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 language | English |
|---|---|
| Pages (from-to) | 408-414 |
| Number of pages | 7 |
| Journal | Menopause |
| Volume | 14 |
| Issue number | 3 |
| DOIs | |
| State | Published - May 1 2007 |
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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 journal › Article
}
TY - JOUR
T1 - Randomized, placebo-controlled trial of the effects of drospirenone- estradiol on blood pressure and potassium balance in hypertensive postmenopausal women receiving hydrochlorothiazide
AU - Preston, Richard A
AU - Norris, Paul M.
AU - Alonso, Alberto B.
AU - Ni, Pingping
AU - Hanes, Vladimir
AU - Karara, Adel H.
PY - 2007/5/1
Y1 - 2007/5/1
N2 - 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.
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.
KW - Aldosterone
KW - Aldosterone antagonists
KW - Diuretics
KW - Drospirenone
KW - Drug interactions
KW - Hormone therapy
KW - Hydrochlorothiazide
KW - Hypertension
KW - Potassium
KW - Progesterone
KW - Progestogens
UR - http://www.scopus.com/inward/record.url?scp=33847011697&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33847011697&partnerID=8YFLogxK
U2 - 10.1097/01.gme.0000243572.63322.f7
DO - 10.1097/01.gme.0000243572.63322.f7
M3 - Article
C2 - 17224857
AN - SCOPUS:33847011697
VL - 14
SP - 408
EP - 414
JO - Menopause
JF - Menopause
SN - 1072-3714
IS - 3
ER -