Estrogen therapy might help heart health of women in their 50s: study
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Wed, 15 Feb 2006 00:00:00 GMT |
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Thomas Blythe |
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Estrogen therapy for postmenopausal women, between the ages of 50 and 59 years, is not harmful for the heart and might even help its health, a study under the Women's Health Initiative has found. The benefits, however, do not extend to women in their 60s and above and estrogen therapy for them might also enhance the risk of cardiac troubles.
Under the new study, 10,700 women were studied for the effect of hormone therapy on their heart. Some of the participants were given placebos while others were administered estrogen pills. The researchers found that 201 women on estrogen had heart attacks, or underwent cardiac procedures or died due to cardiac troubles as against 217 on placeboes. The instances of cardiac problems were reduced significantly in 1,396 women who were aged between 50 and 59 years and took estrogen pills.
However, Dr Judith Hsia, the lead author of the study, said that findings did not mean that women should stay on estrogen therapy for too long, but indicated that it was alright to opt for the therapy to get rid of severe symptoms of menopause for a short term.
“We feel that our data are completely consistent with the current American Heart Association guidelines and the current Food and Drug Administration guidance to use the lowest possible dose for the shortest possible duration,” she said.
Expressing satisfaction with the findings, Jacques Rossouw, a spokesperson for the National Heart, Lung, and Blood Institute, which funded the study, said, “These findings are reassuring for women who want to use these hormones around the age of menopause in the short term for the relief of symptoms.”
One significant feature of the study was that all the women who were given estrogen had undergone hysterectomy, as estrogen therapy is believed to increase the risk of uterine cancers.
The US FDA requires estrogen pill makers to provide labels that warn of increased risk of heart attacks. While some experts advocate for the removal of the strict inserts in wake of the new study, others feel it is too early to do so. Center for Medical Consumers spokesman Arthur Levin said that the inserts should continue holding strong warnings to prevent women from abusing the pills. “I think the issue here is that you want the labeling to reflect the most current science. But at the same time you wouldn't want to change it to overplay the benefit of a single study and downplay the body of all other research,” he said.
Agreed Hsia, who said, “Although this finding does suggest a lower heart disease risk, you have to take all the risks and benefits together. You also have to bear in mind that there still is an increased risk of stroke, dementia and blood clots in the legs. The FDA recommendation that estrogen should not be used for the purpose of heart disease still applies.”
According to Dr Nieca Goldberg, of Lenox Hill Hospital in New York City, further research is required before the study's assertions can be firmly established. “Although there was a trend for younger women, it hasn't definitively proven it. We're trying to get women to understand that they have to take more than maybe a pill to reduce their risk for heart disease,” she said.
The findings of the study have been published in the Archives of Internal Medicine.
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The WHI Estrogen-Alone Study
By:
JWR ,
Thu, 16 Feb 2006 18:53:58 GMT
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This new analysis of the Women's Health Initiative Estrogen-Alone trial is being touted much too strongly by the media, Wyeth, and certain physicians. They have looked at the data, run with it, and made conclusions, which is VERY irresponsible at this point in time.
The analysis showed a insignificant "trend" toward heart disease prevention among women in their 50s, the group of women at lowest risk for heart disease. There were no trends seen for older women. The problem with interpreting these results as "beneficial" is that the number of younger women was too few to draw any conclusions. What's more, the only significant "trend" regarding estrogen alone and heart disease was in the first 2 years of the study, which showed a small INCREASE. After that, almost half of the women dropped out of the study, thus potentially obscuring the results. Like estrogen-progestin, estrogen alone significantly upped the risk of stroke and there was also a small risk of blood clots. The composite outcome for dementia or mild cognitive impairment was also slightly increased among those taking estrogen.
While it is interesting that women on estrogen required fewer revascularization procedures, this finding does not inherently equate with "fewer heart attacks." It's like saying fractures are the same as low bone density. The result of this new analysis is unstable, not only because it lacks significance, but also because it disregards several other factors, such as the earliest time trends, the high dropout rates, and the looming question of whether or not estrogen's effects (if they are truly beneficial) would be SUSTAINED into old age when women are most likely to suffer a heart attack and for whom no beneficial trends were observed.
Also muddying this analysis is whether the scientists' assumptions about heart disease in general are true - that older women have undiagnosed heart disease and that younger women have pre-subclinical disease. Again, a coronary EVENT is not the same as aging arteries. There is a myriad of cardiovascular effects seen with estrogens, some positive, some negative. Though estrogen most certainly has a good effect on cholesterol levels and MIGHT slow atherosclerosis, there are proven drawbacks, including blood clots, elevated CRP, and increased triglycerides. What proponents of estrogen therapy need to be very careful about not doing is to put something into practice based on an analysis that in itself is based on surrogates or clinically unproven parameters, such as a procedure or splicing of subjects by age. The latter most importantly is a continuum, not an absolute with cutoffs and no "early window of opportunity" has been proven to exist.
Lastly, what should not have been ignored in this analysis was unfortunately. The absolute outcomes of the WHI estrogen alone trial practically mirrored those of HERS I and II, showing an early significant increase in coronary events that tapered off to yield an overall neutral effect. WHI I (Prempro) yielded the same results initially, although the overall increase in coronary heart disease never did recede, yielding overall risk. High doses of Premarin increased the risk of heart disease in men treated for prostate cancer. Combining this data with the results of secondary outcome trials and the knowledge about blood clotting, stroke and coronary risks associated with contraceptives (used by YOUNG women by the way) and even with pregnancy (when endogenous estrogen is highest), you can see how this incessant attempt by 'experts' to find a benefit to the heart winds up seeming foolhardy. And, hypothetically, if estrogen alone were to ultimately yield benefit after consideration of all of the lingering questions, scientists would THEN have to prove whether this effect would apply to a non-hysterectomized woman, who may implicity have a lower heart disease risk to begin with simply because her ovaries are intact.
All in all, the results of WHI should be taken at face value, which indicate either net harm or overall lack of benefit. Sub-analyses of data within data have to be considered very carefully if the effects either lack true significance or are in stark contrast to the overall effects observed. Therefore, trying to reinstate estrogen as a preventative would be cavalier at this point and any woman or physician trying to digest this new spin needs to be leery about thinly disguised sales pitches for pharmaceuticals trying to make a rebound. What's more, they should investigate very carefully who's spewing out this "good news" (namely Lila Nachtigall, Wolf Utian, Mitchell Harman, Frederick Naftolin, Howard Hodis, Mary Jane Minkin etc.) and what the driving force behind their motivations might be.
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