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Eplerenone Better Tolerated and as Effective in Reducing Systolic BP Than Amlodipine

Compared to the calcium-channel blocker (CCB) amlodipine, the aldosterone antagonist eplerenone appears to be better tolerated and comparable in reducing systolic blood pressure, according to the findings of a new randomised trial.

Aldosterone is known to contribute to the pathology induced by activation of the renin-angiotensin-aldosterone system. However, spironolactone, until recently the only aldosterone antagonist available, is poorly tolerated. The introduction of eplerenone, an aldosterone receptor antagonist with greater specificity for the mineralocorticoid receptor than spironolactone, may help improve this therapeutic approach.

Norman K. Hollenberg, MD, PhD, with the Department of Medicine, at Brigham and Women's Hospital and Harvard Medical School, Boston, United States and colleagues compared eplerenone with amlodipine in 269 patients older than 50 years with systolic hypertension.

Patients were randomised to receive eplerenone, 50 mg/d, or amlodipine, 2.5 mg/d, and this was titrated to a maximum dose of 200 mg eplerenone or 10 mg amlodipine.

Patients were followed for 24 weeks. Quality-of-life was evaluated with the SF-36 Health Survey and the Symptom Distress Index (SDI) at randomisation and at the end of treatment.

Eplerenone and amlodipine were found to reduce systolic blood pressure to a similar extent (eplerenone = -20.5 mm Hg and amlodipine = -20.1 mm Hg).

For the quality-of-life analysis, 119 patients were randomised to eplerenone and 122 to amlodipine. There was an overall significant treatment effect on symptom distress in favour of eplerenone (p=0.03), and a significant worsening of symptom distress in 36 of 71 symptoms in the amlodipine arm compared to none in the eplerenone arm.

"Significant treatment effect in favour of eplerenone was observed in 5 symptoms: ankle swelling, weight gain, nocturia, increased urination, and shortness of breath," the researchers note. "Patients with symptom distress also showed an erosion of psychosocial measures of quality of life (p<0.001)," they add.

According to Dr. Hollenberg and colleagues, hyperkalemia occurred in 2 eplerenone-treated patients and in 1 amlodipine-treated patient, while hypokalemia occurred in 2 amlodipine-treated patients, and in no eplerenone-treated patients. Erectile dysfunction was reported in 2 of 61 eplerenone-treated men, and in no amlodipine-treated men. Oedema was present in 25.2% of the amlodipine-treated patients and 4.5% of the eplerenone-treated patients.

"The availability of a new, specific, effective, and well-tolerated aldosterone receptor antagonists (sic) will facilitate the exploration of the clinical implications of these findings," the researchers conclude. "The results of this study suggest that eplerenone may be such an agent."
Arch Intern Med 2003;163:1543-1548. "Symptoms and the Distress They Cause: Comparison of an Aldosterone Antagonist and a Calcium Channel Blocking Agent in Patients With Systolic Hypertension"

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