Randomized, placebo-controlled trial of the effects of drospirenone- estradiol on blood pressure and potassium balance in hypertensive postmenopausal women receiving hydrochlorothiazide

Richard A. Preston, Paul Michael Norris, Alberto B. Alonso, Pingping Ni, Vladimir Hanes, Adel H. Karara

Research output: Contribution to journalArticle

29 Scopus citations

Abstract

Objective: Drospirenone (DRSP), a spironolactone analog with aldosterone antagonist activity, is a novel progestogen developed for use as hormone therapy in postmenopausal women in combination with 17β-estradiol (E2). DRSP/E2 lowers blood pressure when used alone in hypertensive postmenopausal women or when administered concomitantly with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. DRSP/E2 has not been studied in combination with the widely prescribed hydrochlorothiazide (HCTZ). We investigated the effects of 3 mg DRSP/1 mg E2 versus placebo on blood pressure and potassium balance when added to existing therapy with 25 mg HCTZ in postmenopausal women with established stage I hypertension. Design: This was a single-center, double-blind, randomized, placebo-controlled, two-treatment, two 4-week treatment period crossover study in 36 postmenopausal women with stage I hypertension maintained on 25 mg HCTZ. The endpoint was a change from baseline in systolic and diastolic blood pressures by 24-hour ambulatory blood pressure monitoring. Safety monitoring included serum potassium (mEq/L) and adverse events. Results: Mean systolic and diastolic blood pressures by 24-hour ambulatory blood pressure monitoring were reduced significantly, by -7.2 and -4.5 mm Hg, respectively, with DRSP/E2 as compared with placebo. The decrease in potassium with HCTZ was 0.2 mEq/L less with DRSP/E2 than placebo, suggesting a potassium-sparing effect. The most frequently observed adverse events with DRSP/E2 were vaginal bleeding and breast tenderness, which were attributable to the hormone therapy. Conclusions: DRSP/E2 substantially lowers systolic and diastolic blood pressure when added to existing antihypertensive therapy with HCTZ in hypertensive postmenopausal women. In addition, DRSP/E2 has a potassium-sparing effect that counteracts HCTZ-induced potassium loss.

Original languageEnglish (US)
Pages (from-to)408-414
Number of pages7
JournalMenopause
Volume14
Issue number3
DOIs
StatePublished - May 1 2007

Keywords

  • Aldosterone
  • Aldosterone antagonists
  • Diuretics
  • Drospirenone
  • Drug interactions
  • Hormone therapy
  • Hydrochlorothiazide
  • Hypertension
  • Potassium
  • Progesterone
  • Progestogens

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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