Eplerenone vs irbesartan as first line therapy in obese hypertensive patients: results of the HEBRO randomized controlled trial

Objective The pathophysiology of hypertension in obese patients is complex and multifactorial. Obesity is significantly associated with adverse cardiovascular outcomes. The relationship between obesity and hypertension is well described. However, little is known about the impact of aldosterone blockade using eplerenone in hypertensive obese patients as first line therapy. Purpose The aim of this study is to compare the efficacy between eplerenone-based strategy and irbesartan-based strategy in obese hypertensive individuals, regarding BP reduction. Methods HEBRO (antiHypertensive treatment with Eplerenone vs. iBesartan in hypeRtensive Obese patients) is a prospective, randomized, open-labeled, multicenter trial that enrolled 198 hypertensive patients aged 30 to 75 years old, with obesity (BMI ≥ 30 kg/m2) and arterial hypertension established by both office and ambulatory BP measurements. Patients were stratified randomized (according to age, gender, initial office BP levels and eGFR) to either 25mg eplerenone bd (99 pts) or 150mg irbesartan od (99 pts). At 2 months and 4 months up-titration with amlodipine 5mg and indapamide 1.5mg respectively was taken place when mean ambulatory BP (ABPM) was over 130/80mmHg. The primary endpoint is the difference in mean ambulatory BP measurements at 6-months follow-up period. Results At baseline, there were no significant differences regarding gender (men 50.5%), age (55.5±10.14 years), BMI (34.18±3.45 kg/m2), renal function (mean eGFR 85.67±16.11 mL/min/1.73m²) and diabetes mellitus (13.6%). Initial office BP was 146.2/91.9 mmHg ± 10.4/9.1 in the irbesartan arm vs. 148.1/92.0 mmHg ± 9.5/9.4 in the eplerenone arm, p=0.168 and p=0.918 respectively) and initial ABPM 137.7/83.3 mmHg ± 9.2/7.6 in the irbesartan arm vs. 140.9/84.8 mmHg ± 9.9/9.1 in the eplerenone arm, p=0.02 and p=0.205 respectively). At 6 months, mean ambulatory BP reduction was -17.5/-9.6 mmHg ± 12.0/6.7 in the irbesartan vs. -19.0/-9.0 mmHg ± 12.6/8.2 in the eplerenone arm, p=0.463 and p=0.611 respectively. At 6 months, the number of antihypertensive drugs was 1.8 ± 0.8 vs 1.9 ± 0.8, p=0.164. Conclusion At 6 months, eplerenone-based antihypertensive strategy is non-inferior compared to irbesartan-based strategy regarding reducing ABPM, under the same number of antihypertensive medications, accompanied by no difference in safety and renal function preservance.