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.
Menopause Symptom Relief
Though both studies offer promise, perhaps the aspect of TSEC that will interest most women is the potential improvement of menopausal symptoms -- problems like hot flashes or vaginal dryness.
"Two of the phase III trials looked at hot flushes, and the combination appears very effective in significantly reducing not only the number, but the severity," says Pickar. This is significant since SERM medications, particularly at high doses, often increase hot flashes.
Moreover, he adds that vaginal symptoms such as dryness and thinning also responded favorably to this TSEC. SERMs alone have no impact on these symptoms.
Although there have been no specific studies on either the protective effects or risks of TSEC on heart health, thus far Pickar says no adverse cardiovascular events have been reported. He adds that the incidence of blood clots and stroke previously associated with hormone therapy "was not different than placebo in our two-year trial of TSEC."
A head-to-head study comparing TSEC with HRT is under way with results expected later this year. Goldstein cautions that there is still much we don't know about this new approach to treating menopause.
"It could be the answer we have been searching for, but women need to realize that there are still many questions that need to be answered before we can say for certain this is a revolutionary treatment option."
Wyeth plans to submit data for drug approval to the FDA in the latter part of 2007. If approved, the first TSEC drug could be available by prescription as early as mid-2008.
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