Background. Sirolimus is an interesting immunosuppressive drug that do
es not seem to cause nephrotoxicity, neurotoxicity, or diabetogenicity
, as commonly seen in patients treated with cyclosporine or tacrolimus
. In this report, we describe a possible association between sirolimus
and observed hyperlipidemia. Methods. Serum levels of triglycerides a
nd cholesterol were analyzed in 11 patients who participated in a pilo
t study evaluating the effect of oral sirolimus or placebo combined wi
th cyclosporine and corticosteroids on the occurrence of acute renal t
ransplant rejection. Results, In four of nine patients given sirolimus
, significantly increased serum triglyceride levels were seen, with pe
ak levels occurring 2-4 months after transplantation and ranging betwe
en 11.7 and 42.0 mmol/L (reference value <2.2 mmol/L), In two patients
given placebo, the serum triglyceride levels remained below 5.0 mmol/
L. after reduction or discontinuation of sirolimus, the serum triglyce
ride levels decreased within 1-2 months and after 1-8 months levels ha
d returned to their pretransplant values. A significant increase in se
rum cholesterol levels was seen in one of nine patients given sirolimu
s. Conclusion. It seems that long-term treatment with sirolimus ipl co
mbination with cyclosporine and corticosteroids may increase the risk
of hypertriglyceridemia.