Title

The effect of fluvastatin on cardiac events in patients with symptomatic coronary artery disease during one year of treatment.

Purpose

To determine whether aggressive therapy with fluvastatin reduces cardiac events within one year in patients with hyperlipidemia and symptomatic coronary artery disease.

Design

Randomized, placebo controlled, multicenter

Patients

365 patients with symptomatic coronary artery disease and hypercholesterolemia. LDL cholesterol had to be > 160 mg/dl.

Follow-up

1 year

Treatment regimen

Fluvastatin (40 mg daily; increased to twice daily if LDL cholesterol did not decrease more than 30%) vs placebo.

Additional therapy

Antianginal drugs including nitrates, calcium blockers, b -blockers, aspirin

Results

• Ten major cardiac events (fatal MI, sudden death, nonfatal MI, CABG, unstable angina pectoris) occurred in patients
on placebo vs 3 in fluvastatin patients.
• Fluvastatin also demonstrated a trend towards less angina and improved exercise tolerance.
• Fluvastatin caused a 17% decrease in total cholesterol, a 27% decrease in LDL cholesterol, and a 25% decrease in
triglycerides (in patients whose triglycerides were > 227 mg/dL).
• The drug was well tolerated.

Conclusion

Although overall event rates were low over 1 year, fluvastatin was associated with less cardiac events, less angina and better exercise tolerance.