Methods |
Country: Canada
Setting/Design: Multicentre
Time frame: NS
Randomisation method: NS
Blinding
‐ Participants: Yes
‐ Investigators: Yes
‐ Outcome assessors: Yes
‐ Data analysis: No
Intention‐to‐treat: Yes
Follow‐up period: mean 4.5 years
Loss to follow‐up:13 |
Participants |
Inclusion criteria
Patients with and without diabetes aged 55 years or older with a history of cardiovascular disease (coronary artery disease, stroke, or peripheral vascular disease) or diabetes plus at least one other cardiovascular risk factor (total cholesterol > 5.2 mmol/L, HDL cholesterol < 0.9 mmol/L, hypertension, known microalbuminuria, or current smoking)
Ramipril group
Number: 1808
Age: 65.3 (6.4)
Sex (M/F): 1112/636
Placebo group
Number: 1769
Age: 65.6 (6.6)
Sex (M/F): 1143/626
Exclusion criteria
Dipstick‐positive proteinuria or established diabetic nephropathy
Other severe renal disease
Hyperkalaemia
CHF
Low ejection fraction (< 0.4)
Uncontrolled hypertension
Recent MI or stroke (< 4weeks)
Use of or hypersensitivity to vitamin E or ACEi
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Interventions |
Ramipril group
10 mg/d Placebo group Co‐interventions: No |
Outcomes |
Development of MI, stroke or cardiovascular death
Total mortality, admission to hospital for CHFor unstable angina, cardiovascular revascularisation or development of overt nephropathy
Any heart failure, worsening angina, and the development of diabetes in people with no history of the disorder
Progression of microalbuminuria or overt nephropathy in participants with diabetes
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |