Key result
Unopposed estrogen therapy for 2 years did not significantly affect all-cause mortality over 14 years in women surviving a first myocardial infarction (HR 1.07; 95% CI 0.88-1.29).
Why the study?
The long-term safety of unopposed estrogen use in women surviving a first myocardial infarction was uncertain.
Does estradiol valerate 2 mg affect death and cancer incidence in women aged 50-69 surviving their first myocardial infarction?
RCT (n=1,017)
randomized
Yes
Does estradiol valerate 2 mg affect death and cancer incidence in women aged 50-69 surviving their first myocardial infarction?
Long-term observational follow-up suggests that 2 years of unopposed estrogen therapy does not increase mortality or cancer risk in women surviving a first myocardial infarction.
Answers are grounded in this paper and cite their sources.
Should not alter estrogen prescribing post-MI; leaves open need for RCTs to confirm long-term safety.
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: 2 mg or placebo treatment for 2 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 12.6 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 50-59 years at recruitment had lower HRs than women aged 60-69 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.
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Cherry et al. (2014) conducted an RCT in first myocardial infarction (n=1,017). estradiol valerate vs. placebo was evaluated on All-cause mortality (HR 1.07, 95% CI 0.88-1.29). Unopposed estrogen therapy for 2 years did not significantly affect all-cause mortality over 14 years in women surviving a first myocardial infarction (HR 1.07; 95% CI 0.88-1.29).
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