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        Eplerenone Appears to Reduce Clinic and Ambulatory BP in Patients With Hypertension

        A DGReview of :"Assessment of the novel selective aldosterone blocker eplerenone using ambulatory and clinical blood pressure in patients with systemic hypertension"
        American Journal of Cardiology

        07/25/2003
        By Emma Hitt, PhD


        Eplerenone, a novel aldosterone-blocking agent, appears to be effective in treating hypertension at doses as low as 25 mg per day and reduces ambulatory and clinic blood pressure (BP) to the same extent, according to the findings of a large randomised trial.

        Eplerenone is a highly selective in inhibitor of aldosterone that was recently approved for the treatment of hypertension; it has also been shown to reduce mortality in post-myocardial infarction patients with heart failure.

        To further assess the efficacy and safety of eplerenone for the treatment of hypertension, William B. White, MD, with the University of Connecticut School of Medicine, Farmington, United States, and colleagues evaluated several doses of eplerenone, measuring both clinic and ambulatory BP.

        In a 12-week multicenter trial, 400 patients were randomised to receive placebo or one of four doses of eplerenone (25, 50, 100, and 200 mg once daily) after they had undergone 3-4 weeks of single-blind placebo therapy. Changes from baseline in serum potassium, active renin activity, and serum aldosterone were noted.

        After 12 weeks, maximum clinic BP reduction was achieved with eplerenone 100 mg, although a significant dose response compared with placebo was observed with 25 mg dose (P<0.01).

        By comparison, ambulatory BP monitoring showed that all doses of eplerenone lowered BP significantly more than placebo with a significant dose response. The 24-hour mean BP reductions ranged from 6.4/4.4 mm Hg to 10.3/5.7 mm Hg on eplerenone compared with 1.3/0.8 mm Hg on placebo (P<0.006 for systolic and P<0.005 for diastolic values versus placebo).

        Increases in serum aldosterone were related to dose but not to reductions in 24-hour BP, the researchers found.

        One patient on placebo and one patient on 200 mg of eplerenone had episodes of elevated serum potassium levels. Side effects and withdrawal rates attributed to eplerenone were similar to those of placebo, they note.

        "Specifically, adverse events such as sexual dysfunction, gynaecomastia, and menstrual irregularities were not observed with eplerenone, a finding that supports its advantage in clinical practice compared to the non-selective agent spironolactone," they add.

        Dr. White and colleagues conclude that eplerenone is an effective antihypertensive agent at doses as low as 25 mg/day, and they point out that the typical mean reduction in ambulatory BPs in clinical trials of antihypertensive agents is about 40% less than the average reduction in the clinic BP.

        "It is also noteworthy that the level of ambulatory BP reductions observed in our study are comparable to most other antihypertensive agents," they add.
        Am J Cardiol 2003;92:1:38-42. "Assessment of the novel selective aldosterone blocker eplerenone using ambulatory and clinical blood pressure in patients with systemic hypertension"

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