TABLE 1.
Baseline characteristics
| ER-tacrolimus (n = 52) | LCP-tacrolimus (n = 53) | |
|---|---|---|
| Recipient demographics at randomization | ||
| Age, y, median (IQR) | 58.50 (46.75–65.25) | 56.50 (46.25–63) |
| Gender, male, n (%) | 41 (78.8) | 35 (66) |
| Body mass index, kg/m2, mean ± SD | 26.13 ± 5.28 | 25.82 ± 4.56 |
| Ethnicity, n (%) | ||
| Caucasian | 46 (88.5) | 49 (92.5) |
| Othera | 4 (7.6) | 4 (7.5) |
| Unknown | 2 (3.8) | 1 (1.9) |
| Primary disease, n (%) | ||
| Hepatocellular carcinoma | 19 (36.5) | 12 (22.6) |
| (Non)alcoholic steatohepatitis | 7 (13.5) | 10 (18.9) |
| Primary sclerosing cholangitis | 10 (19.2) | 8 (15.1) |
| Acute liver failure | 3 (5.8) | 3 (5.7) |
| Cryptogenic cirrhosis | 3 (5.8) | 3 (5.7) |
| Metabolic diseases | — | 4 (7.5) |
| Viral hepatitis | 3 (5.8) | 3 (5.7) |
| Otherb | 7 (13.5) | 11 (20.8) |
| Hematology laboratory results | ||
| Hemoglobin, mmol/L, mean ± SD | 6.3 ± 0.9 | 6.1 ± 0.8 |
| Leucocytes, 109/L, mean ± SD | 9.5 ± 4.8 | 9.5 ± 4.7 |
| Platelets, 109/L, mean ± SD | 263 ± 125 | 249 ± 122 |
| INR, mean ± SD | 1.6 ± 0.5 | 1.2 ± 0.3 |
| Factor V, median (IQR) | 1.71 (1.39–1.71) | 1.47 (1.16–1.66) |
| Chemistry lab | ||
| Albumin, g/L, mean ± SD | 32.9 ± 4.7 | 33.7 ± 4.2 |
| Bilirubin, µmol/L, median (IQR) | 19 (12.8–31.8) | 19 (12.3–27.5) |
| Creatinine, µmol/L, mean ± SD | 77 ± 26 | 82 ± 36 |
| eGFR, mL/min/1.73 m2, mean ± SD | 82 ± 18 | 79 ± 20 |
| Cholesterol total, mmol/L, mean ± SD | 3.65 ± 1.06 | 3.48 ± 0.95 |
| LD lipoprotein, mmol/L, mean ± SD | 1.96 ± 0.86 | 1.90 ± 0.86 |
| Triglyceride, mmol/L, mean ± SD | 2.08 ± 0.85 | 1.87 ± 0.74 |
| Glucose, mmol/L, median (IQR) | 6.65 (5.55–8.45) | 7.15 (5.70–9.28) |
| HbA1c, mmol/mol, mean ± SD | 35.3 ± 10.7 | 33.8 ± 6.4 |
| Blood pressure | ||
| Diastolic, mm Hg, mean ± SD | 77 ± 10 | 75 ± 11 |
| Systolic, mm Hg, mean ± SD | 130 ± 15 | 127 ± 17 |
| Heart rate, beats per minute, mean ± SD | 82 ± 14 | 84 ± 13 |
| Tacrolimus trough blood level, µg/L, mean ± SD | 6.94 ± 3.05 | 7.51 ± 3.29 |
| Pharmacogenetics, n (%) | ||
| Normal CYP3A4 metabolism | 33 (63.5) | 36 (67.9) |
| Intermediar CYP3A4 metabolism | 4 (7.7) | 2 (3.8) |
| Unknown CYP3A4 metabolism | 15 (28.8) | 16 (30.2) |
| CYP3A5 expressor | 9 (17.3) | 7 (13.2) |
| CYP3A5 nonexpressor | 28 (53.8) | 31 (58.5) |
| Unknown CYP3A5 status | 15 (28.8) | 16 (30.2) |
| Recipient demographics pretransplantation | ||
| Pre-existing diabetes, yes, n (%) | 11 (21.2) | 13 (24.5) |
| Pre-existing hypertension, yes, n (%) | 17 (32.7) | 11 (20.8) |
aOther includes Asian and Afro-American.
bOther includes primary biliary cirrhosis, secondary biliary cirrhosis, autoimmune cirrhosis, cholangiocarcinoma, Caroli disease, polycystic liver disease, and neuroendocrine tumor liver metastases.
CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; eGFR, estimated glomerular filtration rate based on the CKD-EPI formula; ER, extended-release; INR, international normalized ratio; IQR, interquartile range; LCP, life cycle pharma.