Cases Commonly Seen in a Menopause Specialist’S Practice
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Volume 10, Issue 2 (April 2014) This clinical e-newsletter from The North American Menopause Society (NAMS) presents questions and cases commonly seen in a menopause specialist’s practice. Recognized experts in the field provide their opinions and practical advice. Gloria Bachmann, MD, the Editor of Menopause e-Consult, encourages your suggestions for future topics. Note that the opinions expressed in the commentaries are those of the authors and are not necessarily endorsed by NAMS or Dr. Bachmann. Case: classifies testosterone and methyltestosterone Your 68-year-old patient wants to continue as potentially inappropriate because of cardiac using estrogen. Will insurance classify this as problems. The notice requests that you weigh high-risk medication requiring a trial of risk versus benefit in your patient and assess alternatives such as selective serotonin whether an alternative therapy could be used. reuptake inhibitors (SSRIs), serotonin- norepinephrine reuptake inhibitors (SNRIs), HEDIS and Beers Criteria gabapentin, or progesterone before continued HEDIS is a registered trademark of the authorization? National Committee for Quality Assurance and mostly uses Beers Criteria and their list of Management issues by: medications.¹ They define older adults as 65 years of age or older. Beers Criteria is Henry M. Hess, MD, PhD, NCMP generated by a US consensus panel of experts University of Rochester and is updated annually. For estrogens, these Medical Center criteria are largely based on Women’s Health School of Medicine and Dentistry Initiative (WHI) and WHI follow-up studies. Rochester, NY Beers Criteria lists oral and transdermal estrogens and estrogen/progestogens as potentially inappropriate because of carcinogenic potential (in the breast and Estrogens in women aged older than endometrium), the lack of cardioprotective 65 years effects, and the lack of cognitive protection in If you have a patient aged older than 65 years older women. Beers Criteria describes the use on hormone therapy (HT), you have or will be of topical intravaginal estrogen cream at a low receiving notification from her insurance dose as acceptable for the prevention of urinary company stating that “this drug falls under tract infections and the management of Beers Criteria for Potentially Inappropriate dyspareunia and other vaginal symptoms. At Medication Use in Older Adults and/or the doses less than 25 µg twice weekly, Beers 2013 Healthcare Effectiveness Data and Criteria finds that evidence exists for safety of Information Set (HEDIS) of high-risk use in women with breast cancer. medications in the elderly due to carcinogenetic effects and the risk of deep vein Extended estrogen use thrombosis, pulmonary embolism, stroke, and Many women currently on HT wish to remain myocardial infarction.” Beers Criteria also on it beyond age 65 for several reasons, 2 including persistent vasomotor symptoms, ACOG recommends against routine dyspareunia caused by vulvovaginal atrophy, discontinuation of systemic estrogen at age 65. and treatment for osteopenia and osteoporosis. As with younger women, use of HT and Many women just plain feel better on HT and estrogen therapy should be individualized comment on improvement cognitively and based on each woman’s risk-benefit ratio and sexually and on how youthful they feel and clinical presentation.”5 look. It is now recognized that the length of time of the menopause transition (and therefore Age 65 and beyond of symptoms) is nearly 12 years in many We have many patients who initiated HT women, not 3 to 4 years as previously thought. within 10 years of menopause and who wish to In a study of older menopausal women, with a stay on HT at age 65 years and beyond. This mean age of 67 years and mean time since milestone can be another opportunity to discuss menopause of 19 years, 11.8% still reported with our patients the benefits, risks, and clinically significant hot flashes.2,3 alternatives to HT. There is a lot of new thinking about extended HT. An excellent When the WHI was initiated, the average recent article by Andrew Kaunitz, MD, on woman in the study was aged approximately 63 when a menopausal woman should discontinue years. Since then, there have been several HT⁶ takes the reader through the different subgroup analyses and other studies that have options for managing the patient who wishes to shown that benefits and risks of HT may stay on extended HT. Kaunitz’s approach is depend on many factors, such as dose, age at very similar to mine: to use transdermal initiation, length of duration of therapy, form estradiol in the lowest possible dose, as low as (oral vs transdermal), the use of progestogens, a .025 mg patch (or equivalent gel/cream) or family history (such as the risk of breast even a .014 mg patch—and for women with an cancer), and more. Individualization of intact uterus, to use progesterone in the lowest therapies has long been advocated by possible dose and as infrequently as possible. numerous articles and professional We often use 200 mg of micronized organizations. The NAMS 2012 position progesterone for 14 nights every 3 months with statement on HT states that “provided that the transdermal estrogen patch doses of .025 mg or woman is well aware of the potential benefits higher. For the .014 mg dose, we use that same and risks and has clinical supervision, amount of micronized progesterone every 12 extending [estrogen and progestin therapy] months. We frequently do an endometrial with the lowest effective dose is acceptable assessment (sonohysterogram and/or under some circumstances, including 1) for the endometrial biopsy) in patients with an intact woman who has determined that the benefits of uterus for abnormal uterine bleeding or when menopause symptom relief outweigh the risks, progesterone is not possible or who use notably after failing an attempt to stop progesterone less often than noted above. We (estrogen and progestin therapy) and 2) for the don’t use extended HT in women at high risk woman at high risk of fracture for whom for endometrial carcinoma or with a family alternative therapies are not appropriate or history of breast cancer. Because of potential cause unacceptable adverse effects.”4 A 2014 cardiovascular risks, we don’t use oral estrogen practice bulletin from the American College of in women aged older than 60 years. Obstetricians and Gynecologists (ACOG) on the management of menopausal symptoms Discussion with the patient regarding risks states that “the decision to continue HT should It is important to keep in mind and discuss with be individualized and be based on a woman’s the patient that the data regarding the risks of symptoms and the risk-benefit ratio, regardless HT are mostly from the WHI and WHI follow- of age. Because some women aged 65 years up studies. The incidence of breast cancer and and older may continue to need systemic HT mortality from breast cancer increased after 3 for the management of vasomotor symptoms, to 5 years of estrogen and progestin therapy, 3 and the risk of stroke remained elevated bedtime has also been suggested. The data on throughout use of this combination. However, breast safety for daily progesterone is limited. in the WHI, the higher-dose Premarin Some women with mild to moderate hot combined with medroxyprogesterone acetate flashes at this time of life may find some herbal was used, a higher and different dose than we therapies helpful. We often recommend black would typically use in a 65-year-old woman cohosh in this situation. As with most herbs, today. The risk of breast cancer and stroke in the integrity of the product is important. We many women might be different and lower recommend Remifemin to our patients. with the use of lower doses of transdermal estrogens and lower doses and longer cycles of Estrogen in women aged older than 65 micronized progesterone. Also, keep in mind years: discussion and documentation that there was no increased risk of breast The age of 65 is another ideal landmark for cancer observed in the estrogen-only arm of the discussion with the patient about menopausal WHI, and this has continued after more than 7 therapies, especially estrogen. There are many years of follow-up.7 It is also very important to situations in which low-dose estrogen or know that newer analyses and interpretations estrogen and progesterone therapies can be of WHI data are showing potential decreases in medically justified and not considered high risk cardiovascular as well as overall mortality, in women aged older than 65 years. especially for estrogen-only users.⁸,⁹ The use Documentation in the electronic medical record of minimal long-term cyclic progesterone in of such a discussion with the patient and HT users may eventually show this same justification for continued estrogen use is the effect. current quality-assurance expectation. What are the options? Disclosure: Dr. Hess reports: Speakers bureau: Noven, Some patients will be interested in continuing Shionogi. HT at age 65 even after there is a discussion of the issues. Some will go off and stay off, and References 1. American Geriatric Society 2012 Beers Criteria some will want to go back on. Some will Update Expert Panel. American Geriatrics Society consider the alternatives. For many of our updated Beers Criteria for potentially inappropriate patients, vasomotor symptoms will be less medication use in older adults. J Am Geriatr Soc. severe than in early menopause, and some of 2012;60(4):616-631. the alternative therapies may be more effective 2. Freeman EW, Sammel MD, Lin H, Liu Z, Gracia CR. Duration of menopausal hot flushes and associated risk at this age than when they were younger. Low- factors. Obstet Gynecol. 2011;117(5):1095-1104. dose SSRI or SNRI therapies may be effective. 3. Huang AJ, Grady D, Jacoby VL, Blackwell TL, Venlafaxine at 37.5 mg has been reported as Bauer DC, Sawaya GF.