Adverse Effects of Tacrolimus and Its Associated Risk Factors in Renal Transplant Recipients.

ABSTRACT

OBJECTIVES: Tacrolimus, an important constituent of the immunosuppressant regimen for renal transplant recipients, can result in posttransplant diabetes mellitus. The adverse effect profile of tacrolimus is yet to be completely understood. The relationship between the blood level of tacrolimus and development of posttransplant diabetes mellitus has not been clearly elucidated in Indian populations. We conducted this study to investigate the frequency of posttransplant diabetes mellitus and other adverse effects of tacrolimus, to enumerate the risk factors associated with posttransplant diabetes mellitus development, and to correlate the blood levels of tacrolimus with its occurrence. MATERIALS AND METHODS: This prospective observational study included 77 renal transplant patients receiving tacrolimus. The blood sugar levels (fasting and postprandial) were monitored, and patients were asked regularly about the adverse effects of tacrolimus experienced by them for 6 months posttransplant. Trough levels of tacrolimus in blood were correlated with occurrence of posttransplant diabetes mellitus. RESULTS: Posttransplant diabetes mellitus developed in 62.3% (48/77) of renal transplant recipients on a tacrolimus-based regimen. Other adverse effects observed included tremors, diarrhea, alopecia, cyto- megalovirus infection, headache, biopsy-proven calci- neurin inhibitor nephrotoxicity, peripheral neuropathy, and BK virus infection. Higher tacrolimus trough level at month 1 posttransplant was significantly associated with the development of posttransplant diabetes mellitus (adjusted odds ratio = 1.379; 95% CI, 1.02-1.86). The best cutoff of tacrolimus trough level at month 1 posttransplant to reduce the risk of posttransplant diabetes mellitus was 8.1 ng/mL. There was a 5 times increased risk of developing posttransplant diabetes mellitus when tacrolimus trough level at month 1 posttransplant was >8.1 ng/mL (adjusted odds ratio = 5.4; 95% CI, 1.4-19.9). CONCLUSIONS: Posttransplant diabetes mellitus is a common adverse effect of tacrolimus among renal transplant recipients. A trough level >8.1 ng/mL at month 1 posttransplant was an important predictor for posttransplant diabetes mellitus.