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, ×109/L | 314 | 7.3 (3.1) | 313 | 6.7 (2. 7) |
| Platelets, ×109/L | 314 | 238.7 (81.8) | 313 | 231.9 (74.9) |
|
| ||||
| De novo diabetes mellitusa, Number (%) | 287 | 51 (17.8) | 278 | 69 (24.8) |
| De novo diabetes mellitusb, Number (%) | 287 | 5 (1.7) | 278 | 20 (7.2) |
FAS
aPatients without pre-existing diabetes mellitus treated with antidiabetic medications for >30 consecutive days at any time during the study. bPatients without pre-existing diabetes mellitus treated with antidiabetic medications for >30 consecutive days and still receiving this treatment at end of study.