Randomized trial of steroid free immunosuppression with basiliximab induction in adult live donor liver transplantation (LDLT)

Kathirvel, M; Mallick, Shweta; Sethi, Pulkit; Thillai, Manoj; Durairaj, M.S.; Nair, Krishnanunni; Sunny, Aleena; Mathew, Johns Shaji; Varghese, Christi Titus; Chandran, Biju; Amma, Binoj Sivasankara Pillai Thankamony; Ramachandran, Riju; Balakrishnan, Dinesh; Gopalakrishnan, Unnikrishnan; Sudhindran, S.

doi:10.1016/j.hpb.2020.09.012

Cited by 12 publications

(19 citation statements)

References 31 publications

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“…On the other hand, a meta-analysis on more than 22000 kidney transplant patients found that early steroid withdrawal during 1 wk after transplantation is associated with less PTDM risk (RR: 0.91; 95%CI: 0.37-0.97; P = 0.04)[ 10 ]. Association between new-onset hyperglycemia and GC-containing maintenance immunosuppression among liver transplant recipients is controversial[ 109 , 110 ]. While a Japanese retrospective analysis on 461 adult liver transplant recipients from living donors did not find any association between taking GC and PTDM[ 109 ], a randomized clinical trial on live donor liver transplant patients reported significantly higher incidences of PTDM among patients taking steroids vs steroid-free group at 3 mo and 6 mo follow-ups[ 110 ].…”

Section: Side Effectsmentioning

confidence: 99%

“…Association between new-onset hyperglycemia and GC-containing maintenance immunosuppression among liver transplant recipients is controversial[ 109 , 110 ]. While a Japanese retrospective analysis on 461 adult liver transplant recipients from living donors did not find any association between taking GC and PTDM[ 109 ], a randomized clinical trial on live donor liver transplant patients reported significantly higher incidences of PTDM among patients taking steroids vs steroid-free group at 3 mo and 6 mo follow-ups[ 110 ]. One confounding factor in data interpretation is the use of different diagnostic criteria for PTDM in different studies.…”

Section: Side Effectsmentioning

confidence: 99%

“…Regarding organ transplant patients, a study on liver transplant recipients showed that taking maintenance GCs was an independent factor associated with hyperlipidemia but not with the two other components of metabolic syndrome (hyperglycemia and hypertension) in this patient population[ 109 ]. In contrast, another study that compared steroid-free vs steroid-taking immunosuppressive regimens in living donor liver transplant recipients found significantly higher incidences of all components of metabolic syndrome, including new-onset hyperglycemia, new-onset hypertension, and post-transplant hypertriglyceridemia among the steroid-taking group[ 110 ].…”

Section: Side Effectsmentioning

confidence: 99%

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Current status of glucocorticoid usage in solid organ transplantation

Dashti‐Khavidaki¹,

Saidi²,

Lü³

2021

WJT

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Glucocorticoids (GCs) have been the mainstay of immunosuppressive therapy in solid organ transplantation (SOT) for decades, due to their potent effects on innate immunity and tissue protective effects. However, some SOT centers are reluctant to administer GCs long-term because of the various related side effects. This review summarizes the advantages and disadvantages of GCs in SOT. PubMed and Scopus databases were searched from 2011 to April 2021 using search syntaxes covering “transplantation” and “glucocorticoids”. GCs are used in transplant recipients, transplant donors, and organ perfusate solution to improve transplant outcomes. In SOT recipients, GCs are administered as induction and maintenance immunosuppressive therapy. GCs are also the cornerstone to treat acute antibody- and T-cell-mediated rejections. Addition of GCs to organ perfusate solution and pretreatment of transplant donors with GCs are recommended by some guidelines and protocols, to reduce ischemia-reperfusion injury peri-transplant. GCs with low bioavailability and high potency for GC receptors, such as budesonide, nanoparticle-mediated targeted delivery of GCs to specific organs, and combination use of dexamethasone with inducers of immune-regulatory cells, are new methods of GC application in SOT patients to reduce side effects or induce immune-tolerance instead of immunosuppression. Various side effects involving different non-targeted organs/tissues, such as bone, cardiovascular, neuromuscular, skin and gastrointestinal tract, have been noted for GCs. There are also potential drug-drug interactions for GCs in SOT patients.

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Section: Side Effectsmentioning

confidence: 99%

Section: Side Effectsmentioning

confidence: 99%

Section: Side Effectsmentioning

confidence: 99%

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Current status of glucocorticoid usage in solid organ transplantation

Dashti‐Khavidaki¹,

Saidi²,

Lü³

2021

WJT

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“…However, treatment with corticosteroids is associated with an increased risk of infection, diabetes mellitus (DM), obesity, and hypertension 2 , 3 . Thus, early withdrawal or complete avoidance of corticosteroids by adding another induction immunosuppressive agent such as T-cell specific antibody has been investigated 1 , 4 , 5 . However, whether corticosteroid minimization provides clear benefits remains unclear 3 .…”

Section: Introductionmentioning

confidence: 99%

T-cell specific antibody induction versus corticosteroid induction immunosuppression for liver transplant recipients: a meta-analysis

Jung

Kuh

Lim

et al. 2023

Sci Rep

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Corticosteroids remain the mainstay of immunosuppression for liver transplant recipients despite several serious complications including infection, hepatitis C virus (HCV) recurrence, diabetes mellitus (DM), and hypertension. We attempted to compare the safety and efficacy of T-cell specific antibody induction with complete corticosteroid avoidance. We searched MEDLINE, EMBASE, and Cochrane central library. Randomized controlled trials comparing T-cell specific antibody induction with corticosteroid induction immunosuppression were included. Our primary outcome was the incidence of biopsy-proven acute rejection. Eleven trials involving 1683 patients were included. The incidence of acute rejection was not significantly different between the antibody and steroid induction groups (risk ratio [RR] 0.85, 95% confidence interval [CI] 0.72, 1.01, P = 0.06, I2 = 0%). However, T-cell specific antibody induction significantly reduced the risk of cytomegalovirus infection (RR 0.48, 95% CI 0.33, 0.70, P = 0.0002, I2 = 3%), HCV recurrence (RR 0.89, 95% CI 0.80, 0.99, P = 0.03, I2 = 0%), DM (RR 0.41, 95% CI 0.32, 0.54, P < 0.0001, I2 = 0%) and hypertension (RR 0.71, 95% CI 0.55, 0.90, P = 0.005, I2 = 35%). Trial sequential analysis for acute rejection showed that the cumulative z-curve did not cross the Trial sequential boundary and the required information size was not reached. T-cell specific antibody induction compared to corticosteroid induction seems to significantly reduce opportunistic infections including cytomegalovirus infection and HCV recurrence and metabolic complications including DM and hypertension. However, given the insufficient study power, low quality of evidence, and heterogeneous immunosuppressive regimens, our results should be cautiously appreciated.

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“… 183 In a recent RCT, basiliximab induction, followed by tacrolimus plus azathioprine maintenance, significantly reduced the incidence of PTDM versus steroid induction both at 3 (64.5% versus 28.1%) and at 6 mo (51.6% versus 15.6%). 184 …”

Section: Introductionmentioning

confidence: 99%

Management of Diabetes in Candidates for Liver Transplantation and in Transplant Recipients

et al. 2021

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Diabetes is common in patients waitlisted for liver transplantation because of end-stage liver disease or hepatocellular cancer as well as in posttransplant phase (posttransplantation diabetes mellitus). In both conditions, the presence of diabetes severely affects disease burden and long-term clinical outcomes; careful monitoring and appropriate treatment are pivotal to reduce cardiovascular events and graft and recipients' death. We thoroughly reviewed the epidemiology of diabetes in the transplant setting and the different therapeutic options, from lifestyle intervention to antidiabetic drug use-including the most recent drug classes available-and to the inclusion of bariatric surgery in the treatment cascade. In waitlisted patients, the old paradigm that insulin should be the treatment of choice in the presence of severe liver dysfunction is no longer valid; novel antidiabetic agents may provide adequate glucose control without the risk of hypoglycemia, also offering cardiovascular protection. The same evidence applies to the posttransplant phase, where oral or injectable noninsulin agents should be considered to treat patients to target, limiting the impact of disease on daily living, without interaction with immunosuppressive regimens. The increasing prevalence of liver disease of metabolic origin (nonalcoholic fatty liver) among liver transplant candidates, also having a higher risk of noncirrhotic hepatocellular cancer, is likely to accelerate the acceptance of new drugs and invasive procedures, as suggested by international guidelines. Intensive lifestyle intervention programs remain however mandatory, both before and after transplantation. Achievement of adequate control is mandatory to increase candidacy, to prevent delisting, and to improve long-term outcomes.

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Randomized trial of steroid free immunosuppression with basiliximab induction in adult live donor liver transplantation (LDLT)

Cited by 12 publications

References 31 publications

Current status of glucocorticoid usage in solid organ transplantation

Current status of glucocorticoid usage in solid organ transplantation

T-cell specific antibody induction versus corticosteroid induction immunosuppression for liver transplant recipients: a meta-analysis

Management of Diabetes in Candidates for Liver Transplantation and in Transplant Recipients

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