Abstract

Blood pressure (BP) control is the main clinical goal in the management of hypertensive patients; however, BP in most of these patients remains uncontrolled, despite the widespread availability of antihypertensive drugs as free-combination therapy. This study compared the efficacy of a fixed-dose triple combination (FDTC) of antihypertensive drugs with that of a free combination of three antihypertensives in patients with uncontrolled hypertension. Ninety-two patients (mean age 60.8 ± 12.1, 58.0% male) with uncontrolled essential hypertension (office systolic BP≥140 or diastolic BP≥90mmHg) previously treated with a renin-angiotensin-aldosterone system (RAAS) inhibitor plus hydrochlorothiazide were switched to once-daily FDTC therapy with perindopril/indapamide/amlodipine (5-10/1.25-2.5/5-10mg). Patients were age- and sex-matched with a control group of hypertensive patients receiving free-combination therapy with three drugs including a RAAS inhibitor, a diuretic, and a calcium channel blocker. Office BP and 24-h ambulatory BP monitoring (ABPM) were evaluated at baseline and after 1 and 4months. Significant reductions in ambulatory 24-h, daytime, and nighttime systolic BP, and pulse pressure (PP) were found in the FDTC group relative to reductions seen with free-combination therapy, after the first month only of follow-up. Target BP values (mean 24-h ambulatory systolic/diastolic BP<130/80mmHg) were reached by more recipients of FDTC than free-combination therapy (64.8% vs. 46.9%, p<0.05) at month 4 of follow-up, despite reductions in 24-h ABPM values from baseline being similar in both groups at this time point. FDTC of perindopril/indapamide/amlodipine was effective at reducing SBP and PP in previously treated patients with uncontrolled hypertension, and well tolerated, providing support for clinicians in choosing a fixed-dose triple combination over the free-combination of a RAAS inhibitor, a diuretic, and a calcium antagonist.

Highlights

  • Blood pressure (BP) control is the main clinical goal in the management of hypertensive patients; BP in most of these patients remains uncontrolled, despite the widespread availability of antihypertensive drugs as free-combination therapy

  • Target BP values were reached by more recipients of fixed-dose triple combination (FDTC) than free-combination therapy (64.8% vs. 46.9%, p\0.05) at month 4 of follow-up, despite reductions in 24-h ambulatory BP monitoring (ABPM) values from baseline being similar in both groups at this time point

  • The study protocol was approved by local ethics committee and institutional review boards, and procedures were followed in accordance with ICH Harmonized Tripartite Guidelines for Good Clinical Practice and with the Helsinki Declaration of 1964, as revised in 2013

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Summary

Introduction

Blood pressure (BP) control is the main clinical goal in the management of hypertensive patients; BP in most of these patients remains uncontrolled, despite the widespread availability of antihypertensive drugs as free-combination therapy. In addition to the potential benefits of combining different drug classes owing to their possible synergistic pharmacological and physiological actions, this approach—in particular if provided at fixed doses in a single pill— improves patient compliance to treatment [7, 8]. This strategy seems more effective than the separate administration of two or more antihypertensive agents (free-drug combination), in blood pressure control and in promoting decreased cardiovascular events [9], hospitalization rates [10], and costs [11]. Many studies have been performed comparing fixed-dose combinations with single agents [10, 12], data comparing fixed-dose and free-drug combinations are limited

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