Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of tacrolimus compared with cyclosporin microemulsion in primary SPK transplantation: 3-year results of the Euro-SPK 001 trial.
Nephrol Dial Transplant 2005; 20 Suppl 2:ii3-10, ii62ND

Abstract

BACKGROUND

Single-centre and retrospective studies suggest superiority of tacrolimus over cyclosporin as cornerstone immunosuppressive therapy for simultaneous pancreas-kidney (SPK) transplantation. This open-label, multicentre trial compared the efficacy and safety of tacrolimus with cyclosporin microemulsion (ME) in diabetic patients with end-stage renal disease undergoing their first cadaveric SPK transplantation. The 3-year results are reported.

METHODS

Patients were recruited from 10 centres in Europe and one centre in Israel: 103 were randomized to receive tacrolimus (initial dose: 0.2 mg/kg/day p.o.) and 102 to cyclosporin-ME (7 mg/kg/day p.o.). All patients received concomitant rabbit anti-T-cell globulin induction, mycophenolate mofetil (MMF) and short-term corticosteroids.

RESULTS

Fewer patients receiving tacrolimus (36.9%) than cyclosporin-ME (57.8%) were discontinued from treatment (P = 0.003). The initial episodes of biopsy-proven rejection were moderate or severe in just one out of 31 (3%) tacrolimus-treated patients compared with 11 out of 39 (28%) patients receiving cyclosporin-ME (P = 0.009). While 3-year patient and kidney survival rates were similar in the two treatment groups, pancreas survival was superior with tacrolimus (89.2 vs 72.4%; P = 0.002). Thrombosis resulted in pancreas graft loss in 10 patients receiving cyclosporin-ME and in only two treated with tacrolimus (P = 0.02). Overall adverse event frequency was similar in both groups, but MMF intolerance was more frequent with tacrolimus and hyperlipidaemia more frequent with cyclosporin-ME.

CONCLUSIONS

In this 3-year study, tacrolimus was more effective than cyclosporin-ME in preventing moderate or severe kidney or pancreas rejection after SPK transplantation. It also provided superior pancreas survival and reduced the risk of pancreas graft thrombosis.

Authors+Show Affiliations

Institute for Clinical and Experimental Medicine, Diabetes Center, Prague, Czech Republic.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15814547

Citation

Saudek, Frantisek, et al. "Efficacy and Safety of Tacrolimus Compared With Cyclosporin Microemulsion in Primary SPK Transplantation: 3-year Results of the Euro-SPK 001 Trial." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 20 Suppl 2, 2005, pp. ii3-10, ii62.
Saudek F, Malaise J, Boucek P, et al. Efficacy and safety of tacrolimus compared with cyclosporin microemulsion in primary SPK transplantation: 3-year results of the Euro-SPK 001 trial. Nephrol Dial Transplant. 2005;20 Suppl 2:ii3-10, ii62.
Saudek, F., Malaise, J., Boucek, P., & Adamec, M. (2005). Efficacy and safety of tacrolimus compared with cyclosporin microemulsion in primary SPK transplantation: 3-year results of the Euro-SPK 001 trial. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 20 Suppl 2, pp. ii3-10, ii62.
Saudek F, et al. Efficacy and Safety of Tacrolimus Compared With Cyclosporin Microemulsion in Primary SPK Transplantation: 3-year Results of the Euro-SPK 001 Trial. Nephrol Dial Transplant. 2005;20 Suppl 2:ii3-10, ii62. PubMed PMID: 15814547.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of tacrolimus compared with cyclosporin microemulsion in primary SPK transplantation: 3-year results of the Euro-SPK 001 trial. AU - Saudek,Frantisek, AU - Malaise,Jacques, AU - Boucek,Petr, AU - Adamec,Milos, AU - ,, PY - 2005/4/9/pubmed PY - 2005/9/2/medline PY - 2005/4/9/entrez SP - ii3-10, ii62 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol. Dial. Transplant. VL - 20 Suppl 2 N2 - BACKGROUND: Single-centre and retrospective studies suggest superiority of tacrolimus over cyclosporin as cornerstone immunosuppressive therapy for simultaneous pancreas-kidney (SPK) transplantation. This open-label, multicentre trial compared the efficacy and safety of tacrolimus with cyclosporin microemulsion (ME) in diabetic patients with end-stage renal disease undergoing their first cadaveric SPK transplantation. The 3-year results are reported. METHODS: Patients were recruited from 10 centres in Europe and one centre in Israel: 103 were randomized to receive tacrolimus (initial dose: 0.2 mg/kg/day p.o.) and 102 to cyclosporin-ME (7 mg/kg/day p.o.). All patients received concomitant rabbit anti-T-cell globulin induction, mycophenolate mofetil (MMF) and short-term corticosteroids. RESULTS: Fewer patients receiving tacrolimus (36.9%) than cyclosporin-ME (57.8%) were discontinued from treatment (P = 0.003). The initial episodes of biopsy-proven rejection were moderate or severe in just one out of 31 (3%) tacrolimus-treated patients compared with 11 out of 39 (28%) patients receiving cyclosporin-ME (P = 0.009). While 3-year patient and kidney survival rates were similar in the two treatment groups, pancreas survival was superior with tacrolimus (89.2 vs 72.4%; P = 0.002). Thrombosis resulted in pancreas graft loss in 10 patients receiving cyclosporin-ME and in only two treated with tacrolimus (P = 0.02). Overall adverse event frequency was similar in both groups, but MMF intolerance was more frequent with tacrolimus and hyperlipidaemia more frequent with cyclosporin-ME. CONCLUSIONS: In this 3-year study, tacrolimus was more effective than cyclosporin-ME in preventing moderate or severe kidney or pancreas rejection after SPK transplantation. It also provided superior pancreas survival and reduced the risk of pancreas graft thrombosis. SN - 0931-0509 UR - https://www.unboundmedicine.com/medline/citation/15814547/Efficacy_and_safety_of_tacrolimus_compared_with_cyclosporin_microemulsion_in_primary_SPK_transplantation:_3_year_results_of_the_Euro_SPK_001_trial_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfh1076 DB - PRIME DP - Unbound Medicine ER -