Title

Simvastatin reduced graft vessel disease and mortality after heart transplantation. A 4 year randomized trial .

Purpose

To determine the effects of long term antihypercholesterolemic therapy with diet and simvastatin on cholesterol levels, survival, and graft rejection .

Design

Prospective, randomized

Patients

72 consecutive patients with heart transplant

Follow-up

4 years

Treatment regimen

35 patients treated with a low cholesterol diet and simvastatin and 37 with diet alone. All patients received azathioprine. Dose of simvastatin adjusted to a maximum of 20 mg/day. Target LDL cholesterol level of 110-120 mg/dL.

Results

• During therapy, mean cholesterol level was lower in the simvastatin group (198 ± 18 mg/dL) than the control group (228 ± 19 mg/dL, p=0.03).
• LDL cholesterol levels were also reduced by simvastatin (115 ± 14 vs 156 ± 17 mg/dL, p=0.002).
• After 4 years, survival rate was higher in the simvastatin group (88.6%) vs the control group (70.3%, p=0.05).
• Severe graft rejection as a cause of death occurred in 1 patient in the simvastatin group and 5 in the control group.
• At 4 years, coronary angiographic signs of GVD were 16.6% in treated vs 42.3% in controls.
• Intravascular ultrasound in a subgroup of patients showed less intimal thickening in patients with LDL cholesterol levels of < 110 mg/dL.

Conclusion

Simvastatin plus diet in heart transplant patients was more effective than diet in reducing total cholesterol, LDL cholesterol, and GVD; and improving survival rate.