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Posts Tagged ‘systemic hormones’

We’ve been following the development of Flibanserin, also called “pink Viagra,” since 2010, when its developer shelved it after hitting a bump in the road to FDA approval. Several years later, we were talking about alternatives, Librido and Lybridos, which were moving forward with clinical trials (and have not yet been approved).

We’ve just learned that the manufacturer that now owns Flibanserin has filed an appeal of the FDA denial, saying that other drugs have been approved with less data and more extreme side effects. And that’s reignited discussion about whether pharmaceutical products targeting women’s sexual disorders are evaluated on a level—or relevant—playing field.

Flibanserin, Librido, and Lybridos (and a small handful of others) are all drugs designed to play a part in awakening libido for women. They counter hypoactive sexual desire disorder (HSDD), in physicians’ terminology (the rest of us call it “not tonight—or tomorrow night, either” syndrome). There are, for context, a couple of dozen FDA-approved drugs for the comparable problem among men, including Viagra.

I don’t have the insider information I’d need to assert a double standard, although people I know and respect—like my colleague Sheryl Kingsberg—suggest there is one. Women’s health psychologist at University Hospitals MacDonald Women’s Hospital, Sheryl said, “There’s a double standard of approving drugs with a high risk for men versus a minimal risk for women.” The side effects for Flibanserin, for example, were reported as dizziness and nausea; Sheryl compares those to side effects of penile pain, penile hematoma, and penile fracture—all from a drug that was approved.

That does sound like some extra protectiveness of women. Given my focus on sexual health for women, I run into a lot of cultural expectations and hesitations; we Americans are still just a bit prudish when it comes to, especially, older women having sex. That’s in spite of what I see in my practice every day: Women themselves want to live whole lives, which means being physically active, emotionally engaged, and sexually active within their relationships.

I recognize that sexuality for women is complex, and there won’t be a “magic bullet.” For women, arousal and desire is a mix of emotional intimacy, biological responses, and psychological responses; a drug won’t address all of the components. But because I’m often working with patients to untangle interlocking causes of problems with sex, I’m eager for as many tools as possible, including pharmaceuticals.

As a physician, I also see the need to evaluate trade-offs and risks. I’ve talked before about the pros and cons of hormone therapy. For some women, living longer doesn’t really count if they’re not able to be active—including being actively sexual. “Pink Viagra” drugs may well require the same kind of close collaboration between women and their doctors to evaluate risks and benefits. Again, Sheryl: “Give women a chance to decide for themselves, within reason. There is no drug out there that has no risk.” In the case of Flibanserin, only 8 percent of testers said the side effects were bad enough to make them want to drop the drug.

These decisions by the FDA are also important because pharmaceutical research is done by businesses, businesses that can decide that one problem or another is too expensive or too complicated to take on. Sheryl sees this, too, saying, “My worry is that research in this area will dry up and will leave many women without a pharmacological option.”

One way to make your voice heard about the importance of continued research is by signing the International Society for the Study of Women’s Sexual Health (ISSWSH) WISH petition. Our sexual health is integral to our overall health, and we need more investigation and even-handed, common-sense consideration of therapies for women.

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Localized estrogen is not thought to be absorbed systemically, which means that blood estrogen levels remain in the menopausal range; if there is any absorption, it is scant. At that level, it does not increase risks of breast cancer. Unfortunately, the “prescribing information” (PI) for localized hormones is required to be the same as for all estrogens, although the risks are significantly different from those of systemic estrogens.

Last month, I attended the North American Menopause Society (NAMS) annual meeting, where I heard that a request has been filed with the FDA to amend the PI to fit more accurately what’s known about localized estrogen use.

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It’s no wonder we’re confused. First it’s good; then it’s bad. Now it’s up to you.

Hormone replacement therapy has had more media makeovers than Liz Taylor, and it continues to grab attention here and there.

The latest, and highly credible, statement on the issue is from an international roundtable of medical experts convened by the Society for Women’s Health Research (SWHR). The purpose of this gathering of experts, which represented various specialties, such as cardiovascular disease, osteoporosis, and cancer, was to take yet another objective and rigorous look at the evidence regarding hormone replacement therapy, and to make recommendations as to its use and safety. The results of this discussion just came out in the Journal of Women’s Health.

This roundtable is a good effort to shed some objective light on the risks and benefits of an issue that’s been hotly debated for over ten years now, ever since the Women’s Health Initiative (WHI) prematurely ended its groundbreaking study of women receiving hormone therapy in 2002 because of a high incidence of breast cancer and cardiovascular complications.

The problem, however, is that hormone therapy (HT) is still the only effective, FDA-approved treatment for menopausal symptoms, such as hot flashes and vaginal changes. Recently two non-hormonal drugs were just nixed by an FDA advisory panel because they were viewed as ineffective.

Ever since the WHI results were released, the pendulum has been swinging wildly with each new medical release or research report. And while this latest SWHR roundtable really moves the chess pieces very little, it does solidly reaffirm positions held by the North American Menopause Society.

(In fact, NAMS had released its latest position statement on hormone treatment barely a month earlier.)

What the roundtable did add, however, is something I strongly advocate: Give women solid information about their treatment options and let them make informed decisions about their own health.

Their findings include:

  • In younger, postmenopausal women with menopausal symptoms, the benefits of HT outweigh the risks;
  • HT is the most effective treatment for osteoporosis and should be considered for the prevention of osteoporosis, especially among at risk women;
  • Contrary to popular misconceptions, HT for early, postmenopausal women does not increase the risk for coronary heart disease (CHD) and may even reduce it;
  • HT does not increase total mortality rates and may, in fact reduce them.

Here’s how the SWHR roundtable puts it: “It’s time to put HT back on the table so that women can discuss with their providers the option of symptom relief and possible long term health benefits.”

Amen to that.

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Estrace is a bio-identical form of estradiol, a plant-based version of the same estrogen made by our ovaries. It comes in two forms—oral (systemic) and vaginal (localized). I use very little oral estrogen in my practice, because we’ve learned that transdermal estrogen (delivered by patch, gel, or spray or other forms that deliver it through the skin) is safer than oral. Because it’s not metabolized by the liver, it doesn’t carry the same risk of thrombosis.

Vaginal Estrace is great from a therapeutic perspective—that is, it’s very effective for treating vaginal atrophy. Because it’s a cream, though, many of my patients don’t love it: Some find creams messy to apply. It’s important to find a form of localized hormones that each patient will actually use!

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The North American Menopause Society (NAMS) has just published its seventh position statement about hormone therapy in the ten years since the Women’s Health Initiative (WHI) linked a whole bunch of unpleasant side effects, notably breast cancer, to hormone replacement therapy.

Before that groundbreaking study, estrogen was the wonder drug that alleviated menopausal symptoms, such as night sweats and hot flashes, and kept our sexual parts juicy. Once a woman reached “that age,” hormone replacement began.

The WHI study was like yelling “fire” in a crowded theater—everyone ran for the exit. From the fountain of youth, estrogen therapy became the disinherited stepchild, suddenly viewed with anxiety and suspicion.

But with ongoing research over the past decade, the effect of hormones is understood better, and the role of hormone therapy is more refined, nuanced—and safer.

Thus the need for all those updates. “In reviewing the recent scientific publications, NAMS determined that there are enough differences now between the effects of combined estrogen plus progestin (EPT) therapy versus estrogen therapy (ET) alone that it was time to make some changes,” said Dr. Margery Gass, executive director, NAMS, in an interview with The Female Patient.

Plus, as NAMS reasserts, hormone therapy is still the most effective treatment for those pesky, and sometimes debilitating, menopausal symptoms. (Hormone therapy shouldn’t be confused with localized hormones in the form of a cream, tablet, or ring that are used in the vagina to treat dryness and discomfort. These aren’t absorbed into the bloodstream, but they don’t treat other menopausal symptoms, either.)

So here’s the takeaway from the latest NAMS position statement:

  • Hormone therapy for women who have NOT undergone a hysterectomy (who still have a uterus) is usually estrogen plus progestin (EPT) because progestin protects against endometrial cancer. If therapy is started early in menopause and continues for less than 3 to 5 years, the risk of complications from breast cancer is low. The increased risk of side effects found in the WHI study was in older women (above age 60) or after long-term use of hormone therapy.
  • There is no greater risk of heart disease from hormone therapy for healthy women under 60. Risk of blood clots or stroke is a little higher—“less than 1 in every 1000 women per year taking HT,” according to the NAMS position statement. That risk can be further reduced with non-oral or transdermal estrogen therapy.
  • Estrogen alone, which is prescribed for women who have had a hysterectomy, has no increased risk of side effects, even after 7 years of therapy.
  • Hormone therapy comes in several forms—a low-dose pill or by patch, gel, skin spray, or cream. These may have fewer side effects than the regular-dose pill, but more research is needed to determine that.
  • It’s important to consider hormone therapy for the right woman, at the right time, and via the right products to maximize benefit and minimize risk. A careful consideration of your own history as well as your family history will help in making that decision.

Because the issue is complex and research is ongoing, NAMS will undoubtedly continue to update its position, but the bottom line, according to Dr. Gass, is that “both these therapies (EPT and ET) are relatively safe for women who are bothered by symptoms of menopause, and who would like to use hormone therapy for a while.”

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Vagifem is a vaginal estrogen, applied locally. It is safe for someone with your medical history, posing no risk of thrombosis. Only oral estrogen, which enters the system rather than being applied directly to vaginal tissues, poses some risk of thrombosis or clotting.

You might find an earlier blog post about localized estrogen helpful; in it I described the benefits, forms, and cautions for using vaginal estrogen.

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Vaginal estrogen is the most effective treatment for vaginal atrophy and its symptoms: dryness, itching, irritation, pain with intercourse. There are three low-dose, localized (without systemic absorption) estrogen options: the vaginal ring (Estring), vaginal tablets (Vagifem), and vaginal creams (Premarin and Estrace). I prefer the ring and tablets, because the cream is messy to use and the absorption is somewhat more variable. Studies confirm is no significant or noted changes in circulating blood estradiol levels with the ring and tablet; the creams are more variable and therefore more likely to have transient elevations in estradiol levels. I have many breast cancer patients who use these methods.

Women who are candidates for vaginal estrogen often also consider over-the-counter lubricants and moisturizers. Lubricants make sex more comfortable in the moment, but don’t improve or prevent the progression of the atrophy. Vaginal moisturizers give more lasting comfort. Used independent of sex on a continuous basis, usually two times a week, they can help restore moisture to the tissues. The moisturizers can also help restore a more healthy pH, promote elimination of dead cells, and increase moisture in the tissues.

If there are multiple menopausal symptoms, which may include vaginal dryness, systemic estrogen (like Vivelle) might be considered, weighing all health factors in the decision.

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There really are no special considerations specific to your diabetes. While I can’t confidently diagnose the cause of your pain with intercourse, I can’t think of a diagnosis or treatment option that would be eliminated because of your diabetes.

If you or your physician are considering systemic estrogen/progesterone, cardiovascular disease risks are taken into consideration. On the other hand, if localized (vaginal) estrogen could be part of the solution, cardiovascular disease risks are really not pertinent: The estrogen isn’t absorbed systemically to any significant extent. (Don’t interpret this to mean diabetics shouldn’t be on hormone therapy. May of our new studies suggest that starting hormone therapy at a younger age–closer to menopause–may actually be cardio-protective.)

I’m so glad you’re taking the initiative to investigate your health and your options!

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