Dr Gary Levy and colleagues from Canada evaluated recipients of primary liver transplants.
The researchers conducted an open-label, multicenter study in which recipients of liver transplants were randomized to cyclosporine microemulsion or tacrolimus.
The team randomized 250 patients in Group 1 to cyclosporine, and monitored blood concentration at 2 hours postdose.
In Group 2, the researchers gave 245 patients tacrolimus, and monitored predose drug blood level.
The team compared efficacy and safety at 3 and 6 months and to evaluate patient status at 12 months.
The patients received steroids with or without azathioprine.
At 12 months, 85% of cyclosporine microemulsion patients, and 86% of tacrolimus patients survived with a functioning graft.
The researchers found that efficacy was similar in deceased- and living-donor recipients.
|More patients required antidiabetic therapy with tacrolimus|
The team noted that 6% of Hepatitis C-positive patients died or lost their graft by 12 months with cyclosporine microemulsion.
Of those receiving tacrolimus, 16% died.
The researchers noted that recurrence of Hepatitis C virus in liver grafts was similar in each group.
Based on biopsies driven by clinical events, the mean time to histological diagnosis of Hepatitis C virus recurrence was 100 days with cyclosporine.
The team observed that the mean time to histological diagnosis of Hepatitis C recurrence with tacrolimus was 70 days.
Median serum creatinine at 12 months was 106 mol/L with cyclosporine microemulsion, and with tacrolimus.
The team found that more patients who were nondiabetic at baseline received antihyperglycemic therapy in the tacrolimus group at 12 months.
Of patients who were diabetic at baseline, more tacrolimus-treated individuals required anti-diabetic treatment at 12 months.
The researchers determined that treatment for de novo or preexisting hypertension or hyperlipidemia was similar in both groups.
Dr Levy's team concludes, “The efficacy of cyclosporine microemulsion monitored by blood concentration at 2 hours postdose and tacrolimus in liver transplant patients is equivalent to 12 months, and renal function is similar.”
“More patients required antidiabetic therapy with tacrolimus regardless of diabetic status at baseline.”