PMID- 31308630
OWN - NLM
STAT- MEDLINE
DCOM- 20200121
LR  - 20220409
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 13
DP  - 2019
TI  - Tablet or capsule form of generic mycophenolate mofetil (My-Rept((R))) after liver 
      transplantation: a prospective randomized trial.
PG  - 2187-2193
LID - 10.2147/DDDT.S204056 [doi]
AB  - BACKGROUND: Tablet and capsule forms have advantages and disadvantages in the 
      market. Generally, the tablet form (500 mg) of mycophenolate mofetil (MMF) is 
      more convenient for drug ingestion and more cost-effective than the capsule form 
      (250 mg). We examined the efficacy and safety of MMF in its different forms 
      combined with tacrolimus in liver transplant recipients. METHODS: A randomized 
      controlled trial was performed to compare the efficacy and safety between the 
      tablet form of MMF (tablet group) and the capsule form of MMF (capsule group) in 
      liver transplant patients. One hundred sixteen patients were enrolled in the 
      present study from 2014 to 2017. Fifty-six patients in the full-analysis set 
      (FAS) population were in the capsule group and 60 were in the tablet group. The 
      primary endpoint was incidence of biopsy-proven acute rejection (BPAR) by 24 
      weeks after liver transplantation (LT). Secondary endpoints were patient 
      survival, serum creatinine level, and adverse events (AEs). RESULTS: In the 
      per-protocol population, 45 patients were in the tablet group and 49 were in the 
      capsule group. There were no statistically significant differences in MMF dose, 
      mycophenolic acid trough level, and tacrolimus trough level between the two 
      groups. The incidence of BPAR at 24 weeks after randomization was 6.7% in the 
      tablet group and 6.1% in the capsule group (P=0.627). All patients with BPAR 
      responded well to steroid pulse therapy and increased tacrolimus. Serum creatine 
      level and eGFR were not different between the two groups. The incidence of 
      serious AEs was 7.2% in the tablet group and 7.6% in the capsule group, and none 
      were related to formulation. There was no significant difference in incidence of 
      discontinuations or serious AEs between the two groups. CONCLUSION: The present 
      study suggests that the new tablet formulation can be a useful treatment option 
      to maintain a consistent systemic exposure level of MMF, which may help reduce 
      graft failure in liver transplant patients.
FAU - Kim, Jong Man
AU  - Kim JM
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Oh, Jong Wook
AU  - Oh JW
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Kim, Sangjin
AU  - Kim S
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Rhu, Jinsoo
AU  - Rhu J
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Lee, Ji Soo
AU  - Lee JS
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Kim, Kyeong Sik
AU  - Kim KS
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Choi, Gyu-Seong
AU  - Choi GS
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Joh, Jae-Won
AU  - Joh JW
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190702
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 0 (Capsules)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Tablets)
RN  - HU9DX48N0T (Mycophenolic Acid)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Capsules
MH  - Graft Rejection/*drug therapy
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage/*therapeutic use
MH  - *Liver Transplantation
MH  - Middle Aged
MH  - Mycophenolic Acid/*administration & dosage/*therapeutic use
MH  - Prospective Studies
MH  - Tablets
MH  - Young Adult
PMC - PMC6617558
OTO - NOTNLM
OT  - efficacy
OT  - immunosuppression
OT  - liver transplantation
OT  - tacrolimus
COIS- The authors report no conflicts of interest in this work.
EDAT- 2019/07/17 06:00
MHDA- 2020/01/22 06:00
PMCR- 2019/07/02
CRDT- 2019/07/17 06:00
PHST- 2019/02/03 00:00 [received]
PHST- 2019/05/15 00:00 [accepted]
PHST- 2019/07/17 06:00 [entrez]
PHST- 2019/07/17 06:00 [pubmed]
PHST- 2020/01/22 06:00 [medline]
PHST- 2019/07/02 00:00 [pmc-release]
AID - 204056 [pii]
AID - 10.2147/DDDT.S204056 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2019 Jul 2;13:2187-2193. doi: 10.2147/DDDT.S204056. 
      eCollection 2019.