Biomedical papers, 2016 (vol. 160), issue 3

Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016, 160(3):407-411 | 10.5507/bp.2016.026

Clinical experience of conversion from cyclosporine to tacrolimus prolonged-release in stabilized kidney transplant patients

Karel Krejcia, Josef Zadrazila, Eva Lackovab, Zuzana Zilinskac, Robert Rolandd, Ivana Dedinskae
a Department of Internal Medicine III - Nephrology, Rheumatology and Endocrinology, University Hospital Olomouc, Czech Republic
b Transplant Centre, University Hospital F.D. Roosevelta, Banska Bystrica, Slovak Republic
c Department of Urology with the Centre for kidney transplant, Academician Derer University Hospital, Bratislava, Slovak Republic
d Fresenius Medical Care Dialysis, Kosice, Slovak Republic
e Department of Surgery and Transplant Centre, University Hospital Martin, Slovak Republic

Background and Aims: The CONCERTO study results showing the beneficial effects of conversion from cyclosporine to tacrolimus prolonged-release (tacrolimus PR) in stabilised patients after kidney transplantation, were first published in 2011. This communication describes our first experience of conversion from cyclosporine to tacrolimus PR in stabilised kidney transplant patients. The aim was to determine whether it could be used in routine clinical practice in the Czech and Slovak Republics.

Methods: Evaluation was carried out at five transplantation centres in the Czech Republic and Slovakia. In all participating Centres, the drug conversion was conducted according to the ICH/GCP guidelines. A total of 104 patients stabilised after kidney transplantation were converted from maintenance therapy with cyclosporine to treatment with tacrolimus PR. The data were collected 26 weeks after the switch. The primary endpoint was change in kidney graft function measured from the estimated glomerular filtration rate (GFR). The effect of conversion on blood pressure, metabolic parameters and cosmetic changes was also recorded. Special attention was paid to the safety and tolerability of treatment with tacrolimus PR.

Results: GFR increased after six months by 10 % (P = 0.040). In addition a significant decrease in serum creatinine and triglycerides level was found together with major reduction in the incidence and severity of gingival hyperplasia and hirsutism. 3% of patients developed new onset of diabetes mellitus. Otherwise, the switch was very well-tolerated, without serious adverse events or acute rejections.

Conclusion: Conversion from cyclosporine to tacrolimus PR was shown to be a safe therapeutic alternative with patient benefits.

Keywords: tacrolimus prolonged-release, cyclosporine, immunosuppressive conversion, kidney transplantation

Received: December 14, 2015; Accepted: April 26, 2016; Prepublished online: May 12, 2016; Published: September 20, 2016


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