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DOI: 10.1055/s-0032-1332601
Three-year follow-up results in heart transplant recipients receiving tacrolimus retard (Advagraf®)
Objectives: Tacrolimus retard (Advagraf®, ADV) is a new oral formulation of tacrolimus. It is given once daily, whereas tacrolimus (Prograf®, PRO) is administered twice daily. We have recently presented data indicating that in heart transplant recipients ADV is as safe as PRO within the first 6 postoperative months. Here, we present 3-year follow-up data.
Methods: We compared 3-year clinical outcomes in 11 patients receiving ADV and 11 patients receiving PRO. The primary endpoint was a composite of death and drug discontinuation. Secondary endpoints were biopsy-proven rejections and safety parameters determined on the basis of laboratory evaluations.
Results: In the ADV and PRO group, the primary endpoint was reached by 18.2% and 36.4% of patients, respectively (P = 0.399). In detail, 3-year survival was 90.0% and 70.0%, respectively (P = 0.291), whereas freedom from drug discontinuation was 90.9% and 90.9%, respectively (P = 0.973). Freedom from biopsy-proven rejections was 90.0% and 70.1%, respectively (P = 0.299). In the surviving patients, postoperative GFR values improved to a similar extent in both study groups (ADV group: from 44.1 ± 21.5 to 62.4 ± 25.2 ml/min/m2; PRO group: from 56.0 ± 25.0 to 75.0 ± 10.7 ml/min/m2, P = 0.550). During follow-up, mean tacrolimus trough levels were significantly lower in the ADV group compared to the PRO group (P = 0.017). In the ADV group, levels were below the target range (5.0 – 8.0 µg/l) at the end of the follow-up period. Liver function, C-reactive protein concentrations and haematological parameters were comparable between groups.
Conclusion: This small follow-up study suggests lower tacrolimus trough levels but similar clinical outcomes in the ADV group compared to the PRO group.