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%).