Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years

Autor: Vincent Leroy, Christophe Duvoux, Claire Vanlemmens, Malka Tindel, Ephrem Salamé, Georges Philippe Pageaux, Yvon Calmus, Faouzi Saliba, Filomena Conti, François Durand, Hakam Gharbi, Jean Gugenheim, Jérôme Dumortier, Nassim Kamar, Jean Hardwigsen, Martine Neau-Cransac, Sébastien Dharancy, Cécile Masson
Přispěvatelé: Hôpital Paul Brousse, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse, CHU Henri Mondor, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Archet 2 [Nice] (CHU), CHU Toulouse [Toulouse], CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Hôpital Beaujon [AP-HP], CHU Saint-Eloi, Hôpital Michallon, Hôpital de la Timone [CHU - APHM] (TIMONE), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital de Rangueil, Hôpital Paul Brousse-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Graft Rejection
Male
medicine.medical_specialty
Basiliximab
medicine.medical_treatment
[SDV]Life Sciences [q-bio]
Posttransplant Care
Urology
030230 surgery
Liver transplantation
Severity of Illness Index
Tacrolimus
Mycophenolic acid
03 medical and health sciences
0302 clinical medicine
medicine
Humans
Everolimus
Prospective Studies
Renal Insufficiency
Chronic
Aged
Randomized Controlled Trials as Topic
Sirolimus
Transplantation
Hepatology
Drug Substitution
business.industry
Graft Survival
Original Articles
Middle Aged
medicine.disease
Liver Transplantation
3. Good health
Discontinuation
Calcineurin
Treatment Outcome
Feasibility Studies
Original Article
Female
030211 gastroenterology & hepatology
Surgery
business
Immunosuppressive Agents
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Follow-Up Studies
medicine.drug
Kidney disease
Zdroj: Liver Transplantation
Liver Transplantation, Wiley, 2019, 25 (12), pp.1822-1832. ⟨10.1002/lt.25664⟩
ISSN: 1527-6465
1527-6473
Popis: International audience; The observational CERTITUDE study follows liver transplant patients who completed the SIMCER trial. SIMCER randomized patients at month 1 after transplant to everolimus (EVR) with stepwise tacrolimus (TAC) withdrawal or to standard TAC, both with basiliximab induction and mycophenolic acid ± steroids. After completing SIMCER at 6 months after transplant, 65 EVR-treated patients and 78 TAC-treated patients entered CERTITUDE. At month 24 after transplant, 34/65 (52.3%) EVR-treated patients remained calcineurin inhibitor (CNI) free. Mean estimated glomerular filtration rate (eGFR) was significantly higher with EVR versus TAC during months 3-12. At month 24, eGFR values were 83.6 versus 75.3 mL/minute/1.73 m2 , respectively (P = 0.90) and adjusted mean change in eGFR from randomization was -8.0 versus -13.5 mL/minute/1.73 m2 (P = 0.15). At month 24, 45.9%, 31.1%, and 23.0% of EVR-treated patients had chronic kidney disease stages 1, 2, and 3, respectively, versus 25.7%, 45.7%, and 28.6% of TAC-treated patients (P = 0.05). Treated biopsy-proven acute rejection affected 4 EVR-treated patients and 2 TAC patients during months 6-24. Adverse events led to study discontinuation in 15.4% and 7.7% of EVR-treated and TAC-treated patients, respectively. Grade 3 or 4 hematological events were rare in both groups. A CNI-free EVR-based maintenance regimen appears feasible in approximately half of liver transplant patients. It preserves renal function effectively with good efficacy without compromising safety or hematological tolerance.
Databáze: OpenAIRE
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