Novartis study shows Neoral more effective than tacrolimus in reducing diabetes after kidney transplant

By Lisa Kerner

Charlotte, N.C., July 14 - Novartis AG said that while a large-scale head-to-head study, known as Direct, showed that Neoral (cyclosporine) and tacrolimus have equivalent efficacy in preventing organ rejection in kidney transplant patients, patients treated with Neoral had a significantly lower incidence (26% compared to 33.6% for the tacrolimus group) of new-onset diabetes, a major risk factor for cardiovascular death in transplant patients.

Neoral prevents rejection in organ transplant patients by selectively blocking specific immune cell activation at an early stage.

In the randomized, six-month, open label, international multi-center trial, 682 patients who received kidney transplants were treated with either Neoral or tacrolimus to prevent organ rejection, according to a company news release.

There was no difference between Neoral and tacrolimus in the composite primary efficacy endpoint, including biopsy-proven acute rejections, graft loss or death, at six months post-transplant.

In addition, the results showed that more tacrolimus patients required diabetes treatment than Neoral patients (18% compared to 12.5%).

"New onset diabetes after transplantation is an under-recognized and serious complication that needs to be effectively controlled from the outset," said Giacomo di Nepi, Novartis Pharma AG head of infectious diseases, transplant and immunology, in a company news release.

"The findings of the Direct study suggest that clinicians need to consider carefully the selection of immunosuppressive agents based not only on efficacy, but also on the risk reduction of post-transplant diabetes."

Novartis is a Basel, Switzerland-based pharmaceutical company.

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