A conversation about hormone therapy: is there an appropriate dose, route, and duration of use?

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Abstract

The North American Menopause Society (NAMS) held the 3rd Utian Translational Symposium on October 4, 2016, in Orlando, Florida, to answer questions about the benefits and risks of hormone therapy (HT) for postmenopausal women. This report is a record of the proceedings of that symposium.

The maxim about HT for the past 15 years since the publication of the initial results of the Women's Health Initiative (WHI) has been to prescribe the “lowest dose for the shortest period of time.” With new clinical trials, observational data, and further analysis of the WHI and the cumulative 13 years’ follow-up, it was time to hold a conversation about the state of the evidence and recommendations for HT dose, route, and duration of use.

The symposium brought together experts in the field of HT to speak on these topics, organized by session, after which working groups gathered to synthesize the presentations into areas of what still needs to be known and how to proceed with areas of needed research. After the presentations, there was consensus that postmenopausal women aged younger than 60 years or within 10 years of menopause onset without contraindications and who desire to take HT for relief of vasomotor symptoms or prevention of bone loss if at elevated risk can safely do so.

The working groups raised the possibility that the use of “Big Data” (pharmacy and cancer databases) would allow answers that cannot be found in clinical trials. This could lead to more appropriate FDA labeling and patient package inserts reflecting the true risks associated with various types and formulations of HT, with differences among estrogen alone, estrogen with a progestogen, and estrogen plus a selective estrogen-receptor modulator for the younger women most likely to initiate these therapies for symptom relief. Differences were found for potential risk among estrogen alone, estrogen with synthetic progestins contrasted to progesterone, lower doses, nonoral doses, and low-dose vaginal estrogen.

With all of the available routes and dosages, including vaginal estrogen alone for genitourinary symptoms, there are many options when considering the most appropriate type, dose, formulation, route of administration, and duration of use, taking into account the age of the woman at initiation of HT and the time from menopause.

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