Open prospective study to evaluate cardiovascular risk factors and renal function in 2 dosage regimens of tacrolimus combined with mycophenolate mofetil and steroids in renal transplant patients: 5-year results.
BACKGROUND
Cyclosporine and tacrolimus (TAC) are the most potent immunosuppressants. TAC is considered less nephrotoxic, but may be an important factor in chronic graft dysfunction. The aim of the study was to evaluate kidney function and cardiovascular risk profile in 2 groups of low immunological risk kidney allograft recipients receiving 2 TAC dosages.


METHODS
Patients were randomly assigned to 2 TAC-based treatments (group I [n = 14], standard dose; group II [n = 15], reduced dose). Patient and graft survival, graft function, occurrence of cardiovascular events (cardiac death, myocardial infarction, stroke), incidence of new-onset diabetes mellitus after transplantation, and cardiovascular risk factors were assessed over a 5-year period.


RESULTS
Patient demographics and transplant characteristics were not statistically different between groups. TAC trough levels were significantly higher in group I for 24 months post transplant. Patient survival did not differ, but there were more acute rejection episodes and graft losses in group II. There were no significant differences in the rate of cardiac events. Graft function measured as serum creatinine levels and calculated glomerular filtration rate did not differ between groups. The same applies to new-onset diabetes mellitus after transplantation incidence. Office blood pressures were numerically higher in group I up to 24 months but this difference did not reach significance at any time. Similar results were obtained for serum lipids.


CONCLUSIONS
Immunosuppression based on low doses of tacrolimus seems to be safe in the group of low immunological risk patients but in the 60-month follow-up does not offer any clear benefits in terms of potential nephrotoxicity or cardiovascular risk.
Department of Nephrology, Transplantation and Internal Medicine, Medical University of Gdańsk, Poland; Department of General Nursing, Medical University of Gdańsk, Poland. Electronic address: chamien@gumed.edu.pl.
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A
Chamienia
Department of Nephrology, Transplantation and Internal Medicine, Medical University of Gdańsk, Poland.
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A
Dębska-Ślizień
Department of Nephrology, Transplantation and Internal Medicine, Medical University of Gdańsk, Poland.
E
E
Król
Department of Nephrology, Transplantation and Internal Medicine, Medical University of Gdańsk, Poland.
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B
Biedunkiewicz
Department of Nephrology, Transplantation and Internal Medicine, Medical University of Gdańsk, Poland.
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B
Rutkowski
D000293:Adolescent; D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000209:etiology*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007668:Kidney / Q000503:physiopathology; D016030:Kidney Transplantation / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D011241:Prednisone / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D012307:Risk Factors; D016559:Tacrolimus / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D011241:Prednisone; D016559:Tacrolimus