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Lupus Clinical Trials

New Medical Therapies™

Heart Transplantation

April 15, 2002

Study results suggest that Novartis' Certican (everolimus) significantly reduces the incidence of acute rejection episodes and the potential for graft vasculopathy in heart transplant recipients, compared to add-on therapy with azathioprine. The 12-month, double-blind, international trial included 634 heart transplant subjects who were receiving the standard regimen of Neoral (cyclosporine) and steroids. Subjects were randomized to also receive Certican 1.5mg/day, Certican 3.0mg/day or azathioprine 1-3mg/kg/day. The acute rejection rate was 30.6% in subjects receiving Certican 1.5mg/day and 21.3% in those receiving Certican 3.0mg/day, compared to 45.8% with azathioprine 1-3mg/kg/day. Additionally, allograft vasculopathy was lower in the Certican 1.5mg and 3.0mg groups (35.7% and 30.4%), compared to subjects receiving azathioprine (52.8%).

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.