title: Azilsartan compared to ACE inhibitors in anti-hypertensive therapy: one-year outcomes of the observational EARLY registry.
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.
authors.affiliation: Institut für Herzinfarktforschung, Bremser Strasse 79, 67063, Ludwigshafen, Germany. gitta@klilu.de.|Herzzentrum Ludwigshafen, Medizinische Klinik B, Ludwigshafen, Germany. gitta@klilu.de.
authors.forename: Anselm K
authors.initials: AK
authors.lastname: Gitt
authors.affiliation: Institut für Pharmakologie und präventive Medizin, Mahlow, Germany. peter.bramlage@ippmed.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
authors.affiliation: Universitätsklinikum Düsseldorf, Klinik für Nephrologie, Düsseldorf, Germany. sebastian.potthoff@med.uni-duesseldorf.de.
authors.forename: Sebastian A
authors.initials: SA
authors.lastname: Potthoff
authors.affiliation: Clemens-Hospital Münster, Klinik für Innere Medizin I, Münster, Germany. p.baumgart@clemenshospital.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Baumgart
authors.affiliation: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III, Homburg/Saar, Germany. felix.mahfoud@uniklinikum-saarland.de.
authors.forename: Felix
authors.initials: F
authors.lastname: Mahfoud
authors.affiliation: MedCommTools, Medical-scientific consultancy, Hannover, Germany. dr.buhck@medcommtools.de.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Buhck
authors.affiliation: Takeda Pharma Vertriebs GmbH, Berlin, Germany. martina.ehmen@takeda.com.
authors.forename: Martina
authors.initials: M
authors.lastname: Ehmen
authors.affiliation: Institut für Herzinfarktforschung, Bremser Strasse 79, 67063, Ludwigshafen, Germany. ouarrak@ihf.de.
authors.forename: Taoufik
authors.initials: T
authors.lastname: Ouarrak
authors.affiliation: Institut für Herzinfarktforschung, Bremser Strasse 79, 67063, Ludwigshafen, Germany. senges@ihf.de.
authors.forename: Jochen
authors.initials: J
authors.lastname: Senges
authors.affiliation: Universitätsklinikum Erlangen, Medizinische Klinik 4, Schwerpunkt Nephrologie / Hypertensiologie, Erlangen, Germany. roland.schmieder@uk-erlangen.de.
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
mesh_terms: D000328:Adult; D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D062186:Arterial Pressure / Q000187:drug effects*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D005260:Female; D005858:Germany; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D010069:Oxadiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D012042:Registries; D012084:Renin-Angiotensin System / Q000187:drug effects; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D010069:Oxadiazoles; C521273:azilsartan