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New Treatment for Menopause Symptoms
June 4, 2007 -- Women seeking to quell the symptoms of menopause and build stronger bones may soon have a new treatment option -- possibly with fewer risks normally associated with traditional hormone replacement therapy (HRT).
In two two-year studies of nearly 4,000 women researchers from Wyeth Pharmaceuticals reported on a new class of drugs known as tissue selective estrogen complex (TSEC) -- medications said to offer the benefits of traditional estrogen while minimizing troubling side effects and risks of traditional HRT. The studies were presented this week at the annual meeting of the Endocrine Society in Toronto.
"We're seeing a number of what I think are going to be significant improvements over the previous generation of HRT. This is really a new generation of treatment," says study researcher James H. Pickar, assistant vice president of clinical research and development at Wyeth Research.
In the research, the TSEC drug, yet to be named, combined a conjugated estrogen ( Premarin) with basedoxifene, a drug commonly known as a SERM (selective estrogen receptor modulator). SERMS have some of the benefits of estrogen -- such as helping to increase bone density -- without increasing the risk of breast or endometrial cancer.
But rather than just seeing the benefits of combining two separate medications, Pickar says the surprising effect was greater than the sum of its parts.
"What you get is not simply the addition of one to the other, but a brand new profile. That's what makes it so exciting," says Pickar.
That new profile, he says, appears to offer women all the benefits of HRT -- including better bone density -- while minimizing the risks normally associated with hormone therapy.
NYU professor Steven Goldstein, MD, says if the claims are true, then women might indeed have reason to celebrate. But he cautions that questions on long-term use -- particularly effects on breast tissue -- still hang in the balance.
"If we truly can combine the benefits of estrogen -- relief of hot flashes and vaginal dryness -- with the benefits of a SERM -- including decreased bone fracture with breast and uterine protection -- and not increase the risks previously associated with both treatments ... then this will indeed be a revolution in menopausal medicine," says Goldstein.
But he cautions that questions on long-term use - including any impact on breast tissue -- can only be answered with further research.
What We Know Right Now
In the first of the two new trials being presented, researchers looked at the impact of TSEC on the endometrium (the lining of the uterus) in nearly 4,000 women aged 40 to 75 over the course of two years.
The study showed that new cases of endometrial hyperplasia (a thickening of the lining frequently associated with estrogen therapy and sometimes a precursor to cancer) were similar to placebo. Moreover, there was also no increase in bleeding and spotting or breast pain, all common side effects of hormonal therapy.
In the second study, doctors tested the same TSEC on bone mineral density (BMD). They found that it yielded a greater increase in bone mineral density of the spine and hip when compared with placebo or Evista, another SERM.
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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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