Comparable Renal Function at 6 Months with Tacrolimus Combined with Fixed-Dose Sirolimus or MMF: Results of a Randomized Multicenter Trial in Renal Transplantation

Table 5

Clinical laboratory results, concomitant medications, and safety results.

	$n$	Tacrolimus/Sirolimus $N=318$	$n$	Tacrolimus/MMF $N=316$
Total cholesterol, mean (SD), mmol/L	285	5.2 (1.4)	291	5.0 (1.1)
Change from baseline	241	0.5 (1.5)	240	0.3 (1. 5)
LDL, mean (SD), mmol/L	248	3.0 (1.0)	255	2.9 (1.0)
Change from baseline	178	0.3 (1.1)	183	0.2 (1.1)
HDL, mean (SD), mmol/L	258	1.4 (0.5)	265	1.3 (0.4)
Change from baseline	192	0.1 (0.5)	195	0.0 (0.4)
Triglycerides, mean (SD), mmol/L	285	2.3 (1.6)	291	2.1 (1.5)
Change from baseline	245	0.2 (1.5)	244	$-$ 0.1 (1.7)
Hematology, mean (SD):
WBC, $\times$10^9/L	314	7.3 (3.1)	313	6.7 (2. 7)
Platelets, $\times$10^9/L	314	238.7 (81.8)	313	231.9 (74.9)
De novo diabetes $\text{mellitu}{\text{s}}^{\text{a}}$, Number (%)	287	51 (17.8)	278	69 (24.8)
De novo diabetes $\text{mellitu}{\text{s}}^{\text{b}}$, Number (%)	287	5 (1.7)	278	20 (7.2)

FAS
${}_{}{}^{\text{a}}\text{Patients}$ without pre-existing diabetes mellitus treated with antidiabetic medications for $>$30 consecutive days at any time during the study. ${}_{}{}^{\text{b}}\text{Patients}$ without pre-existing diabetes mellitus treated with antidiabetic medications for $>$30 consecutive days and still receiving this treatment at end of study.