Effects of oral conjugated equine estrogens with or without medroxyprogesterone acetate on incident hypertension in the Women's Health Initiative hormone therapy trials

Yael Swica, Michelle P. Warren, Joann E. Manson, Aaron K. Aragaki, Shari S. Bassuk, Daichi Shimbo, Andrew Kaunitz, Jacques Rossouw, Marcia L. Stefanick, Catherine Womack

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objective: The aim of the study was to determine the effect of menopausal hormone therapy on incident hypertension in the two Women's Health Initiative hormone therapy trials and in extended postintervention follow-up. Methods: A total of 27,347 postmenopausal women aged 50 to 79 years were enrolled at 40 US centers. This analysis includes the subsample of 18,015 women who did not report hypertension at baseline and were not taking antihypertensive medication. Women with an intact uterus received conjugated equine estrogens (CEE; 0.625mg/d) plus medroxyprogesterone acetate (MPA; 2.5mg/d) (n=5,994) or placebo (n=5,679). Women with prior hysterectomy received CEE alone (0.625mg/d) (n=3,108) or placebo (n=3,234). The intervention lasted a median of 5.6 years in the CEE plus MPA trial and 7.2 years in the CEE-alone trial with 13 years of cumulative follow-up until September 30, 2010. The primary outcome for these analyses was self-report of a new diagnosis of hypertension and/or high blood pressure requiring treatment with medication. Results: During the CEE and CEE plus MPA intervention phase, the rate of incident hypertension was 18% higher for intervention than for placebo (CEE: hazard ratio [HR], 1.18; 95% CI, 1.09-1.29; CEE plus MPA: HR, 1.18; 95% CI, 1.09-1.27). This effect dissipated postintervention in both trials (CEE: HR, 1.06; 95% CI, 0.94-1.20; CEE plus MPA: HR, 1.02; 95% CI, 0.94-1.10). Conclusions: CEE (0.625mg/d) administered orally, with or without MPA, is associated with an increased risk of hypertension in older postmenopausal women. Whether lower doses, different estrogen formulations, or transdermal route of administration offer lower risks warrant further study.

Original languageEnglish (US)
Pages (from-to)753-761
Number of pages9
JournalMenopause
Volume25
Issue number7
DOIs
StatePublished - Jul 1 2018

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Conjugated (USP) Estrogens
Medroxyprogesterone Acetate
Women's Health
Hormones
Hypertension
Placebos
Therapeutics
Cutaneous Administration
Hysterectomy
Self Report
Antihypertensive Agents
Uterus
Estrogens

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

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Effects of oral conjugated equine estrogens with or without medroxyprogesterone acetate on incident hypertension in the Women's Health Initiative hormone therapy trials. / Swica, Yael; Warren, Michelle P.; Manson, Joann E.; Aragaki, Aaron K.; Bassuk, Shari S.; Shimbo, Daichi; Kaunitz, Andrew; Rossouw, Jacques; Stefanick, Marcia L.; Womack, Catherine.

In: Menopause, Vol. 25, No. 7, 01.07.2018, p. 753-761.

Research output: Contribution to journalArticle

Swica, Yael ; Warren, Michelle P. ; Manson, Joann E. ; Aragaki, Aaron K. ; Bassuk, Shari S. ; Shimbo, Daichi ; Kaunitz, Andrew ; Rossouw, Jacques ; Stefanick, Marcia L. ; Womack, Catherine. / Effects of oral conjugated equine estrogens with or without medroxyprogesterone acetate on incident hypertension in the Women's Health Initiative hormone therapy trials. In: Menopause. 2018 ; Vol. 25, No. 7. pp. 753-761.
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abstract = "Objective: The aim of the study was to determine the effect of menopausal hormone therapy on incident hypertension in the two Women's Health Initiative hormone therapy trials and in extended postintervention follow-up. Methods: A total of 27,347 postmenopausal women aged 50 to 79 years were enrolled at 40 US centers. This analysis includes the subsample of 18,015 women who did not report hypertension at baseline and were not taking antihypertensive medication. Women with an intact uterus received conjugated equine estrogens (CEE; 0.625mg/d) plus medroxyprogesterone acetate (MPA; 2.5mg/d) (n=5,994) or placebo (n=5,679). Women with prior hysterectomy received CEE alone (0.625mg/d) (n=3,108) or placebo (n=3,234). The intervention lasted a median of 5.6 years in the CEE plus MPA trial and 7.2 years in the CEE-alone trial with 13 years of cumulative follow-up until September 30, 2010. The primary outcome for these analyses was self-report of a new diagnosis of hypertension and/or high blood pressure requiring treatment with medication. Results: During the CEE and CEE plus MPA intervention phase, the rate of incident hypertension was 18{\%} higher for intervention than for placebo (CEE: hazard ratio [HR], 1.18; 95{\%} CI, 1.09-1.29; CEE plus MPA: HR, 1.18; 95{\%} CI, 1.09-1.27). This effect dissipated postintervention in both trials (CEE: HR, 1.06; 95{\%} CI, 0.94-1.20; CEE plus MPA: HR, 1.02; 95{\%} CI, 0.94-1.10). Conclusions: CEE (0.625mg/d) administered orally, with or without MPA, is associated with an increased risk of hypertension in older postmenopausal women. Whether lower doses, different estrogen formulations, or transdermal route of administration offer lower risks warrant further study.",
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T1 - Effects of oral conjugated equine estrogens with or without medroxyprogesterone acetate on incident hypertension in the Women's Health Initiative hormone therapy trials

AU - Swica, Yael

AU - Warren, Michelle P.

AU - Manson, Joann E.

AU - Aragaki, Aaron K.

AU - Bassuk, Shari S.

AU - Shimbo, Daichi

AU - Kaunitz, Andrew

AU - Rossouw, Jacques

AU - Stefanick, Marcia L.

AU - Womack, Catherine

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N2 - Objective: The aim of the study was to determine the effect of menopausal hormone therapy on incident hypertension in the two Women's Health Initiative hormone therapy trials and in extended postintervention follow-up. Methods: A total of 27,347 postmenopausal women aged 50 to 79 years were enrolled at 40 US centers. This analysis includes the subsample of 18,015 women who did not report hypertension at baseline and were not taking antihypertensive medication. Women with an intact uterus received conjugated equine estrogens (CEE; 0.625mg/d) plus medroxyprogesterone acetate (MPA; 2.5mg/d) (n=5,994) or placebo (n=5,679). Women with prior hysterectomy received CEE alone (0.625mg/d) (n=3,108) or placebo (n=3,234). The intervention lasted a median of 5.6 years in the CEE plus MPA trial and 7.2 years in the CEE-alone trial with 13 years of cumulative follow-up until September 30, 2010. The primary outcome for these analyses was self-report of a new diagnosis of hypertension and/or high blood pressure requiring treatment with medication. Results: During the CEE and CEE plus MPA intervention phase, the rate of incident hypertension was 18% higher for intervention than for placebo (CEE: hazard ratio [HR], 1.18; 95% CI, 1.09-1.29; CEE plus MPA: HR, 1.18; 95% CI, 1.09-1.27). This effect dissipated postintervention in both trials (CEE: HR, 1.06; 95% CI, 0.94-1.20; CEE plus MPA: HR, 1.02; 95% CI, 0.94-1.10). Conclusions: CEE (0.625mg/d) administered orally, with or without MPA, is associated with an increased risk of hypertension in older postmenopausal women. Whether lower doses, different estrogen formulations, or transdermal route of administration offer lower risks warrant further study.

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