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The Monitored Atherosclerosis Regression Study (MARS). Design, methods and baseline results.

L Cashin-Hemphill¹, D M Kramsch, S P Azen

¹Atherosclerosis Research Institute, University of Southern California School of Medicine, Los Angeles 90033.

The Online Journal of Current Clinical Trials

|October 23, 1992

Summary

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The Monitored Atherosclerosis Regression Study (MARS) evaluated lovastatin

Area of Science:

Cardiology
Pharmacology
Medical Research

Background:

Atherosclerosis is a significant contributor to coronary artery disease.
Statins, such as HMG-CoA reductase inhibitors, are widely used for cholesterol lowering.
The Monitored Atherosclerosis Regression Study (MARS) was initiated to investigate the impact of statin monotherapy on atherosclerosis progression.

Purpose of the Study:

To evaluate the effect of cholesterol lowering by monotherapy with an HMG-CoA reductase inhibitor on atherosclerosis progression and regression.
To present the design, methods, and baseline results of the MARS trial.

Main Methods:

A prospective, randomized, double-blind, placebo-controlled trial.
270 participants with angiographically documented coronary artery disease received either lovastatin (40 mg b.i.d.) or placebo, alongside a low-fat, low-cholesterol diet.

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Primary endpoint: average change in percent diameter stenosis (%S) by quantitative coronary angiography (QCA); secondary endpoints included categorical progression and minimum lumen diameter (MLD) changes.

Main Results:

Baseline characteristics of the 270 participants (91.5% male, mean age 57.9 years) were comparable between lovastatin and placebo groups.
Mean baseline lipid levels included Total Cholesterol (TC) 231 mg/dL, LDL-C 157 mg/dL, HDL-C 43 mg/dL, and triglycerides 160 mg/dL.
No significant differences in baseline lipid levels or angiographic characteristics were observed between the treatment groups.

Conclusions:

The baseline data from MARS confirm successful randomization.
The lovastatin and placebo groups demonstrated comparability in demographic, lipid, and angiographic profiles.
This comparability supports the validity of the study's design for evaluating the efficacy of lovastatin in atherosclerosis.