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 M. Norris, Alberto B. Alonso, Pingping Ni, Vladimir Hanes, Adel H. Karara

Research output: Contribution to journalArticle

29 Citations (Scopus)

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

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Hydrochlorothiazide
Estradiol
Potassium
Randomized Controlled Trials
Placebos
Blood Pressure
Ambulatory Blood Pressure Monitoring
Therapeutics
Hormones
Hypertension
Mineralocorticoid Receptor Antagonists
drospirenone
Spironolactone
Uterine Hemorrhage
Angiotensin Receptor Antagonists
Progestins
Angiotensin-Converting Enzyme Inhibitors
Cross-Over Studies
Antihypertensive Agents
Breast

Keywords

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

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Randomized, placebo-controlled trial of the effects of drospirenone- estradiol on blood pressure and potassium balance in hypertensive postmenopausal women receiving hydrochlorothiazide. / Preston, Richard A; Norris, Paul M.; Alonso, Alberto B.; Ni, Pingping; Hanes, Vladimir; Karara, Adel H.

In: Menopause, Vol. 14, No. 3, 01.05.2007, p. 408-414.

Research output: Contribution to journalArticle

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AU - Ni, Pingping

AU - Hanes, Vladimir

AU - Karara, Adel H.

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AB - 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.

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KW - Potassium

KW - Progesterone

KW - Progestogens

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