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