Bioidentical Hormones - U.S. Senate Special Committee on Aging

Treatmnent recommendations
Based on current evidence, postmenopausal hormone therapy
Is not recommended for prevention or treatment of
CHD or stroke.' For primary prevention, the American
Heart Association (ARA) states that firm recommendations
should await the results of ongoing randomized dinical trials,
and that there are currently Insufficient data to suggest
that hormone therapy should be initiated for the sole purpose
of primary prevention of cardiovascular diseae.64
The AHA makes a stronger statement that hormone therapy
should not be initiated for the secondary prevention of
cardiovascular disease; however women on hormone therapy
for several years do not necessarily have to stop since
they have presumably passed through the period of initial
Increased risk. Women with a prior history of venous thromboemboldsm
should be counseled against using hormone
therapy.6i
Because the trials have failed to show benefit for secondary
prevention, and there are no published trial data for
primary prevention, In both instances decisions about
hormone therapy should be based on established noncardiovascular
risks and benefits.04 The major proven benefits
of estrogen are relief of the symptoms accompanying the
menopause, urogenital atrophy, and prevention of osteoporosis.
Known risks include endometrial cancer, venous
thromboembolism, pancreatitis (in women with high blood
triglycerldes), and gallbladder disease. At the average age of
menopause, the risk for cardiovascular and non-cardlovascutar
disease conditions is low, and therefore, the short-term
use of estrogens to manage the menopause is not at Issue.a5
However, long-term use (5 years or more) of hormone
therapy is more problematic, given the possible Increase In
breast cancer associated with prolonged use.
0 5 Calculations
show that in older women and with prolonged use, the
potential risks for breast cancer, stroke, and venous thromboembolism,
may outwelgh the potential beriefit for reducton
In fractures if the treatment does not reduce risk for
CHD.°° Since CHD and stroke are by far the most common
causes of disease and death in older women, the cltnical
trial data on the long-term effects of hormone therapy on
cardiovascular disease will provide the key Information on
whether long-term estrogen should be prescribed for any
Indication in older women. It these trials show that longterm
use confers cardiovascular benefit (and If methods are
192
Postmenopausal hormone therapy and cardiovascular disease
found to screen out women at high initial risk for cardiovascular
complications), then hormone therapy may In future
play a more prominent role as a viable prevention strategy.
However, until these clinical trial data are known, It may
be wise to consider alternatives to hormone therapy even
for proven Indications such as prevention of osteoporosis.1 5
For osteoporosis prevention, exercise, diet, calcium, and
vitamin D may be recommended, and for treatment the bisphosphonates
and raloxifene have been shown to prevent
fractures. Lifestyle measures and medical management of
risk factors such as high blood cholesterol and high blood
pressure will prevent many cases of CHD and stroke, and
for secondary prevention of CHD aspirin, statins, 0 blockers,
and ACE inhibitors have all been found to be effective.6'
The AHiA statement acknowledges that the current
recommendations are based mainly on data from trials using
standard doses of conjugated equine estrogens and medroxyprogesterone,
and that evidence is insufficient for different
preparations, routes of delivery, and doses that may have a
more favorable or more adverse effect on cardiovascular
outcomes.
Addendum
On July 9, 2002, the National Heart, Lung, and Blood
Imistute announced that the WHI trials of estrogen plus
progestin versus placebo in 16608 healthy women with
an intact uterus had been stopped early, after an average of