New Treatment for Menopause Symptoms
2-Drug Combo May Reduce Menopause Symptoms While Building Bone
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
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
"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
"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
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.