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Long-Term Hormone Therapy Increases Risk for Blood Clots and Gallbladder Disease
July 3, 2002 — Postmenopausal women with coronary heart disease (CHD) should not take estrogen plus progestin hormone therapy to reduce their risk of CHD events, such as a non-fatal heart attack or death from coronary disease, according to an article in the July 3 issue of The Journal of the American Medical Association (JAMA). In an accompanying report, long-term hormone therapy increased the risk for venous thromboembolism (blood clots) and gallbladder disease.
Deborah Grady, M.D., M.P.H., of the University of California in San Francisco, and colleagues investigated whether the trend toward reduced risk of CHD events among women who were taking hormone therapy in the later years of the Heart and Estrogen/progestin Replacement Study (HERS) persisted with additional years of follow-up and resulted in an overall reduced risk of CHD events. Grady et al followed a group of participants in HERS (which lasted 4.1 years) for an additional 2.7 years for their study, HERS II.
HERS was a randomized, blinded, placebo controlled trial of 2,763 postmenopausal women, average age 67 at enrollment, with CHD. Women were randomly assigned to receive either 0.625 mg/d conjugated estrogen plus 2.5 mg medroxyprogesterone acetate (n=1,380) or placebo (n=1,383).
The 1998 report on the HERS study found "no significant differences between the hormone and placebo groups in the primary outcome of CHD events (nonfatal myocardial infarction [MI] plus CHD-related death) or in any secondary cardiovascular outcomes. However, ... analyses showed a statistically significant time trend, with more CHD events in the hormone group than in the placebo group during the first year of treatment, and fewer in years three to five."
The researchers enrolled 2,321 women for HERS II, 93 percent of the surviving HERS participants. The women were prescribed hormone therapy at the discretion of their physicians after HERS ended and their study group — hormone or placebo — was unblinded. Many women in the hormone group decided to take hormones during HERS-II, and fewer of those in the placebo group did.
Editor's Note: This study was funded by Wyeth-Ayerst Research. During the conduct of HERS, all authors were supported by contracts from Wyeth-Ayerst. Dr. Grady received research support from Berlex and Eli Lilly. For the financial disclosures of the other authors, please see the JAMA article.
Long-Term HRT Increases Risk for Blood Clots and Gallbladder Surgery
In an accompanying article, Stephen Hulley, M.D., M.P.H., of the University of California in San Francisco, and colleagues, looked at noncardiovascular effects of HRT during the 6.8 years of follow-up in HERS and HERS II participants.
They found that treatment with estrogen plus progestin in older women with coronary disease caused a two-fold increase in the rates of blood clots in the legs and lungs, with most of the increase in risk taking place in the first few years. There was nearly a 50 percent increase in the rates of gallbladder disease requiring surgery. There was no benefit of hormone therapy for any major disease outcome, including the overall risk of dying.
The authors note that among younger and healthier women with menopausal symptoms such as hot flashes and insomnia, the clear benefit of hormone therapy in relieving symptoms could outweigh the risks, which would likely be smaller. Additional randomized clinical trials will be helpful for addressing this issue. Meanwhile, HERS and HERS II demonstrate that, among older women with coronary disease, hormone therapy using this estrogen plus progestin regimen has no benefit and causes significant harm.
Editor's Note: This study was funded by Wyeth-Ayerst Research. During the conduct of HERS, all authors were supported by contracts from Wyeth-Ayerst. For the financial disclosures of the authors, please see the JAMA article.
Editorial: Hormone Replacement Therapy for Prevention; More Evidence, More Pessimism
In an accompanying editorial, Diana B. Petitti, M.D., of Kaiser Permanente Southern California in Pasadena, writes that the findings of the two studies should not discourage postmenopausal women from taking other therapies that have been shown to decrease health risks associated with CHD. "Pessimism about HRT and ERT [estrogen replacement therapy] does not mean pessimism about disease prevention in postmenopausal women," she writes.
She names beta-blockers and aspirin as therapies that can help prevent CHD events, as well as other therapies that can lower the risk for various diseases and illnesses. "An appropriately pessimistic view of HRT as an omnibus agent to prevent disease in postmenopausal women should focus more attention on these preventive interventions, which have a strong evidence base," she concludes.