Dyslipidemia in renal transplant recipients treated with a sirolimus and cyclosporine-based immunosuppressive regimen: incidence, risk factors, progression, and prognosis.
BACKGROUND
This retrospective study compared the incidence, severity, and predisposing factors for dyslipidemia among renal transplant patients treated for up to 6 years with a cyclosporine +/- prednisone-based concentration-controlled regimen without (n=118) or with (n=280) ascending exposures to sirolimus.


METHODS
The diagnosis of dyslipidemia was established when the serum cholesterol value (CHO) was more than 240 mg/dL or serum triglycerides (TG) were more than 200 mg/dL. Generalized estimating equations and mixed-modeling procedures were used for statistical analyses.


RESULTS
Hypercholesterolemia was observed in 46% to 80% and hypertriglyceridemia in 43% to 78% of sirolimus-treated patients during the first 6 posttransplantation months. The mean peak serum lipid levels among patients in the sirolimus group (CHO=285.5 mg/dL; TG=322.4 mg/dL) were significantly higher than those in the nonsirolimus group (CHO=250.2 mg/dL and TG=267.6 mg/dL; both P<0.01). The lipid values, which were persistently elevated during the first posttransplantation year, decreased slowly thereafter but remained significantly higher than the pretransplantation levels beyond 4 years after transplantation. The two forms of hyperlipidemia tended to occur in parallel (Pearson's coefficient of correlation, r=0.5, P<0.001), showing a positive predictive value of 0.67 and a negative predictive value of 0.65. However, there was no significant difference in the incidence of cardiovascular events within 4 years after transplantation among patients treated with versus without sirolimus.


CONCLUSIONS
The dyslipidemia associated with sirolimus therapy, albeit persistent, does not seem to represent a major risk factor for the early emergence of cardiovascular complications.
Chueh
Shih-Chieh J
SC
Division of Organ Transplantation, Department of Surgery, The University of Texas Medical School at Houston, Houston, TX, USA.
Kahan
Barry D
BD
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects; D002318:Cardiovascular Diseases / Q000453:epidemiology; D015331:Cohort Studies; D016572:Cyclosporine / Q000009:adverse effects*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000139:chemically induced / Q000453:epidemiology*; D015228:Hypertriglyceridemia / Q000139:chemically induced / Q000453:epidemiology*; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000097:blood; D015994:Incidence; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000009:adverse effects; D011379:Prognosis; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D020123:Sirolimus / Q000009:adverse effects* / Q000097:blood
D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D011239:Prednisolone; D020123:Sirolimus