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Randomized Controlled Trial
. 2013 Jul 2:13:46.
doi: 10.1186/1471-2261-13-46.

EARLY Treatment with azilsartan compared to ACE-inhibitors in anti-hypertensive therapy--rationale and design of the EARLY hypertension registry

Anselm K Gitt  1 , Peter Baumgart, Peter Bramlage, Felix Mahfoud, Sebastian A Potthoff, Jochen Senges, Steffen Schneider, Hartmut Buhck, Roland E Schmieder; EARLY Registry Group
Collaborators, Affiliations
Randomized Controlled Trial

EARLY Treatment with azilsartan compared to ACE-inhibitors in anti-hypertensive therapy--rationale and design of the EARLY hypertension registry

Anselm K Gitt et al. BMC Cardiovasc Disord. .

Abstract

Background: Arterial hypertension is highly prevalent but poorly controlled. Blood pressure (BP) reduction substantially reduces cardiovascular morbidity and mortality. Recent randomized, double-blind clinical trials demonstrated that azilsartan medoxomil (AZM) is more effective in reducing BP than the ubiquitary ACE inhibitor ramipril. Therefore, we aimed to test whether these can be verified under clinical practice conditions.

Methods/design: The "Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy" (EARLY) registry is a prospective, observational, national, multicenter registry with a follow-up of up to 12 months. It will include up to 5000 patients on AZM or ACE-inhibitor monotherapy in a ratio of 7 to 3. A subgroup of patients will undergo 24-hour BP monitoring. EARLY has two co-primary objectives: 1) Description of the safety profile of azilsartan and 2) achievement of BP targets based on recent national and international guidelines for patients treated with azilsartan in comparison to those treated with ACE-inhibitors. The most important secondary endpoints are the determination of persistence with treatment and the documentation of cardiovascular and renal events. Recruitment commenced in January 2012 and will be completed by February 2013.

Conclusions: The data obtained will supplement previous results from randomized controlled trials to document the potential value of utilizing azilsartan medoxomil in comparison to ACE-inhibitor treatment for target BP achievement in clinical practice.

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Figures

Figure 1
Figure 1
Office blood pressure reduction in a comparative trial of Azilsartan Medoxomil (AZM) and ramipril (RAM)[11].
Figure 2
Figure 2
Principal design of EARLY. Patients will be recruited on a consecutive basis, given their compliance with the in- and exclusion criteria defined, in a ratio of 7 (AZM) to 3 (ACE inhibitors).
Figure 3
Figure 3
Patient recruitment and follow-up.
See this image and copyright information in PMC

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