Simvastatin Reduced Graft Vessel Disease and Mortality after Heart Transplantation: A 4 year randomized Trial

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18 Aug, 10

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.

Conclusions

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

Circulation 1997;96:1398-402