Prospective study on late consequences of subclinical non-compliance with immunosuppressive therapy in renal transplant patients.

In this prospective study we compared the incidence of late acute rejections (LAR) and changes in serum-creatinine over time between compliers and noncompliers with immunosuppressive therapy more than 1 year post transplantation and explored the relative contribution of non-compliance and other risk factors in the occurrence of LAR. One hundred and forty-six adult renal transplant recipients were followed during a 5-year period. Patients were interviewed at the beginning of the study and categorized as non-compliers if they admitted to have skipped immunosuppressive medication on a regular basis during the previous 12 months. The occurrence of LAR during the follow-up period was recorded. We identified 22.6% non-compliers of which 21.2% experienced a late acute rejection compared with 8% in the group of compliers at 5 years postinclusion (p < 0.05). Kaplan-Meier survival analysis showed a decreased rejection free time in non-compliers compared with compliers (p = 0.03). Non-compliant patients had a 3.2 higher risk of LAR (Cox regression analysis, p = 0.005). Non-compliers experienced a higher increase in serum-creatinine over time (Linear Mixed Models, p < 0.001). Non-compliance in renal transplant patients more than 1-year post transplantation is associated with an increased risk for LAR and a higher increase in serum-creatinine during the following 5 years. Copyright 2004 Blackwell Munksgaard