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(Circulation. 2005;112:1979-1984.)
© 2005 American Heart Association, Inc.

Hypertension

Antihypertensive Effects of Drospirenone With 17ß-Estradiol, a Novel Hormone Treatment in Postmenopausal Women With Stage 1 Hypertension

William B. White, MD; Bertram Pitt, MD; Richard A. Preston, MD; Vladimir Hanes, MD

From the Section of Hypertension and Clinical Pharmacology (W.B.W.), Pat and Jim Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington; the Division of Cardiology (B.P.), University of Michigan Medical School, Ann Arbor; the Division of Clinical Pharmacology (R.P.), University of Miami School of Medicine, Miami, Fla; and Berlex Laboratories (V.H.), Montville, NJ.

Reprint requests to William B. White, MD, Section of Hypertension and Clinical Pharmacology, University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT 06030-3940. E-mail wwhite{at}nso1.uchc.edu

Received August 19, 2004; revision received July 4, 2005; accepted July 12, 2005.

Background— Drospirenone (DRSP) is a novel progestin with antimineralocorticoid activity that has been developed for hormone therapy in combination with 17ß-estradiol (E2) in postmenopausal women. In prior studies with DRSP in postmenopausal women that were focused on relief of menopausal symptoms, DRSP/E2 yielded significant reductions in blood pressure (BP).

Methods and Results— The effects of 3 mg DRSP/1 mg E2 on clinic and 24-hour ambulatory BP as well as potassium homeostasis were evaluated in postmenopausal women with stage 1 hypertension (systolic, 140 to 159 and/or diastolic, 90 to 99 mm Hg) in a 12-week, multicenter, double-blind, randomized, placebo-controlled study. Clinic BPs were measured at baseline and at 2, 4, 6, 8, and 12 weeks of therapy, whereas potassium was measured at 2, 6, and 12 weeks of therapy. Ambulatory BP was performed in a substudy at baseline and at the end of the trial. In the intention-to-treat population of 213 women, the clinic BP was reduced significantly on DRSP/E2 (clinic BP, –14.1/–7.9 for DRSP/E2 versus –7.1/–4.3 mm Hg for placebo, P<0.0001). In the subgroup of 43 women with ambulatory BP monitoring, the 24-hour BP fell by –8.5/–4.2 mm Hg versus –1.8/–1.6 mm Hg on placebo (P=0.002/0.07). There were no significant changes from baseline in potassium levels or in the incidence of hyperkalemia (5.5 meq/L) on DRSP/E2 compared with placebo.

Conclusions— Combination therapy with DRSP/E2 significantly lowered both clinic and 24-hour systolic BP in postmenopausal women with stage 1 systolic hypertension. This characteristic may lead to benefit for cardiovascular risk reduction in this population.

Key Words: hormones • hypertension • blood pressure • aldosterone antagonists • menopause

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