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Simvastatin reduces graft vessel disease and mortality after heart transplantation: a four-year randomized trial
Insights
Simvastatin combined with a low-cholesterol diet significantly reduces LDL-cholesterol levels, improving long-term survival and decreasing graft vessel disease (GVD) in heart transplant recipients compared to diet alone.
Area of Science:
- Cardiology
- Transplantation Medicine
- Pharmacology
Background:
- Accelerated graft vessel disease (GVD) is a major long-term complication following heart transplantation.
- Post-transplantation hypercholesterolemia is a suspected cause of this progressive coronary vascular disease.
Purpose of the Study:
- To evaluate the efficacy of primary antihypercholesterolemic therapy with simvastatin versus general dietary therapy in heart transplant recipients.
- To maintain post-transplantation LDL-cholesterol levels below 120 mg/dL.
Main Methods:
- A 4-year prospective randomized study involving 72 heart transplant recipients on standard triple immunosuppression.
- Patients were randomized to either a low-cholesterol diet with simvastatin (n=35) or general dietary measures (n=37).
- Outcomes assessed included LDL-cholesterol levels, long-term survival, incidence of GVD, and intimal thickening via intracoronary ultrasound.
Main Results:
- The simvastatin group achieved significantly lower LDL-cholesterol levels (115+/-14 mg/dL vs. 156+/-17 mg/dL, P=.002).
- Long-term survival was significantly higher in the simvastatin group (88.6% vs. 70.3%, P=.05).
- The incidence of GVD was significantly lower (16.6% vs. 42.3%, P=.045), with less intimal thickening observed in the simvastatin group.
Conclusions:
- Combining a low-cholesterol diet with simvastatin significantly reduces cholesterol levels post-heart transplantation.
- This combination therapy leads to significantly improved long-term survival rates.
- The use of simvastatin in conjunction with diet significantly lowers the incidence of graft vessel disease.
Background:
Accelerated graft vessel disease (GVD) represents the most serious long-term complication of heart transplantation. A possible cause underlying this progressive coronary vascular disease is believed to be post-transplantation hypercholesterolemia.
Methods And Results:
In a 4-year prospective randomized study with heart transplant recipients, the efficacy of primary antihypercholesterolemic therapy with simvastatin was compared with that of general dietary therapy. The aim of the treatment was to maintain post-transplantation LDL-cholesterol levels at <120 mg/dL. Seventy-two heart transplant recipients receiving standard triple immunosuppression were randomly assigned to an active-treatment group (low-cholesterol diet and simvastatin, n=35) or a control group (general dietary measures, n=37). In the course of 4 years after transplantation, the simvastatin group had significantly lower LDL-cholesterol concentrations than the control group (mean+/-SD, 115+/-14 versus 156+/-17 mg/dL,P=.002), a significantly better long-term survival (88.6% versus 70.3%,P=.05), and a lower incidence of GVD in the coronary angiographic findings (16.6% versus 42.3%,P=.045). The incidence of graft rejections did not differ between the two groups, although there was a tendency toward a lower number of serious rejections in the simvastatin group (2.8% versus 13.5%, P=.1). Intracoronary ultrasound performed after 4 years in a subgroup of 27 patients (simvastatin, 10; control, 17) showed less intimal thickening in patients with LDL-cholesterol levels of <110 mg/dL (170+/-84 versus 370+/-171 microm, P=.04) and a lower intimal index (13.8+/-7.1% versus 27.9+/-12.1%,P=.04).
Conclusions:
In comparison with dietary measures alone, the combination of a low-cholesterol diet and simvastatin after heart transplantation led to a significant reduction in cholesterol levels, a significantly higher long-term survival rate, and a lower incidence of GVD.