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Menopause Hormone Therapy: 'Safe' Time?
Feb. 4, 2009 -- New research confirms that taking estrogen plus progestin as hormone replacement therapy for menopausal symptoms raises breast cancer risk, but that risk fades within about two years after quitting hormone therapy.
The findings come from two new studies, one published in The New England Journal of Medicine and the other in Cancer.
Here's what the researchers want women to take away from the findings:
- It's still advisable to have hormone therapy only if needed and at the lowest dose for the shortest time to be effective. And women should weigh the pros and cons of hormone therapy in consultation with their doctors.
- The longest "shortest time" might be as brief as two years, which some of the researchers say may be a "safe" period, though that's not certain.
- Working with their doctors, women may want to take a break from hormone replacement therapy after three to five years to see if they still need it.
- The increased risk of breast cancer is mostly about taking estrogen plus progestin, not estrogen alone. But about two years after quitting hormone therapy, that risk may be gone.
Hormone Replacement Therapy and Breast Cancer Risk
Hormone replacement therapy is approved to treat hot flashes and vaginal dryness related to menopause.
The Women's Health Initiative (WHI), a national women's health study, showed that long-term use (at least five years) of hormone replacement therapy combining two hormones -- estrogen plus progestin -- raised women's risk of heart disease, stroke, blood clots, and breast cancer (and lowered the risk of colorectal cancer and bone fractures) compared to women taking a placebo.
In the wake of those findings, the FDA recommended that menopausal hormone therapy using estrogens and progestins should be used at the lowest doses for the shortest duration to reach treatment goals.
But how short is the "shortest duration"? And what about hormone therapy that only includes estrogen without progestin, a treatment plan typically limited to women who've had their uterus surgically removed (a hysterectomy)? And is the breast cancer risk linked to hormone therapy reversible? Those are some of the questions tackled by the two new studies.
New Findings on Hormone Replacement Therapy
The two new studies agree on four things:
1. The long-term breast cancer risk from estrogen-plus-progestin therapy is real. Rowan Chlebowski, MD, PhD, who worked on The New England Journal of Medicine study, says that risk has been characterized as being "small," but at least 20,000 cases of breast cancer per year in the U.S. may be due to hormone therapy. "It's not a hypothetical number, something that never happens," Chlebowski tells WebMD.
2. Quitting hormone therapy cuts breast cancer risk. The increased breast cancer risk from hormone replacement therapy appears to end about two years after quitting hormone therapy. That's "good news," Chlebowski tells WebMD. In the WHI data, "it looked like the risk starts to go down right away. And after between one and two years, it looks like pretty much like that risk is gone," says Chlebowski, who works at the Los Angeles Biomedical Research Institute at the Harbor-UCL Medical Center.
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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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