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Table 3 Blood pressure reductions: comparison of treatment groups (AZL-M versus ramipril) by RCT eligibility in those with 12-mo. follow-up

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

 

RCT eligible

RCT not eligible

 

RCT(+) AZL-M value (95 % CI)

RCT(+) rami value (95 % CI)

Mean difference (95 % CI)

P-value

RCT(−) AZL-M value (95 % CI)

RCT(−) rami value (95 % CI)

Mean difference (95 % CI)

P-value

Raw (unadjusted)

 Δ Systolic, mmHg

29.9 (29.0–30.9)

27.1 (25.4–28.7)

2.8 (1.1–4.7)

<0.01

22.7 (21.5–23.9)

18.9 (16.9–21.0)

3.8 (1.3–6.3)

<0.01

 Δ Diastolic, mmHg

14.7 (14.1–15.3)

12.5 (11.4–13.6)

2.2 (1.0–3.4)

<0.01

11.6 (10.9–12.3)

10.7 (9.4–12.0)

0.9 (−0.6–2.5)

0.07

 Δ Mean pressure, mmHg

19.8 (19.2–20.4)

17.4 (16.3–18.5)

2.4 (1.2–3.6)

<0.001

15.3 (14.5–16.1)

13.4 (12.1–14.8)

1.9 (0.2–3.5)

<0.01

 Δ Pulse pressure, mmHg

15.2 (14.4–16.1)

14.5 (13.1–16.0)

0.7 (−1.0–2.4)

0.37

11.1 (10.1–12.1)

8.3 (6.5–10.0)

2.8 (0.7–5.0)

<0.05

 Δ Heart rate, bpm

3.9 (3.4–4.4)

3.7 (2.9–4.5)

0.7 (−0.7–2.0)

0.45

2.3 (1.6–2.9)

2.2 (1.1–3.4)

0.1 (−1.3–1.3)

0.79

 BP <140/90 mmHg, %

64.1 (61.0–67.2)

56.1 (50.7–61.3)

n.a.

<0.01

58.7 (55.9–61.5)

57.7 (52.4–62.8)

n.a.

0.73

Model 1 (adjusted)

 Δ Systolic, mmHg

29.7 (28.9–30.4)

27.8 (26.5–29.0)

1.9 (0.4–3.4)

<0.05

22.0 (21.3–22.7)

21.6 (20.2–22.9)

0.4 (−1.1–1.9)

0.58

 Δ Diastolic, mmHg

14.5 (14.1–15.0)

13.0 (12.2–13.8)

1.5 (0.6–2.5)

<0.01

11.4 (10.9–11.8)

11.6 (10.7–12.4)

−0.2 (−1.2–0.8)

0.68

 Δ Mean pressure, mmHg

19.6 (19.0–20.1)

17.9 (17.0–18.7)

1.7 (0.7–2.6)

<0.001

15.0 (14.4–15.4)

15.0 (14.0–15.8)

0.0 (−1.0–1.0)

0.99

 Δ Pulse pressure, mmHg

15.1 (14.5–15.8)

14.7 (13.7–15.9)

0.4 (−0.9–1.7)

0.57

10.6 (10.0–11.2)

10.0 (8.8–11.2)

0.6 (−0.7–2.0)

0.35

 Δ Heart rate, bpm

3.9 (3.4–4.4)

3.7 (2.9–4.5)

0.2 (−0.7–1.1)

0.65

2.3 (1.9–2.8)

2.0 (1.2–2.8)

0.3 (−0.6–1.3)

0.48

 BP <140/90 mmHg, %

64.1 (61.1–67.1)

56.0 (50.8–61.1)

n.a.

<0.01

58.7 (55.9–61.5)

56.6 (51.4–61.7)

n.a.

0.38

Model 2 (adjusted)

 Δ Systolic, mmHg

29.7 (28.9–30.5)

27.7 (26.4–28.9)

2.0 (0.6–3.5)

<0.01

22.0 (21.3–22.7)

21.4 (20.1–22.7)

0.6 (−0.9–2.1)

0.43

 Δ Diastolic, mmHg

14.5 (14.0–15.0)

13.1 (12.3–13.9)

1.4 (0.5–2.4)

<0.01

11.1 (10.9–11.8)

11.6 (10.7–12.4)

−0.2 (−1.1–0.8)

0.67

 Δ Mean pressure, mmHg

19.6 (19.1–20.1)

17.9 (17.1–18.8)

1.6 (0.7–2.6)

<0.01

14.9 (14.4–15.4)

14.8 (14.0–15.7)

0.1 (−0.9–1.1)

0.91

 Δ Pulse pressure, mmHg

15.2 (14.6–15.9)

14.6 (13.5–15.7)

0.6 (−0.6–1.9)

0.35

10.7 (10.0–11.3)

9.8 (8.7–11.0)

0.8 (−0.5–2.1)

0.22

 Δ Heart rate, bpm

3.9 (3.4–4.4)

3.7 (2.9–4.5)

0.2 (−0.7–1.1)

0.66

2.3 (1.9–2.8)

2.0 (1.2–2.8)

0.3 (−0.6–1.3)

0.47

 BP <140/90 mmHg, %

64.4 (61.3–67.4)

55.7 (50.4–60.9)

n.a.

<0.01

59.4 (56.7–62.2)

56.3 (51.0–61.5)

n.a.

0.30

  1. Legend: AZL-M azilsartan medoxomil, ACEi angiotensin-converting enzyme inhibitor, rami ramipril, RCT randomized controlled trial, CI confidence interval, BP blood pressure, SBP systolic blood pressure, DBP diastolic blood pressure, n.a. not applicable. To illustrate the adjusted changes in BP, three pretreatment BP values were chosen to represent the three borders between four quartiles; model 1: adjusted for SBP/DBP at baseline; model 2: adjusted for SBP/DBP at baseline (model 1), newly diagnosed or established hypertension, age, gender, and diabetes