Title

Extended follow-up of patients on 4S shows increased survival benefit of simvastatin therapy

Purpose

To assess whether the benefit of reduction in cardiac outcomes from lipid lowering remained 2 years after the original 5.4 year study completed.

Design

As per 4S.

Patients

4444 patients (aged 35-70 years) were in original 4S trial. Mean baseline LDL was 188 mg/dL and mean total cholesterol at baseline was 261 mg/dL.

Follow-up

Median 7.4 years

Treatment regimen

As per 4S. Then at the conclusion of the study, further therapy was left to the discretion of the physician.

Results

The 30% decrease in risk of death reported in the original study was maintained during 2 year follow up; that is up to 7-8 years. Over the 5.4 study period plus 2 year follow-up, 15.8% assigned to placebo group had died vs 11.5% of patients assigned to simvastatin.

Conclusion

Treatment with simvastatin for up to 8 years in patients with CHD is safe and yields continued clinical benefit.