WHI says estrogen HRT drugs still too hot to handle (US)

Ooh, it's so hot in here my bones are getting brittle. Thank the devil for Wyeth. They gotta new drug. Or do they?
Ooh, it's so hot in here my bones are getting brittle. Thank the devil for Wyeth. They gotta new drug. Or do they?

By VIVIAN GRANT

It was the report by the Women’s Health Initiative that the dangers (our words) of hormone replacement therapy drugs for the treatment of symptoms of menopause outweighed any benefits that started the downward spiral (and upward spiral of later lawsuits) of pharmas like the Premarin (R) family of drugs manufactured by Wyeth.

That was a long time ago, and after their initial testing, they stopped.

Then the WHI resumed, and the results are not surprisingly, the same.

In a press release from earlier this year they tell us:

New results from the Women’s Health Initiative (WHI) confirm that the health risks of long-term use of combination (estrogen* plus progestin) hormone therapy in healthy, post-menopausal women persist even a few years after stopping the drugs and clearly outweigh the benefits. Researchers report that about three years after women stopped taking combination hormone therapy, many of the health effects of hormones such as increased risk of heart disease are diminished, but overall risks, including risks of stroke, blood clots, and cancer, remain high. The WHI is sponsored by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Results of the WHI three-year follow-up study of the estrogen-plus-progestin clinical trial are published in the March 5, 2008, issue of the Journal of the American Medical Association.

“The good news is that after women stop taking combination hormone therapy, their risk of heart disease appears to decrease,” noted Elizabeth G. Nabel, M.D., NHLBI director. “However, these findings also indicate that women who take estrogen plus progestin continue to be at increased risk of breast cancer, even years after stopping therapy. Today’s report confirms the study’s primary conclusion that combination hormone therapy should not be used to prevent disease in healthy, post-menopausal women.”

The FDA recommends that hormone therapy never be used to prevent heart disease, and, when hormone therapy is used for menopausal symptoms, it should only be taken at the smallest dose and for the shortest time possible.

*Pregnant mare’s urine, or CEE (conjugated equine estrogen), notation added by Editor and not part of the press release.

The risks were reported in abstract by JAMA, the Journal of the American Medical Association as follows:

The risk of cardiovascular events after the intervention was comparable by initial randomized assignments, 1.97% (annualized rate) in the CEE plus MPA (343 events) and 1.91% in the placebo group (323 events). A greater risk of malignancies occurred in the CEE plus MPA than in the placebo group (1.56% [n = 281] vs 1.26% [n = 218]; hazard ratio [HR], 1.24; 95% confidence interval [CI], 1.04-1.48). More breast cancers were diagnosed in women who had been randomly assigned to receive CEE plus MPA vs placebo (0.42% [n = 79] vs 0.33% [n = 60]; HR, 1.27; 95% CI, 0.91-1.78) with a modest trend toward a lower HR during the follow-up after the intervention. All-cause mortality was somewhat higher in the CEE plus MPA than in the placebo group (1.20% [n = 233] vs 1.06% [n = 196]; HR, 1.15; 95% CI, 0.95-1.39). The global index of risks and benefits was unchanged from randomization through March 31, 2005 (HR, 1.12; 95% CI, 1.03-1.21), indicating that the risks of CEE plus MPA exceed the benefits for chronic disease prevention. Read full abstract >>, Read full content >>

Wyeth have a drug in its final clinical trial period awaiting FDA approval called Aprela that will reportedly be marketed to women and men as a treatment for the loss of bone density experienced by both during the “change of life” period. It contains CEE, so has the added bonus of helping with hot flashes and night sweats. Physician’s notes state that Premarin treats the loss of bone density too. Is Aprela simply a new way to market Premarin? The FDA will knowingly approve it?

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