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| |  AHA: Early Positive Results with Tacrolimus Monotherapy in Cardiac Transplantation By Jill Stein CHICAGO, IL -- November 20, 2002 -- Tacrolimus monotherapy can achieve a high success rate as primary immunosuppression in adult cardiac transplant patients, according to a review of four-year data. In fact, the study showed that rates of rejection, infection, malignancy, and graft vasculopathy were low and thus support such a strategy, said researchers here November 19 at the 2002 Scientific Sessions of the American Heart Association (AHA). Tacrolimus is a macrolide antibiotic that inhibits T-cell proliferation through calcineurin inhibition. The drug is used increasingly in cardiac transplantation because of its efficacy compared to cyclosporine, according to the researchers. The team, led by Dr. David Baran, assistant professor of medicine at Mount Sinai Medical Center, in New York, United States, reviewed data on 59 patients who were started on tacrolimus with steroids alone as primary immunosuppression. Prednisone was tapered at each successive biopsy that confirmed the transplanted heart had not been rejected. In this series, 51 patients (86.4 percent) were weaned off steroids to monotherapy at a mean of 232 days post-transplant. The mean follow-up was 2.4 years. During the initial phase, while steroids were being weaned off, these patients had 747 biopsies, and there were 47 rejections (6.2 percent). This is equivalent to 0.92 rejections per patient, and 55 percent freedom from rejection during the steroid weaning phase. In the subsequent year on tacrolimus monotherapy, 14 of 1,054 (1.3 percent) biopsies showed rejection, or 0.27 rejections per patient (p<0.01), with a 78 percent freedom from rejection. Among eight steroid-dependent patients who underwent 118 biopsies in the first year post-transplant, there were 22 rejections (18.6 percent), corresponding to 2.75 rejections per patient, and 25 percent freedom from rejection. One of 51 monotherapy patients developed de novo graft vasculopathy (8 percent) during the follow-up period, and one of eight (12.5 percent) steroid-dependent patients developed vasculopathy. Three monotherapy patients had donor coronary lesions diagnosed at the initial one-month angiography, which progressed post-transplant. The one steroid-dependent patient who developed vasculopathy had a normal coronary angiogram at one month. Cytomegalovirus infection occurred in two patients, both on monotherapy. Two monotherapy patients developed post-transplant lymphoproliferative disease at two years. No steroid-dependent patient developed a malignancy. Six of 59 patients died, including two early postoperative deaths. Three monotherapy patients died from acute rejection, stroke, and multi-organ failure at 238, 782, and 1,002 days, respectively. One steroid-dependent patient died of unknown causes at 766 days post-transplant. Excluding the two early deaths, the steroid-dependent group's survival rate was 100 percent, 60 percent, and 60 percent at one, three, and five years, respectively. The monotherapy group was similar, with 98 percent, 89.6 percent, and 89.6 percent at one, three, and five years. Dr. Baran said the data show that immunosuppression can be safely tailored to individual cardiac transplant recipients with adequate allograft protection, decreased exposure to toxicity or side effects, and excellent survival.
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