Symptoms and the distress they cause: a comparison of eplerenone and amlodipine in patients treated for elevated systolic BP

Abstract

This study was designed to compare the influence of eplerenone(EPL) and amlodipine(AML) on systolic blood pressure (SBP) and on symptom distress (SDI). Patients over 50 yrs with SBP were randomized to either EPL 50mg or AML 2.5mg daily and titrated to a maximum 200mg EPL or 10mg AML dose. Patients were followed for 24 wks. Quality of life(QOL) questionnaires (SDI and SF-36 Health Survey) were administered 2-4 wks pre-randomization, 14 wks, and 24 wks after randomization. Change from baseline to week 24 in the SDI was analyzed using the Wilcoxon Rank Sum Test(WRST) to compare the ranks and first principal component analysis(FPCT). The BP response to EPL and AML did not differ (EPL=20.5 mmHg and AML= -20.1 mmHg); 241 were eligible for the QOL analysis, of which 119 were randomized to EPL and 122 of AML. No significant treatment group differences in the SDI were detected at baseline. Both the WRST and the FPCT detected an overall significnt treatment effect in favor of EPL(p=0.038 & p=0.027). Change in SDI showed significant worsening distress in 21 of 73 symptoms in the AML arm and none in the EPL arm. Significant treatment effect in favor of EPL was observed in five symptoms: ankle swelling, weight gain, nocturia, increased urination, and shortness of breath. EPL is better tolerated than AML evidenced by symptoms frequency and by the distress associated with the symptoms.