Reduced-dose tacrolimus with mycophenolate mofetil vs. standard-dose tacrolimus in liver transplantation: a randomized study

Autor: Christophe Duvoux, Christian Ducerf, Christophe Camus, Ephrem Salamé, R. Lorho, Alain Renault, Karim Boudjema, Eric Bellissant, Georges Philippe Pageaux, Faouzi Saliba, Yvon Calmus, Catherine Mouchel, Philippe Compagnon
Přispěvatelé: Service de Chirurgie Hépatobiliaire et Digestive, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Centre hépato-biliaire (CHB), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de Biologie Cellulaire, Université Paris Descartes - Paris 5 (UPD5), Unité de Transplantation, CHU Cochin [AP-HP], the French Ministry of Health (2001 Clinical Research Hospital Program, PHRC 2001), Service de Chirurgie Hépatobiliaire et Digestive [Rennes] = Hepatobiliary and Digestive Surgery [Rennes], CHU Pontchaillou [Rennes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Chirurgie Hépatobiliaire et Digestive [Rennes], Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Centre hépato-biliaire ( CHB ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Paris Descartes - Paris 5 ( UPD5 )
Jazyk: angličtina
Rok vydání: 2011
Předmět:
Male
medicine.medical_treatment
MESH : Prospective Studies
MESH : Diarrhea
MESH : Dose-Response Relationship
Drug
030230 surgery
Liver transplantation
MESH: Leukopenia
Kidney
Gastroenterology
MESH: Hypertension
renal insufficiency
MESH: Dose-Response Relationship
Drug
MESH : Mycophenolic Acid
0302 clinical medicine
Diabetes mellitus
Immunology and Allergy
MESH : Female
Pharmacology (medical)
Prospective Studies
MESH : Immunosuppressive Agents
tacrolimus
Antibacterial agent
MESH: Treatment Outcome
immunosuppression
MESH: Middle Aged
MESH : Thrombocytopenia
MESH : Hypertension
MESH : Leukopenia
Immunosuppression
MESH : Adult
Middle Aged
MESH : Kidney
3. Good health
MESH: Diabetes Complications
MESH: Diarrhea
Treatment Outcome
surgical procedures
operative
MESH : Diabetes Complications
[ SDV.MHEP.HEG ] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology
Female
030211 gastroenterology & hepatology
France
MESH: Immunosuppressive Agents
graft rejection
Immunosuppressive Agents
medicine.drug
Adult
Diarrhea
medicine.medical_specialty
MESH: Liver Transplantation
hypertension
MESH : Male
MESH: Graft Rejection
MESH : Treatment Outcome
Mycophenolic acid
Diabetes Complications
03 medical and health sciences
Internal medicine
medicine
MESH: Tacrolimus
Humans
MESH : Middle Aged
MESH : France
MESH: Thrombocytopenia
MESH: Mycophenolic Acid
Transplantation
MESH: Humans
Dose-Response Relationship
Drug
business.industry
MESH : Humans
mycophenolate mofetil
MESH : Graft Rejection
MESH: Adult
[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology
MESH : Tacrolimus
Leukopenia
MESH: Kidney
Mycophenolic Acid
medicine.disease
Thrombocytopenia
Tacrolimus
MESH: Male
MESH: Prospective Studies
Liver Transplantation
Surgery
Calcineurin
MESH: France
MESH : Liver Transplantation
business
MESH: Female
Kidney disease
Zdroj: American Journal of Transplantation
American Journal of Transplantation, Wiley, 2011, 11 (5), pp.965-76. ⟨10.1111/j.1600-6143.2011.03486.x⟩
American Journal of Transplantation, Wiley, 2011, 11 (5), pp.965-76. 〈10.1111/j.1600-6143.2011.03486.x〉
ISSN: 1600-6135
1600-6143
DOI: 10.1111/j.1600-6143.2011.03486.x⟩
Popis: International audience; We conducted a multicenter randomized study in liver transplantation to compare standard-dose tacrolimus to reduced-dose tacrolimus with mycophenolate mofetil to reduce the occurrence of tacrolimus side effects. Two primary outcomes (censored criteria) were monitored during 48 weeks post-transplantation: occurrence of renal dysfunction or arterial hypertension or diabetes (evaluating benefit) and occurrence of acute graft rejection (evaluating risk). Interim analyses were performed every 40 patients to stop the study in the case of increased risk of graft rejection. One hundred and ninety-five patients (control: 100; experimental: 95) had been included when the study was stopped. Acute graft rejection occurred in 46 (46%) and 28 (30%) patients in control and experimental groups, respectively (HR = 0.59; 95% CI: [0.37-0.94]; p = 0.024). Renal dysfunction or arterial hypertension or diabetes occurred in 80 (80%) and 61 (64%) patients in control and experimental groups, respectively (HR = 0.68; 95% CI: [0.49-0.95]; p = 0.021). Renal dysfunction occurred in 42 (42%) and 23 (24%) patients in control and experimental groups, respectively (HR = 0.49; 95% CI: [0.29-0.81]; p = 0.004). Leucopoenia (p = 0.001), thrombocytopenia (p = 0.017) and diarrhea (p = 0.002) occurred more frequently in the experimental group. Reduced-dose tacrolimus with mycophenolate mofetil reduces the occurrence of renal dysfunction and the risk of graft rejection. This immunosuppressive regimen could replace full-dose tacrolimus in adult liver transplantation.
Databáze: OpenAIRE
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