EPLERENONE VS IRBESARTAN AS FIRST LINE THERAPY IN OBESE HYPERTENSIVE PATIENTS: BASELINE CHARACTERISTICS FROM THE HEBRO TRIAL POPULATION

Objective: 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. The aim of this study is to compare the efficacy between eplerenone-based strategy and irbesartan-based strategy in obese hypertensive individuals.Design and method: HEBRO (antiHypertensive treatment with Eplerenone vs. irBesartan in hypeRtensive Obese patients) is a prospective, randomized, open-label, multicenter trial planned to enroll (body mass index, BMI > 30 kg/m2) hypertensive patients aged 30-75 years old, evaluated by home BP, office BP and ambulatory BP measurements. Patients were randomized (stratified randomization) to either 25 mg eplerenone twice or 150 mg irbesartan (99) once daily in the morning. The primary endpoint was the baseline minus follow-up difference in ambulatory BP measurement after a follow-up period of 6 months. If necessary, up titration with 5 mg amlodipine or 1,5 mg indapamide followed at scheduled visits 2 and 4 months after randomization. Secondary endpoints were baseline minus follow-up differences in left ventricular hypertrophy and diastolic function indices. Safety endpoints include regular assessment of renal function. Results: The study included 198 patients, 99 in the eplerenone and 99 in the irbesartan arm. At baseline, there were no significant differences between regarding gender (female 49,4%, p=0.883), age (54.8±10.8 in the eplerenone arm vs. 56.9±9.6 in the irbesartan arm, p=0.150), BMI (34.2 ± 3.8 vs. 35.1±8.6, p=0.362, respectively), renal function (mean eGFR 86.5±17.8 vs. 84.5±15.2, p=0.420, respectively) and the presence of diabetes mellitus (13.3% vs 15.9%, p=0.627, respectively). Regarding ambulatory blood pressure measurements, mean BP was 139.9±11.3/84.1±8.5mmHg in the eplerenone arm vs. 138.3±9.0/82.9±7.7 mmHg in the irbesartan arm, p=0.282/0.302. Regarding office blood pressure measurements, mean BP was 147.8±9.6/91.9±9.3mmHg in the eplerenone arm vs. 146.8±10.5/92.0±9.3 mmHg in the irbesartan arm, p=0.513/0.943. Echocardiographic assessment showed mean LVMI 80.4±17. vs 77.2±12.3, p=0.164 and mean LAVI 30.7±9.4. vs 32.2±14.1, p=0.443, respectively. Conclusions: The two study arms did not differ in most baseline characteristics, suggesting true homogeneity among comparison arms. Soon, we anticipate the results from the primary endpoint completion