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Table 4 Safety during 1-year follow-up in patients receiving AZL-M or 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

Adverse events (AEs) at 1 year

RCT(+) AZL-M

RCT(+) rami

Mean difference (95 % CI)

P-value

RCT(−) AZL-M

RCT(−) rami

Mean difference (95 % CI)

P-value

Death, % (95 % CI)

0.4 (0.1–1.1)

0.0

n.a.

0.23

0.5 (0.2–1.0)

0.3 (0.0–1.5)

n.a.

0.61

Patients without AE, %

94.0

94.9

n.a.

0.53

92.0

91.0

n.a.

0.51

Patients with any AE, %

6.0

5.1

n.a.

0.53

8.0

9.0

n.a.

0.51

Laboratory values

 ∆ HbA1c, %

0.02 ± 0.78

0.15 ± 0.72

−0.13 (−0.40–0.14)

0.35

0.01 ± 1.10

0.08 ± 1.06

−0.07 (−0.39–0.25)

0.69

 ∆ Glucose fasting, mg/dl

5.76 ± 77.68

1.90 ± 19.59

3.85 (−23.65–31.4)

0.91

0.12 ± 21.13

2.81 ± 15.17

−2.69 (−10.70–5.32)

0.37

 ∆ Creatinine, mg/dl

0.04 ± 0.17

0.01 ± 0.20

0.03 (−0.02–0.08)

0.09

−0.06 ± 1.06

−0.10 ± 1.14

0.04 (−0.22–0.31)

0.90

 ∆ Potassium, mmol/L

0.05 ± 0.39

0.04 ± 0.53

0.02 (−0.16–0.20)

0.69

0.00 ± 0.51

0.08 ± 0.54

−0.08 (−0.25–0.09)

0.42

 ∆ GFR, ml/min/1.73 m2

−2.26 ± 10.10

−0.05 ± 11.58

−2.21 (−5.26–0.84)

0.11

−1.45 ± 14.15

−1.08 ± 14.90

−0.37 (−3.86–3.12 )

0.69

  1. Legend: AZL-M azilsartan medoxomil, rami ramipril, AE adverse event, SAE serious adverse event, GFR glomerular filtration rate, n.a. not applicable