21 May 2009
Safety and tolerance of enteric-coated mycophenolate sodium in patients after kidney transplantation – an observational study
J Gozdowska, T Bączkowska, J Pazik, B Matłosz, T Cieciura, J Szmidt, A Chmura, M DurlikAnn Transplant 2009; 14(1): 75-75 :: ID: 880477
Abstract
Background: Enteric-coated mycophenolate sodium (MPS) has been developed as an alternative agent to mycophenolate mofetil (MMF), with aim to provide reduction in gastrointestinal (GI) complications.
Material/Methods: Between February 2006 and December 2007, 74 patients,
mean age 42.26 years, in whom MMF was switched to MPS were included in
the study. The mean time from transplantation to change in treatment was 3.69 years. Follow-up was 3 months (Visit 0, Visit 2 after 1 month and Visit 3 after 3 months). During Visit 2 and 3, the impact changing the treatment on the severity of GI symptoms was assessed on a scale from 1 to 4 (1 - wors-ening, 2 - no change, 3 - improvement, 4 - resolved). Tolerance of therapy, patient compliance and physician's satisfaction with treatment were also assessed (1 to 4 scale: 1 - bad, 2 - fair, 3 - good, 4 - very good). During Visits 2 and 3, adverse events (AEs) were recorded.
Results: Follow-up was completed in 63 patients (85.1%). Patients received MPS in doses ranging from 720 to 1440 mg (mean dose 1092 mg). The mean GI symptom severity score in the MMF to MPS conversion group was 3.41. The most common symptoms that were the reason for conversion were: abdominal pain, diarrhoea, abdominal colic, nausea, anorexia and vomiting. Out of 175 reported complaints 144 (82%) either improved or were completely resolved. Worsening was noted with regard to only 5 (2.86%) of reported complaints, and no change was seen in 25 (14.86%) symptoms. Patient's compliance was graded as 3.70 for Visit 3. Mean physician's satisfaction score assessed during the last visit was 3.02. 9 AEs (including 2 severe) were reported. Causal relationship with the medication was suspected in 5 cases (including 1 case of SAE). The most important AEs were: anaemia, infection (including 1 case of sepsis), GI symptoms (abdominal pain, diarrhoea).
Conclusions: 1. Sodium mycophenolate is well tolerated. 2. After switching from MMF to MPS, gastrointestinal symptoms decrease. 3. MPS is a safe
medication, with a low adverse event rate.
Keywords: Immunosuppression, Kidney Transplantation, clinical outcome
In Press
15 Mar 2024 : Review article
Approaches and Challenges in the Current Management of Cytomegalovirus in Transplant Recipients: Highlighti...Ann Transplant In Press; DOI: 10.12659/AOT.941185
18 Mar 2024 : Original article
Does Antibiotic Use Increase the Risk of Post-Transplantation Diabetes Mellitus? A Retrospective Study of R...Ann Transplant In Press; DOI: 10.12659/AOT.943282
20 Mar 2024 : Original article
Transplant Nephrectomy: A Comparative Study of Timing and Techniques in a Single InstitutionAnn Transplant In Press; DOI: 10.12659/AOT.942252
28 Mar 2024 : Original article
Association Between FEV₁ Decline Rate and Mortality in Long-Term Follow-Up of a 21-Patient Pilot Clinical T...Ann Transplant In Press; DOI: 10.12659/AOT.942823
Most Viewed Current Articles
05 Apr 2022 : Original article
Impact of Statins on Hepatocellular Carcinoma Recurrence After Living-Donor Liver TransplantationDOI :10.12659/AOT.935604
Ann Transplant 2022; 27:e935604
12 Jan 2022 : Original article
Risk Factors for Developing BK Virus-Associated Nephropathy: A Single-Center Retrospective Cohort Study of ...DOI :10.12659/AOT.934738
Ann Transplant 2022; 27:e934738
22 Nov 2022 : Original article
Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipient...DOI :10.12659/AOT.937988
Ann Transplant 2022; 27:e937988
15 Mar 2022 : Case report
Combined Liver, Pancreas-Duodenum, and Kidney Transplantation for Patients with Hepatitis B Cirrhosis, Urem...DOI :10.12659/AOT.935860
Ann Transplant 2022; 27:e935860