RESUMEN
BACKGROUND: The rate of change to immunosuppression discharge regimens over time is unknown. We examined the frequency of changes to initial drug treatment regimens and factors associated with a drug change following renal transplantation. METHODS: Scientific Registry of Transplant Recipients data from adult recipients who underwent primary renal transplantation between January 1998 and December 2002 were analysed. The Kaplan-Meier analysis was used to determine the frequency of regimen changes for the most common immunosuppression discharge regimens, type of change, and to examine switching between the calcineurin inhibitors tacrolimus (Tacro) and ciclosporin United States Pharmacopera (USP) modified (CsA). Cox proportional hazard regression was used to examine recipient, donor and transplant characteristics associated with a drug change. RESULTS: The majority of patients experienced a change to their discharge regimen post-transplantation, and more changes were observed within higher-risk sub-groups of patients. Switching from CsA to Tacro was more common than Tacro to CsA. Significant factors associated with a drug change included those associated with graft loss. CONCLUSIONS: Significant immunosuppression regimen changes occur during the first 4 years post-transplantation. It is possible that early graft survival benefits proven in prospective clinical trials may not translate into long-term success in clinical practice, possibly in part because efficacious regimens are not necessarily maintained long-term.
Asunto(s)
Inmunosupresores/uso terapéutico , Trasplante de Riñón , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Inhibidores de la Calcineurina , California , Estudios de Cohortes , Ciclosporina/administración & dosificación , Ciclosporina/uso terapéutico , Quimioterapia Combinada , Utilización de Medicamentos , Femenino , Estudios de Seguimiento , Rechazo de Injerto/prevención & control , Supervivencia de Injerto , Enfermedad Injerto contra Huésped/prevención & control , Humanos , Inmunosupresores/administración & dosificación , Inmunosupresores/clasificación , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Ácido Micofenólico/administración & dosificación , Ácido Micofenólico/análogos & derivados , Ácido Micofenólico/uso terapéutico , Alta del Paciente/estadística & datos numéricos , Periodo Posoperatorio , Grupos Raciales , Reoperación , Factores de Riesgo , Sirolimus/administración & dosificación , Sirolimus/uso terapéutico , Tacrolimus/administración & dosificación , Tacrolimus/uso terapéutico , Donantes de TejidosRESUMEN
Outcomes specifically in mycophenolate mofetil (MMF)-treated diabetic renal transplant patients have not been previously reported. This study compared acute rejection (AR), late acute rejection (LAR), patient survival [and specifically death from cardiovascular (CV), infectious and malignant causes], incidence of post-transplant malignancies, and graft loss in MMF- or azathioprine (AZA)-treated renal transplant patients with pre-transplant diabetes. Outcomes were compared between MMF- (n = 14 144) and AZA- (n = 3001) treated diabetic patients using the Scientific Registry of Transplant Recipients data on all U.S. adult renal transplants performed between 1995 and 2002. Statistical analyses included Kaplan-Meier survival analysis, Cox multivariable regression and chi-square tests. MMF patients had less AR compared with AZA-treated patients (23.5% vs. 28.3%, p < 0.001) and less risk for LAR over 4 yr [hazard ratio (HR): 0.64, 95% CI 0.44, 0.92; p = 0.02]. While time to any-cause death did not differ between the groups, MMF treatment was associated with a 20% decreased risk of CV death (HR: 0.80, 95% CI 0.67, 0.97; p = 0.020) compared with AZA treatment. MMF patients also had a lower incidence of malignancies than AZA patients (2.2% vs. 3.7%, p < 0.001). These results suggest treatment with MMF compared with treatment with AZA in diabetic transplant patients is associated with less AR, less risk of LAR, a decreased risk of CV death, and a lower incidence of malignancies.