Therapeutic Advances in Cardiovascular Disease 00(0)

Table 1. Baseline characteristics of the patients.*

Characteristics Trandolapril (n = 1247) Placebo (n = 1265)

Age (year) 65±8 64±8

Age > 75 years (% of patients) 11.15 10.59

Female sex (% of patients) 15.40 14.23

Body mass index 28±5 28±5

Medical history (% of patients)  

• Documented myocardial infarction 61.69 64.82

• Coronary disease on angiography 55.86 57.71

• Angina pectoris 68.51 69.09

• PCI 40.63 38.02

• CABG 42.97 44.66

• PCI or CABG 73.70 72.73

• DM 19.18† 15.89

• HTN 43.74 44.35

• DM with HTN or 12.67 11.38

DBP 90 or SBP 140 mmHg

• Kidney disease (GFR <60 ml/min) 8.04 8.40

• Stroke or transient ischemic attack 6.66 7.43

• Syncope 0.16 0.08

• Intermittent claudication 9.07 9.17

• Current cigarette smoking 12.06 14.24

• Skin rash 1.28 1.34

CCS functional classification (% of patients)  

• Class I 72.13 74.62

• Class II 17.83 16.13

• Class III 8.76 8.06

• Class IV 1.29 1.19

Blood pressure before run-in phase (mmHg)  

• SBP 133 ± 17 133 ± 17

• DBP 77±10 78±10

DBP ≥ 90 or SBP ≥ 140 mmHg (% of patients) 38.1 41.7

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 T Alzahrani, J Tiu et al.

Table 1. (Continued)

Characteristics Trandolapril (n = 1247) Placebo (n = 1265)

Laboratory values  

• Estimated GFR (ml/min) 77±18 78±20

• Serum cholesterol (mg/dl) 193 ± 39 193 ± 40

• Serum potassium (mg/dl) 4.4 ± 0.4 4.4 ± 0.4

Ejection fraction (%) 47±3 47±3

Medications (% of patients)  

• Calcium channel blocker 32.77 31.43

• Beta blocker 58.63 59.70

• Aspirin or antiplatelet medication 89.09 90.74

• Lipid-lowering drug 65.43 68.59

• Diuretic agent 10.36 10.92

• Potassium-sparing diuretic 3.13 2.69

• Digitalis 4.82 4.43

• Antiarrhythmic agent 2.33 2.53

• Anticoagulant 6.43 5.85

• Insulin 3.61 3.87

• Hormone replacement therapy 3.85 3.72

*Values are means ± SD.

†p < 0.05 for the comparison with placebo.
CABG, coronary artery bypass grafting; CCS, Canadian Cardiovascular Society; DBP, diastolic blood pressure; DM,
diabetes mellitus; GFR, glomerular filtration rate; HTN, hypertension; PCI, percutaneous coronary intervention; SBP,
systolic blood pressure; SD, standard deviation

Table 2. Incidence of cardiovascular disease and death.

Trandolapril Placebo Relative risk p-value

(n = 1247) (n = 1265) (95% CI)
  No. of patients (%)  
Composite outcome 175 (14.0) 217 (17.2) 0.79 (0.63–0.98) 0.03
(all-cause mortality,
nonfatal MI and stroke)

All-cause mortality 101 (8.1) 134 (10.6) 0.85 (0.73–0.99) 0.03

Cardiovascular mortality 53 (4.3) 67 (5.3) 0.88 (0.72–1.09) 0.22

Noncardiovascular 48 (3.9) 67 (5.3) 0.83 (0.67–1.04) 0.08

mortality

Nonfatal MI 72 (5.8) 79 (6.3) 0.96 (0.81–1.14) 0.62

Stroke 19 (1.5) 25 (2.0) 0.87 (0.62–1.22) 0.39

CI, confidence interval; MI, myocardial infarction.

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Therapeutic Advances in Cardiovascular Disease 00(0)

Table 3. Incidence of secondary outcome.

Trandolapril Placebo Relative risk p-value

(n = 1247) (n = 1265) (95% CI)
  No. of patients (%)  

Hospitalization for nonfatal 47(3.8) 51(4.0) 0.96 (0.78–1.19) 0.73

congestive heart failure

Coronary artery 84(6.7) 88(7.0) 0.98 (0.84–1.15) 0.83

bypass grafting

Percutaneous coronary 159 (12.8) 164 (13.0) 0.99 (0.88–1.12) 0.87

intervention
New diabetes 89(7.14) 128 (10.12) 0.81 (0.69–0.96) 0.01

Figure 1. Cumulative incidence of the composite outcome (all-cause mortality, nonfatal MI and stroke)
according to treatment group
The effect of ACE inhibitors on the incidence of diabetes mellitus type II is a well-known
phenom-enon. Several clinical trials have shown that ACE inhibitors, as well as ARBs,
reduce the risk of dia-betes mellitus type II by 14–34% compared with placebo and other
antihypertensive drugs.16,20–24 ACE inhibitors and ARBs reduce the risk of dia-betes by
increasing insulin secretion from the pancreas and by enhancing insulin sensitivity in the
adipocytes and muscle fibers. The underlying
mechanism of this protective effect is still not fully understood, but it is thought to be driven by the increase in
the level of bradykinin.25–27

Previous clinical studies have shown that ACE inhibitors reduce mortality and hospitaliza-tion among patients
with reduced left ventricular (LV) EF < 40%.28 ACE inhibitors have also been shown to reduce the rates of
cardiovascular events and mortality in patients with coronary