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

Abstract

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 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. Design and method: A prospective, randomized, open-labeled, multicenter trial enrolled 80 hypertensive patients aged 30 to 75 years old, with obesity [body mass index BMI >or = 30 kg/m2)], evaluated by home BP, office BP and ambulatory BP measurements. Subjects randomly received 25mg eplerenone twice or 150mg irbesartan once daily. The primary endpoint is the difference in ambulatory BP measurements after 6 months follow-up period and the secondary endpoints are the differences in left ventricular hypertrophy and albuminuria after 6 months follow-up period. Results: At baseline, there were no significant differences between the two study arms regarding gender (men 49,3%, p = 0.732), age (53.9± 10.4 in the eplerenone arm vs. 56.1 ± 10 in the irbesartan arm, p = 0.326), BMI (34.2 ± 3.3 vs. 34.9 ± 3.3, p = 0.376, respectively), renal function (mean eGFR 84.6 ± 16.4 vs. 81.3± 13.1, p = 0.358, respectively) and the presence of diabetes mellitus (9.8% vs 10.5%, p = 0.910, respectively). Moreover, there were no significant differences regarding home BP (142.5/88.5 mmHg ± 8.6/7.3 vs. 141.8/89.4 mmHg ± 8.3/6.7, p = 0.716 and p = 0.558 respectively), office BP (146.3/91.3 mmHg ± 8.2/9.4 vs. 145.1/92.3 mmHg ± 9.1/9.1, p = 0.506 and p = 0.547 respectively) and ambulatory BP (140.9/85.5 mmHg ± 8.4/8.8 vs. 140.1/84.7 mmHg ±7.8/7.5, p = 0.662 and p = 0.667 respectively). Regarding left atrial geometry, evaluated by left atrial volume index (LAVI), there was no significant difference (30.7 mL/m2± 11.1 vs. 30.6 mL/m2 ± 16.9, p = 0.979, respectively). Finally, regarding arterial stiffness evaluated by pulse-wave velocity, there was no significant difference (9.5 m/s ± 1.7 vs. 10.1 m/s ± 2.4, p = 0.435, respectively) Conclusions: In conclusion, 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.