Neoral equivalent to tacrolimus, study says

BOSTON-- Neoral (cyclosporine) and tacrolimus have equivalent efficacy in preventing organ rejection in kidney transplant patients, but those treated with Neoral had a significantly lower incidence of new-onset diabetes, according to a recent study presented today at the World Transplant Congress in Boston.
 
"The results of this study are especially important in view of the clear association between diabetes and the development of cardiovascular disease, which is the leading cause of death in post-transplant patients with a functioning graft," said Flavio G. Vincenti, MD, a kidney and pancreas transplant specialist with the Department of Medicine at the University of California at San Francisco. "By demonstrating the equivalence of Neoral and tacrolimus in preventing organ rejection, this study elevates the need to address diabetes risk as a new strategy to prolong life in transplant patients."

The study, called DIRECT, is one of the largest conducted in transplant patients and looked into the incidence of new-onset diabetes following transplantation. Diabetes post-transplantation is associated with a three-fold increase in the risk of ischemic heart disease and related mortality, according to the authors.

DIRECT (Diabetes Incidence after Renal transplantation: NEoral C-2 monitoring versus Tacrolimus) was a randomized, six-month, open label, international multi-center trial in which 682 patients who received kidney transplants were treated with either Neoral or tacrolimus to prevent organ rejection. At six months post-transplant, the study found no difference between Neoral and tacrolimus in the composite primary efficacy endpoint, including biopsy-proven acute rejections, graft loss or death.

However, there was a significantly lower incidence of new-onset diabetes or impaired fasting glucose in the Neoral group than the tacrolimus group (26 percent vs. 33.6 percent. The study results found more tacrolimus patients required diabetes treatment than Neoral patients (18 percent vs. 12.5 percent).

Neoral is a microemulsion formulation of the calcineurin inhibitor cyclosporine, which prevents rejection in organ transplant patients by selectively blocking specific immune cell activation at an early stage.