PMID- 32657909
OWN - NLM
STAT- MEDLINE
DCOM- 20211115
LR  - 20211115
IS  - 1536-3694 (Electronic)
IS  - 0163-4356 (Linking)
VI  - 42
IP  - 6
DP  - 2020 Dec
TI  - Immunosuppressive Drug-Associated Adverse Event Profiles in De Novo Kidney 
      Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses.
PG  - 811-820
LID - 10.1097/FTD.0000000000000790 [doi]
AB  - BACKGROUND: The safety of immunosuppressive regimens is influenced by the 
      induction agent, maintenance drug combination, and prophylactic strategy for 
      cytomegalovirus (CMV) infection. Herein, this safety analysis compares rabbit 
      antithymocyte globulin (r-ATG) or basiliximab (BAS) combined with everolimus 
      (EVR) versus BAS combined with mycophenolate sodium (MPS) in kidney transplant 
      recipients receiving tacrolimus, prednisone, and preemptive CMV therapy. METHODS: 
      In this single-center, prospective, randomized study, adverse events (AEs), 
      serious AEs (SAEs), viral infections, laboratory abnormalities, dose reductions, 
      and temporary or permanent discontinuation of the immunosuppressant were compared 
      among patients receiving r-ATG/EVR (n = 85), BAS/EVR (n = 102), and BAS/MPS (n = 
      101). RESULTS: A total of 2741 AEs and 344 SAEs were observed. There were no 
      differences in the proportion of patients with at least one AE (96% versus 98% 
      versus 96%, respectively; P > 0.05). The proportion of patients with at least one 
      SAE was highest in the BAS/MPS group (33% versus 48% versus 69%, respectively; P 
      < 0.05). This difference was due primarily to a high incidence of CMV infection 
      in the BAS/MPS group (4.7% versus 10.8% versus 37.6%, respectively). The 
      incidence of mild/moderate abnormalities in creatinine, cholesterol, and 
      triglyceride levels was higher in both EVR groups. The cumulative freedom from 
      dose reduction or treatment discontinuation due to an AE was higher in both EVR 
      groups than in the BAS/MPS group (89.2% versus 92.8% versus 76.3%, respectively, 
      P = 0.003). There was no difference in the incidence of biopsy-confirmed acute 
      rejection (9.4% versus 18.6 versus 15.8%, respectively; P = 0.403). CONCLUSIONS: 
      This analysis suggests that r-ATG induction combined with EVR is associated with 
      a comparable incidence of acute rejection, lower incidence of CMV infection, and 
      fewer changes in initial immunosuppressive regimen due to AEs in kidney 
      transplant recipients receiving tacrolimus, prednisone, and preemptive CMV 
      therapy.
FAU - Miranda, Tamiris A
AU  - Miranda TA
AD  - Division of Nephrology, Hospital do Rim, Universidade Federal de Sao Paulo, Sao 
      Paulo, Sao Paulo, Brazilo; and.
FAU - Felipe, Claudia R
AU  - Felipe CR
AD  - Division of Nephrology, Hospital do Rim, Universidade Federal de Sao Paulo, Sao 
      Paulo, Sao Paulo, Brazilo; and.
FAU - Santos, Renato H N
AU  - Santos RHN
AD  - HCor Research Institute, Hospital do Coracao, Sao Paulo, Sao Paulo, Brazil.
FAU - Medina Pestana, Jose O
AU  - Medina Pestana JO
AD  - Division of Nephrology, Hospital do Rim, Universidade Federal de Sao Paulo, Sao 
      Paulo, Sao Paulo, Brazilo; and.
FAU - Tedesco-Silva Junior, Helio
AU  - Tedesco-Silva Junior H
AD  - Division of Nephrology, Hospital do Rim, Universidade Federal de Sao Paulo, Sao 
      Paulo, Sao Paulo, Brazilo; and.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Ther Drug Monit
JT  - Therapeutic drug monitoring
JID - 7909660
RN  - 0 (Antilymphocyte Serum)
RN  - 0 (Immunosuppressive Agents)
RN  - 9927MT646M (Basiliximab)
RN  - 9HW64Q8G6G (Everolimus)
RN  - HU9DX48N0T (Mycophenolic Acid)
RN  - VB0R961HZT (Prednisone)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Antilymphocyte Serum/therapeutic use
MH  - Basiliximab/therapeutic use
MH  - *Everolimus/adverse effects
MH  - Graft Rejection/epidemiology/prevention & control
MH  - Humans
MH  - *Immunosuppressive Agents/adverse effects
MH  - *Kidney Transplantation
MH  - Mycophenolic Acid/adverse effects
MH  - Prednisone/therapeutic use
MH  - Prospective Studies
MH  - *Tacrolimus/adverse effects
EDAT- 2020/07/14 06:00
MHDA- 2021/11/16 06:00
CRDT- 2020/07/14 06:00
PHST- 2020/07/14 06:00 [pubmed]
PHST- 2021/11/16 06:00 [medline]
PHST- 2020/07/14 06:00 [entrez]
AID - 00007691-202012000-00002 [pii]
AID - 10.1097/FTD.0000000000000790 [doi]
PST - ppublish
SO  - Ther Drug Monit. 2020 Dec;42(6):811-820. doi: 10.1097/FTD.0000000000000790.