Effects of drospirenone/17-β estradiol on blood pressure and potassium balance in hypertensive postmenopausal women

Richard A. Preston, William B. White, Bertram Pitt, George Bakris, Paul Michael Norris, Vladimir Hanes

Research output: Contribution to journalArticle

69 Scopus citations

Abstract

Background: Drospirenone (DRSP) is a novel progestin with aldosterone receptor antagonist activity developed for hormone therapy as DRSP /17-β estradiol (DRSP/E2). Because of a significant aldosterone antagonist activity, we studied the effects of DRSP/E2 on serum potassium (K) and blood pressure (BP) in hypertensive postmenopausal women with and without diabetes mellitus. Methods: This was a multicenter trial in postmenopausal women 44 to 70 years of age, either with type 2 diabetes mellitus (n = 82) or without type 2 diabetes mellitus (n = 148) and using an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor antagonist. Patients were randomized to 28 days of DRSP/E2 or placebo. Study endpoints were the number and percentage subjects who developed hyperkalemia (K ≥ 5.5 mEq/L) and changes from baseline in clinic systolic and diastolic BP. To increase the likelihood of unmasking hyperkalemia, the nondiabetic group was also administered ibuprofen for 5 days. Results: There were no statistical differences in the overall number and percentage of subjects with hyperkalemia for DRSP/E2 versus placebo. No subject had symptoms or electrocardiographic changes related to hyperkalemia. Blood pressure was reduced by -8.6/-5.8 mm Hg in patients receiving DRSP/E2 versus -3.7/-2.9 mm Hg in those receiving placebo (P < .01 for both SBP and DBP). Conclusions: In hypertensive postmenopausal women, treatment with DRSP/E2 was not associated with a greater incidence of hyperkalemia than with placebo in patients with and without type 2 diabetes mellitus and concomitant use of ACE inhibitors, angiotensin receptor antagonists, or ibuprofen. Furthermore, DRSP/E2 was found to have a significant antihypertensive effect in this high-risk population.

Original languageEnglish (US)
Pages (from-to)797-804
Number of pages8
JournalAmerican journal of hypertension
Volume18
Issue number6
DOIs
StatePublished - Jun 1 2005

Keywords

  • Aldosterone
  • Aldosterone antagonists
  • Chronic renal failure
  • Drospirenone
  • Hormone therapy
  • Hyperkalemia
  • Hypertension
  • Progesterone

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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