mycophenolic-acid and Vomiting

To evaluate the safety of mycophenolate mofetil (MMF) versus azathioprine (Aza) in renal transplantation, we compared their side effects using evidence-based 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.. 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.. 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.

Topics: Azathioprine; Cytomegalovirus Infections; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Mycophenolic Acid; Pain; Postoperative Complications; Randomized Controlled Trials as Topic; Retrospective Studies; Safety; Skin Neoplasms; Time Factors; Vomiting

The tolerance and pharmacokinetics (PK) of tacrolimus (T) by the addition of mycophenolate mofetil (MMF) in stable kidney transplant patients (6/group) on long-term tacrolimus-based therapy were investigated. Patients received combination T and MMF therapy at three MMF doses: 1, 1.5, and 2 g/day administered twice daily. A 12-hour blood PK profile for T was obtained prior to MMF dosing; concomitant 12-hour profiles for T, mycophenolic acid (MPA), and mycophenolic acid glucuronide (MPAG) were obtained after 2 weeks of administration. Tolerance was monitored through 3 months. The intra- and intergroup PK of T were variable. The mean AUC0-12 of T for each group was increased after 2 weeks of concomitant MMF administration, but the increase was not statistically significant. Both drugs were well tolerated. Gastrointestinal events were of interest as such have been attributed to both T and MMF. Events reported were diarrhea, nausea, dyspepsia, and vomiting. Other common adverse events were headache, hypomagnesemia, and tremors. Most were mild, although a few were considered to be moderate. There was no apparent relationship between the incidence of any adverse event and MMF treatment group. In the present study, the coadministration of T and MMF did not significantly alter T pharmacokinetics.

Topics: Adult; Area Under Curve; Diarrhea; Dose-Response Relationship, Drug; Drug Interactions; Dyspepsia; Female; Glucuronates; Glucuronides; Humans; Immunosuppressive Agents; Kidney Transplantation; Male; Metabolic Clearance Rate; Middle Aged; Mycophenolic Acid; Nausea; Prodrugs; Tacrolimus; Vomiting

Mycophenolate mofetil (MMF) is a new immunosuppressive drug that selectively inhibits de novo purine synthesis. It has been tested in three large double-blind controlled trials for the prevention of rejection in renal transplant patients. These studies indicate that the use of MMF dramatically decreases the incidence of biopsy-proven rejection, the use of multiple courses of steroids for rejection, and the use of antilymphocyte preparations for treatment of rejection. The drug was well tolerated with an acceptable safety profile. The main side effects were gastrointestinal (nausea, vomiting, diarrhea), but seldom resulted in the cessation of drug therapy. Hematologic side effects similar to those with azathioprine occurred and were reversible. There was a slight increase in CMV-invasive disease with the use of MMF, but no deaths. Rates of malignancy were within published ranges for transplant recipients. Mycophenolate mofetil is a safe and efficacious drug for prevention of rejection in kidney transplant recipients.

Topics: Antilymphocyte Serum; Azathioprine; Cytomegalovirus Infections; Diarrhea; Double-Blind Method; Graft Rejection; Humans; Immunosuppressive Agents; Incidence; Kidney Transplantation; Mycophenolic Acid; Nausea; Neoplasms; Opportunistic Infections; Placebos; Purines; Safety; Steroids; Vomiting

Topics: Abdomen; Abdominal Pain; Acute Kidney Injury; Administration, Intravenous; Adult; Anti-Inflammatory Agents; Ascites; Asthenia; Contrast Media; Creatinine; Disease Progression; Edema; Enzyme Inhibitors; Female; Humans; Jejunum; Lupus Erythematosus, Systemic; Methylprednisolone; Mycophenolic Acid; Prednisone; Tomography, X-Ray Computed; Ultrasonography; Vomiting