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March 2, 2004 — Today, based on concerns about an increased risk of stroke, the National Institutes of Health (NIH) announced that it has instructed the 11,000 healthy, postmenopausal women participating in the estrogen-alone arm of the Women's Health Initiative (WHI) to stop taking their study pills and to begin the follow-up phase of the study. This follow-up will include data collection from mammograms and other outcomes.
Researchers found, after nearly seven years of study, that use of estrogen alone (hereafter referred to as estrogen therapy or ET) did not appear to affect heart disease by either increasing or decreasing a woman's risk of the disease. ET did not appear to increase the risk of breast cancer during the period of the study. ET decreased the risk of hip fracture, but it appeared to increase the risk of stroke at approximately the same rate found in the WHI study of estrogen-plus-progestin therapy (hereafter combined hormone therapy or HT). In that study, reported in July 2002, women taking HT had eight more strokes per year for every 10,000 women than did women taking a placebo.
According to NIH, it appears that the risks associated with ET are less adverse than those found in the WHI study of HT — which included increased risks of breast cancer, heart disease, blood clots and stroke. In fact, the WHI Data and Safety Monitoring Board was split as to whether women in the ET study should stop their pills or have the option to continue their pills after being informed of the risks of continued use. Nevertheless, the NIH decided to ask participants in the ET study to stop their study pills because they believed (1) an increased stroke risk is not acceptable in healthy women in a research study, and (2) after seven years of follow-up, results were unlikely to change in the one year remaining in the ET study.
The NIH decision was made against the backdrop of the original purpose of the WHI hormone therapy studies. These studies were intended to assess the risks or benefits of postmenopausal hormone use for conditions like heart disease, stroke or breast cancer — not to rate the effectiveness of HT or ET in treating menopausal symptoms such as hot flashes.
ACOG has noted previously that to date ET and HT are the most effective treatments for such menopausal symptoms as hot flashes. ET is generally taken for relief of such menopausal symptoms in women who have had a hysterectomy. HT — which adds progestin to estrogen — is the therapy prescribed for women who have not had a hysterectomy, since estrogen alone can increase the risk of uterine cancer.
The NIH also notes that in two months WHI researchers will publish not only the results of the ET study, but also results of the WHI-Memory Study (WHIMS), an ancillary study of women over 65 years of age in the WHI hormone trials. The NIH says WHIMS data suggest that among women on ET there was an increased risk of probable dementia and/or mild cognitive impairment.
In an advisory to physicians today, the NIH said, "Until such time as the final data are available, and the FDA and the physician groups have had an opportunity to consider revisions to practice guidelines, the NIH advises physicians to follow the current FDA guidance."
ACOG concurs with this approach, particularly since the FDA's current advice is similar to the recommendations ACOG issued on HT use following the WHI announcement of July 2002. Among those ACOG recommendations:
· HT is effective and FDA-approved for the relief of menopausal symptoms such as hot flashes.
· Although HT is effective for prevention of postmenopausal osteoporosis, consider non-estrogen medications first if osteoporosis prevention is the sole reason for using HT.
· HT should not be used for the prevention of heart disease.
· Although the WHI study of HT used a specific prescription product [PremproTM, estrogen plus progestin], absent further data it should not be assumed that the risks would be different for any other hormone therapies or products.
· Before using HT for symptoms such as hot flashes, a woman should discuss the risks and benefits of such use for her particular circumstances with her physician.
· When using HT, women should do so at the lowest effective dose and for the shortest possible duration for her circumstances.
The current FDA guidance goes even farther by applying such recommendations to both HT and ET use. Until ACOG has the opportunity to review the forthcoming published articles on ET, it is reasonable for physicians to follow FDA recommendations regarding ET use.