Antihypertensive effects of drospirenone with 17β-estradiol, a novel hormone treatment in postmenopausal women with stage 1 hypertension

Background - Drospirenone ( DRSP) is a novel progestin with antimineralocorticoid activity that has been developed for hormone therapy in combination with 17 beta-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.