Long-term safety of unopposed estrogen used by women surviving myocardial infarction

14 year follow-up of the ESPRIT randomised controlled trial

N. Cherry, R. McNamee, A. Heagerty, H. Kitchener, P. Hannaford

Research output: Contribution to journalArticle

25 Citations (Scopus)
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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: 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.
Original languageEnglish
Pages (from-to)700-705
Number of pages6
JournalBJOG-An International Journal of Obstetrics and Gynaecology
Volume121
Issue number6
Early online date18 Feb 2014
DOIs
Publication statusPublished - May 2014

Fingerprint

Infarction
Estrogens
Randomized Controlled Trials
Myocardial Infarction
Safety
Placebos
estradiol valerate
Arm
Neoplasms
Heart Neoplasms
Intention to Treat Analysis
Mortality
Information Storage and Retrieval
Wales
Endometrial Neoplasms
Endometrium
England
Uterus
Myocardial Ischemia
Heart Diseases

Keywords

  • cancer
  • estrogen
  • randomised controlled trial

Cite this

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.

In: BJOG-An International Journal of Obstetrics and Gynaecology, Vol. 121, No. 6, 05.2014, p. 700-705.

Research output: Contribution to journalArticle

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abstract = "ObjectiveTo compare health outcomes during 14-year observational follow-up in women initially randomised to unopposed estrogen or placebo.DesignAt 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.SettingWomen were recruited from 35 hospitals in the northwest of England and Wales in July 1996–February 2000.SampleWomen aged 50–69 surviving their first myocardial infarction.MethodsAll 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 measuresDeath (all-cause, cardiac disease, stroke or cancer) and cancer incidence (any, breast or endometrium).ResultsThere 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.ConclusionsThese results suggest that unopposed estrogen may be used safely by women with an intact uterus surviving a first myocardial infarction.",
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N2 - ObjectiveTo compare health outcomes during 14-year observational follow-up in women initially randomised to unopposed estrogen or placebo.DesignAt 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.SettingWomen were recruited from 35 hospitals in the northwest of England and Wales in July 1996–February 2000.SampleWomen aged 50–69 surviving their first myocardial infarction.MethodsAll 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 measuresDeath (all-cause, cardiac disease, stroke or cancer) and cancer incidence (any, breast or endometrium).ResultsThere 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.ConclusionsThese results suggest that unopposed estrogen may be used safely by women with an intact uterus surviving a first myocardial infarction.

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