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WHI Protocol Modified Due to PEPI Data

WHI Protocol Modified Due to PEPI Data

BETHESDA, Md--Data on a single slide presented in November, 1994,
led quickly to a key change in the hormone arm of the Women's
Health Initiative (WHI), sponsored by the National Institutes
of Health.

As a result, any women in the program who still had her uterus
faced no grave worries when she heard about findings from the
Postmenopausal Estrogen/Progestin Interventions (PEPI) study.
WHI investigators had already stopped giving unchallenged estrogen
to women with intact uteruses.

PEPI researchers found that a daily 0.625 mg dose of conjugated
equine estrogens significantly increased a woman's chances of
developing endometrial hyperplasia. However, no risk was found
among women in the study who took the estrogen in combination
with either medroxyprogesterone acetate or micronized progesterone
(JAMA Feb. 7, 1996).

Findings Spotted at 1994 Meeting

Although many physicians did not learn of the PEPI hyperplasia
findings until their formal publication, WHI researchers spotted
indications of potential problems for their study in a slide displayed
during a report at the American Heart Association's 1994 scientific
meeting that described preliminary results from PEPI.

WHI's hormone study seeks to learn the overall risks and benefits
of such treatments on women's health, particularly the effectiveness
of estrogen in preventing coronary heart disease and osteopor-osis
and its possible role in breast cancer.

Originally, the hormone trial, which begin enrolling postmenopausal
participants in September, 1993, randomly assigned women to one
of three groups: estrogen alone, an estrogen-progestin combination,
or placebo. WHI officials modified that protocol as a result of
the early findings from PEPI.

At the 1994 Heart meeting, one slide shown at the PEPI presentation
gave rates of adenomatous and atypical hyperplasia. "Those
were significantly high for us to sit up and take notice,"
Dr. Jacques Rossouw, WHI's Lead Project Officer, said in an interview
with Oncology News International.

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