Table 1.
Population characteristics at randomization by treatment group (ITT population).
| EVR/rTAC N=245 | TAC Elimination N=231 | TAC Control N=243 | |
|---|---|---|---|
| Age (years) | 53.6 (9.2) | 53.2 (10.8) | 54.5 (8.7) |
| Male sex, n (%) | 180 (73.5) | 164 (71.0) | 179 (73.7) |
| Body mass index (kg/m2) | 25.1 (4.2) | 25.3 (4.3) | 24.5 (4.2) |
| Diabetes, n (%) | 95 (38.8) | 83 (35.9) | 101 (41.6) |
| Primary disease leading to liver transplantation, n (%) | |||
| Alcoholic cirrhosis | 71 (29.0) | 49 (21.2) | 51 (21.0) |
| Hepatitis C | 62 (25.3) | 56 (24.2) | 57 (23.5) |
| Hepatocellular carcinoma | 42 (17.1) | 31 (13.4) | 35 (14.4) |
| Hepatitis B | 17 (6.9) | 17 (7.4) | 15 (6.2) |
| Other | 53 (21.6) | 78 (33.8) | 85 (35.0) |
| MELD score* | 19.2 (9.0) | 19.6 (7.5) | 19.0 (7.6) |
| eGFR, mL/min/1.73 m2 | 81.1 (32.6) | 82.6 (37.2) | 78.0 (27.5) |
| eGFR <60mL/min/1.73 m2 (%) | 71 (29.0) | 61 (26.4) | 61 (25.1) |
| Medical history of cardiac disorders, n (%) | 58 (23.7) | 49 (21.2) | 53 (21.8) |
| Mitral valve incompetence | 7 (2.9) | 9 (3.9) | 9 (3.7) |
| Tricuspid valve incompetence | 7 (2.9) | 4 (1.7) | 4 (1.6) |
| Left ventricular hypertrophy | 8 (3.3) | 8 (3.5) | 0 |
| Coronary artery disease | 6 (2.4) | 5 (2.2) | 10 (4.1) |
| Atrial fibrillation | 5 (2.0) | 4 (1.7) | 5 (2.1) |
*
Based on laboratory values only.
Continuous variables are shown as mean (SD). eGFR – estimated GFR (calculated by abbreviated Modification of Diet in Renal Disease [MDRD4] equation; EVR – everolimus; MELD – Model for End-stage Liver Disease; TAC – tacrolimus.