A prospective study of correlation of blood levels of tacrolimus to graft function and adverse effect of tacrolimus in postrenal transplant patients

Abstract

Introduction: There are limited data on the symptoms of immune-suppressive therapy after transplant on Indian patients and how tacrolimus blood level correlates with graft function and its adverse effects. This study was planned to study these factors. Materials and Methods: The study was conducted as a prospective longitudinal study. Adult patients who underwent the live renal transplant and matched the inclusion criteria from March 2018 to April 2019 were enrolled for the study. Trends of all the parameters were analyzed and their correlation was done with corresponding tacrolimus blood levels. Blood for tacrolimus level was collected at d1, 5, 15, 30, 90, and 180, and values of serum creatinine, diabetes status, hypertensive status, lipid profile, infection occurrence, and liver function tests were recorded at the same time. The subjective symptom occurrence was also recorded by Modified Transplant Symptom Occurrence and Symptom Distress Scale questionnaire at 3 months. Results: The mean age of the study population was 33.7 ± 10.1 years. The incidence of infection was highest at 48% in the 1–3 month period. The incidence of posttransplant diabetes mellitus (PTDM) was 13.7%. Patients requiring antihypertensive decreased from 93.1% immediate posttransplant to 51.5% after 6 months of transplant. There was an increase in posttransplant triglyceride levels, total cholesterol, and low-density lipoprotein level with only high-density lipoprotein showing a protective trend. Liver functions did not show any derangements during the study period. There was no significant correlation between any of the adverse effects and tacrolimus blood levels. Excessive appetite was the most commonly experienced symptoms whereas tremor was the most distressing one. There was a statistically significant increase in symptoms experienced in patients whose tacrolimus blood level was above the normal level for that period. Conclusion: Our study showed no significant correlation between blood levels of tacrolimus and graft function and also with hypertension, dyslipidemia, PTDM, and incidence of posttransplant infections. The incidence of adverse effects was significantly higher in patients who had tacrolimus blood levels higher than recommended.