Table 4.
Changes from baseline to 3 years in vital signs and laboratory parameters in the safety analysis population
| < 65 years | ≥ 65 years | P value for comparison between age groupsa | |||||
|---|---|---|---|---|---|---|---|
| Mean value ± SD | Change from baseline ± SD | Mean value ± SD | Change from baseline ± SD | ||||
| Baseline | 3 years | Baseline | 3 years | ||||
| Heart rate, BPM | 79.2 ± 12.7 (n = 3715) | 77.4 ± 11.7 (n = 2268) | − 0.9 ± 10.3** (n = 1814) | 74.8 ± 10.9 (n = 1478) | 74.1 ± 10.6 (n = 899) | − 0.1 ± 9.6 (n = 742) | 0.081 |
| WBC count, /µL | 7259.1 ± 1995.1 (n = 4242) | 6902.4 ± 1752.4 (n = 2519) | − 275.0 ± 1447.8** (n = 1991) | 6517.8 ± 1667.5 (n = 1768) | 6392.7 ± 1540.0 (n = 1053) | − 148.7 ± 1323.7* (n = 830) | 0.031 |
| RBC count, × 104/μL | 489.8 ± 115.8 (n = 4238) | 504.5 ± 47.8 (n = 2529) | 17.3 ± 32.3** (n = 1988) | 453.0 ± 46.4 (n = 1771) | 471.0 ± 47.2 (n = 1057) | 16.5 ± 31.4** (n = 836) | 0.533 |
| Hemoglobin, g/dL | 14.67 ± 1.50 (n = 4239) | 15.18 ± 1.43 (n = 2538) | 0.53 ± 1.02** (n = 1998) | 13.83 ± 1.42 (n = 1754) | 14.39 ± 1.41 (n = 1052) | 0.45 ± 0.99** (n = 835) | 0.053 |
| Hematocrit, % | 43.80 ± 3.98 (n = 4246) | 45.84 ± 3.94 (n = 2523) | 2.03 ± 2.99** (n = 1979) | 41.72 ± 3.94 (n = 1782) | 43.85 ± 4.20 (n = 1060) | 1.85 ± 3.14** (n = 835) | 0.147 |
| BUN, mg/dL | 14.15 ± 4.11 (n = 4217) | 15.56 ± 4.13 (n = 2512) | 1.34 ± 3.65** (n = 2005) | 16.58 ± 4.98 (n = 1639) | 17.46 ± 4.85 (n = 950) | 1.15 ± 3.98** (n = 747) | 0.232 |
| Serum albumin, g/dL | 4.36 ± 0.37 (n = 2129) | 4.36 ± 0.35 (n = 1285) | 0.01 ± 0.30 (n = 907) | 4.23 ± 0.44 (n = 863) | 4.25 ± 0.36 (n = 512) | − 0.01 ± 0.33 (n = 359) | 0.314 |
| Serum creatinine, mg/dL | 0.721 ± 0.204 (n = 4827) | 0.734 ± 0.214 (n = 2854) | 0.019 ± 0.122** (n = 2316) | 0.780 ± 0.255 (n = 1936) | 0.786 ± 0.257 (n = 1141) | 0.021 ± 0.136** (n = 924) | 0.764 |
| Sodium, mmol/L | 139.9 ± 2.5 (n = 3362) | 140.5 ± 2.3 (n = 1901) | 0.4 ± 2.6** (n = 1487) | 140.5 ± 2.4 (n = 1371) | 141.0 ± 2.4 (n = 779) | 0.5 ± 2.6** (n = 594) | 0.742 |
| Chloride, mmol/L | 102.4 ± 2.9 (n = 3268) | 102.8 ± 2.7 (n = 1877) | 0.4 ± 2.9** (n = 1457) | 103.0 ± 2.8 (n = 1345) | 103.4 ± 2.7 (n = 766) | 0.4 ± 2.8** (n = 584) | 0.899 |
| Potassium, mmol/L | 4.19 ± 0.40 (n = 3537) | 4.22 ± 0.39 (n = 1955) | 0.01 ± 0.39 (n = 1529) | 4.30 ± 0.47 (n = 1503) | 4.28 ± 0.42 (n = 811) | − 0.02 ± 0.42 (n = 616) | 0.219 |
| Calcium, mmol/L | 9.36 ± 0.45 (n = 1067) | 9.31 ± 0.45 (n = 645) | − 0.05 ± 0.42* (n = 424) | 9.29 ± 0.44 (n = 434) | 9.23 ± 0.44 (n = 275) | 0.00 ± 0.44 (n = 172) | 0.146 |
| Phosphorus, mg/dL | 3.29 ± 0.69 (n = 574) | 3.40 ± 0.56 (n = 348) | 0.11 ± 0.51* (n = 211) | 3.17 ± 0.55 (n = 221) | 3.22 ± 0.56 (n = 144) | 0.18 ± 0.58* (n = 75) | 0.333 |
| Magnesium, mg/dL | 2.07 ± 0.24 (n = 171) | 2.20 ± 0.22 (n = 165) | 0.08 ± 0.22* (n = 51) | 2.13 ± 0.22 (n = 91) | 2.28 ± 0.23 (n = 89) | 0.13 ± 0.22* (n = 24) | 0.434 |
| Serum ketone body, μmol/L | 127.79 ± 124.83 (n = 112) | 111.63 ± 174.35 (n = 86) | 0.82 ± 78.22 (n = 28) | 144.54 ± 184.88 (n = 28) | 110.93 ± 99.43 (n = 29) | 13.10 ± 101.09 (n = 9) | –b |
| Fasting C-peptide, ng/mL | 3.595 ± 4.724 (n = 283) | 2.791 ± 1.693 (n = 112) | − 0.848 ± 1.995* (n = 54) | 3.046 ± 2.123 (n = 91) | 2.981 ± 2.021 (n = 36) | − 0.478 ± 1.148 (n = 15) | 0.496 |
| eGFR, mL/min/1.73 m2 | 85.56 ± 19.35 (n = 4762) | 82.46 ± 18.71 (n = 2839) | − 3.18 ± 12.24** (n = 2289) | 70.56 ± 17.96 (n = 1935) | 69.05 ± 17.22 (n = 1140) | − 2.21 ± 10.74** (n = 922) | 0.035 |
| pH | 5.99 ± 0.73 (n = 2904) | 5.93 ± 0.71 (n = 1697) | − 0.05 ± 0.83* (n = 1310) | 5.98 ± 0.76 (n = 946) | 5.96 ± 0.77 (n = 559) | − 0.02 ± 0.87 (n = 421) | 0.508 |
| Urinary albumin, mg/g·Cr | 115.66 ± 413.90 (n = 620) | 81.76 ± 347.36 (n = 332) | − 22.31 ± 247.97 (n = 162) | 89.14 ± 225.92 (n = 160) | 64.78 ± 175.08 (n = 105) | − 38.57 ± 310.31 (n = 55) | 0.695 |
| Urinary creatinine, mg/dL | 116.767 ± 139.480 (n = 472) | 76.143 ± 57.129 (n = 254) | − 27.398 ± 72.246** (n = 116) | 87.824 ± 99.304 (n = 150) | 55.990 ± 37.936 (n = 96) | − 16.975 ± 52.858* (n = 46) | 0.376 |
BUN blood urea nitrogen, eGFR estimated glomerular filtration rate, RBC red blood cell, SD standard deviation, WBC white blood cell
*P < 0.05, **P < 0.001 vs baseline (one-sample t test)
aTwo-sample t test for the comparison of change from baseline between patients aged < 65 years and patients aged ≥ 65 years
bNo P value was calculated when at least one element of the contingency table was < 10