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

RISKS AND BENEFITS OF ESTROGEN PLUS PROGESTIN
163
dependent covariate, detected no trend some evidence for an increasing risk of
with time for CHD, stroke colorectal breast cancer over time with estrogen
cancer, hip fracture, total mortality, or plus progestin (z= 2.56 compared with
the global index (TABLE 4). There was a nominal z score for statistical signifi-
Figure 3. Kaplan-Meier Estimates of Cumulative Hazards for Selected Clinical Outcomes
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cance of 1.96) and a decreasing risk of
VTE with time (z=-2.45). These results
must be viewed cautiously because
the number of events in each
interval is modest, the data in later
years are still incomplete, and later year
comparisons are limited to women
still at risk of their first event for that
outcome.
Subgroup Analyzes
Cardiovascular Disease. A small subset
of women (n=400; average followup,
57.4 months) in WHI reported conditions
at baseline that would have
made them eligible for HERS, ie, prior
Ml or revascularization procedures.
Among these women with established
coronary disease, the HR for subsequent
CHD for estrogen plus progestin
relative to placebo was 1.28 (95%
Cl, 0.64-2.56) with 19 vs 16 events. The
remainingwomen, those without prior
CHD. had an identical HR for CHD
(145 vs 106; HR. 1.28; 95% Cl 1.00-
1.65). Few women with a history of
VTE were enrolled, but these data suggest
a possibility that these women may
be at greater risk of future VTE events
when taking estrogen plus progestin (7
vs 1; HR. 4.90; 95% Cl, 0.58-41.06)
than those without a history of VTE
(144 vs 66; Hk, 2.0U; 95% Cl,
1.54-2.76). For stroke, prior history did
not confer additional risk (1 vs 5 in
women with prior stroke; HR, 0.46;
95% Cl, 0.05-4.51; 126 vs 80 with no
prior stroke; HR, 1.47; 95% Cl.
1.11-1.95). No noteworthy interactions
with age, race/ethniciy, body mass
index, prior hormone use, smoking status,
blood pressure, diabetes. aspirin
use, or statin use were found for the
effect of estrogen plus progestin on
CHD, stroke, or VTE.
Breast Cancer. Women reporting
prior postmenopausal hormone use
had higher HRs for breast cancer associated
with estrogen plus progestin
use than those who never used postmenopausal
hormones (among never
users. 114 vs 102; HR, 1.06; 95% Cl,
0.81-1.38; for women with