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Observational Study
. 2016 Mar 8:16:56.
doi: 10.1186/s12872-016-0222-6.

Azilsartan compared to ACE inhibitors in anti-hypertensive therapy: one-year outcomes of the observational EARLY registry

Anselm K Gitt  1   2 , Peter Bramlage  3 , Sebastian A Potthoff  4 , Peter Baumgart  5 , Felix Mahfoud  6 , Hartmut Buhck  7 , Martina Ehmen  8 , Taoufik Ouarrak  9 , Jochen Senges  10 , Roland E Schmieder  11 ; EARLY Registry Group
Affiliations
Observational Study

Azilsartan compared to ACE inhibitors in anti-hypertensive therapy: one-year outcomes of the observational EARLY registry

Anselm K Gitt et al. BMC Cardiovasc Disord. .

Abstract

Background: Azilsartan medoxomil (AZL-M), has been demonstrated to be more effective than the other sartans currently in use; however, there is insufficient information available comparing it with ACE-inhibitors. Therefore, we aimed to compare the efficacy, safety, and tolerability of AZL-M with that of ACE-inhibitors in a real life clinical setting.

Methods: The EARLY registry is a prospective, observational, national, multicentre registry with a follow-up period of 12 months. There were two principal objectives: 1) documentation of the achievement of target BP values set according to recent national and international guidelines, and 2) description of the safety profile of AZL-M.

Results: A total of 3 849 patients with essential arterial hypertension were recruited from primary care offices in Germany. Patients who initiated monotherapy at baseline comprising either AZL-M or an ACE-inhibitor were included at a ratio of seven to three. Results demonstrated that a blood pressure target of <140/90 mmHg was achieved by a significantly greater proportion of patients in the AZL-M group (61.1 %) compared with the ACE-inhibitor group (56.4 %; p < 0.05; OR, 1.21; 95 % CI, 1.03-1.42), with this finding maintained after adjusting for differences in baseline characteristics. AZL-M appeared to have an equivalent safety profile to the ACE-inhibitors, with a similar incidence of adverse events in the two patient groups (p = 0.73).

Conclusions: These data add to the results of previous randomized controlled clinical trials suggesting that, compared with other agents that target the renin-angiotensin system, AZL-M provides statistically significant albeit small improvements in blood pressure control.

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Figures

Fig. 1
Fig. 1
Patient flow chart
Fig. 2
Fig. 2
AZL-M vs. ACE-inhibitors in patients with a 12 month follow-up–target BP achievement (<140/90 mmHg). Legend: HT, hypertension; BMI, body mass index; target BP achievement is defined as an SBP of <140 mmHg and a DBP of <90 mmHg
Fig. 3
Fig. 3
AZL-M vs. ACE-inhibitors in patients with a 12 month follow-up–any AE. Legend: HT, hypertension; BMI, body mass index
Fig. 4
Fig. 4
AZL-M vs. ACE-inhibitors in patients with a 12 month follow-up–no treatment target adjustment. Legend: HT, hypertension; BMI, body mass index
See this image and copyright information in PMC

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