De Novo Sirolimus and Reduced‐Dose Tacrolimus Versus Standard‐Dose Tacrolimus After Liver Transplantation: The 2000–2003 Phase II Prospective Randomized Trial

• Published in: American journal of transplantation Vol. 14; no. 2; pp. 356 - 366
• Main Authors: Asrani, S. K., Wiesner, R. H., Trotter, J. F., Klintmalm, G., Katz, E., Maller, E., Roberts, J., Kneteman, N., Teperman, L., Fung, J. J., Millis, J. M.
• Format: Journal Article
• Language: English
• Published: Hoboken, NJ Wiley 01.02.2014; Elsevier Limited
• Subjects: Adult; Biological and medical sciences; Black box; Blood and lymphatic vessels; Cardiology. Vascular system; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Dose-Response Relationship, Drug; Drug therapy; Female; Follow-Up Studies; graft failure; Graft Rejection - drug therapy; Graft Rejection - etiology; Graft Rejection - mortality; Graft Survival - drug effects; hepatic artery thrombosis; Humans; Immunosuppressive Agents - therapeutic use; International Agencies; Liver; Liver Diseases - complications; Liver Diseases - mortality; Liver Diseases - surgery; Liver Transplantation; Liver, biliary tract, pancreas, portal circulation, spleen; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Nephropathies. Renovascular diseases. Renal failure; patient death; portal vein thrombosis; Prognosis; Prospective Studies; rapamycin; Renal failure; Sirolimus - therapeutic use; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the digestive system; Survival Rate; Tacrolimus - therapeutic use; Thrombosis; Time Factors; Transplantation Immunology; Transplants & implants; Antineoplastic agent; Warning; Calcineurin inhibitor; Sirolimus; Liver; Cardiovascular disease; Black box; Homotransplantation; Posology; Macrocycle; Venous disease; Arterial disease; Vascular disease; Prospective; Randomization; Surgery; 2003; Phase II trial; Graft; Protein synthesis inhibitor; patient death; Kidney disease; Hepatic artery; Human; Urinary system disease; Digestive system; Low dose; Lactone; 2000; Patient; Macrolide; De novo; Standards; Graft failure; Immunomodulator; Antibiotic; Treatment; hepatic artery thrombosis; Tacrolimus; portal vein thrombosis; renal failure; Immunosuppressive agent; Artery thrombosis; Antibacterial agent; Comparative study; Liver transplantation; rapamycin; graft failure

We studied whether the use of sirolimus with reduced‐dose tacrolimus, as compared to standard‐dose tacrolimus, after liver transplantation is safe, tolerated and efficacious. In an international multicenter, open‐label, active‐controlled randomized trial (2000–2003), adult primary liver transplant r...