Everolimus in de novo liver transplant recipients: a systematic review

Tang, Chengyong; Shen, Ai; Wei, Xufu; Li, Qingdong; Li, Rui; Deng, Hejun; Wu, Yongzhong; Wu, Zhongjun

doi:10.1016/s1499-3872(15)60419-2

Cited by 24 publications

(32 citation statements)

References 43 publications

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“…Infections frequently occur among the solid organ transplant recipients due to the immunosuppressive property of mTOR inhibitors. Previous meta‐analyses reported that everolimus treatment significantly increased the risk of infection . However, the present study did not show identical outcomes.…”

Section: Discussioncontrasting

confidence: 90%

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: Discussioncontrasting

confidence: 90%

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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“…Different strategies, including the use of induction therapy at the time of transplantation followed by delayed and low‐dose CNIs and CNI minimization/withdrawal associated with the initiation of a different class of immunosuppressive agents, have been investigated to overcome CNI‐induced renal toxicity . Studies on EVR introduction after de novo LT confirmed the safety of a minimization/withdrawal mTOR inhibitor–based approach …”

Section: Discussionmentioning

confidence: 99%

“…(11)(12)(13) This observation was strengthened by the results of a few well-designed, randomized, controlled trials on early EVR initiation (1 month after transplant) with subsequent CNI minimization or discontinuation. (5,8,14,15) However, very early (between 1 week and 1 month) EVR-facilitated CNI reduction or discontinuation has not been deeply investigated because of concerns of increased rejection rate (16) and evidence of an increased risk of hepatic artery thrombosis (sirolimus).…”

Section: Original Article | 243mentioning

confidence: 99%

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

et al. 2019

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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.

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“…Rates of BPAR, graft loss, and death were similar between groups. A meta‐analysis of 4 studies confirmed an improvement in renal function 12 months after transplant in patients who continued on an mTOR inhibitor after CNI withdrawal within the first few months after LT …”

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confidence: 96%