Drospirenone (DRSP), a
progestin with antialdosterone activity, has been developed for
hormone therapy in combination with 17-beta-estradiol (E2) in postmenopausal women. We evaluated the
antihypertensive efficacy and safety of various doses of DRSP and E2 and
estradiol alone in postmenopausal women with
hypertension using ambulatory and clinic blood pressure (BP) monitoring. This was a randomized, double-blind clinical trial of 3 doses of DRSP combined with
estradiol,
estradiol alone, and placebo in 750 postmenopausal women with stage 1 to 2
hypertension between 45 to 75 years. Ambulatory and clinic BPs,
potassium,
aldosterone, and
lipid measurements and adverse events were evaluated in postmenopausal women with stages 1 to 2
hypertension during 8 weeks of double-blind
therapy. DRSP and E2 induced dose-related reductions in the ambulatory and clinic systolic BP with physiological increases in serum
aldosterone. Significant decreases in 24-hour systolic pressure were observed at doses of 2 and 3 mg of DRSP combined with
estradiol but not by
estradiol alone or 1 mg of DRSP with
estradiol. There were no significant changes from baseline in
potassium in any treatment group. Small, significant reductions in total and
low-density lipoprotein cholesterol occurred on all of the active treatments, and serum
triglycerides did not change. Adverse event rates were low and similar across treatment groups. In conclusion, these data show that DRSP combined with E2 significantly reduces BP in postmenopausal women with
hypertension and did not induce significant increases in serum
potassium. These characteristics may lead to a new benefit for this novel
hormone therapy in postmenopausal women with
hypertension.