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Study Shows Neoral® Provides Kidney Transplant Patients With Efficacy Equivalent To Tacrolimus And Significantly Lower Incidence Of Diabetes
A large-scale head-to-head study has shown that 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.
Diabetes is a major risk factor for cardiovascular death in transplant patients. The study results suggest that immunosuppressant efficacy is not the only factor to affect the long-term outcome for patients surviving organ transplantation. The findings of the study were 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 ever conducted in transplant patients and gives new insight 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 mortality2.
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. Cyclosporine has the longest record in patient and organ survival of any immunosuppressant. Neoral is commonly used in combination with other agents and remains a cornerstone of immunosuppressive regimens.
Neoral is approved for the prevention of organ rejection following kidney, liver, heart, lung, combined heart-lung, pancreas and bonemarrow transplantation. It is also indicated for the prophylaxis of graft-versus-host disease (GVHD) following bonemarrow transplantation.*
Launched in 1995, Neoral is one the world's most widely prescribed immunosuppressants for organ transplant patients. More than 200,000 people worldwide currently protect their transplanted organs with Neoral or Sandimmun®.