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After HRT, Some Health Risks Remain
March 4, 2008 -- For postmenopausal women who stop their hormone replacement therapy (HRT), there is good news, bad news, and surprising news from a new study that followed women for about two and a half years after they stopped the regimen.
On the plus side, some risks associated with the use of the combined estrogen and progestin therapy disappear after the regimen is stopped, including the increased risks of heart disease, stroke, and blood clots in the lungs, the researchers found. Unfortunately, the protective effects the hormones provide for hip fracture and colorectal cancer also disappear once women quit the regimen.
Even two and a half years later, former HRT users still have an increased risk of breast cancer, which was discovered in the original study, called the Women's Health Initiative (WHI). The increased risk after stopping the hormones, however, was not statistically significant. And, in a surprise finding, former HRT users also have a higher overall risk of getting cancers of many types compared to nonusers, the researchers found.
Despite the new findings, including the surprise finding about cancer, "the bottom line hasn't changed," says study researcher Gerardo Heiss, MD, professor of epidemiology in the School of Public Health at the University of North Carolina, Chapel Hill. The standard advice still applies, Heiss tells WebMD.
And that is for women to take the lowest possible dose of HRT for the shortest amount of time if they need it to quell bothersome symptoms such as hot flashes.
The study is published in the March 5 issue of The Journal of the American Medical Association.
HRT and Health Risks: Study Details
Heiss and his colleagues followed up 15,730 of the 16,608 women who participated in the original study, the WHI, designed to examine the health effects of taking estrogen plus progestin in older women. The WHI study was halted in 2002, after an average of 5.6 years of treatment, when researchers found an increased breast cancer risk among those who took the hormone therapy vs. those who took a placebo.
During the trial, they also found hormone users were at higher risk of heart disease, stroke, and blood clots than were nonusers but at lower risk of colorectal cancer and fractures.
In the new follow-up study, conducted from July 2002 to March 2005, Heiss' team looked at the effect that stopping the hormones had on six outcomes: heart disease, stroke, blood clots in the lungs (pulmonary embolism), invasive breast cancer, colorectal cancer, and hip fracture.
HRT and Health Risks: Findings
"We have some good news," says Rowan T.Chlebowski, MD, PhD, a medical oncologist at the Los Angeles Biomedical Research Institute in California and another study researcher. "The cardiovascular disease risk really ended once you stopped the hormones."
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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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