Seven RCTs (2,415 participants) were included in the review. Only one study met all the quality criteria. Only two studies described randomisation clearly. Study duration ranged from six months to 12 years.
There were no significant differences between tacrolimus and control groups for acute rejection at three months (OR 0.77, 95% 0.52 to 1.13; six RCTs, Ι²=68.4%) and graft survival at 12 months (OR 1.11, 95% CI 0.72 to 1.71; six RCTs, Ι²=68.1%).
Patients treated with tacrolimus were significantly more likely to develop post-transplant diabetes (OR 1.90, 95% CI 1.09 to 3.30; seven RCTs, Ι²=74.4%) and neurotoxicity (OR 1.61, 95% CI 1.15 to 2.25, 4 RCTs, Ι²=49.5%) but less likely to develop hypertension (OR 0.80, 95% CI 0.65 to 0.98; six RCTs, Ι²=14.2%).