Efficacy and Safety of Tacrolimus Versus Cyclosporine Microemulsion in Primary Cardiac Transplant Recipients: 6-Month Results in Taiwan

INTRODUCTION: This study compared the efficacy and safety of a tacrolimus (TAC)-based with a cyclosporine (CsA) microemulsion-based immunosuppressive regimen in primary cardiac transplantation. METHODS: Heart recipients were randomly assigned to receive either TAC or CsA regimen after sequential induction with rabbit anti-thymoglobulin. Endomyocardial biopsies were performed at weeks 1, 2, 3, and 4 and months 2, 3, and 6. RESULTS: Among 21 adult patients( TAC, 11; CsA, 10) in this study, patient survival rates were 100% in both groups at the end of 6 months. One patient (9%) in the TAC group experienced acute rejection ( ISHLT > or = 1B) versus 6 patients (60%) in the CsA group (P = .02). The effects on hematology, biochemistry, cytomegalovirus infection, and hemodynamics were similar in both groups except for better lipid profiles in the TAC group. There were no significant differences in severe adverse events. CONCLUSION: The TAC-based regimen had a lower risk of acute rejection compared with CsA in heart transplant recipients. The safety profiles were similar in both groups. Therefore, TAC is an alternative to CsA as a primary maintenance immunosuppressant in heart transplantatio