LOW-DOSE SIMVASTATIN IS A WELL-TOLERATED AND EFFICACIOUS CHOLESTEROL-LOWERING AGENT IN CYCLOSPORINE-TREATED KIDNEY-TRANSPLANT RECIPIENTS - DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY IN 40 PATIENTS

The high prevalence of hypercholesterolemia in kidney transplant recip ients probably contributes to the high cardiovascular mortality in the se patients. Except for diet, there is no generally recommended choles terol-lowering treatment. We conducted a double-blind, randomized, pla cebo-controlled study with low-dose simvastatin in 40 ciclosporin (CS) -treated kidney transplant recipients during 16 weeks, focusing on sid e effects and dose finding. In the simvastatin group, the mean serum t otal and LDL cholesterol concentrations decreased by 23 and 33%, respe ctively, and the mean serum HDL cholesterol concentration increased by 12%, after 4 weeks of treatment with simvastatin 10 mg daily. Increas ing the dose to 20 mg daily in a few patients only resulted in margina l further reductions of the serum cholesterol concentrations at the ex pense of doubling the plasma simvastatin 3-hydroxy-3-methylglutaryl-co enzyme A reductase inhibitory activity concentrations. The differences between the changes in the serum cholesterol concentrations in the si mvastatin group and the negligible changes in the placebo group were s tatistically significant. There was no case of proximal myopathy and t he serum creatine kinase concentrations did not differ between treatme nt groups. In conclusion, low-dose simvastatin appears to be a well to lerated and efficacious cholesterol-lowering treatment in CS-treated k idney transplant recipients. Simvastatin 10 mg daily seems to be the m ost suitable dose for the majority of these patients.