Another Caution on Cardiovascular Risks From HRT

[Guest guest]

Another Caution on Cardiovascular Risks From HRT

 

By Neil Osterweil, Senior Associate Editor, MedPage Today

Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of

Pennsylvania School of Medicine.

July 12, 2007

 

ADELAIDE, Australia, July 12 -- Once again, hormone replacement therapy

started a decade or more past menopause has been found to increase the risk for

cardiovascular and thromboembolic events, with no significant benefits in

return.

 

The 12-month follow-up results of the Women's International Study of Long

Duration [O]estrogen After Menopause (WISDOM) trial, reported online in the BMJ,

came on the fifth anniversary of the report from the Women's Health Initiative,

the clinical trial with similar findings that dashed hopes that HRT could be

cardioprotective in postmenopausal women. " Data from WISDOM suggest that

women starting or restarting combined estrogen and progestogen therapy an

average of 14 years after menopause are at increased risk of cardiovascular

disease and venous thromboembolism, at least in the early years of treatment, "

wrote Alastair H. MacLennan, M.D., of the University of Adelaide, and colleagues

in Britain and New Zealand. Enrollment in the WISDOM study, originally

planned to include 23,000 women, was stopped after fewer than 5,700 had started

treatment, following publication of the initial WHI results. Similarly, the two

studies in WHI trial were also halted early because

of an excess number of thromboembolic events, and no evidence of a protective

cardiovascular benefit. Although the investigators found that compared with

placebo, combined HRT significantly increased the risk of major cardiovascular

events or venous thromboembolism, the trial did not answer the question of

whether use of HRT for control of severe hot flashes and night sweats in early

menopause has any long term benefits or detriments. In an accompanying BMJ

editorial, Helen Roberts, M.D., M.P.H., of the University of Auckland, in New

Zealand, pointed out that " postmenopausal hormone therapy has come full circle. "

Originally used to treat menopausal symptoms, then becoming an agent to a

prevent late coronary risks, HRT has gone back to its original purposes of hot

flashes, night sweats, and vaginal dryness. " It is the best treatment we have at

present for these symptoms. " Dr. Roberts noted that hot flashes and night

sweats are mostly self limiting, and cited

current recommendations that women use the lowest dose needed for relief for

the shortest possible time. " Healthy women in early menopause are at a low

absolute risk whether they take hormones or not, and they are unlikely to face

substantially increased risks when using hormones for a few years, " she wrote.

That sentiment was echoed by JoAnn Manson, M.D., Dr.P.H., of Boston's Brigham

and Women's Hospital and Harvard, who was on the steering committee of the WHI,

at a briefing to mark the WHI anniversary. " When you combine the findings

from the estrogen-plus-progestin trial and the estrogen-alone trial, there's a

suggestion of a lower risk of heart disease in the women who were less than 10

years since onset of menopause, " she said, " whereas there's an increased risk of

heart disease for women who were more than 20 years past menopause, and a

suggestion of a trend across time since menopause. " Dr. Manson and

colleagues reported in the June 21 issue of the

New England Journal of Medicine that estrogen reduced coronary calcium in women

younger than 60 who took the hormone following a hysterectomy. (See Estrogen May

Reduce Coronary Calcium in Women Younger than 60) But they also said that

the findings should not be construed as evidence that estrogen should be

routinely used to reduce the risk of heart disease in older women. At the

WHI-anniversary briefing, Nieca Goldberg, M.D., of New York University's Women's

Heart Program, agreed that " hormone therapy should never be given to a woman who

has cardiovascular disease. " Yet she noted that this represents a clinical

problem for young women who have had heart attacks who are going through

menopause because " there is nothing that we can prescribe that's as effective as

hormone therapy " for their symptoms. " Before trial enrollment was halted,

the WISDOM investigators enrolled 5,692 healthy women in the United Kingdom,

Australia, and New Zealand. The mean t age was 63,

and the mean time from menopause was 15 years. Women with intact uteruses

were randomly assigned to placebo or combined HRT with conjugated equine

estrogens 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg orally daily

(Prempro). Women who had had hysterctomies were assigned to estrogen alone,

combined therapy, or placebo. The mean follow-up was 11.9 months. The

primary endpoints were major cardiovascular disease, osteoporotic fractures, and

breast cancer. Secondary outcomes were other cancers, death from all causes,

venous thromboembolism, cerebrovascular disease, dementia, and quality of life.

The authors found in a comparison of combined HRT (2,196 patients) and placebo

(2,189 patients) that there was a significant increase in major cardiovascular

events among patients on the active drugs. There were seven events among

patients on combined HRT, compared with none for patients on placebo (P=0.016).

In addition, there were 22 cases of venous

thromboembolism among patients on the combined therapies, compared with three

among patients on placebo (hazard ratio 7.36, 95% confidence interval. 2.20 to

24.60). There were no statistically significant differences in either

numbers of breast or other cancers (22 for HRT versus 25 for placebo, hazard

ratio 0.88, 95% CI, 0.49 to 1.56), cerebrovascular events (14 versus 19

respectively, HR 0.73, 95% CI, 0.37 to 1.46), fractures (40 versus 58, HR 0.69,

95% CI. 0.46 to 1.03), or overall deaths (eight versus five, HR, 1.60 (0.52 to

4.89). There were also no significant differences in outcomes among patients

on combined HRT compared with estrogen alone.

 

The WISDOM study was supported by multiple government and non-profit agencies

in the United Kingdom, Australia, and New Zealand. All of the co-authors

declared that they have no direct conflicts of interest.

 

Related Article(s):

 

NAMS: HRT With a Novel Progestin Sidesteps Some Unwanted Heart Effects

 

Timing May Influence Effect of Hormone Therapy on Coronaries

 

Additional HRT Coverage

 

 

 

Additional source: BMJ

Source reference:

Vickers MR et al. " Main morbidities recorded in the women's international study

of long duration oestrogen after menopause (WISDOM): a randomised controlled

trial of hormone replacement therapy in postmenopausal women. " BMJ 2007;

DOI:10.1136/bmj.39266.425069.AD.

 

Additional source: BMJ

Source reference:

Roberts H. " Hormone replacement therapy comes full circle. " BMJ 2007; DOI:

10.1136/bmj.39266.425069.AD

 

http://www.medpagetoday.com/OBGYN/HRT/dh/6138

 

 

 

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[Guest guest]

If they would do a study using NATURAL biodentical hormones, with estrogens and

progesterone in proper balance they would no doubt come up with totally

different findings. They use horse estrogen and progestin, which are not the

same molecule and the body's hormone receptors don't know what to do with them.

Even if these studies were funded by the government, etc. apparently drug

company interests have been given priority.