Background: A new formulation of tacrolimus that is characterized by prolonged release has been developed to facilitate treatment and patient compliance. Initial therapy with prolonged release formula in heart transplantation is not widely accepted.
Material and methods: We enrolled 19 patients into a randomized analysis divided into 2 groups with different initial regimens. There were 8 patients with a mean age of 44 ± 13 years treated by Advagraf, and 11 patients with a mean age of 41 ± 9 years treated by Prograf. Serum concentration of immunosuppressive drug was followed by its oral dosage and endomyocardial biopsy results. Arterial hypertension, kidney function, and incidence of diabetes mellitus were recorded.
Results: There were no perioperative deaths. The risk of acute rejection within 6 months following surgery was 1 (2%) in the Advagraf group and 1 (1.5%) in the Prograf group. Although the serum tacrolimus results were comparable between groups, the drug's daily dosages were different after 6 months of therapy (3 ± 1 mg in the Advagraf group and 6 ± 2 mg in the Prograf group (p<0.05). The low rate of adverse effects throughout the study was noted.
Conclusions: Prolonged-release tacrolimus formula is an efficient immunosuppressant in heart transplantation. Its initial application after surgery has low risk of adverse effects with similar results to conventional formula.