American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
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Randomized Controlled Trial Multicenter Study Comparative Study
Everolimus versus azathioprine in maintenance lung transplant recipients: an international, randomized, double-blind clinical trial.
Everolimus is a proliferation signal inhibitor with immunosuppressive activity that may reduce the rate of progression of chronic rejection, bronchiolitis obliterans syndrome (BOS), after lung transplantation. In a randomized, double-blind clinical trial, 213 BOS-free maintenance patients received everolimus (3 mg/day) or azathioprine (AZA, 1-3 mg/kg/day) in combination with cyclosporine and corticosteroids. The prospectively defined primary endpoint was the incidence of efficacy failure (decline in FEV1 >15%[deltaFEV1 >15%], graft loss, death or loss to follow-up) at 12 months. ⋯ At 24 months, only incidence of acute rejection remained significantly less in the everolimus group. Treatment discontinuations (particularly due to adverse events), serious adverse events and high serum creatinine values were more common with everolimus. For the first time, a drug has demonstrated significant slowing of loss in lung function, suggesting that patients kept on prolonged maintenance treatment with everolimus may benefit from replacing AZA with everolimus 3 months after lung transplantation.
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Historical Article
Organ donation and utilization, 1995-2004: entering the collaborative era.
Continued progress in organ donation will help enable transplantation to alleviate the increasing incidence of end-stage organ disease. This article discusses the implementation and effect of the federally initiated Organ Donation Breakthrough Collaborative; it then reviews organ donation data, living and deceased, from 1995 to 2004. It is the first annual report of the Scientific Registry of Transplant Recipients to include national data following initiation of the collaborative in 2003. ⋯ The number of organs recovered from donation after cardiac death (DCD) grew from 64 in 1995 to 391 in 2004. While efforts are ongoing to develop methodologies for identifying expanded criteria donors (ECD) for organs other than kidney, it is clear DCD and ECD raise questions regarding cost and recovery. The number of living donor organs increased from 3493 in 1995 to 7002 in 2004; data show trends toward more living unrelated donors and those providing non-directed donations.
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Comparative Study
Organ donation decision: comparison of donor and nondonor families.
Family members continue to play a prominent role in donation decisions at time of death. This study examined the relative influence of donor and next-of-kin factors, requestor characteristics, communication processes and satisfaction with the health care team on the donation decision. ⋯ Subsequent logistic regression analyses revealed that donation was more likely when the deceased was younger, white (OR = 3.20, CI = 1.3, 5.7) and had made his/her donation intentions known (OR = 4.35, CI = 2.6, 7.3), and when the next-of-kin had more favorable organ donation beliefs (OR = 8.72, CI = 5.2, 14.7), was approached about donation by an OPO coordinator (OR = 3.74, CI = 2.2, 6.4), viewed the requestor as sensitive to their needs (OR = 2.70, CI = 1.6, 4.5) and perceived the timing of the request as optimal (OR = 6.63, CI = 3.6, 12.1) (total regression model, chi square = 133.2, p < 0.001, 92.7% of cases correctly predicted). Findings highlight the need for continued public education efforts to maximize positive beliefs about organ donation, to share and document donation decisions and to improve communication processes among the OPO personnel, hospital staff and prospective donor families.