Liver Int. 2022 Aug 13. doi: 10.1111/liv.15396. Online ahead of print.
ABSTRACT
BACKGROUND AND AIMS: To report 5-year outcomes of the CERTITUDE study.
METHODS: An observational study in patients with liver transplantation (LTx) that compared long-term impact of immunosuppression (with/without a calcineurin inhibitor) on renal function, cancers, major cardiovascular events (MACE), and other safety parameters. All patients completing the 6-month SIMCER study were recruited and analyzed according to treatment received at randomization and actual treatment received during follow-up.
RESULTS: Of the 143 enrolled patients, 119 completed the 5-year follow-up (everolimus [EVR], n=55; tacrolimus [TAC], n=64). The mean absolute change in estimated glomerular filtration rate was not statistically different between both groups (TAC, -15.53 mL/min/1.73 m2 and EVR, -14.56 mL/min/1.73 m2 ). In the treatment subgroups based on actual treatment received, renal function was preserved better in the EVR subgroup compared with other subgroups (P=0.051). Treated biopsy-proven acute rejection was higher in the EVR group (15.4% vs 6.4%); however, the majority of events were mild in severity. MACE occurred in 9.2% vs 14.1% of patients in the EVR and TAC groups, respectively (P=0.370). De novo cancer was reported in 14 and 5 patients in EVR and TAC groups, respectively. Hepatocellular carcinoma (HCC) recurrence was observed in TAC group alone (n=4). Adverse events and treatment discontinuation due to adverse event were higher in the EVR group.
CONCLUSIONS: The CERTITUDE study demonstrated that EVR- and TAC-based regimens have a comparable efficacy, safety, and tolerability up to 5 years post-LTx.
PMID:35962772 | DOI:10.1111/liv.15396
