Table 5.
Changes from baseline to 3 years in vital signs and laboratory parameters in the effectiveness 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 | ||||
| FPG, mg/dL | 167.7 ± 59.6 (n = 3692) | 136.3 ± 37.6 (n = 2038) | − 29.3 ± 50.5** (n = 1745) | 164.7 ± 56.6 (n = 1455) | 135.2 ± 37.6 (n = 788) | − 27.5 ± 49.1** (n = 700) | 0.418 |
| Fasting insulin, μU/mL | 13.60 ± 9.51 (n = 411) | 11.64 ± 8.58 (n = 181) | − 2.87 ± 8.24** (n = 96) | 11.42 ± 9.60 (n = 151) | 8.30 ± 4.38 (n = 85) | − 3.45 ± 8.30* (n = 44) | 0.699 |
| BMI, kg/m2 | 29.93 ± 5.37 (n = 4771) | 28.62 ± 4.97 (n = 2581) | − 1.27 ± 1.66** (n = 2453) | 26.83 ± 4.08 (n = 1552) | 25.82 ± 3.98 (n = 838) | − 1.19 ± 1.42** (n = 787) | 0.203 |
| Waist circumference, cm | 98.75 ± 12.64 (n = 995) | 94.27 ± 12.19 (n = 472) | − 2.82 ± 4.65** (n = 373) | 92.83 ± 10.13 (n = 397) | 89.88 ± 10.25 (n = 234) | − 2.99 ± 4.67** (n = 190) | 0.666 |
| SBP, mmHg | 133.0 ± 15.2 (n = 5245) | 128.8 ± 13.1 (n = 3031) | − 4.4 ± 14.7** (n = 2766) | 134.3 ± 14.9 (n = 1899) | 129.9 ± 13.0 (n = 1099) | − 4.2 ± 14.6** (n = 1011) | 0.682 |
| DBP, mmHg | 79.5 ± 10.2 (n = 5178) | 76.9 ± 9.4 (n = 3017) | − 2.8 ± 10.1** (n = 2731) | 74.1 ± 9.8 (n = 1888) | 72.0 ± 9.1 (n = 1093) | − 2.4 ± 9.9** (n = 1001) | 0.342 |
| AST, U/L | 31.2 ± 20.3 (n = 4271) | 25.7 ± 12.8 (n = 2440) | − 4.6 ± 14.9** (n = 2104) | 27.2 ± 16.2 (n = 1542) | 24.4 ± 13.6 (n = 906) | − 3.0 ± 15.6** (n = 771) | 0.010 |
| ALT, U/L | 41.8 ± 31.1 (n = 4330) | 31.9 ± 21.5 (n = 2460) | − 8.5 ± 22.6** (n = 2135) | 28.0 ± 19.2 (n = 1552) | 23.3 ± 14.8 (n = 909) | − 5.3 ± 16.2** (n = 778) | < 0.001 |
| ALP, U/L | 243.9 ± 83.3 (n = 2303) | 228.7 ± 70.4 (n = 1338) | − 10.0 ± 54.4** (n = 1035) | 248.6 ± 84.5 (n = 847) | 234.6 ± 70.9 (n = 495) | − 12.9 ± 58.6** (n = 382) | 0.380 |
| γ-GTP, U/L | 62.1 ± 72.8 (n = 3987) | 46.7 ± 55.3 (n = 2286) | − 12.1 ± 47.8** (n = 1938) | 49.2 ± 64.6 (n = 1435) | 35.6 ± 39.7 (n = 835) | − 11.8 ± 39.0** (n = 709) | 0.905 |
| Total cholesterol, mg/dL | 199.0 ± 40.1 (n = 2728) | 192.8 ± 36.0 (n = 1455) | − 3.0 ± 33.9* (n = 1210) | 190.4 ± 38.6 (n = 993) | 187.6 ± 32.6 (n = 528) | − 2.9 ± 28.6* (n = 446) | 0.944 |
| LDL-C, mg/dL | 116.2 ± 32.4 (n = 3913) | 110.1 ± 28.4 (n = 2303) | − 5.8 ± 30.4** (n = 1882) | 109.9 ± 29.9 (n = 1430) | 106.0 ± 27.6 (n = 833) | − 4.6 ± 26.4** (n = 691) | 0.347 |
| HDL-C, mg/dL | 49.9 ± 13.0 (n = 4132) | 53.6 ± 16.3 (n = 2368) | 3.2 ± 8.7** (n = 2018) | 53.5 ± 14.7 (n = 1448) | 56.1 ± 14.3 (n = 853) | 3.0 ± 10.3** (n = 719) | 0.580 |
| Triglycerides, mg/dL | 208.5 ± 198.9 (n = 4322) | 183.2 ± 154.1 (n = 2475) | − 15.1 ± 148.9** (n = 2122) | 163.5 ± 126.4 (n = 1532) | 147.1 ± 79.0 (n = 893) | − 12.4 ± 86.9** (n = 759) | 0.633 |
| Uric acid, mg/dL | 5.40 ± 1.31 (n = 3808) | 5.12 ± 1.20 (n = 2199) | − 0.23 ± 1.01** (n = 1810) | 5.17 ± 1.33 (n = 1369) | 4.89 ± 1.21 (n = 795) | − 0.26 ± 1.03** (n = 655) | 0.473 |
| Total bilirubin, mg/dL | 0.637 ± 0.256 (n = 1906) | 0.650 ± 0.257 (n = 1145) | 0.030 ± 0.208** (n = 891) | 0.627 ± 0.238 (n = 764) | 0.654 ± 0.228 (n = 452) | 0.026 ± 0.185* (n = 351) | 0.754 |
γ-GTP gamma-glutamyl transpeptidase, ALT alanine aminotransferase, ALP alkaline phosphatase, AST aspartate aminotransferase, BMI body mass index, DBP diastolic blood pressure, FPG fasting plasma glucose, HDL-C high-density lipoprotein cholesterol, LDL low-density lipoprotein cholesterol, SD standard deviation, SBP systolic blood pressure
*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