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Eplerenone and Enalapril Equally Effective as Monotherapy for Hypertension, but Eplerenone Produces Greater Reduction in Albuminuria

Eplerenone is as effective and safe as is enalapril for the treatment of hypertension, and is more effective in reducing albuminuria, according to a recent American study.

Eplerenone is a steroid nucleus-based anti-mineralocorticoid that has been shown to effectively reduce blood pressure (BP) when administered as monotherapy in the dose range of 25 to 200 mg/day. However, long-term studies of the efficacy of eplerenone have not previously been reported.

Researchers led by Gordon H. Williams, MD, of the Brigham and Women's Hospital, Boston, Massachusetts, and colleagues performed a 12-month study to compare the efficacy and safety of eplerenone with enalapril, an angiotensin converting-enzyme (ACE) inhibitor.

Patients were randomised with 253 receiving eplerenone (40.7% females, mean age=54.7) and 246 receiving enalapril (48.8% females, mean age=55.7) for a 6-month period. Starting doses were 50 mg eplerenone or 10 mg enalapril. Doses could be subsequently doubled up to 2 times if the diastolic BP was not lower than 90 mm Hg at 4, 8 or 12 weeks. After 6 months, dosages reduced by half and were followed for an additional 6 months in patients who achieved a diastolic BP lower than 90 mm Hg.

The 2 treatment groups showed similar reductions at 6 months in both systolic BP (eplerenone, -14.5 mm Hg; enalapril, -12.7 mm Hg; P = .199) and diastolic BP (eplerenone, -11.2 mm Hg; enalapril, -11.3 mm Hg; P = .910), and the improvements remained comparable between the groups at 12 months (eplerenone, -16.5/-13.3 mm Hg, p=.251; enalapril, -14.8/-14.1 mm Hg, P = .331). BP response showed a significant correlation with baseline renin levels in the enalapril group, as expected for an ACE inhibitor, whereas no correlation was detected in the eplerenone group. Both treatments reduced albuminuria in patients with elevated levels at baseline, but the improvement was significantly greater in the eplerenone group (-61.5% vs. 25.7%, P = .01).

"These results suggest that the mechanism of action of eplerenone in lowering BP may not be entirely due to diuresis but may also be associated with effects of blocking mineralocorticoid receptors in the brain and vasculature," the researchers write.

The 2 treatments were similarly well tolerated, and the researchers report comparable withdrawal rates for adverse events (at 6 months: eplerenone 7.9%, enalapril 9.3%) and treatment failures (at 6 months: eplerenone 23.3%, enalapril 22.8%). Two patients taking eplerenone and 2 taking enalapril experienced hyperkalemia of 5.5 mmol/L or more, but no patient had an elevated potassium level of greater than 6.0 mmol/L.

"This study demonstrates that eplerenone is as effective as enalapril for monotherapy in patients with stage 1 or 2 hypertension regardless of their renin level, is more effective in reducing albuminuria, and is well tolerated up to 12 months," the researchers conclude.










Am J Cardiol 2004 Apr 15;93:8:990-6. "Efficacy of eplerenone versus enalapril as monotherapy in systemic hypertension"

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