Very early introduction of everolimus in de novo liver transplantation: results of a multicenter, prospective, randomized trial (EPOCAL).

07:00 EST 28th December 2018 | BioPortfolio

Summary of "Very early introduction of everolimus in de novo liver transplantation: results of a multicenter, prospective, randomized trial (EPOCAL)."

Early everolimus introduction and tacrolimus minimization after liver transplantation may represent a novel immunosuppressant approach. This phase 2, multicenter, randomized, open-label trial evaluated safety and efficacy of early everolimus initiation. Patients treated with corticosteroids, tacrolimus, and basiliximab, were randomized (2:1) to receive everolimus (1.5 mg bid) in day 8 and gradually minimize or withdraw tacrolimus when everolimus was stable >5 ng/mL, or to continue tacrolimus at 6-12 ng/mL. Primary endpoint was the proportion of treated biopsy proven acute rejection (tBPAR)-free patients at 3 months after transplant. As secondary endpoints, composite tBPAR plus graft/patient loss rate, renal function, tacrolimus discontinuation rate, and adverse events were assessed. Ninety-three patients were treated with everolimus and 47 were controls. After 3 months from transplantation, 87.1% of patients with everolimus and 95.7% of controls were tBPAR-free (p=0.09); composite endpoint-free patients with everolimus were 85% (vs 94%, p=0.15). 37.6% patients were in monotherapy with everolimus at 3 months; tBPAR rate was 11.4%. eGFR was significantly higher with everolimus, as early as 2 weeks after randomization. In the study group higher rate of dyslipidemia (15% vs 6.3%), wound complication (18.2% vs 0) and incisional hernia (25.8% vs 6.3%) were observed while neurological disorders were more frequent in control group (13.9% vs 31.9%) p<0.05. In conclusion, an early everolimus introduction and tacrolimus minimization may represent a suitable approach, when immediate preservation of renal function is crucial. NCT01423708 This article is protected by copyright. All rights reserved.


Journal Details

This article was published in the following journal.

Name: Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society
ISSN: 1527-6473


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Medical and Biotech [MESH] Definitions

A form of ischemia-reperfusion injury occurring in the early period following transplantation. Significant pathophysiological changes in MITOCHONDRIA are the main cause of the dysfunction. It is most often seen in the transplanted lung, liver, or kidney and can lead to GRAFT REJECTION.

Final stage of a liver disease when the liver failure is irreversible and LIVER TRANSPLANTATION is needed.

The transference of a part of or an entire liver from one human or animal to another.

Genes that show rapid and transient expression in the absence of de novo protein synthesis. The term was originally used exclusively for viral genes where immediate-early referred to transcription immediately following virus integration into the host cell. It is also used to describe cellular genes which are expressed immediately after resting cells are stimulated by extracellular signals such as growth factors and neurotransmitters.

Conditions in which the LIVER functions fall below the normal ranges. Severe hepatic insufficiency may cause LIVER FAILURE or DEATH. Treatment may include LIVER TRANSPLANTATION.

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