TABLE 2.
Characteristics of the Cohort at Baseline
| Overall, n (%) | RISK*, 62,612 (77.2%) | NAFLD, 17,582 (21.7%) | NASH, 914 (1.1%) | Total, 81,108 (100%) | P Value of RISK vs. NAFLD | P Value of RISK vs. NASH | P Value of NAFLD vs. NASH |
|---|---|---|---|---|---|---|---|
| Age at enrollment (years), median (IQR) | 63 (14) | 57 (20) | 58 (20) | 62 (14) | <0.001 | <0.001 | 0.318 |
| Male sex, n (%) | 33,010 (52.7) | 6,852 (39.0) | 332 (36.3) | 40,194 (49.6) | <0.001 | <0.001 | 0.110 |
| Race/ethnicity, n (%) | <0.001 | <0.001 | <0.001 | ||||
| White | 50,604 (80.8) | 13,752 (78.2) | 765 (83.7) | 65,121 (80.3) | |||
| Black or African American | 8,421 (13.4) | 2,455 (14.0) | 58 (6.3) | 10,934 (13.5) | |||
| Other † | 1,096 (1.8) | 455 (2.6) | 29 (3.2) | 1,580 (1.9) | |||
| Unknown | 2,491 (4.0) | 920 (5.2) | 62 (6.8) | 3,473 (4.3) | |||
| BMI (kg/m † ), median (IQR) | 32.2 (5.3) | 31.0 (8.3) | 32.1 (7.8) | 32 (5.9) | <0.001 | 0.128 | <0.001 |
| Patients by BMI groups, n (%) | <0.001 | <0.001 | <0.001 | ||||
| Underweight (<18.5 kg/m † ) | 217 (0.5) | 209 (1.6) | 1 (0.2) | 427 (0.7) | |||
| Normal weight (18.5‐24.9 kg/m † ) | 2,424 (5.1) | 1,834 (14.4) | 59 (8.9) | 4,317 (7.1) | |||
| Overweight (25‐29.9 kg/m † ) | 8,440 (17.8) | 3,329 (26.2) | 179 (27) | 11,948 (19.6) | |||
| Obese (≥30 kg/m † ) | 36,435 (76.7) | 7,332 (57.7) | 423 (63.9) | 44,190 (72.6) | |||
| Tobacco, n (%) | 95 (0.2) | 55 (0.3) | 0 (0.0) | 150 (0.2) | <0.001 | <0.001 | 0.012 |
| Comorbidities, n (%) | |||||||
| Metabolic syndrome | 9,397 (15) | 2,691 (15.3) | 121 (13.2) | 12,209 (15.1) | <0.001 | <0.001 | <0.001 |
| T2DM | 22,312 (35.6) | 5,048 (28.7) | 422 (46.2) | 27,782 (34.3) | <0.001 | 0.002 | <0.001 |
| Hyperlipidemia | 41,481 (66.3) | 10,195 (58) | 500 (54.7) | 52,176 (64.3) | <0.001 | <0.001 | <0.001 |
| Hypertension | 36,168 (57.8) | 9,274 (52.7) | 537 (58.8) | 45,979 (56.7) | <0.001 | 0.219 | 0.751 |
| Cardiovascular disease | 39,109 (62.5) | 10,624 (60.4) | 622 (68.1) | 50,355 (62.1) | <0.001 | <0.001 | <0.001 |
| MACE ‡ | 11,097 (17.7) | 2,620 (14.9) | 118 (12.9) | 13,835 (17.1) | 0.095 | <0.001 | <0.001 |
| Charlson Comorbidity Index, median (IQR) | 2 (1) | 3 (2) | 3 (2) | 2 (1) | <0.001 | <0.001 | 0.176 |
| Laboratory data, n (%) | |||||||
| HbA1c > 5.6% | 30,820 (88.5) | 7,471 (82.3) | 393 (77.8) | 38,683 (87.1) | <0.001 | <0.001 | <0.001 |
| Hyperglycemia ≥ 1.1 g/L | 28,714 (46.8) | 7,414 (43.1) | 461 (52.2) | 36,589 (46.1) | <0.001 | 0.174 | 0.891 |
| LDL‐C ≥ 100 mg/dL | 17,853 (42.5) | 4,851 (47.3) | 213 (43.1) | 22,917 (43.5) | <0.001 | 0.938 | 0.446 |
| HDL‐C < 40 mg/dL/m), <50 mg/dL (f) | 20,872 (33.3) | 6,077 (34.6) | 290 (31.7) | 27,239 (33.6) | 0.002 | 0.322 | 0.080 |
| Triglycerides > 150 mg/dL | 19,136 (43.9) | 5,112 (47.4) | 235 (47) | 24,483 (44.6) | 0.177 | 0.012 | 0.034 |
| Platelets < 150 K/mcl | 6,038 (9.7) | 1,998 (11.4) | 275 (30.2) | 8,311 (10.3) | 0.032 | 0.004 | 0.020 |
| FIB‐4 category, n (%) | <0.001 | <0.001 | <0.001 | ||||
| <1.3 | 32,092 (51.3) | 10,002 (56.9) | 349 (38.2) | 42,443 (52.3) | |||
| 1.3‐2.66 | 23,700 (37.9) | 5,473 (31.1) | 282 (30.9) | 29,455 (36.3) | |||
| ≥2.67 | 6,820 (10.9) | 2,107 (12.0) | 283 (31.0) | 9,210 (11.4) | <0.001 | <0.001 | <0.001 |
| Liver‐related outcomes at baseline, n (%) | |||||||
| Cirrhosis § | <0.001 | <0.001 | <0.001 | ||||
| Compensated Cirrhosis | 130 (14.2) | 348 (2.0) | 89 (0.1) | 567 (0.7) | |||
| End‐stage liver disease | 11,856 (18.9) | 4,829 (27.5) | 351 (38.4) | 17,036 (21.0) | |||
| MELD ≥ 15 | 5,269 (8.4) | 1,313 (7.5) | 113 (12.4) | 6,695 (8.3) | <0.001 | <0.001 | <0.001 |
| Portal hypertension | 10 (0.0) | 46 (0.3) | 23 (2.5) | 79 (0.1) | <0.001 | <0.001 | <0.001 |
| Ascites | 3,595 (5.7) | 2,123 (12.1) | 178 (19.5) | 5,896 (7.3) | <0.001 | <0.001 | <0.001 |
| Encephalopathy | 1,633 (2.6) | 6,661 (3.8) | 104 (11.4) | 2,398 (3.0) | <0.001 | <0.001 | <0.001 |
| Varices | 273 (0.4) | 275 (1.6) | 63 (6.9) | 611 (0.8) | <0.001 | <0.001 | <0.001 |
| Liver failure | 127 (0.2) | 208 (1.2) | 91 (10.0) | 426 (0.5) | <0.001 | <0.001 | <0.001 |
| HCC | 91 (0.1) | 163 (0.9) | 21 (2.3) | 275 (0.3) | <0.001 | 0.019 | <0.001 |
| Liver transplantation | 152 (0.2) | 124 (0.7) | 47 (5.1) | 323 (0.4) | <0.001 | 0.114 | 0.653 |
Statistical analyses for continuous variables were performed using Fisher’s exact test for categorical variables and the Wilcoxon rank‐sum test for continuous variables.
*
RISK includes patients with risk profile of NASH using with the following formula: age > 50 years and ALT > 30 U/L and (BMI > 30 kg/m2 or T2DM).
†
Other includes American Indian or Alaska, Asian, Native Hawaiian, or other Pacific Island.
‡
Major adverse cardiac events included myocardial infarction, hospitalization for unstable angina or heart failure, coronary revascularization and stroke.
§
Does not consider FIB‐4.
Abbreviations: HbA1c, hemoglobin A1c; and MACE, major adverse cardiac events.