Donor Simvastatin Treatment Is Safe and Might Improve Outcomes After Liver Transplantation: A Randomized Clinical Trial

Abstract

The first author (D.P.) has been selected to receive an Early Career Investigator Award in Clinical/Translational Science for the 2021 The Liver Meeting Digital Experience (TLMdX) being held from 12 to 15 November 2021 from the American Association for the Study of Liver Diseases Foundation Board of Trustees, and the Abstract 14 was selected for "The Best of The Liver Meeting ® " -Liver Transplant Section, created by the Scientific Program Committee. D.P. and E.O. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept

Use of statins after liver transplantation is associated with improved survival: results of a nationwide study

“…On the other hand, even within a limited number of events, we observed a trend for a protective effect of donor statin exposure against post‐LT biliary‐vascular complications, analogous to that observed for recipient statin exposure. From a mechanistic point of view, this data is in line with preclinical data in experimental models of ischemia/reperfusion injury and cold liver preservation, 16,17 and with the preliminary results of a recent randomised controlled trial 33 . Interestingly, the biologic effect of statins on vascular function and liver grafts is quite similar to that exerted by pulsatile flow perfusion 17,34 which successfully minimises biliary‐vascular complications after LT 35…”

“…From a mechanistic point of view, this data is in line with preclinical data in experimental models of ischemia/reperfusion injury and cold liver preservation, 16,17 and with the preliminary results of a recent randomised controlled trial. 33 Interestingly, the biologic effect of statins on vascular function and liver grafts is quite similar to that exerted by pulsatile flow perfusion 17,34 which successfully minimises biliary-vascular complications after LT. 35 This study has some limitations, the main one being the applicability of the results of cohort studies to clinical practice, which usually require confirmation in ad hoc prospective studies. To minimise this limitation, we adopted a statistical strategy that is more processoriented than conventional regression analysis and that provides higher generalizability to real-life scenarios.…”

Letter: PCSK9 inhibitor for liver transplant patients during the post‐statin era? Authors' reply

“…2 This is consistent with the findings of a recent small, double-blind randomised controlled trial. 6 Lastly, but not an irrelevant issue, the current prescription status of these drugs and their cost make them difficult to integrate into the standard of care for patients who do tolerate statins -the vast majority in our studies.…”

Donor Simvastatin Treatment in Liver Transplantation: Post Hoc Analysis of a Randomized Placebo-controlled Trial With Long-term Follow-up

“…Preclinical studies indicated that donor treatment with simvastatin or addition of simvastatin to the cold-storage solution alleviated IRI in liver allografts. [1][2][3] A recent randomized trial by Pagano et al 4 suggested that donor simvastatin treatment reduced major post-LT complications and was associated with a statistically significant survival benefit at 6 mo post-LT.…”