July 5, 2002 Although therapy with hormones was once thought to protect women's hearts after menopause, a UCSF-led study has found that, at least for women with heart disease, estrogen plus progestin therapy does not reduce the risk of heart attack or death.
The July 3, 2002 issue of the Journal of the American Medical Association (JAMA) contains two articles with the results of the Heart and Estrogen/Progestin Replacement Follow-up Study (HERS II).
HERS was a randomized, blinded trial to determine the effects of estrogen plus progestin (compared with placebo) in older postmenopausal women with heart disease. In 1998 HERS scientists reported that, surprisingly, risk of heart attack increased in the hormone therapy group during the first year of HERS. The risk seemed to decrease in the next several years, leading to the HERS II follow-up study to evaluate the effects of longer-duration hormone therapy.
The trend toward a reduced risk of heart attacks did not persist with additional follow-up. During almost 7 years, combining HERS and HERS II, there was no reduction in risk among women taking hormones.
"This follow-up study found no reduction in risk of heart attacks or death for women with heart disease during up to seven years of hormone therapy. Not only was there no cardiovascular benefit, there were adverse affects, including blood clots and gallbladder disease," said Deborah Grady, MD, MPH, UCSF professor of epidemiology and medicine and co-principal investigator on the studies. Grady is also director of the UCSF/Mount Zion Women's Health Clinical Research Center.
The hormone therapy caused a 2-fold increase in the risk of blood clots in the legs and lungs, with most of the increased risk in the early years of treatment, according to principal investigator Stephen Hulley, MD, MPH, professor and chair of the UCSF department of epidemiology and biostatistics. There was a nearly 50 percent increase in the risk of gallbladder disease requiring surgery, and no benefit of hormone therapy for any other major disease outcome including overall risk of dying.
"These observations confirm the wisdom of 'evidence-based medicine,' basing treatment decisions on the balance of benefits and harms established in randomized clinical trials," said Hulley. "Our study indicates that for older women with heart disease, estrogen plus progestin therapy is not beneficial and does have some harmful effects."
HERS II was a 2.7 year follow-up of the 4.1 year HERS study, the first randomized, blinded, placebo-controlled trial large enough to detect the effects of hormone therapy on disease outcomes. Participants in HERS were randomly assigned to receive either 0.625 mg/d conjugated estrogen plus 2.5 mg medroxyprogesterone acetate, or a placebo that was identical in appearance. During the HERS II follow-up the women chose whether or not to take hormones based on advice from their personal physicians; many in the hormone group continued taking hormones, and fewer in the placebo group began. Research was conducted at outpatient and community settings at 20 United States clinical centers. A total of 2,763 postmenopausal women with coronary heart disease and average age of 67 were enrolled in HERS.
About 1.8 million American women each year reach menopause and many suffer symptoms related to the loss of estrogen. Most symptoms resolve within a few years whether or not they are treated. Hormones are effective in relieving hot flashes and sleep disturbances that substantially diminish quality of life, according to Grady. For most women early in menopause, a few years of hormone therapy will relieve symptoms with minimal risk of adverse effects, said Grady.
Additional authors on the study of cardiovascular disease outcomes are: Eric Vittinghoff, PhD, UCSF; David Herrington, MD, MHS, Wake Forest University; Vera Bittner, MD, University of Alabama, Birmingham; Roger Blumenthal, MD, Johns Hopkins University; Michael Davidson, MD, Rush-Presbyterian-St. Luke's Medical Center; Mark Hlatky, MD Stanford University; Judith Hsia, MD, George Washington University; Alan Herd, MD, Baylor; Steven Khan, MD, UCLA; L. Kristin Newby, MD, Duke University; David Waters, MD, UCSF; Nanette Wenger, MD, Emory University.
Additional authors on the study of noncardiovascular disease outcomes are: Curt Furberg, MD, PhD, Wake Forrest University; Elizabeth Barrett-Connor, MD, UCSD; Jane Cauley, PhD, University of Pittsburgh; William Haskell, PhD, Stanford University; Robert Knopp, MD, University of Washington; Maureen Lowery, MD, University of Miami; Suzanne Satterfield, MD, University of Tennessee; Helmut Schrott, MD, University of Iowa; Donald Hunninghake, MD, University of Minnesota. Funding for these studies was provided by Wyeth-Ayerst Research.
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