OBSERVATIONAL PROSPECTIVE STUDY OF AZILSARTAN MEDOXOMIL/ CHLORTALIDONE COMPARED WITH IRBESARTAN/ HYDROCHLOROTHIAZIDE COMBINATION THERAPY IN OBESE HYPERTENSIVES (PUZZLE)

Abstract

Objective: Attainment of blood pressure (BP) control is important to successful management of arterial hypertension (AH). It is more difficult to reach recommended BP goals in obese hypertensives. Combination of ARB and thiazide diuretics is recommended. Azilsartan medoxomil/chlorthalidone (AZL-C) is potent and currently the only fixed combination of ARB and thiazide-like diuretic used for AH. The objective of this study was to evaluate influence of AZL-C on office, 24-hour brachial, central blood pressure and aortic stiffness parameters compared with irbesartan/hydrochlorothiazide (IRB-H). Design and method: We included 94 patients 35–55 years old with I-II grade AH and obesity at high cardiovascular risk. Patients with symptomatic organ damage, intolerance of ARB, thiazide diuretics, secondary AH were exluded. All patients underwent phisical exam, office, ambulatory BP measurement with arterial stiffness analysis on inclusion, during 1, 3 and 6 months visit. After inclusion 47 patients received AZL-C dose 40/12.5 or 40/25 mg, 47 patients received IRB-H dose 150/12.5 or 300/25 mg. The study was approved by local ethic committee and registered on clinicaltrials.gov (NCT03006796). Results: On 1 month visit 37(79%) patients reached office BP goals in AZL-C group vs 32(68%) in IRB-H, finally the proportion was 45(96%) vs 41(87%). After 3 months significantly more patients received higher doses of IRB-H: 18(38%) vs 9(19%) in AZL-C group. The mean office systolic/diastolic BP on the final visit was 126,4/84,5 in AZL-C vs 132,7/89,9 mmHg in IRB-H group. The mean ambulatory SBP/DBP was 124,6/77,6 in AZL-C vs 127,4/81,7 mmHg in IRB-H group. After 6 months the mean ambulatory central SBP and aortic augmentation index reduced in both groups, more significantly in AZL-C patients: from 129,4 to 115,3 vs. from 129,5 to 117,6 mmHg in IRB-H group; from 26% to 17% vs. from 28% to 21% in IRB-H. There were no changes in ambulatory PWV in both groups, which may be due to the variability of this parameter during the day. Conclusions: Both fixed combinations of ARB and diuretic are safe and effective treatment of AH in obese patients, but long-term treatment with AZL-C allows to achieve more stable peripheral and central BP decrease.