Very Early Introduction of Everolimus in De Novo Liver Transplantation: Results of a Multicenter, Prospective, Randomized Trial

Salvatore Agnes, Erida Nure, Umberto Cillo, Laura Saracino, Alessandro Vitale, Alessandra Bertacco, Mauro Salizzoni, Francesco Lupo, Michele Colledan, Vittorio Corno, Giorgio Rossi, Paolo Reggiani, Umberto Baccarani, Vittorio Bresàdola, Luciano De Carlis, Iacopo Mangoni, Raphael Ramirez Morales

Risultato della ricerca: Contributo in rivistaArticolo in rivista

4 Citazioni (Scopus)

Abstract

Abstract Early everolimus (EVR) introduction and tacrolimus (TAC) minimization after liver transplantation may represent a novel immunosuppressant approach. This phase 2, multicenter, randomized, open-label trial evaluated the safety and efficacy of early EVR initiation. Patients treated with corticosteroids, TAC, and basiliximab were randomized (2:1) to receive EVR (1.5 mg twice daily) on day 8 and to gradually minimize or withdraw TAC when EVR was stable at >5 ng/mL or to continue TAC at 6-12 ng/mL. The 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, TAC discontinuation rate, and adverse events were assessed. A total of 93 patients were treated with EVR, and 47 were controls. After 3 months from transplantation, 87.1% of patients with EVR and 95.7% of controls were tBPAR-free (P = 0.09); composite endpoint-free patients with EVR were 85% (versus 94%; P = 0.15). Also at 3 months, 37.6% patients were in monotherapy with EVR, and the tBPAR rate was 11.4%. Estimated glomerular filtration rate was significantly higher with EVR, as early as 2 weeks after randomization. In the study group, higher rates of dyslipidemia (15% versus 6.4%), wound complication (18.32% versus 0%), and incisional hernia (25.8% versus 6.4%) were observed, whereas neurological disorders were more frequent in the control group (13.9% versus 31.9%; P < 0.05). In conclusion, an early EVR introduction and TAC minimization may represent a suitable approach when immediate preservation of renal function is crucial
Lingua originaleEnglish
pagine (da-a)242-251
Numero di pagine10
RivistaLiver Transplantation
Volume25
DOI
Stato di pubblicazionePubblicato - 2019

Keywords

  • Allografts
  • Biopsy
  • Calcineurin Inhibitors
  • Drug Substitution
  • Everolimus
  • Female
  • Glomerular Filtration Rate
  • Graft Rejection
  • Graft Survival
  • Humans
  • Immunosuppressive Agents
  • Kidney
  • Kidney Function Tests
  • Liver
  • Liver Transplantation
  • Male
  • Middle Aged
  • Postoperative Period
  • Prospective Studies
  • Tacrolimus
  • Time Factors

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