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Objective: To compare patient survival, graft survival and financial costs at 3 years after renal transplant in graft recipients who received pre-emptive or deferred treatment of cytomegalovirus (CMV) disease. Clinical outcomes and CMV-related charges at an average of 16 months' follow-up have been reported previously. Design and Setting: This was a randomised, nonblind trial in patients enrolled between June and December 1994 at a single US centre. Patients and Participants: 36 adult renal transplant recipients who themselves, or their donors, were CMV-seropositive were randomised into 15 patients in the pre-emptive treatment group and 21 patients in the deferred treatment group. Methods: Patients in the pre-emptive treatment group received intravenous ganciclovir 5 mg/kg every 12 hours once CMV viraemia was detected. Patients in the deferred treatment group received the same intravenous ganciclovir regimen after developing symptomatic CMV disease. Cost data were collected for inpatient hospitalisations, outpatient intravenous medications and dialysis treatments. Results: A comparison of the descriptive characteristics of the two groups revealed no significant differences. Three of 15 patients in the pre-emptive group died with graft function during the third year post-transplant, whereas none of 21 patients in the deferred group died during the study. However, none of the 3 deaths appear to be causally related to the study (myocardial infarction, lung cancer and homicide). Estimates of graft failure, censored for death with function, show a trend towards more graft loss in the deferred treatment group (p = 0.089). Average treatment costs were not significantly different during the first year post-transplant. However, by the third year post-transplant, costs were significantly higher in the deferred group (an additional $US15 277/patient, p < 0.001). Conclusions: With an average of 16 months' follow-up and an assessment of CMV-related charges, it was concluded that the deferred strategy was preferred because of equivalent clinical outcomes at lower CMV treatment charges. The results of the current study with 3-year follow-up and an analysis of total post-transplant treatment costs reverses the previous conclusion. We now conclude that a pre-emptive strategy for treating CMV disease is preferred because of similar clinical outcomes with lower total medical costs. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the economic implications for transplant centres, Medicare and society of treatment of corticosteroid-resistant Banff Grades I, II and III acute kidney transplant rejection with the antithymocyte globulins Thymoglobulin or Atgam.Design and Setting: This was a cost analysis of a randomised double-blind multicentre clinical trial comparing the safety and efficacy of Thymoglobulin and Atgam that was performed at 25 centres in the US in 1994 to 1996.Patients and Participants: The study enrolled 163 patients, 82 in the Thymoglobulin arm and 81 in the Atgam arm.Methods: Estimates of the cost of care from the initiation of rejection therapy to 90 days post-therapy were derived from various publicly available sources and applied to patient-specific clinical events documented in the clinical trial. Patients received either intravenous Thymoglobulin (1.5 mg/kg/day) for an average of 10 days or intravenous Atgam (15 mg/kg/day) for an average of 9.7 days.Results: On average, Thymoglobulin provided significant cost savings compared with Atgam from the perspective of society [$US5977 (1996 values); 95% confidence interval (CI) $US3719 to $US8254], Medicare ($US4967; 95% CI $US3256 to $US6678) and the transplant centre ($US3087; 95% CI $US1512 to $US4667). The overall advantage attributable to Thymoglobulin was primarily due to savings from fewer recurrent rejection treatments and less frequent return to dialysis.Conclusions: Treatment of acute renal transplant rejection with Thymoglobulin is a cost saving strategy when compared with treatment with Atgam. [ABSTRACT FROM AUTHOR]