Multicenter randomized trial comparing tacrolimus (FK506) and cyclosporine in the prevention of renal allograft rejection: a report of the European Tacrolimus Multicenter Renal Study Group.

BACKGROUND: To confirm the results of a number of studies conducted in Europe, the United States, and Japan, this multicenter, randomized trial compared the 12-month efficacy and safety of tacrolimus- and cyclosporine-based immunosuppressive regimens in the prevention of renal allograft rejection. METHODS: A total of 448 renal transplant recipients were recruited from 15 centers and assigned to receive triple-drug therapy consisting of tacrolimus (n=303) or cyclosporine (n=145) in conjunction with azathioprine and low-dose corticosteroids. RESULTS: At 12 months after transplantation, tacrolimus therapy was associated with a significant reduction in the frequency of both acute (tacrolimus 25.9% vs. cyclosporine 45.7%; P<0.001 [absolute difference: 19.8%, 95% confidence interval: 10.0-29.6%]) and corticosteroid-resistant rejection (11.3% vs. 21.6%; P=0.001 [absolute difference: 10.3%, 95% confidence interval: 2.5-18.2%]). Actuarial 1-year patient (tacrolimus 93.0% vs. cyclosporine 96.5%; P=0.140) and graft survival rates (82.5% vs. 86.2%; P=0.380) did not differ significantly between the two treatment groups. Overall, the safety profiles of the tacrolimus- and cyclosporine-based regimens were quite comparable. Infections, renal impairment, neurological complications, and gastrointestinal complaints were frequently reported but were mostly reversible in both groups. Higher incidences of elevated serum creatinine, tremor, diarrhea, hyperglycemia, diabetes mellitus, and angina pectoris were reported in the tacrolimus treatment group, whereas acne, arrhythmia, gingival hyperplasia, and hirsutism were more frequent with cyclosporine treatment. CONCLUSIONS: The significant reduction in the incidence of episodes of allograft rejection observed with tacrolimus therapy may have important long-term implications given the prognostic influence of rejection on graft survival.

A new central supply system as alternative source for bicarbonate dialysate.

Bicarbonate dialysis is mandatory for high efficiency treatment. In most cases bicarbonate is delivered either as prepacked powder or as a stable liquid concentrate in 6-10 I plastic containers. With a newly designed central supply system (CSS) using 800 I tanks of custom-made sterile and pyrogen free concentrates, we investigated the risk of bacterial contamination of dialysate in a 30-bed dialysis unit. During three months, samples of reverse osmosis (RO) water, concentrates and dialysate were taken every two weeks. Colony forming units (CFU) were counted after 48 h incubation. Further samples were taken during nine months of continuous use of the CSS without further intermittent disinfection. None of the samples had greater than 10/ml CFU. Pseudomonas, corynebacteria and enterobacter were the predominant species. In summary, this CSS proved reliable in providing bacteriologically safe bicarbonate dialysate as defined by international standards (CFU less than 200/ml). It significantly reduces costs, workload and environmental pollution by plastic waste.