Table 1.
Baseline Characteristics of Adults with NAFLD, According to Fibrosis Stage at Enrollment.*
| Variable | Stage F4, Cirrhosis (N = 167) | Stage F3, Bridging Fibrosis (N = 369) | Stage F0 to F2, No, Mild, or Moderate Fibrosis (N = 1237) | Total (N = 1773) |
|---|---|---|---|---|
| Demographic characteristics | ||||
| Age — yr | 57±9 | 55±12 | 50±12 | 52±12 |
| Sex — no. (%) | ||||
| Male | 44 (26) | 116 (31) | 472 (38) | 632 (36) |
| Female | 123 (74) | 252 (69) | 765 (62) | 1141 (64) |
| Race — no. (%)† | ||||
| White | 160 (96) | 321 (87) | 1028 (83) | 1509 (85) |
| Other or not reported | 7 (4) | 48 (13) | 211 (17) | 264 (15) |
| Hispanic ethnic group† | ||||
| Yes | 10 (6) | 30 (8) | 177 (14) | 217 (12) |
| No | 157 (94) | 339 (92) | 1060 (86) | 1556 (88) |
| Body-mass index‡ | ||||
| Median (IQR) | 35 (31 to 40) | 34 (31 to 40) | 33 (29 to 37) | 33 (30 to 38) |
| Distribution — no. (%) | ||||
| <25 | 5 (3) | 17 (5) | 55 (4) | 77 (4) |
| 25 to <30 | 27 (16) | 61 (17) | 325 (26) | 413 (23) |
| 30 to <35 | 52 (31) | 121 (33) | 403 (33) | 576 (33) |
| ≥35 | 83 (50) | 168 (46) | 451 (37) | 702 (40) |
| NAFLD history | ||||
| Median age at diagnosis (IQR) — yr | 53 (47–60) | 52 (44–61) | 47 (37–56) | 49 (39–57) |
| Median time since diagnosis (IQR) — yr | 3.8 (0.5–7.1) | 3.1 (0.4–6.4) | 2.3 (0.3–5.4) | 2.7 (0.4–5.7) |
| Histologic features | ||||
| NAFLD activity score§ | 4.2±1.3 | 5.1±1.6 | 4.0±1.7 | 4.2±1.7 |
| Steatosis score | 1.2±0.8 | 1.7±0.9 | 1.8±0.9 | 1.7±0.9 |
| Lobular inflammation score | 1.4±0.7 | 1.8±0.8 | 1.4±0.6 | 1.5±0.7 |
| Ballooning score | 1.6±0.7 | 1.5±0.7 | 0.8±0.8 | 1.0±0.9 |
| Fibrosis stage¶ | 4.0±0.0 | 3.0±0.0 | 0.9±0.8 | 1.6±1.3 |
| NASH diagnosis — no. (%) | ||||
| Definite or borderline NASH | 154 (92) | 347 (94) | 827 (67) | 1338 (75) |
| NAFLD, not NASH | 13 (8) | 12 (3) | 410 (33) | 435 (25) |
| Median time since biopsy (IQR) — mo | 3.4 (1.8–33.2) | 2.6 (1.6–7.9) | 2.7 (1.5–17.9) | 2.7 (1.6–17.5) |
| Biopsy specimen length — mm | 22±12 | 22±10 | 20±10 | 20±10 |
| Liver tests | ||||
| Median ALT (IQR) — U/liter | 42 (28–60) | 59 (37–96) | 50 (32–76) | 51 (32–79) |
| Median AST (IQR) — U/liter | 44 (31–63) | 52 (37–76) | 35 (26–52) | 38 (28–59) |
| Median ALP (IQR) — U/liter | 88 (72–112) | 81 (65–97) | 73 (59–88) | 75 (61–93) |
| Total bilirubin — mg/dl | 0.8±0.5 | 0.7±0.4 | 0.7±0.4 | 0.7±0.4 |
| INR | 1.11±0.25 | 1.05±0.13 | 1.01±0.14 | 1.03±0.15 |
| Laboratory results | ||||
| Median serum creatinine (IQR) — mg/dl | 0.7 (0.6–0.9) | 0.8 (0.7–0.9) | 0.8 (0.7–0.9) | 0.8 (0.7–0.9) |
| Median eGFR (IQR) — ml/min/1.73 m2‖ | 93 (80–104) | 94 (80–104) | 96 (82–107) | 96 (81–106) |
| Serum albumin (IQR) — g/dl | 4.1 (3.8–4.4) | 4.3 (4.0–4.5) | 4.3 (4.1–4.6) | 4.3 (4.0–4.5) |
| Platelets per μL (IQR) | 154,000 (116,000–207,000) | 209,000 (160,000–255,000) | 237,000 (197,000–281,000) | 227,000 (184,000–270,000) |
Plus–minus values are means ±SD. Percentages may not total 100 because of rounding. Differences seen according to fibrosis stage in this population may not be true for the general population. To convert the values for creatinine to micromoles per liter, multiply by 88.4. Data were missing for the following variables: race (1 patient), body-mass index (5 patients); age at diagnosis and time since diagnosis (199 patients whose data were not captured in the FLINT trial); biopsy length (9 patients); alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, serum creatinine, estimated glomerular filtration rate (eGFR), and platelets (3 patients each); and albumin (4 patients). INR denotes international normalized ratio, IQR interquartile range, NAFLD nonalcoholic fibrotic liver disease, and NASH nonalcoholic steatohepatitis.
Race and ethic group were reported by the patient.
Body-mass index is the weight in kilograms divided by the square of the height in meters. A body-mass index of less than 25 indicates normal weight, of 25 to less than 30 overweight, of 30 to less than 35 obesity, and of 35 or above morbid obesity.
The NAFLD activity score was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure are steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2).
The fibrosis stage was assessed on a scale of 0 to 4, with higher scores indicating more severe fibrosis.
The eGFR was calculated with the use of the Chronic Kidney Disease Epidemiology Collaboration formula.