Title :

Five-year Outcomes in Liver Transplant Patients Receiving Everolimus with or without a Calcineurin Inhibitor: Results from the CERTITUDE Study.

Author(s) :

Saliba, Faouzi [Auteur]
Physiopathologie et traitement des maladies du foie
Duvoux, Christophe [Auteur]
Hôpital Henri Mondor
Dharancy, Sebastien [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Dumortier, Jerôme [Auteur]
Hôpital Edouard Herriot [CHU - HCL]
Calmus, Yvon [Auteur]
CHU Saint-Antoine [AP-HP]
Gugenheim, Jean [Auteur]
Hôpital l'Archet
Kamar, Nassim [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Salamé, Ephrem [Auteur]
CHU Trousseau [APHP]
Neau-Cransac, Martine [Auteur]
Hôpital Haut-Lévêque [CHU Bordeaux]
Vanlemmens, Claire [Auteur]
Hôpital JeanMinjoz
Durand, François [Auteur]
Hôpital Beaujon [AP-HP]
Pageaux, Georges-Philippe [Auteur]
Hôpital Saint Eloi [CHU Montpellier]
Hardwigsen, Jean [Auteur]
Hôpital de la Timone [CHU - APHM] [TIMONE]
Benkhatar, Yasmina [Auteur]
Derquenne, François [Auteur]
Conti, Filomena [Auteur]
Université Côte d'Azur [UniCA]

Journal title :

Liver International

Abbreviated title :

Liver Int

Volume number :

42

Pages :

2513-2523

Publication date :

2022-08-15

ISSN :

1478-3231

English keyword(s) :

calcineurin inhibitor
everolimus
immunosuppression
immune modulation
liver transplant
long-term outcomes

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Background and Aims To report 5-year outcomes of the CERTITUDE study. Methods An observational study in patients with liver transplantation (LTx) compared the long-term impact of immunosuppression (with/without a ...
Show more >Background and Aims To report 5-year outcomes of the CERTITUDE study. Methods An observational study in patients with liver transplantation (LTx) compared the long-term impact of immunosuppression (with/without a calcineurin inhibitor) on renal function, cancers, major cardiovascular events (MACEs) and other safety parameters. All patients completing the 6-month SIMCER study were recruited and analysed according to treatment received at randomization and actual treatment received during the 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 = .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 = .370). De novo cancer was reported in 14 and 5 patients in EVR and TAC groups respectively. Hepatocellular carcinoma (HCC) recurrence was observed in the TAC group alone (n = 4). Adverse events and treatment discontinuation owing to an adverse event were higher in the EVR group. Conclusions The CERTITUDE study demonstrated that EVR- and TAC-based regimens have comparable efficacy, safety and tolerability up to 5 years post-LTx.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Autres travaux scientifiques

Submission date :

2024-01-12T00:51:59Z
2024-03-29T10:41:44Z
2024-03-29T14:45:46Z