Effects of a New Hormone Therapy, Drospirenone and 17-β-Estradiol, in Postmenopausal Women With Hypertension
Abstract
Drospirenone (DRSP), a progestin with antialdosterone activity, has been developed for hormone therapy in combination with 17-β-estradiol (E2) in postmenopausal women. We evaluated the antihypertensive efficacy and safety of various doses of DRSP and E2 and estradiol alone in postmenopausal women with hypertension using ambulatory and clinic blood pressure (BP) monitoring. This was a randomized, double-blind clinical trial of 3 doses of DRSP combined with estradiol, estradiol alone, and placebo in 750 postmenopausal women with stage 1 to 2 hypertension between 45 to 75 years. Ambulatory and clinic BPs, potassium, aldosterone, and lipid measurements and adverse events were evaluated in postmenopausal women with stages 1 to 2 hypertension during 8 weeks of double-blind therapy. DRSP and E2 induced dose-related reductions in the ambulatory and clinic systolic BP with physiological increases in serum aldosterone. Significant decreases in 24-hour systolic pressure were observed at doses of 2 and 3 mg of DRSP combined with estradiol but not by estradiol alone or 1 mg of DRSP with estradiol. There were no significant changes from baseline in potassium in any treatment group. Small, significant reductions in total and low-density lipoprotein cholesterol occurred on all of the active treatments, and serum triglycerides did not change. Adverse event rates were low and similar across treatment groups. In conclusion, these data show that DRSP combined with E2 significantly reduces BP in postmenopausal women with hypertension and did not induce significant increases in serum potassium. These characteristics may lead to a new benefit for this novel hormone therapy in postmenopausal women with hypertension.
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The type of oral contraceptives is important, with combined oral contraceptives (progestin and estradiol) associated with blood pressure elevations at greater rates than lower-dose estradiol-only and progestin-only oral contraceptives.
“The type of oral contraceptives is important, with combined oral contraceptives (progestin and estradiol) associated with BP elevations at greater rates than lower-dose estradiol-only and progestin-only oral contraceptives.207,208”
From Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association (2018) · cites this paper as [207]
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- Authors
- White, W. B., Hanes, V., Chauhan, V., & Pitt, B.
- Affiliations
- University of Connecticut (US)
- Venue
- Hypertension
- Published
- 2006-08
- Volume
- 48
- Issue
- 2
- Pages
- 246-253
- ISSN
- 0194-911X (ISSN-L)
- 1524-4563
- OpenAlex
- W2101795816
- Cited by
- 119
- References
- 30
- Citations by year
- 2026: 2 · 2025: 4 · 2023: 1 · 2022: 4 · 2021: 3 · 2020: 5 · 2019: 2 · 2018: 4 · 2016: 4 · 2015: 3 · 2014: 5 · 2013: 7 · 2012: 6
- FWCI
- 11.46
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Hypertension (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Keywords
- drospirenone, estradiol, hormone replacement therapy, postmenopausal hypertension, antihypertensive efficacy, serum aldosterone, potassium, cholesterol, triglycerides, dose-response relationship, ambulatory blood pressure
- MeSH terms
- Aged, Aldosterone, Androstenes, Blood Pressure, Cholesterol, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Estradiol, Female, Heart Rate, Humans, Hypertension, Middle Aged, Potassium, Estrogen Replacement Therapy, Treatment Outcome, Postmenopause, Blood Pressure Monitoring, Ambulatory
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