Table 2.
Detailed physical examination and laboratory evaluation of patients who completed the study at each visit (significant changes in bold font)
Screen (n=24) | Inpatient stay | Outpatient visits (n=14) | End of drug (n=14) | P value compared to start of drug | |||||
---|---|---|---|---|---|---|---|---|---|
Day 1: Start of drug (n=17) | Day 2 (n=17) | Day 3 (n=16) | |||||||
Day number | 0 | 14 | 15 | 16 | 18-19 | 21-22 | 23-25 | 28 | |
Modified orientation log | 24 | 24 | 24 | 24 | 23 | 24 | 24 | 24 | 0.8 |
Mini-mental status exam | 29.3 | 29.6 | 29.5 | 29.0 | 29.1 | 29.5 | 29.4 | 29.5 | 0.94 |
HE development | — | — | — | — | — | — | — | — | |
Systolic BP | 107.5 | 104.0 | 109 | 106.1 | 108.3 | 102.3 | 106.4 | 104.8 | 0.35 |
Diastolic BP | 60.8 | 62.0 | 64.9 | 63.2 | 64.7 | 59.8 | 62.7 | 59.7 | 0.56 |
Heart rate | 80.9 | 80.5 | 81.8 | 79.3 | 79.5 | 84.3 | 79.8 | 78.4 | 0.73 |
Weight (lb) | 184.3 | 187.7 | 184.4 | 184.7 | 191.7 | 194.9 | 184.6 | 177.3 | 0.03 |
Tolvaptan dose (mg/day) | -- | 15 | 19.6 | 23 | 24 | 27 | 21 | 22 | |
Na (meq/L) | 124 | 126 | 130.9 | 131.6 | 132.3 | 132 | 131.1 | 133 | 0.001 |
K (meq/L) | 4.5 | 4.4 | 4.2 | 4.4 | 4.5 | 4.4 | 4.4 | 4.5 | 0.21 |
Ammonia (μmol/L) | 63.3 | 63.5 | 65.4 | 54.7 | 49.7 | 49.8 | 46.7 | 44.0 | 0.02 |
Creatinine (mg/dl) | 1.0 | 1.0 | 1.0 | 1.1 | 1.2 | 1.2 | 1.1 | 1.2 | 0.82 |
INR | 1.7 | 1.7 | 1.7 | 1.7 | 1.9 | 2.0 | 1.7 | 1.9 | 0.42 |
AST | 85.4 | 82.1 | 79.8 | 74.2 | 82.6 | 73.1 | 78.1 | 73.4 | 0.56 |
ALT | 58.6 | 60.1 | 55.5 | 51.2 | 60.5 | 53.8 | 65.7 | 54.5 | 0.78 |
Total bilirubin (mg/dl) | 4.2 | 4.2 | 4.9 | 6.5 | 6.1 | 5.0 | 5.0 | 0.56 |