Tags

Type your tag names separated by a space and hit enter

Effects of immediate switch from cyclosporine microemulsion to tacrolimus at first acute rejection in renal allograft recipients.
Transplantation 2003; 75(12):2058-63T

Abstract

BACKGROUND

A number of institutions have reported favorable results in renal transplant patients after conversion from cyclosporine (CsA) to tacrolimus at the time of acute rejection, but no prospective, controlled study has been performed to date. Here, we report the first randomized study comparing patients whose therapy was changed at a first episode of acute rejection to tacrolimus with those who were maintained on CsA microemulsion (ME).

METHODS

This 3-month, prospective, open, multicenter, parallel-group study was conducted at 15 centers in seven European countries. In total, 119 renal graft recipients experiencing a first biopsy-proven acute rejection episode while receiving CsA-ME were randomized (1:1) to start tacrolimus-based therapy (n=61) or to continue CsA-ME-based therapy (n=58).

RESULTS

Baseline characteristics were comparable for both groups. The initial rejection episode responded to steroid treatment in 93.4% (tacrolimus) and 63.8% (CsA-ME) (P=0.001), respectively. In patients at risk, the incidence of recurrent rejection events within 3 months was significantly lower with tacrolimus therapy (5/57, 8.8%) compared with CsA-ME therapy (15/44, 34.1%) (P=0.002). Patient and graft survival were similar in both study groups 3 months after randomization. The most frequently reported adverse events were increased serum creatinine (29.5% vs. 22.4%), hypertension (24.6% vs. 22.4%), and urinary tract infection (18.0% vs. 20.7%) for tacrolimus versus CsA-ME. Tremor was more common in tacrolimus treated-patients (17.4% vs. 2.1%, P=0.011).

CONCLUSIONS

Early conversion to tacrolimus therapy benefited the resolution of acute rejection episodes and significantly reduced the risk of recurrent rejection compared with continuation of CsA-ME.

Authors+Show Affiliations

The Renal Unit, Western Infirmary, Glasgow, Scotland, UK. douglas.briggs@ukgateway.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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

12829912

Citation

Briggs, Douglas, et al. "Effects of Immediate Switch From Cyclosporine Microemulsion to Tacrolimus at First Acute Rejection in Renal Allograft Recipients." Transplantation, vol. 75, no. 12, 2003, pp. 2058-63.
Briggs D, Dudley C, Pattison J, et al. Effects of immediate switch from cyclosporine microemulsion to tacrolimus at first acute rejection in renal allograft recipients. Transplantation. 2003;75(12):2058-63.
Briggs, D., Dudley, C., Pattison, J., Pfeffer, P., Salmela, K., Rowe, P., & Tydén, G. (2003). Effects of immediate switch from cyclosporine microemulsion to tacrolimus at first acute rejection in renal allograft recipients. Transplantation, 75(12), pp. 2058-63.
Briggs D, et al. Effects of Immediate Switch From Cyclosporine Microemulsion to Tacrolimus at First Acute Rejection in Renal Allograft Recipients. Transplantation. 2003 Jun 27;75(12):2058-63. PubMed PMID: 12829912.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of immediate switch from cyclosporine microemulsion to tacrolimus at first acute rejection in renal allograft recipients. AU - Briggs,Douglas, AU - Dudley,Chris, AU - Pattison,James, AU - Pfeffer,Per, AU - Salmela,Kaija, AU - Rowe,Peter, AU - Tydén,Gunnar, AU - ,, PY - 2003/6/28/pubmed PY - 2003/8/30/medline PY - 2003/6/28/entrez SP - 2058 EP - 63 JF - Transplantation JO - Transplantation VL - 75 IS - 12 N2 - BACKGROUND: A number of institutions have reported favorable results in renal transplant patients after conversion from cyclosporine (CsA) to tacrolimus at the time of acute rejection, but no prospective, controlled study has been performed to date. Here, we report the first randomized study comparing patients whose therapy was changed at a first episode of acute rejection to tacrolimus with those who were maintained on CsA microemulsion (ME). METHODS: This 3-month, prospective, open, multicenter, parallel-group study was conducted at 15 centers in seven European countries. In total, 119 renal graft recipients experiencing a first biopsy-proven acute rejection episode while receiving CsA-ME were randomized (1:1) to start tacrolimus-based therapy (n=61) or to continue CsA-ME-based therapy (n=58). RESULTS: Baseline characteristics were comparable for both groups. The initial rejection episode responded to steroid treatment in 93.4% (tacrolimus) and 63.8% (CsA-ME) (P=0.001), respectively. In patients at risk, the incidence of recurrent rejection events within 3 months was significantly lower with tacrolimus therapy (5/57, 8.8%) compared with CsA-ME therapy (15/44, 34.1%) (P=0.002). Patient and graft survival were similar in both study groups 3 months after randomization. The most frequently reported adverse events were increased serum creatinine (29.5% vs. 22.4%), hypertension (24.6% vs. 22.4%), and urinary tract infection (18.0% vs. 20.7%) for tacrolimus versus CsA-ME. Tremor was more common in tacrolimus treated-patients (17.4% vs. 2.1%, P=0.011). CONCLUSIONS: Early conversion to tacrolimus therapy benefited the resolution of acute rejection episodes and significantly reduced the risk of recurrent rejection compared with continuation of CsA-ME. SN - 0041-1337 UR - https://www.unboundmedicine.com/medline/citation/12829912/Effects_of_immediate_switch_from_cyclosporine_microemulsion_to_tacrolimus_at_first_acute_rejection_in_renal_allograft_recipients_ L2 - http://dx.doi.org/10.1097/01.TP.0000069041.48226.DD DB - PRIME DP - Unbound Medicine ER -