minimal risk. Risks of breast cancer, coronary heart disease, and probable dementia increase when a progestin is included in the HT regimen, which is necessary in nonhysterectomized women to counter the proliferative effects of estrogens on the endometrium. Attempts to further optimize the risk-benefit profile of menopausal therapies have led to the introduction of newer selective estrogen receptor modulators (bazedoxifene for osteoporosis, ospemifene for dyspareunia), tissue-selective estrogen complexes (conjugated estrogens/bazedoxifene for vasomotor symptoms and osteoporosis), and non-HT (low-dose paroxetine for vasomotor symptoms).

Conclusions Recent studies suggest that HT has a neutral or even beneficial effect on coronary heart disease and cognition when used in the early postmenopausal years. The risk-to-benefit ratio of estrogen therapy in hysterectomized women is more favorable than that of estrogen-progestin regimens in nonhysterectomized women. Conjugated estrogens/bazedoxifene now provides a progestin-free option for managing vasomotor symptoms in postmenopausal women with an intact uterus. Low-dose paroxetine may be an alternative for some women when hormonal treatments are contraindicated.

From the 1Women’s Health, Pfizer Inc, Collegeville, PA; 2Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA; and 3Department of Obstetrics and Gynecology, Columbia University, New York, NY.

Received February 19, 2014; revised and accepted May 13, 2014.

All authors were involved in drafting the manuscript or in critically revising the manuscript for important intellectual content and gave approval for the final version.

Funding/support: Medical writing support was provided by Lauren Cerruto of Peloton Advantage, LLC, and funded by Pfizer.

Financial disclosure/conflicts of interest: B.S.K. is an employee of Pfizer. S.M. was formerly an employee of Pfizer. D.F.A. serves as consultant to AbbVie, Agile Therapeutics, Bayer Healthcare, CHEMO, EndoCeutics, Merck, Shionogi Inc, and Warner Chilcott, and is a member of the speakers bureau for Shionogi, Pfizer, Bayer, Besins, Merck, and Noven. He has received institutional grants from AbbVie, Bayer, EndoCeutics, Pfizer, TherapeuticsMD, and Warner Chilcott. He has been compensated for developing educational presentations for Besins. He owns stocks or stock options for Agile. J.H.P. was formerly an employee of Wyeth Research and has consulted for Wyeth/Pfizer, Depomed, BHR Pharma, ASCEND Therapeutics, TherapeuticsMD, Ausio Pharmaceuticals, and Shionogi.

Address correspondence to: Barry Komm, PhD, Senior Medical Director, Pfizer, Global Medical Affairs, 500 Arcola Road, Rm E4217, Collegeville, PA 19426. E-mail: barry.komm@pfizer.com

© 2015 by The North American Menopause Society.