A decade past WHI — what have we learned?
Since the July 2002 publication of the first Women's Health Initiative (WHI) report, many changes have been made in the approach to hormone therapy (HT). A just-published review of evidence over the last 10 years looks to the return to a "classic use" of HT, initiated near the menopause, to aid women who have such indications as significant menopausal symptoms or osteoporosis.1
When clinicians assess the lessons learned from the WHI, as well as from large observational studies, it becomes clear that the benefit/risk profile for menopausal hormone therapy is most favorable when it is used to treat vasomotor symptom in women considered "young" (those younger than age 60) or "recently menopausal'" (within one decade of menopause), says Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine — Jacksonville. Kaunitz serves as a co-author of the current review
If a symptomatic menopausal woman is post-hysterectomy, estrogen–alone hormone therapy is safe for most "young/recently menopausal" candidates, notes Kaunitz. If such women are obese, Kaunitz says his preference is for transdermal over oral estrogen therapy. Results from observational studies indicate that transdermal estrogen, which was not studied in the WHI, has less impact on the risk of venous thrombosis than does oral estrogen,2,3 states Kaunitz. "If a symptomatic menopausal woman has an intact uterus, combination estrogen-progestin HT is safe with short-term use," he says. "However, such women such be counseled that with more than 3-5 years of combination HT, a modest increase risk of breast cancer is observed."
Changes seen since WHI
Clinicians and women have seen a sea change in menopause treatment since the first WHI studies were published in 2002. Prior to that time, prescriptions for hormone therapy were rising, professional organizations advocated hormone therapy for prevention of osteoporosis and coronary heart disease (CHD), and one-third of HT prescriptions were for women older than age 60.
In 2002, the WHI trial of estrogen plus progestin in women with an intact uterus was halted when early data indicated increased risks of breast cancer, CHD, stroke, and pulmonary embolism outweighed potential benefits.4 In 2004, scientists also ceased the companion trial of estrogen alone in hysterectomized women, due to an increased risk of stroke.5
The findings from the two initial Women's Health Initiative studies led to a sharp decline in postmenopausal hormone therapy use. According to a retrospective database analyses of national pharmacy claims, by the end of 2002, the total number of hormone therapy claims dropped approximately 30% from 2002 second quarter claims. This trend continued during the next seven years; by 2009, hormone therapy claims were reduced by more than 70%.6
Move to "classic" use
A 2012 major reappraisal of post WHI-data by international experts recently was published in the journal Climacteric, the official journal of the International Menopause Society in Geneva, Switzerland.7 The results of the re-analyses of the WHI data and new data from other studies do not justify the continuing negative attitude to hormone therapy in symptomatic women who start treatment near menopause, experts note.8 Data indicates that in women with symptoms or other indications, initiating HT near menopause, which is the classic pattern of use, probably will provide a favorable benefit/risk ratio, the experts conclude.7
The International Menopause Society hosted a 2012 "think tank" to review the WHI studies 10 years out; one participant was Susan Wysocki, WHNP-BC, FAANP. The discussion among the world leaders in menopause was a "full circle" back to where clinicians were 10 years ago before the WHI, says Wysocki, who serves as president & chief executive officer of iWomansHealth in Washington, DC, which focuses on information on women's health issues for clinicians and consumers.
Headlines generated following the 2002 WHI results were premature; as a result, many women became terrified of estrogen, and still are, says Wysocki. "Now we have this new Rossouw paper, as well as a number of innovative products that are coming down the line that are non-hormonal," she says. "Both the 'lessons learned' and new products should expand women's choices."
References
- Rossouw JE, Manson JE, Kaunitz AM, et al. Lessons learned from the Women's Health Initiative trials of menopausal hormone therapy. Obstet Gynecol 2013; 121(1):172-176.
- Olié V, Canonico M, Scarabin PY. Risk of venous thrombosis with oral versus transdermal estrogen therapy among postmenopausal women. Curr Opin Hematol 2010; 17(5):457-463.
- Speroff L. Transdermal hormone therapy and the risk of stroke and venous thrombosis. Climacteric 2010; 13(5):429-432.
- Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin for healthy postmenopausal women. JAMA 2002; 288:321-33.
- Anderson GL, Limacher M, Assaf AR, et al; Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. JAMA 2004; 291:1,701-1,712.
- Ettinger B, Wang SM, Leslie RS, et al. Evolution of postmenopausal hormone therapy between 2002 and 2009. Menopause 2012;19(6):610-615.
- Langer RD, Manson JE, Allison MA. Have we come full circle - or moved forward? The Women's Health Initiative 10 years on. Climacteric 2012; 15(3):206-212.
- Burger HG, MacLennan AH, Huang KE, et al. Evidence-based assessment of the impact of the WHI on women's health. Climacteric 2012;15(3):281-287.
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