Title

Reduced coronary events in simvastatin-treated patients with coronary heart disease and diabetes or impaired fasting glucose levels. Subgroup analysis in the Scandinavian Simvastatin Survival Study.

Purpose

To determine the effect of simvastatin on coronary events in patients with coronary heart disease and diabetes or impaired fasting glucose levels.

Design

As per 4S

Patients

678 patients had plasma glucose levels > 110 mg/dL but less than 126 mg/dL which is diagnostic for impaired fasting glucose; 281 patients had plasma glucose > 126 mg/dL but did not have a previous clinical history of diabetes; and 202 had clinical histories of diabetes (total of 483 patients with diabetes as defined by 1997 American Diabetes Association criteria). 3237 patients had normal fasting glucose.

Follow-up

5.4 years

Treatment regimen

As per 4S

Additional therapy

As per 4S

Results

• Incidence of coronary events increased in the placebo group by baseline glucose status. Impaired fasting glucose group
had a relative risk of 1.15; in diabetics with elevated fasting glucose but no prior history, this was 1.19; in diabetics with a
history, relative risk was increased to 1.83. The relative risk of having increased coronary heart events in the combined
diabetic groups vs. those with a normal fasting blood sugar was increased at 1.44 (95% CI=1.14-1.82).

• Diabetic patients treated with simvastatin had decreased number of major coronary events compared to the placebo group
(RR=0.58; p=0.001) as well as revascularization procedures (RR=0.52; p=0.005).

• There was a nonsignificant trend toward a reduction in total and coronary mortality in diabetic patients that received
simvastatin vs. placebo.

• Simvastatin also decreased the incidence of major coronary events (RR=0.62; p=0.003), revascularizations
(RR=0.57; p=0.009), and total (RR=0.57; p=0.02) and coronary (RR=0.45; p=0.007) mortality in patients with
impaired fasting glucose but not overt diabetes.

Conclusion

Cholesterol lowering with simvastatin decreased coronary events and revascularizations in patients with diabetes (as defined by 1997 American Diabetes Association) and decreased the incidence of coronary events, revascularization, and mortality in patients with impaired fasting glucose levels.