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Novartis' Neoral Lowers Diabetes Incidence After Kidney Transplant

Posted on: Tuesday, 25 July 2006, 12:00 CDT

A large-scale head-to-head study has shown that Novartis' Neoral and the widely used 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 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. It was a randomized, six-month, open label, international multi-center trial in which 682 patients who received kidney transplants were treated with either Neoral (cyclosporine) 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% vs. 33.6%). The study results indicate significantly more tacrolimus patients required diabetes treatment than Neoral patients (18% vs. 12.5%).

"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 Dr Flavio Vincenti, 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."

Source: Datamonitor

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