The randomized, prospective, multi-center, three-arm comparison study was designed to establish which combination of immunosuppressive agents is most advantageous to cardiac transplant patients in preventing acute rejection. The study evaluated tacrolimus + mycophenolate mofetil and steroids, vs. cyclosporine microemulsion (CYA) + MMF and steroids, vs. tacrolimus + sirolimus (SRL) and steroids.
"Though significant improvements in survival have been made over the past two decades as a result of advances in immunosuppression, no one combination of anti-rejection therapy has been proven as the safest and most effective," said Dr. Jon Kobashigawa, M.D., lead investigator of the study, and professor of medicine at the University of California, Los Angeles, Medical Center. "These initial data are quite strong and we believe the final results of this study will help to establish the best practice of combination immunosuppressants for heart transplant recipients."
The primary objective of the 28-site study enrolling 343 patients was to compare any incidence of rejection requiring treatment in the three triple-therapy regimens. Secondary objectives were to compare in each treatment regimen: patient and graft (transplanted organ) survival, incidence of normal lipid profile (indicating cardiovascular function), safety (infectious complications, malignancies, adverse drug effects) and cumulative total dose of steroids and doses at six and 12 months.
After six months, initial study results
Contact: Lauren Mason
International Society for Heart and Lung Transplantation