Assessment of the novel selective aldosterone blocker eplerenone using ambulatory and clinic BP in 400 patients with systemic hypertension: results from a pivotal multinational trial

For more than a decade, new antihypertensive agents have been evaluated using both clinic and ambulatory BP recordings in pivotal trials that determine dose ranges, level of efficacy, and pharmacodynamic benefits. Eplerenone is a novel selective aldosterone blocker that is being developed for the treatment of both hypertension and congestive heart failure. To evaluate its utility in systemic hypertension, we performed a 12-week double-blind, placebo-controlled, parallel arm, fixed-dose study over a range of doses in the treatment of stage I–III hypertension. Following single-blind placebo therapy for 3–4 weeks to obtain baseline clinic and ambulatory BP measures, 400 patients were randomized to receive placebo or 1 of 4 doses of eplerenone (25, 50, 100, and 200 mg QD). Patients were reassessed using clinic and ambulatory BP at the end of 12 weeks of therapy (see Table)