ImmunosuppressionA Multicenter, Prospective, Randomized, Double-Blind Trial of Basiliximab in Heart Transplantation
Section snippets
Study Design
This was a multicenter, double-blind, randomized pilot study conducted at 5 sites in the United States. Heart transplant recipients were randomized (computer generated) in a 1:1 ratio to receive a first dose of either basiliximab or placebo within 4 to 6 hours after separation from cardiopulmonary bypass (Figure 1). On Day 4 post-transplantation, patients received a second dose of study medication. Patients were then followed for 1 year, in which the first 6 months were double-blind.
Patient Population
Patients
Results
Fifty-six heart transplant recipients were randomized to double-blind treatment at 5 transplant centers. Of these, 25 (44.6%) patients were treated with basiliximab and 31 (55.4%) patients received placebo. Four patients died: 3 (12%) in the basiliximab group and 1 (3.2%) in the placebo group. Of the 3 deaths in the basiliximab group, 1 each was attributed to a cerebral hemorrhage (Day 11), aspiration (Day 33), and a multilobular pneumonia at Day 244. The death in the placebo group was
Discussion
The primary objective of this pilot study was to assess the safety and tolerability of basiliximab in de novo heart transplant recipients and more important, to evaluate its pharmacokinetics. Basiliximab was generally well tolerated and exhibited an overall safety profile comparable with placebo during the first year post-transplantation. The adverse events seen in basiliximab-treated patients were typical of those observed in heart transplantation. These findings are consistent with those of
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This study was supported by a grant from Novartis Pharmaceuticals Corporation.