Late-Breaking Clinical Trials:American College of Cardiology
Conference coverage
Source: American College of Cardiology Scientific Sessions, March 12-15, 2000, Anaheim, CA.
The ERA Trial
The estrogen replacement and atherosclerosis (era) trial randomized 309 postmenopausal women with documented coronary artery disease (CAD) to hormone replacement therapy (HRT) or placebo for three years. Three groups of approximately 100 individuals each received conjugated equine estrogen (CEE) alone or with methylprogesterone acetate, or placebo, and underwent serial quantitative coronary angiography. The results indicated no difference in change in the coronary mean minimum diameter; there was slight progression in all groups, comparable among estrogen, estrogen plus progesterone, and placebo. There was no difference in mean minimum diameter in coronary vessels designated as mild, moderate, or more severe stenosis at baseline; there was no effect on stenosis diameter as well as new lesions.
Comment by Jonathan Abrams, MD
The ERA study results, while not particularly surprising, indicate that hormone replacement does not (at least for a relatively short period of several years) prevent coronary atherosclerosis progression or induce regression. In contrast, the results of many regression trials with lipid lowering have been positive with respect to rates of progression and regression. The calcium antagonist amlodopine (PREVENT trial) also failed to demonstrate an effect of the calcium antagonist on CAD progression, although older work, as well as animal studies, suggests a role for these agents in slowing atherosclerosis.
The ERA study did not address the issue of safety of HRT in postmenopausal women with CAD, which has recently received more bad news. The NIH Women’s Health Initiative announced a warning that the hormone replacement component of this important trial, comprising approximately 25,000 women, was associated with a small, nonstatistically significant increase in vascular events, including stroke, myocardial infarction (MI), and deep venous thrombosis. The study has not been stopped. This is a primary prevention population; the data (unpublished and unavailable) indicate a slight hazard at two years, disappearing subsequently. This preliminary report mirrors the HERS trial, suggesting that there may be a true cardiovascular adverse action of HRT for several years after initiation of therapy.
None of the available data in this somewhat confusing area suggest that women who have been on HRT for longer than 24 months and are doing well, whether they have clinical vascular disease or not, should be taken off of this therapy because of the early risk associated with initiation of estrogen replacement.
Secondary prevention of CAD progression in older women is best accomplished with:
a. estrogen.
b. lipid-lowering drugs.
c. calcium channel blockers.
d. antibiotics.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content