Effects of Ramipril and Vitamin E on Atherosclerosis
Why the study?
Does long-term treatment with ramipril and vitamin E reduce atherosclerosis progression in high-risk patients ≥55 years of age with vascular disease or diabetes?
Population
732 patients ≥55 years of age who had vascular disease or diabetes and at least one other risk factor, and…
Comparison
Ramipril 2.5 mg/d or 10 mg/d and vitamin E 400… vs Matching placebos.
Design
RCT, Randomly assigned in a 3x2 factorial design, Double-blind
Follow-up
Average 4.5 years
Authors
Discussion
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Implication
Ramipril slows carotid atherosclerosis progression in high-risk patients; confirms ACE inhibitor vascular benefits independent of vitamin E.
Key Points
- This research aims to assess the impact of long-term ramipril and vitamin E treatment on the progression of atherosclerosis.
- Prospective double-blind 3x2 factorial trial involving 732 patients aged 55+ with vascular disease or diabetes.
- Patients were randomly assigned to receive ramipril at 2.5 mg/d or 10 mg/d and vitamin E at 400 IU/d or placebos.
- Atherosclerosis progression was measured using B-mode carotid ultrasound over an average follow-up of 4.5 years.
- Atherosclerosis progression slope was 0.0217 mm/year in the placebo group, 0.0180 mm/year in the ramipril 2.5 mg/d group, and 0.0137 mm/year in the ramipril 10 mg/d group (P=0.033).
- There were no significant differences in progression rates between the vitamin E and placebo groups.
- Long-term treatment with ramipril showed a beneficial effect on atherosclerosis progression, while vitamin E had no effect.
Structured PICO
Does long-term treatment with ramipril and vitamin E reduce atherosclerosis progression in high-risk patients ≥55 years of age with vascular disease or diabetes?
P
Population
732 patients ≥55 years of age who had vascular disease or diabetes and at least one other risk factor, and who did not have heart failure or a low left ventricular ejection fraction.
I
Intervention
Ramipril 2.5 mg/d or 10 mg/d and vitamin E (RRR-alpha-tocopheryl acetate) 400 IU/d in a 3x2 factorial design.
C
Comparator
Matching placebos.
O
Outcome
Atherosclerosis progression evaluated by B-mode carotid ultrasound (progression slope of the mean maximum carotid intimal medial thickness).surrogate
Long-term treatment with ramipril, but not vitamin E, significantly reduced the progression of atherosclerosis as measured by carotid intimal medial thickness in high-risk patients.
Cite This Study
Lonn et al. (2001) studied this question.