Racial differences in renal transplantation after immunosuppression with tacrolimus versus cyclosporine. FK506 Kidney Transplant Study Group.
BACKGROUND
Results of a multicenter, randomized, clinical trial demonstrated that tacrolimus was more effective than cyclosporine in preventing acute rejection in cadaveric renal transplant patients. As African-Americans comprised approximately 25% of the study population, their outcome was analyzed relative to the experience of Caucasian patients.


METHODS
Of the 205 patients randomized to tacrolimus, 56 (27.3%) were African-American and 114 (55.6%) were Caucasian. Of the 207 patients randomized to cyclosporine, 48 (23.2%) were African-American and 123 (59.4%) were Caucasian. The efficacy variables were 1-year patient survival, graft survival, and incidence of acute rejection.


RESULTS
The incidence of acute rejection was significantly lower in African-American and Caucasian patients treated with tacrolimus than with cyclosporine. Additionally, no African-American patient who was treated with tacrolimus experienced moderate or severe acute rejection, as determined by blinded independent review. The incidence of nephrotoxicity, cardiovascular and gastrointestinal events, malignancies, and opportunistic infections was similar between treatments and race groups. However, there was an increased incidence of posttransplant diabetes mellitus in tacrolimus-treated patients, particularly in African-Americans, and tacrolimus was associated with significantly lower lipid levels in both Caucasians and African-Americans. African-American patients required a 37% mean higher dose of tacrolimus than Caucasian patients to achieve comparable blood concentrations.


CONCLUSIONS
Tacrolimus is more effective than cyclosporine in preventing acute rejection in both African-American and Caucasian patients. However, tacrolimus was associated with an increased risk of posttransplant diabetes mellitus, particularly in African-Americans, which was reversible in some patients.
Neylan
J F
JF
Emory University, Atlanta, Georgia 30322, USA.
D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data; D044383:Black People; D016572:Cyclosporine / Q000627:therapeutic use*; D003920:Diabetes Mellitus / Q000453:epidemiology; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015994:Incidence; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality / Q000706:statistics & numerical data; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology*; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D014481:United States; D044465:White People / Q000706:statistics & numerical data
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus