Clinicians treating vasomotor and genitourinary symptoms of menopause should consider estrogen therapy for healthy women with moderate to severe symptoms and no contraindications to hormone therapy, according to a new clinical practice guideline issued by the Endocrine Society.
The guideline, developed by an international panel, is designed to be a comprehensive document that emphasizes individualized clinical recommendations and generally takes a conservative approach to balancing risks and benefits, said Dr. Cynthia Stuenkel, chair of the task force that developed the guideline and professor of medicine at the University of California, San Diego.
“We need to be very mindful of the individual health concerns of our patient – is the individual therapy that we choose safe for her?” noted Dr. Stuenkel during a web-hosted press conference announcing the publication of the guideline.
For women under 60 years of age or fewer than 10 years past menopause who have bothersome vasomotor symptoms (VMS) and are without contraindications, the guideline suggests initiating estrogen therapy, supplemented by a progestogen for those women who have a uterus (J Clin Endocrinol Metab. 2015. doi: 10.1210/jc.2015-2236).
The discussion regarding treatment options should be grounded by a obtaining a baseline history of and assessing risk for cardiovascular disease (CVD) and breast cancer. “Menopause is a portal to the second half of life,” so clinicians should address bone health, smoking cessation, alcohol use, and cardiovascular and cancer risks and screening in their discussion, said Dr. Stuenkel.
The panel makes specific recommendations to tailor treatment depending on risk. For example, women at intermediate to high risk of breast cancer should be steered toward nonhormonal therapies to relieve VMS. Those at moderate risk of CVD can consider transdermal estradiol, while nonhormonal therapies are recommended for the high–CVD risk group.
The genitourinary symptoms of menopause (GSM) can include not just vulvovaginal atrophy but also urinary frequency and recurrent urinary tract infections, said Dr. Stuenkel, so the panel used the broader terminology to address estrogen’s effect on both organ systems.
An initial trial of vaginal moisturizers, used at least twice weekly, supplemented by lubricants as needed before sexual activity, should be the first-line treatment for GSM. For women with persistent symptoms and no history of estrogen-dependent cancers, low-dose vaginal estrogen therapy is a logical next step and does not require accompanying progestogen treatment, according to the guideline.
For women with symptomatic GSM who have had breast or endometrial cancer whose symptoms are not sufficiently treated by nonhormonal methods, low-dose vaginal estrogen is a consideration. This option should be considered with a shared decision-making approach that involves the patient’s oncologist.
Conjugated equine estrogens plus bazedoxefine, a novel selective estrogen receptor modulator (Duavee) can treat VMS and provide protection against bone loss, said the task force. The guideline recommends against the use of custom-compounded hormonal therapy and recommends the use of Food and Drug Administration–approved formulations. Ospemifene can be considered in women with significant dyspareunia and without contraindications, which include a history of breast cancer.
In conclusion, the guideline calls for ongoing rigorous study of the optimal agents and dosing for treatment of symptoms, how best to balance symptom relief with chronic disease prevention, and the merits of long-term hormone therapy beyond the period when symptomatic relief of VMS is needed. “International registries and clinical trials are overdue to address the long-reaching implications of these important issues,” said Dr. Stuenkel and coauthors of the guideline.
Dr. Stuenkel reported no relevant financial disclosures. Three task force members, Dr. Susan Davis, Dr. JoAnn Pinkerton, and Dr. Richard Santen, reported financial ties to pharmaceutical companies. Cosponsoring organizations included the Australasian Menopause Society, the British Menopause Society, European Menopause and Andropause Society, the European Society of Endocrinology, and the International Menopause Society.
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