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

group (P= 04001), and In this subgroup the estradiol group
but not the placebo group showed regression (P = 0-002 for
difference). The authors conclude that reduction in the progression
of subclinical carotid atherosclerosis was seen in
women who did not take Uipid loweting medication but not
In those who took these medications. From these results, it
would appear that estrogens would not augment the known
benefits of statins for Inhibiting atherosclerosis.
Cinkal bine
WHI is the only clinical trial of healthy women that has provided
any indication of the effect of hormone therapy on
strokes. As noted above, study participants have been
informed of a small absolute increase in the number of
strokes in the hormone groups compared to the placebo
groups during the first few years of the triaL.s Stroke is also
a predefined outcome of interest in the WISDOM ulial.35
Secondary prevention
Clinical trals with surrogate outcomes
A randomized trial of oral estradlol I mg with standard dose
psogeatn (gestodene 0-025mg 12 days every month), or
estradiot with low-dose progestin (gestodene 0-025mg
12 days every third month), or placebo for 4 years in 321
women aged 40-70 at high risk for cardiovascular disease
(that is, carotid IMT > I mm) failed to show any benefit for
reducing the rate of progression of subcin-ical atherosclerosis
In the carotid arteriesse Exclusion of the small number of
subjects (14%) who received lipid towering therapy did not
alter these results. LDL cholesterol decreased by 13% in the
active treatment groups and fibrinogen by 20%. Adherence
was good with only 12-20% of participants discontinuing
study medications; compliance was 98% in the emainnBg
participants. Reasons for the difference in outcome of this
study with the study of Hodis et al- are not known. It is
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Postmenopausal hormone therapy and cardiovascular disease
possible that the addition of a progestin to the estradiol may
have negated the effects of estradiol, but the fact that the
results in the standard and low-dose gestodene groups did
not differ argues against that possibility. Though this study is
regarded as secondary prevention, the distinction is somewhat
artificial and is based on the entry level of carotid IMT.
Cevnixa trals
Where HERS examined the effect of hormone therapy on
recurrent coronary disease, WEST is its counterpart for
recurrent stroke. 5 3 There are important parallels between
the two trials, and also a few differences. WEST randomized
664 women aged 46-91 who had suffered a transient
ischernic attack or stroke In the previous 90 days to receive
oral estradiol I mg or placebo and followed them for an
average of 2-8 years. By the end of the trial 34% had stopped
estradlol and 24% had stopped placebo. Compared to
placebo, estradiol had no effect on the primary outcome of
combined non-fatai stroke and all-cause mortality, or on
non-fatal stroke or death individually (Table 20.5). However
estradiol Increased the risk for fatal stroke (relative risk 2-9,
95% CI 0-9-9-0) and the non-fatal strokes in the estradiol
group were associated with more functional and neurologic
deficits. A post-hoc analysis of strokes by time since randomization
indicated that during the first 6 months, there
were three fatal strokes and eighteen non-fatal strokes in the
estradiol group, compared to one fatal and eight non-fatal
strokes In the placebo group (relative risk for any stroke 2-3,
95% Cl 1-1-5-0). There were no differences in the rates of
transient ischemic attacks or myocardial infarction.
HERS has published a more complete analysis of the
stroke data, which indicated that there was no significant
effect of hormone therapy on any category of stroke (fatal,
non-fatal, ischemic, hemorrhagic, any stroke, transient
ischemic attack).60 However, the point estimate was above