PMID- 27122116
OWN - NLM
STAT- MEDLINE
DCOM- 20170130
LR  - 20211203
IS  - 2329-0358 (Electronic)
IS  - 1425-9524 (Linking)
VI  - 21
DP  - 2016 Apr 28
TI  - Dosing of Enteric-Coated Mycophenolate Sodium Under Routine Conditions: An 
      Observational, Multicenter Study in Kidney Transplantation.
PG  - 250-61
AB  - BACKGROUND Dosing of enteric-coated mycophenolate sodium (EC-MPS) should be 
      adjusted to reflect concomitant immunosuppression, but it is largely undocumented 
      whether such modifications are carried out during routine clinical practice. 
      MATERIAL AND METHODS MyLIFE was an observational study of adult kidney-only or 
      kidney-pancreas transplant patients starting -EC-MPS at 33 French transplant 
      centers. Data were collected at first EC-MPS dose and 6 months later. The primary 
      objective was to describe initial EC-MPS dosing according to concomitant 
      immunosuppression. RESULTS There were 461 patients analyzed (174 started EC-MPS 
      by month 1 post-transplant ['de novo'] and 287 started EC-MPS >1 month 
      post-transplant ['maintenance']), receiving cyclosporine (CsA) (n=76), tacrolimus 
      (n=363), or a mammalian target of rapamycin (mTOR) inhibitor (n=22). Mean (SD) 
      starting dose was 1130 (511) mg/day, 1006 (441) mg/day, and 769 (300) mg/day in 
      the CsA, tacrolimus, and mTOR inhibitor groups, respectively (p=0.003). In the de 
      novo subpopulation, the starting dose was 1440 mg/day in 66.7% (14/21) of 
      CsA-treated patients and 71.9% (110/153) of tacrolimus-treated patients, with an 
      intensified dose of 2160 mg/day in 28.6% (6/21) and 8.5% (13/153), respectively. 
      There was a non-significant trend to a higher rate of biopsy-proven acute 
      rejection in patients receiving CsA versus tacrolimus or an mTOR inhibitor 
      (p=0.082). Adverse events with a suspected relation to EC-MPS occurred in 21.0%, 
      23.1%, and 9.1% of the CsA, tacrolimus, and mTOR inhibitor subpopulations, 
      respectively. CONCLUSIONS EC-MPS is usually initiated at the dose recommended for 
      de novo CsA-treated kidney transplant patients, then titrated downwards as 
      required. An early intensified regimen is not used frequently. The EC-MPS dose is 
      modified in <20% of de novo patients to account for concomitant tacrolimus 
      therapy instead of CsA administration.
FAU - Albano, Laetitia
AU  - Albano L
AD  - Department of Nephrology and Renal Transplantation, Hospital Pasteur, Nice, 
      France.
FAU - Buchler, Matthias
AU  - Buchler M
AD  - Department of Nephrology and Clinical Immunology, Hospital Bretonneau, Tours, 
      France.
FAU - Cantarovich, Diego
AU  - Cantarovich D
AD  - Department of Nephrology and Clinical Immunology, Hospital Hotel Dieu, Nantes, 
      France.
FAU - Cassuto, Elisabeth
AU  - Cassuto E
AD  - Department of Nephrology and Renal Transplantation, Hospital Pasteur, Nice, 
      France.
FAU - Cointault, Olivier
AU  - Cointault O
AD  - Department of Nephrology and Organs Transplantation, Hospital de Rangueil, 
      Toulouse, France.
FAU - Mazouz, Hakim
AU  - Mazouz H
AD  - Department of Nephrology, Hospital Sud, Amiens, France.
FAU - Vetromile, Fernando
AU  - Vetromile F
AD  - Department of Nephrology, Hospital Lapeyronnie, Montpellier, France.
FAU - Lecuyer, Aurelie
AU  - Lecuyer A
AD  - , Novartis Pharma SAS, Rueil-Malmaison, France.
FAU - Tindel, Malka
AU  - Tindel M
AD  - , Keyrus Biopharma, Levallois Perret, France.
FAU - Kamar, Nassim
AU  - Kamar N
AD  - Department of Nephrology and Organ Transplantation, Hospital de Rangueil, Paul 
      Sabatier University, INSERM U1043, IFR-BMT, Toulouse, France.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20160428
PL  - United States
TA  - Ann Transplant
JT  - Annals of transplantation
JID - 9802544
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Tablets, Enteric-Coated)
RN  - 83HN0GTJ6D (Cyclosporine)
RN  - EC 2.7.1.1 (MTOR protein, human)
RN  - EC 2.7.11.1 (TOR Serine-Threonine Kinases)
RN  - HU9DX48N0T (Mycophenolic Acid)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cyclosporine/administration & dosage
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage/adverse effects
MH  - *Kidney Transplantation
MH  - Male
MH  - Middle Aged
MH  - Mycophenolic Acid/*administration & dosage/adverse effects
MH  - TOR Serine-Threonine Kinases/antagonists & inhibitors
MH  - Tablets, Enteric-Coated
MH  - Tacrolimus/administration & dosage
MH  - Treatment Outcome
EDAT- 2016/04/29 06:00
MHDA- 2017/01/31 06:00
CRDT- 2016/04/29 06:00
PHST- 2016/04/29 06:00 [entrez]
PHST- 2016/04/29 06:00 [pubmed]
PHST- 2017/01/31 06:00 [medline]
AID - 896213 [pii]
AID - 10.12659/aot.896213 [doi]
PST - epublish
SO  - Ann Transplant. 2016 Apr 28;21:250-61. doi: 10.12659/aot.896213.