PMID- 19857665
OWN - NLM
STAT- MEDLINE
DCOM- 20100301
LR  - 20161125
IS  - 1873-2623 (Electronic)
IS  - 0041-1345 (Linking)
VI  - 41
IP  - 8
DP  - 2009 Oct
TI  - Safety and tolerance of sodium mycophenolate in patients after renal 
      transplantation--an observational study.
PG  - 3016-8
LID - 10.1016/j.transproceed.2009.07.102 [doi]
AB  - BACKGROUND: Enteric-coated mycophenolate sodium (EC-MPS) was developed as an 
      alternative agent to mycophenolate mofetil (MMF), aimed at reduction of 
      gastrointestinal (GI) complications. METHODS: Seventy-four patients (mean age 
      42.3 years) switched from MMF to MPS were included in the study and followed-up 
      for 3 months (Visit 0, Visit 2 after 1 month and Visit 3 after 3 months). The 
      mean time from transplantation to switch was 3.7 years. During Visit 2 and 3 the 
      following were recorded: impact of treatment change on the severity of GI 
      symptoms (4 point scale: 1-worsening, 2-no change, 3-improvement, 4-resolution), 
      EC-MPS tolerance, adverse events (AEs), patient compliance and physician 
      satisfaction with treatment (4 point scale: 1-bad, 2-fair, 3-good, 4-very good). 
      RESULTS: Sixty-three patients completed the study (85.1%). EC-MPS dose ranged 
      from 720 to 1440 mg. GI symptom severity score averaged at 3.41. Symptoms most 
      commonly compelling a conversion were: abdominal pain, diarrhea, abdominal colic, 
      nausea, anorexia and vomiting. Out of 175 complaints, 144 (82%) either improved 
      or resolved, 5 (2.86%) aggravated, and 25 (14.86%) persisted. Patient compliance 
      and mean physician satisfaction score averaged at 3.70 and 3.02 at Visit 3, 
      respectively. 9 AEs (2 severe) were reported. Causal relationship with the 
      medication was suspected in 5 cases (1 case of SAE). The most common AEs were: 
      anemia, infection (including sepsis), GI symptoms (abdominal pain, diarrhea). 
      CONCLUSIONS: The following was concluded in our study: (1) sodium mycophenolate 
      is well tolerated; (2) after switching from MMF to EC-MPS, gastrointestinal 
      symptoms alleviated; (3) EC-MPS is a safe medication, with a low adverse events 
      rate.
FAU - Gozdowska, J
AU  - Gozdowska J
AD  - Department of Transplantation Medicine and Nephrology, The Infant Jesus Teaching 
      Hospital, Medical University of Warsaw, 02-005, Lindley Str. No 4, Warsaw, 
      Poland. jola-MD@prokonto.pl
FAU - Urbanowicz, A
AU  - Urbanowicz A
FAU - Baczkowska, T
AU  - Baczkowska T
FAU - Pazik, J
AU  - Pazik J
FAU - Matlosz, B
AU  - Matlosz B
FAU - Cieciura, T
AU  - Cieciura T
FAU - Szmidt, J
AU  - Szmidt J
FAU - Chmura, A
AU  - Chmura A
FAU - Durlik, M
AU  - Durlik M
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PL  - United States
TA  - Transplant Proc
JT  - Transplantation proceedings
JID - 0243532
RN  - 0 (Immunosuppressive Agents)
RN  - 83HN0GTJ6D (Cyclosporine)
RN  - HU9DX48N0T (Mycophenolic Acid)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Adult
MH  - Cyclosporine/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Drug Tolerance
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunosuppressive Agents/adverse effects/*therapeutic use
MH  - Kidney Transplantation/*immunology
MH  - Male
MH  - Mycophenolic Acid/adverse effects/*analogs & derivatives/*therapeutic use
MH  - Safety
MH  - Tacrolimus/therapeutic use
EDAT- 2009/10/28 06:00
MHDA- 2010/03/02 06:00
CRDT- 2009/10/28 06:00
PHST- 2009/10/28 06:00 [entrez]
PHST- 2009/10/28 06:00 [pubmed]
PHST- 2010/03/02 06:00 [medline]
AID - S0041-1345(09)01137-3 [pii]
AID - 10.1016/j.transproceed.2009.07.102 [doi]
PST - ppublish
SO  - Transplant Proc. 2009 Oct;41(8):3016-8. doi: 10.1016/j.transproceed.2009.07.102.