Q J Med 2000; 93: 699-702
© 2000 Association of Physicians
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Oestrogen and women's heart disease: ESPRIT-UK
University of Manchester, University of Aberdeen
Sir,
The recent review article by Edmunds and Lip1 was very timely, because in spite of the recently recorded drop in coronary heart disease (CHD), it remains a leading cause of death in the developed world.2 Although CHD is sometimes thought to be a male disease, many thousands of women also develop these disorders, especially following the menopause. In the UK, the death rate among women for CHD is one of the highest amongst the world, now accounting for 1 in 4 deaths.2–5 Of particular concern is the slower decline in CHD death rates in women than men between 1981 and 1991 (17% and 25%, respectively).2 Although men and women share many risk factors for CHD, there are important differences, even after the menopause, in the presentation, prognosis and management of heart disease. Women, however, are less likely to be included in clinical trials.1
Edmunds and Lip's article highlighted the uncertainty surrounding the role of hormone replacement therapy (HRT) for the prevention of CHD in postmenopausal women. They concluded that, although many of the observational studies suggested a beneficial cardiovascular effect, in primary prevention, with the use of unopposed oestrogen replacement therapy, such observational studies can be misleading and could contain significant biases through self-selection of women to active treatment.
There has been a lack of prospective randomized placebo-controlled studies which would help to resolve this uncertainty. The Heart and Estrogen/progestin Replacement Study (HERS),6 was an American randomized, placebo-controlled, secondary coronary prevention trial. It found no significant difference in cardiovascular events, including non-fatal myocardial infarction (MI) and CHD death, after an average follow-up of 4 years, in patients with heart disease randomized to either placebo or combined HRT. However, there was a significant trend over time, with more cardiac events occurring in those on active treatment during the first year and fewer cardiac events in years three and four.
There are a number of other large randomized placebo-controlled HRT clinical outcomes studies in progress. Two are of primary prevention. In the US, the Women's Health Initiative study,7 plans to recruit 26 000 postmenopausal women and, in the UK, the Women's International Study of long Duration Oestrogen after Menopause (WISDOM), plans to recruit 22 000. The ESPRIT study (oEStrogen in the Prevention of Re-Infarction Trial) is a secondary coronary prevention study funded by the NHS Research and Development Cardiovascular and Stroke Programme.
In ESPRIT, postmenopausal women aged 50–69 years, with a first MI, were randomized within 30 days of the event to receive either placebo or oestradiol valerate 2 mg daily for 2 years. The primary end point for the study is cardiac death or re-infarction. Recruitment began in July 1996 and involved 35 hospitals mainly in the North West of England. Recruitment ended in February 2000 when a total of 1017 women had been recruited. The mean age of patients at the time of their index MI was 62.2 years. The age distribution is shown in Figure 1
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Of the 1017 patients recruited, 24% had had a hysterectomy, and the average time since last menstrual period, in those without, was 15 years. Follow-up is scheduled to be completed in February 2002.
ESPRIT will provide important information about the cardio-protective effects of oestrogen in postmenopausal women who have suffered a recent MI. This data will inform decisions made by patients and physicians during the important rehabilitation period, information which, as Edmunds and Lip correctly remind us, is currently unavailable.
References
1.
Edmunds E, Lip GYH. Cardiovascular risk in women: the cardiologist perspective. Q J Med2000; 93:135–45.
2. Rayner M. Coronary heart disease statistics. British Heart Foundation/Coronary Prevention Group statistics Database. London, British Heart Foundation, 1994.
3. Office of Population Censuses and Surveys. Mortality statistics 1992: Cause. England and Wales. Series DH2, no 19. London, HMSO, 1993.
4. Registrar General Scotland. Annual report 1992. Edinburgh, General Register Office, 1993.
5. Registrar General Northern Ireland. Annual report 1992. Belfast, General Register Office, 1993.
6. Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, Vittinghoff E. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA1998; 20:605–13.
7. The Women's Health Initiative Study Group: Design of the Women's Health Initiative Clinical Trial and observational study. Control Clin Trials1998; 19:61–109.[Web of Science][Medline]
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