NIV Congres

Background In contrast to the conventional tacrolimus (Tac) formulation (Prograft®), the slow-release Tac formulation (Advagraf®) can be taken only once a day, which may result in improved adherence to medication. We studied the effect of conversion from Prograft to Advagraf on clinical and laboratory parameters in a large cohort of kidney transplant recipients.

Methods Patients who were taking Tac-Prograft and were at least 6 months after transplantation were asked to participate. Tac-Prograft to Tac-Advagraf conversion was done on a 1:1 daily dose basis. Follow-up time was one year. Clinical and laboratory data were retrospectively collected for visits at -3 and -6 months and prospectively at months 0 (conversion), 3, 6, 9, and 12 after conversion.

Results A total of 311 patients were asked to participate of whom 252 agreed to undergo a conversion of their Tac formulation. Patients were enrolled between September 2009 and October 2011. Twenty-six patients did not complete the study: 3 never started Advagraf (1.2%); 3 died (1.2%); 8 did not adhere to all follow-up visits (3.2%), while 11 patients (4.4%) discontinued Advagraf because of adverse events. The 226 remaining patients were median 51 (range 18-80) years of age. 76% were male and median time after transplantation was 3 (range 0.5-26) years. Conversion had no effect on median serum creatinine, haemoglobin and cholesterol levels. Fasting blood sugar levels remained stable and no new cases of new-onset diabetes were diagnosed. Also no effect on blood pressure and weight was found. Advagraf dose did not change over time, but median Tac predose concentrations decreased with 12% from 5.8 to 5.1 ng/ml. No acute rejections were observed.

Conclusions Conversion from Tac-Prograft to Tac-Advagraf appears to be safe as it did not affect renal function nor resulted in late acute rejections. Only 4.4 % of the patients discontinued medication because of self reported complaints. The 1:1 daily dosage conversion resulted in a 12% decrease in Tac predose concentrations.