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Table 1 Selection criteria for the Bönner trial [8] and the corresponding criteria applied to the selection of EARLY patients

From: The renin-angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin-converting enzyme inhibitor ramipril in clinical trials versus routine practice: insights from the prospective EARLY registry

 

Bönner et al. [8]

EARLY RCT+ population

Proportion of eligible patients (%)

Inclusion criteria

 Age

≥18 years

≥18 years

100.0

 SBP

150–180 mmHg

150–180 mmHg

70.0

 Laboratory profile

Not considered clinically significant

Not recorded

 

Exclusion criteria

 SBP

>180 mmHg

>180 mmHg

7.9

 DBP

>114 mmHg

>114 mmHg

2.6

 Secondary hypertension

Excluded

As to SPC

 

 Severe renal disease; eGFR ≤30 ml/1.73 m2

Excluded

Renal insufficiency

2.8

 Major CV event or intervention <6 month

Excluded

Stroke excluded

2.7

 Sign. cardiac conduction defects

Excluded

  

 Aortic valve stenosis

Excluded

Not recorded

 

 Concomitant antihypertensive treatment or medication known to affect BP

Excluded

Excluded at baseline

32.5

 Previous history of cancer not in remission for at least 5 years

Excluded

Malignancy excluded

2.6

 Type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c >8.0 %)

Excluded

Hemoglobin A1c >8.0 % excluded; diabetes type not recorded

5.0

 Hyperkalemia (serum potassium > upper limit of normal, 5.5 mmol/L)

Excluded

Potassium >5.5 mmol/L excluded

0.9

 Night shift work

Excluded

Not recorded

 

 Pregnant or nursing women and woman of childbearing potential not using approved means of contraception

Excluded

Pregnant or nursing women were excluded

 

 Patients with alcohol or drug abuse

Not considered for exclusion

Excluded

 

Treatment

 Pre-treatment

Not specified

Newly diagnosed or non-RAS monotherapy pretreatment

 

 Treatment

AZL-M vs. ramipril

AZL-M vs. ramipril; other ACEi excluded