Safety of mycophenolate mofetil versus azathioprine in renal transplantation: a systematic review.
BACKGROUND
To evaluate the safety of mycophenolate mofetil (MMF) versus azathioprine (Aza) in renal transplantation, we compared their side effects using evidence-based methods.


METHODS
Medline, Embase, Cochrane library, and Chinese Biomedicine database (CBM) were searched to select randomized clinical trials that had one group using MMF and another group using Aza as an immunosuppressive drugs. Safety analysis consist of the following factors: diarrhea, abdominal pain, vomiting, nausea, constipation, CMV infection, leukopenia, anemia, thrombocytopenia or skin malignancy. RevMan 4.11 software was used for the systematic review analysis.


RESULTS
Twenty trials including 6387 patients were identified. The diarrhea incidence with MMF (3 g/d) was higher than for Aza at 1 and 3 years (P < .05). Diarrhea on MMF (2 g/d) was higher than for Aza within 6 months (P < .05). CMV infection incidence on MMF (3 g/d) was higher than for Aza's at 3 years (P < .05), but MMF (2 g/d) did not show a statistical significance compared with Aza. Leukopenia incidence on MMF (3 g/d) was higher than that on Aza, whereas the incidence with MMF (2 g/d) was not significantly different from Aza. Skin malignancy incidence showed no statistical difference between MMF 3 g/d, MMF 2 g/d, or Aza.


CONCLUSIONS
The use of MMF is associated with slight increases in gastrointestinal adverse effects, some hematologic adverse events, and CMV infections compared with Aza. Larger sample sizes of randomized controlled trials are needed to evaluate the safety of MMF.
Wang
K
K
Department of Urology, the Lab of Transplant Engineering and Immunology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Zhang
H
H
Li
Y
Y
Wei
Q
Q
Li
H
H
Yang
Y
Y
Lu
Y
Y
D001379:Azathioprine / Q000627:therapeutic use*; D003586:Cytomegalovirus Infections / Q000453:epidemiology; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D010146:Pain; D011183:Postoperative Complications / Q000145:classification; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012449:Safety; D012878:Skin Neoplasms / Q000139:chemically induced / Q000453:epidemiology; D013997:Time Factors; D014839:Vomiting / Q000139:chemically induced / Q000453:epidemiology
D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D001379:Azathioprine