September 26, 2000Circulation
Effect of Amlodipine on the Progression of Atherosclerosis and the Occurrence of Clinical Events
Key result
Amlodipine did not significantly slow the 36-month angiographic progression of coronary atherosclerosis compared to placebo (0.095 mm vs 0.084 mm reduction in minimal diameter; P=0.38).
Why the study?
Does amlodipine slow the progression of early coronary atherosclerosis in patients with angiographically documented coronary artery disease?
Population
825 patients with angiographically documented coronary artery disease
Comparison
Amlodipine vs Placebo
Design
RCT, randomized, double-masked
Follow-up
36-month
Authors
Discussion
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Implication
Amlodipine does not slow angiographic coronary atherosclerosis progression; challenges prior calcium channel blocker data and does not support use for this indication.
Key Points
- To determine if amlodipine slows the progression of coronary atherosclerosis and reduces clinical events in patients with documented coronary artery disease.
- Multicenter, randomized, placebo-controlled, double-masked clinical trial with 825 patients
- Primary outcome assessed average 36-month angiographic change in diameters with baseline stenosis of 30%
- Secondary outcome measured carotid artery atherosclerosis using B-mode ultrasonography for intimal-medial thickness.
- Amlodipine showed no significant difference in the progression of coronary atherosclerosis (P=0.38)
- Reduction in carotid arterial atherosclerosis with amlodipine demonstrated significant improvement: -0.0126 mm vs +0.033 mm in placebo (P=0.007)
- No differences in all-cause mortality or major cardiovascular events, but fewer unstable angina cases and coronary revascularizations with amlodipine.
Study Design
Type
RCT (n=825)
Blinding
double-masked
Randomization
randomized
Multicenter
Yes
Structured PICO
Does amlodipine slow the progression of early coronary atherosclerosis in patients with angiographically documented coronary artery disease?
P
Population
825 patients with angiographically documented coronary artery disease
I
Intervention
Amlodipine
C
Comparator
Placebo
O
Outcome
Average 36-month angiographic change in mean minimal diameters of segments with a baseline diameter stenosis of 30%surrogate
Main Result
Absolute Event Rate: 0.095% vs 0.084%
p-value: p=0.38
Amlodipine did not slow the angiographic progression of coronary atherosclerosis but significantly slowed carotid atherosclerosis progression and reduced hospitalizations for unstable angina and revascularization.
Cite This Study
Pitt et al. (2000) conducted an RCT in coronary artery disease (n=825). amlodipine vs. placebo was evaluated on average 36-month angiographic change in mean minimal diameters of segments with a baseline diameter stenosis of 30% (p=0.38). Amlodipine did not significantly slow the 36-month angiographic progression of coronary atherosclerosis compared to placebo (0.095 mm vs 0.084 mm reduction in minimal diameter; P=0.38).