A decade into menopause, and I'm still hot (no, not that kind of hot, just middle-of-the-night way too warm hot). For ten years I weighed estrogen pluses, namely good for the bones, brain, and heart, with estrogen negatives, that nagging worry regarding breast health, and I revisited that analysis annually. Just this past year, estrogen yikes overtook estrogen yay, and I dropped my weekly dose to just a tick over negligible. And subsequently lost two checks, a zillion pens, one notebook, my pedometer, my keys again and again, 5 pounds of muscle, and 1/2 inch of height.
Enter a new kid on the menopausal treatment list, a so-called TSEC or tissue selective estrogen complex, also known by the not-so-catchy name of Duavee. It was approved in October, 2013, but I only found out about it in the March issue of the journal "Menopause" which featured a long article and accompanying editorial about this drug.
Duavee is a combo drug, a pharmaceutical 'two-fer'. It contains Premarin (no, I don't love that about it either, but more on that later) and bazedoxifene which is not approved as a stand-alone drug in the U.S. although it is available in Europe. Each of these drugs interact with estrogen receptors in the body, but while Premarin stimulates the 'on switch' when it couples with cellular receptors, bazedoxifene turns some estrogen receptors on and some of them off depending on the specific tissue involved. It is one of a class of drugs called selective estrogen receptor modulators (SERMs).
Tamoxifen is also a SERM long-used to decrease risk of estrogen-receptor positive breast cancer or to prevent its recurrence. Tamoxifen, unfortunately, stimulates estrogen receptors in the uterus, thus increasing risk of uterine cancer, and some women do not like the way they feel when they're on it. Another SERM that's been around for awhile is raloxifene or Evista which is prescribed for the prevention and treatment of osteoporosis. Evista works well on preserving bone density, protects the breast against estrogen stimulation, but aggravates hot flashes.
The ideal treatment for the health challenges of menopause would turn on all the right estrogen receptors (bone, brain, vascular tissue, genitalia) and would turn off those better left quiescent in aging ladies (breast and uterus). Estrogen works wonders on hot flashes also known as vasomotor symptoms; in fact, it's the very thing. It supports bone density and has a number of favorable effects on brain and cardiovascular health. Unfortunately for women no longer in their reproductive years, it stimulates breast and uterine tissue in an unwanted sort of proliferative way that, over many years, increases risk of cancer and fibroids. As a result, progesterone is added to hormone regimens to offset the estrogenic stimulation to the uterus, but this addition only increases the breast cancer risk. In addition, the effect of oral estrogen, particularly non-human oral estrogen such as Premarin, has undesirable effects on inflammation and clotting in the body. While many women did well for many years on the combo drug known as Prempro (Premarin plus a synthetic progesterone called Provera), the results of the Women's Health Initiative released in 2002 included significant increases in incidence of stroke, heart attacks, breast cancer, and dementia in women on the Premarin/Provera combination. Of note, however, is that women taking only Premarin did not experience an increased risk of breast cancer. Nevertheless, this study drastically changed prevailing opinion on the benefits of post-menopausal hormone therapy, and its use has since dramatically dropped.
The combination of bazedoxifene and estrogen is just short of perfect. The estrogen component decreases hot flashes although the dose is lower than ideal to completely beat not only the heat but also genital atrophy (as in painful intercourse). Better yet would be bazedoxifene all by itself to be used along with an estrogen skin patch. For now, however, as I work on my personal equation of health goals vs. personal fears, Duavee gets a tentative one to two thumbs up.
Interested in more insider scoops on good health choices for the rest of your life? Stay tuned for September announcements on small group seminars on menopause, osteoporosis, and cardiovascular health.
Check out Duavee review and Duavee and sleep for an update on my Duavee journey.
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8 comments:
This drug is questionable. CEEs are known carcinogens and bazedoxifene a SERM - SERMs have many inherent risks. And yada, yada they claim the two work synergistically but I don't buy it - it it's turning off estrogen receptors in the breast where is it turning them on etc.? Limited trial data and all the issues Pfizer/Wyeth has had bringing this to market. As we all know cancer is an insidious disease and can take years to develop. This drug is merely an opportunity for Pfizer to maintain patent protection and high prices. There are safer alternatives and the warnings are exactly the same as its parent drug Premarin. Beware.
AJ: Thanks for taking the time to comment. I certainly share your concerns, both ethical and medical, about Premarin. In fact, I haven't prescribed it for almost 20 years. I don't agree with your take on SERMs, however, and if bazedoxifene was available here as a stand alone drug, I would choose to try it. I suppose I could use Evista and an estrogen patch, and perhaps I will when I finish my Duavee samples. Both options promise to be crazy expensive.
These medical decisions are so complex, looking for best case scenario drugs and lifestyles to maintain a satisfying level of health. Duavee comes close, and the science behind it sufficiently allays my breast cancer fears enough to allow me to comfortably make a decision to try it for brain, bone, and quality of life reasons. I can't yet say whether I function better with or without--the decision-making process is still under review. I am pleased, though, by the new opportunities in menopausal treatment.
My understanding is that any FDA-approved pharmaceutical product with estrogen is stuck with the exact label warnings as other estrogen formulations even if it has not been shown to have the same WHI proven outcomes found for the Premarin/Provera combo.
Other than diet, exercise, calcium, etc, what safer alternatives do you advocate?
The WHI study demonstrated the opposite, premarin is the only estrogen I am aware of that has been tested and shown to actually reduce breast cancer. The key thing is that the addition of he progestin (MPA) increased breast cancer. progestins are mitogenic in breast, it is too well known to be beyond debate. The so called biodentical hormones estradiol and progesterone clearly increase breast cancer risk lest why else do aromatase inhibitors and SERMs prevent breast cancer? They work by blocking estradiol in the body - However, in menopausal women (those having low estradiol levels), women taking conjugated estrogens had a decreased risk of breast cancer. The beauty of the TSEC is that it replaces the progestin which is known to increase breats cancer with a drug that is known to block estrogen effects ( a SERM). Better yet, no vaginal bleeding and no progestin side effects. bazedoxifene and premarin have been each tested separately and together in multiple clinical phase 3 studies with thousands of women, older and younger. bazedoxifene treated women hasd less breats and uterine cancer than women taking no hormones. It is amazing to me that the most tested of all drugs are the ones we are most skeptical of wen there is actually data and instead we prefer voodoo and other unproven alternatives because we can say nice things like they are natural. estradiol is an incredibly potent proliferator of brest cancer cells - it is the bioidentical estrogen and it stimulates breast cancer growth. Conjugated estrogens are much less potent on the same tissues. But who cares about data and facts when it is better to read Suzanne Somers and make our medical decisions by Dr OZ
Great information and great comments! Thank you for this, Denverdoc. I'm a low-grade DCIS patient, 53, suffering myself from being too "hot" (and way too uncomfortable in a myriad of ways) just two months ago. Duavee has so far made a significant difference. And my doc is comfortable with my using it despite my history. Also very impressed. Thank you for the validation. Here's my story.
http://dcisnorads.blogspot.com/2013_07_01_archive.html
I'd like to thank you for this lovely article that marks HRT seem like a reasoned choice and offers hope. The mental, physical and emotional chaos that menopause has caused in my own life has left me no other choice. I dealt with this unsuccessfully with yoga, diet, etc., and I'm now giving Duavee a try. I'm cautiously optimistic that in a few months I'll be back in my groove.
My Dr. just recommended Duavee and I'm wondering if anyone who has tried it has an update on how you've felt on it and if you've learned anything else about the potential dangers of using it.
I was on a birth control pill for many, many years, When I turned 51, my periods got heavy and terrible cramping. My Doctor suggested I get off birth control and he put me on Duavee. I have been on Duavee for 3 1/2 years. It has worked awesome for me.
I got off for 2 months (because my breast doctors suggested I get off it). Those 2 months were a living hell. Hot flashes, mood swings, depression, etc... it was not good. I got back on and I will never get off again. My breast doctor said my quality of life was more important than anything so he was ok with me getting back on the Duavee.
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