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

mal studies, and laboratory studies,
which have focused mainly on the effects
of estrogen on normal coronary arteries
or women wvithout clinical cardiovascular
disease.t-" However
differences remain. One observational
study examining this Issue predicted a
reduced riskof CHDiis healthywomen
who commenced hormone therapy
within 4 years since menopause, and no
effect in women with 10 or moreyears
since menopause, while our combined
trial data find a nonsigniftcani reduction
in women starting hormone
therapy during 10 or less years since
menopause and increasing risks thereafter.
Women's Health Initiative data
suggest an advantage for CEE compared
with CEE+MPA in regard to
CHD, but the observational data would
predict similar effects for these formulations
(at least for CEE with the cyclical
MPA more commonly used in observational
studies).'- '^
204
HORMONE THERAPY USE AND RISK OF CARDIOVASCULAR DISEASE
There is also a divergence in regard
to secondary prevention, with observational
study but not trial data on
women with existing disease suggesting
CHD benefit for hormone users.
1 ' '7 The inclusion of a small proportion
of women with prior disease in
this analysis of trial data and in similar
analyses of observational study data
did not change the estimates of CHD
risk ots hormone therapy by age or years
since menopause appreciably, possibly
because there were relatively few
such women in younger age categories,
and in the older age categories the
presence of prior CHD is but one of
many other factors contributing to risk.'
Some observational and trial data agree
in predicting early harm in women after
initataon of hormone therapy. t tt
'-"
Confounding due to the healthier characteristics
of hormone users, and failure
to account for years since hormone
therapy initiation, would lead to
rPgwe 1. Estimated Absolute Excess Risk per 10000 Person-Years by Age Group at Baseline
CH0
70-19
70-79
co-on
AO. rG-p. Y
10-79
ftt tommy
70-79
room2 r
too P r-0,
0.2n ra
090 072
03 027
0 70 Om6
30 0,34
o03 am
12t .It
O.r7 r.ot
t t3
3.s 306e
Crentkron Trots
i 1
*
FFt
i H
-05 0 00 on t2o
Eto..,..
Atit EmI PM
oo 1os P10000bers-
0r7
sor
0.9s
0.15
01
0.70
overestimation of benefit for CHD in
observational studies, even after adjusting
for measurable factors.'
Absolute risks may be more helpful
than HRs to clinicians weighing the pros
and cons of hormone therapy for particular
patients. Because of low event
rates in more recently menopausal
women, the absolute excess risk will be
very small, even in the presence of some
increased relative risk due to hormone
therapy. On the other hand the higher
event rates in women more distant from
menopause, together with their increased
HRs, translate into large absolute
excess risks. The low or absent cxcess
risks of CHD in women with less
than 10 years since menopause may be
somewhat reassuring to women considering
the use of hormones in the first few
years after menopause. However, the incTeased
absolute risk ofstroke in this subgroup
(although not apparent us women
aged 50-59 years in the CEE trial and at-
CE TAtW CEE .?iPA TM
0eZo
5. 0. so
31 27 H
et
o.
02t D.: 775
0.77 0.:
1.r3 1.27
t
.ro
IE~s
otto.
MMg tsw
000 0.
0 35 0.
070
i2 t
02
0.ts 0'a
r1oe It.
i7 I f
Sso ~
2,07
3.O7
2C
31
3
-. 10 0
009 Ot
W
t 035 r t
F l
~~~~~~0
so t O
-00 0 00 95 t2O
tnn9OAio^2esetssssrho
mer ioomPeoiri-tha
totsoamd Ariroto roams otiti
mertoooo Peconyna st.
Thees ifated abstote caress r- s kray dfter stightnyon tr abfolate erb s riskdehd isti from thedlterer,-i inc-aes per 100 p--na-sears bten adiste hiarene
ar-d pia-eba grarps. Esirr.etdt esueht- tisk- , pe. t0tmo peIon-years iluted as toana.toed prr-etage n the pia..bo groap x (had rato mtor ptaoeho
gmup-1)1t 1000. Ertenars bidlsate 95% wtnkdltsu tisiemats. estnated sing boots2trp meftods. CEE mdtrorrygatedespanre estrogens: CHD. io0naty
heoart d se: SMPA. medro ryprogesterox acette.
*P..03 conpaed MsMth the age groap of 50 to s yeas.
tP=.02 compared rht the age group of 50 to 59 ypas
OP= .01 mOrparcd roth at g gro up of so to s years.
02007 Amerie Itislteatl Asoiaution AU rights enexred. (Ftprnted) IAMA, Apl 4. 2OO7-VYI 297. N. 13 1473
fotloeded hrom mm.jo 0mm at Natioaal estitate of Hlth. rot April 5, 2007