PURPOSE: We conducted a systematic review of randomized trials to compare the benefits and harms of tacrolimus versus cyclosporine as primary immunosuppression after heart transplantation. METHODS AND RESULTS: We searched electronic databases and bibliographies up to April 2010. Our review followed the Cochrane and PRISMA guidelines. The meta-analysis included 10 randomized trials with 952 patients. Tacrolimus was significantly superior to cyclosporine (both formula-combined) with regard to hypertension (relative risk [RR] 0.8; 95% confidence interval [CI] 0.69-0.93, p = 0.003), hyperlipidaemia (RR 0.57; 95% CI 0.44-0.74, p < 0.0001), hirsutism (RR 0.17 95% CI 0.04-0.62, p = 0.008), and gingival hyperplasia (RR 0.07 95% CI 0.01-0.37, p = 0.002). No significant differences between the two calcineurin inhibitors were found with regard to acute rejections causing haemodynamic instability, diabetes, renal dysfunction, infection, malignancy, or neurotoxicity. Tacrolimus was significantly superior to microemulsion cyclosporine with regard to mortality (RR 0.64; 95% CI 0.42-0.96, p = 0.03), acute severe biopsy-proven rejection (RR 0.71; 95% CI 0.56-0.90, p = 0.004), hyperlipidaemia (RR 0.57; 95% CI 0.41-0.79, p = 0.0009), hirsutism (RR 0.17 95% CI 0.04-0.62, p = 0.008), and gingival hyperplasia (RR 0.07; 95% CI 0.01-0.37, p = 0.002). Tacrolimus was significantly superior to oil-based cyclosporine with regard to hypertension (RR 0.66; 95% CI 0.54-0.80, p < 0.0001), and hyperlipidaemia (RR 0.57; 95% CI 0.38-0.87, p = 0.009). CONCLUSION: Tacrolimus seems to be superior to cyclosporine in heart transplant patients with regard to hypertension, hyperlipidaemia, gingival hyperplasia and hirsutism. In addition, tacrolimus seems to be superior to microemulsion cyclosporine in heart transplant patients with regard to a number of outcomes, including death. More trials with a low risk of bias are needed to determine if the results of the present meta-analysis can be confirmed.
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