A RANDOMIZED CONTROLLED COMPARISON OF THE EFFICACY AND SAFETY OF PRAVASTATIN AND SIMVASTATIN IN HEART TRANSPLANTATION

Abstract

627 The clinical importance of lipid-lowering therapy in heart transplantation is being increasingly recognized. The purpose of our study was to investigate the comparative efficacy and safety of pravastatin and simvastatin in the treatment of hyperlipidemia after heart transplantation. We randomized 49 heart transplant recipients between 1995 and 1997 with sustained elevations in LDL cholesterol (> 130 mg/dl) to receive either pravastatin (n = 23; mean dose 20 ± 5 mg) or simvastatin (n = 26; mean dose 11 ± 6 mg) for at least six months. During this period, detailed lipid profiles, hepatic function tests, and creatinine phosphokinase measurements were performed at three monthly intervals. Clinical evaluations for the development of adverse effects were routinely performed, and drug compliance and withdrawals were assessed. Results:Table There were no instances of significant transaminase elevations, myopathy, or rhabdomyolysis requiring drug withdrawal in either group.Inferences: In pharmacologically equipotent doses, simvastatin is more effective than pravastatin in the treatment of hyperlipidemia after heart transplantation. At the low doses used in our study, there are no significant clinical differences in the safety profiles of these two agents. Whether the greater efficacy of simvastatin translates into a more pronounced impact on clinical outcomes with allograft rejection and cardiac allograft vasculopathy remains to be determined.