The Pharmaceutical Journal
Vol 268 No 7196 p597-604
4 May 2002

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News summary

New immunosuppressant reduces rejection in transplant patients

A new immunosuppressant, everolimus (Certican), has been shown to reduce acute rejection and graft vasculopathy following heart transplantation. Everolimus, which is being developed by Novartis Pharmaceuticals, inhibits cell proliferation.

In an international phase III trial, researchers randomly assigned 634 heart transplant patients, who were receiving Neoral (ciclosporin) and steroids, to one of three treatment groups: everolimus 1.5mg daily, everolimus 3mg daily or azathioprine 1–3mg/kg daily.

They found that after 12 months of therapy, both acute rejection rates and the incidence of graft vasculopathy (proliferation of smooth muscle cells in the innermost wall of graft vessels) were lower in patients receiving everolimus than in those receiving azathioprine. The study also showed a lower incidence of cytomegalovirus in patients treated with everolimus, an important risk factor for the development of vasculopathy, Novartis says.

The company adds that the findings suggest that everolimus may be "superior to azathioprine as part of a triple immunosuppressive regimen in transplant patients". The trial will continue for another year.

Data were presented at the International Society of Heart and Lung Transplantation congress held in Washington in April.