A trial study to determine the effects of steroid withdrawal on patients who have had liver transplants. Liver transplantation has evolved into the procedure of choice for an array of liver ailments in end stage liver disease. Throughout the development of liver transplantation, steroids have been a mainstay in immunosuppression, both short and long term As the other, newer agents utilized improve, there is a movement in the transplant community to withdraw steroids from the protocol. The side effects seen with steroids include high blood pressure, osteoporosis, hyperglycemia, high lipids, and high cholesterol. Several studies have shown a reduction in cholesterol and LDL levels for kidney and heart recipients after only six months of steroid withdrawal. The long term effects related to steroids are difficult to guage in all patients, but clearly, discontinuance would be beneficial to the patient assuming the graft function does not suffer. The goal of this program is to test the validity of withdrawing steroids in liver transplant patients treated with mycophenolate mofetil compared to imuran and ultimately offer this option to all patients after the details and lab analysis are completed. In addition, the study will help to identify those patients that are at increased risk following steroid withdrawal and allow for a special protocol for these cases. The study will examine two groups of patients. Patients will be randomly assigned to either group, one being the group that will undergo steroid withdrawal and the other group will not undergo withdrawal. All patients must display the following characteristics: greater than six months out of surgery with no signs of rejection, stable cyclosporin or FK levels and stable mycophenolate mofetil or imuran, on 5mg a day at the start of the protocol, not involved in any other study, no hepatitis B, ABO compatable graft, transaminases < 50 except Hep C patients. Procedure will be a history and physical exam, a full set of labs, continue medications at the prestudy level and decrease the steroid level to 2.5mg. Data concerning liver function and lipid profile will be collected on all patients in both the study and control groups. Comparison of values will be done with the Chi-square or Fisher's exact test. The sample size will be greater than 200 patients which will allow satisfactory analysis.

Project Start
1999-12-01
Project End
2000-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
38
Fiscal Year
2000
Total Cost
$648
Indirect Cost
Name
Virginia Commonwealth University
Department
Type
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23298
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