Eplerenone vs Irbesartan as First Line Therapy in Obese Hypertensive Patients: Preliminary Results of Hebro Trial in Ambulatory Blood Pressure Measurements

Objective: Obesity is significantly associated with hypertension and cardiovascular outcomes. Little is known about the impact of aldosterone blockade using eplerenone on hypertensive obese patients as first line therapy. The aim of this study is to compare the efficacy between eplerenone-based strategy and irbesartan-based strategy in obese hypertensive individuals, regarding blood pressure reduction in office and out-of-office measurements. Design and method: HEBRO (antiHypertensive treatment with Eplerenone vs. irBesartan in hypeRtensive Obese patients) is a prospective, randomized, open-labeled, multicenter trial enrolled 112 obese hypertensive patients aged 30-75 years old, evaluated by home BP, office BP and ambulatory BP measurements. Patients were randomized to either 25 mg eplerenone twice (59) or 150 mg irbesartan (53) once daily. The primary endpoint is the difference in ambulatory BP measurements after 6 months follow-up period. Results: We enrolled 112 patients, 54.6 years old, 53% female, mean BMI 34.4 kg/m2 and mean eGFR 82.5 ml/min/1.73m2. At baseline, mean ABPM was 139.3/84.3 mmHg +/- 9.2/7.1 in the irbesartan arm vs. 140.7/84.8 mmHg +/- 9.8/9.0 in the eplerenone arm and mean OBP was 145.2/93.1 mmHg +/- 9.4/9.0 in the irbesartan arm vs. 147.9/92.8 mmHg +/- 8.3/10.2 in the eplerenone arm. At 2 months, mean ABPM drop since baseline was -13.5/-6.1 mmHg +/- 13.3/7.9 in the irbesartan arm vs. -8.1/-4.4 mmHg +/- 13.6/8.5 in the eplerenone arm, p=0.065 and p=0.319 for systolic and diastolic BP respectively. At 4 months, mean ABPM drop since baseline, was -17.1/-9.7 mmHg +/- 11.9/7.9 in the irbesartan arm vs. -16.1/-8.3 mmHg +/- 12.8/7.9 in the eplerenone arm, p=0.738 and p=0.456 respectively. At 6 months, mean ABPM drop since baseline, was -18.6/-10.2 mmHg +/- 11.9/6.5 in the irbesartan arm vs. -15.8/-8.6 mmHg +/- 13.8/9.3 in the eplerenone arm, p=0.358 and p=0.376. Conclusions: Mean ambulatory BP measurements were similar in both study arms at baseline and all follow-up time frames. Eplerenone-based strategy was non-inferior compared to irbesartan-based strategy, regarding ambulatory BP reduction in obese hypertensives, with no statistical significance. However, there was a trend towards irbesartan arm in the 2 months’ time frame. Patients are still enrolled and data on larger pool are anticipated.