years hormone replacement therapy has been a common treatment for
menopausal women, and long-term observational studies have been
interpreted as showing a 40 to 50 percent reduction in risk of heart
disease in women on the therapy. Now, results from several randomized
clinical trials are throwing into question those earlier findings.
of those studies is the Women's Health Initiative (WHI) Hormone
Program, a clinical trial in which UMDNJ is participating. The study
recently informed participants nationwide that preliminary data
compiled after two years of follow-up indicate a "small increase"
in the number of heart attacks, strokes, and blood clots in the
lungs of women who were taking estrogen or estrogens combined with
WHI hormone trial includes 27,348 women and is part of a larger
WHI study of 161,861 women - sponsored by NIH - investigating the
leading causes of illness and death among women ages 50 to 79. It
is examining the relationship between lifestyle and disease and
conducting controlled clinical trials on the effects of a low-fat
diet, calcium/vitamin D supplementation, and hormone replacement.
The women in the study are receiving either Premarin (.625 mg a
day), Premarin plus the equivalent of Provera (2.5 mg a day) or
a placebo. UMDNJ is one of 40 clinical research centers participating
the data are preliminary, the WHI Data and Safety Monitoring Board
(DSMB) - an independent monitoring body - advised WHI to notify
participants of a potential risk not thought possible when they
signed their original consent form. It also recommended that the
study continue, since these early results did not indicate a major
safety threat to participants. In fact, the trend appeared to be
than 1 percent of WHI women had any problems, regardless of whether
it was the estrogen, estrogen plus progestin, or a placebo that
they took," says Norman Lasser, MD, PhD, professor of medicine at
UMDNJ-New Jersey Medical School and UMDNJ's principal investigator
for the study. This was lower than expected in this group of women.
Although the preliminary hormone replacement therapy findings were
unexpected, Lasser said the study will continue. He emphasized that
the findings are only preliminary, and that it is important to continue
the study so that the long-term benefits of hormone replacement
therapy can be assessed.