Comparison between a two-drug regimen with tacrolimus and steroids and a triple one with azathioprine in kidney transplantation: results of a European trial with 3-year follow up.
This study was designed to assess the efficacy and safety of two immunosuppressant regimens in kidney transplantation based on the administration of tacrolimus-one of them with tacrolimus, azathioprine, and corticosteroids (n=239) and the other with tacrolimus, and corticosteroids (n=236). After completing the initial 3-month study, the patients remaining in the study (197 and 195, respectively) were assessed for 3 years. The incidence of acute rejection (AR) episodes treated during this period was 28.8% with dual-drug therapy and 29.7% with triple-drug therapy. Late AR: episodes between 4 and 36 months were scarce (3.3% in dual and 4.2% in triple therapy). Chronic rejection incidence was 7.7% and 8.9%, respectively. The patients who experienced AR episodes during the first 3 months developed chronic rejection more frequently than those who did not suffer AR. Patient survival at 3 years was 95% vs 95.6%, and graft survival was 86.6% vs 86.5% (NS). Doses and blood levels of tacrolimus were similar in the two groups. Adverse effects were similar among both treatment groups. Median SCr was 123.8 micromol/L vs 114.9 micromol/L in patients who did experience AR: 145.9 micromol/L vs 132.6 micromol/L in those with early AR; and 194.5 micromol/L vs 152 micromol/L in those who presented with late AR. Need for de novo posttransplant insulin was 4.2% in the dual-drug group and 3.8% in the triple-drug cohort. These results demonstrate that, after 3 years of follow up, there were similar efficacy data among the dual- and triple-drug regimens. Thus, addition of azathioprine does not contribute any advantage in the middle term.
Pascual
J
J
Department of Nephrology, Hospital Ramón y Cajal, Madrid, Spain.
Segoloni
G
G
Gonzalez Molina
M
M
del Castillo
D
D
Capdevila
L
L
Arias
M
M
Garcia
J
J
Ortuño
J
J
D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use*; D002908:Chronic Disease; D003404:Creatinine / Q000097:blood; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006085:Graft Survival / Q000276:immunology / Q000502:physiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015994:Incidence; D007558:Italy; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality / Q000502:physiology; D012008:Recurrence; D013030:Spain; D016019:Survival Analysis; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D003404:Creatinine; D001379:Azathioprine; D016559:Tacrolimus