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- PMID: 24533510
- UKPMCID: 24533510
- DOI: 10.1111/1471-0528.12598
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Long-term safety of unopposed estrogen used by women surviving myocardial infarction: 14-year follow-up of the ESPRIT randomised controlled trial.
Cherry, N; McNamee, R; Heagerty, A; Kitchener, H; Hannaford, P
BJOG : an international journal of obstetrics and gynaecology. 2014;121(6):700-5; discussion 705.
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Full-text held externally
- PMID: 24533510
- UKPMCID: 24533510
- DOI: 10.1111/1471-0528.12598
Abstract
OBJECTIVE: To compare health outcomes during 14-year observational follow-up in women initially randomised to unopposed estrogen or placebo. DESIGN: At recruitment to the Estrogen for the Prevention of Re-Infarction Trial (ESPRIT) women were assigned to estradiol valerate: 2Â mg or placebo treatment for 2Â years. SETTING: Women were recruited from 35 hospitals in the northwest of England and Wales in July 1996-February 2000. SAMPLE: Women aged 50-69 surviving their first myocardial infarction. METHODS: All women were followed by data linkage to UK mortality and cancer records; mean follow-up 14.1 and 12.6Â years, respectively. In an intention-to-treat analysis, hazard ratios (HRs) were computed, overall and stratified by age at recruitment. OUTCOME MEASURES: Death (all-cause, cardiac disease, stroke or cancer) and cancer incidence (any, breast or endometrium). RESULTS: There were 418 deaths in 1017 women randomised. The all-cause mortality HR of 1.07 (95% CI 0.88-1.29) indicated no significant difference between treatment groups. Women aged 50-59Â years at recruitment had lower HRs than women aged 60-69Â years for all outcomes except ischaemic heart disease. Among 149 incident cancers there were seven cases of breast cancer in the intervention arm and 15 in the placebo; HR 0.47 (95% CI 0.19-1.15). There were no deaths from endometrial cancer but three incident cases, one in the active arm and two in placebo. CONCLUSIONS: These results suggest that unopposed estrogen may be used safely by women with an intact uterus surviving a first myocardial infarction.