146 Early Introduction of Everolimus in De Novo Liver Transplantation: A Multicenter Randomized Clinical Trial (Epocal)

Cillo, U.; Vitale, Alessandra; Salizzoni, Mauro; Coledan, M.; Rossi, G.; Baccarani, Umberto; Carlis, Luciano De; Bertacco, Alessandra; Saracino, Laura; Morales, R. Ramirez; Agnes, Salvatore

doi:10.1016/s0168-8278(13)60148-8

Cited by 1 publication

(8 citation statements)

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“…Since the number of the included studies was limited, the potential publication bias was not estimated by Egger's or Begg's test. The funnel plot illustrated that the dot of Cillo et al deviated from the central line (Figure ), and hence, this study might be biased. After excluding this trial, the pooled result did not change apparently (RR = 1.08, 95% CI: 0.86‐1.37, P = .50).…”

Section: Resultsmentioning

confidence: 76%

“…The funnel plot illustrated that the dot of Cillo et al 25 deviated from the central line ( Figure 5), and hence, this study might be biased. After excluding this trial, 25 the pooled result did not change apparently (RR = 1.08, 95% CI: 0.86-1.37, P = .50). The remaining plots did not reveal any asymmetric distribution of the dots visually, indicating the lack of putative publication bias (Figures 3 and 4).…”

Section: Publication Biasmentioning

confidence: 84%

“…De Simone et al recruited the maintenance liver transplant recipients. Manzia et al began the study at postoperative day 1, Cillo et al began at postoperative day 7, while Masetti et al began the study at postoperative day 10. The randomization was performed for the rest of the included studies about 30 days after the surgery .…”

Section: Resultsmentioning

confidence: 99%

“…Everolimus binds to the intracellular receptor immunophilin FK506‐binding protein 12 (FKBP12), which is adjacent to the catalytic site of mTORC1 in an allosteric fashion. This binding weakens the interaction between mTORC1 and raptor, arrests the cells in the G1 stage of the cell cycle and, subsequently, inhibits the downstream events including functional regulation of immune cells . On the other hand, mTORC2 is recognized as a resistant molecule to mTOR inhibitors.…”

Section: Discussionmentioning

confidence: 99%

“…The process of study inclusion is illustrated in Figure 1. A total of eight trials reported in 12 articles [7][8][9]13,14,[20][21][22][23][24][25][26] were included in the present study. De Simone et al 21 recruited the maintenance liver transplant recipients.…”

Section: Study Characteristicsmentioning

confidence: 99%

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Efficacy and safety of everolimus treatment on liver transplant recipients: A meta‐analysis

Guan

Lin

et al. 2019

Eur J Clin Investigation

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Background Everolimus is an effective immunosuppressant in organ transplantation without impaired renal function. The present study aimed to evaluate the efficacy and safety of everolimus therapy in liver transplant recipients. Materials and methods A systematic literature search was conducted to identify the eligible studies. The quality of the included studies was assessed. The outcomes of interest were biopsy‐proven acute rejection (BPAR), graft loss, death, renal function and adverse events. Results Eight trials involving 1570 participants were included. Compared to the standard exposure to calcineurin inhibitors (CNIs), the incidences of BPAR, graft loss and death were not increased in the everolimus combined with reduced CNIs group. The renal function was significantly improved after everolimus combined with reduced CNI therapy, and the glomerular filtration rate (GFR) was estimated to be elevated by 5.59 (95% CI: 2.17‐9.01, P = .001) as compared to the standard exposure to CNIs. The risk of any adverse event was increased by everolimus combined with reduced CNI therapy (RR = 1.22, 95% CI: 1.04‐1.42, P = .01) as compared to the standard exposure to CNIs. The likelihood of infection was not associated with the regimen. Any publication bias was not identified. Conclusions Although everolimus combined with reduced CNI therapy significantly improved the renal function in liver transplant recipients, it did not influence the incidence of BPAR, graft loss and death. This regimen might be associated with an increased risk of adverse events, which needs to be elucidated further.

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Section: Resultsmentioning

confidence: 76%

Section: Publication Biasmentioning

confidence: 84%