Table 2.
Liver, hematologic, and lipid effects
| Parameter | VITAL (N = 9) | CL08 (N = 10) | ||
|---|---|---|---|---|
| Baseline (n = 9), median (range) |
End of studya (n = 4), median (range) |
Baseline (n = 9), median (range) |
End of studyb (n = 5), median (range) |
|
| ALT | ||||
| U/L | 145.0 (16–297) | 26.5 (18–38) | 37.0 (28–248) | 29.0 (22–106) |
| µkat/L | 2.42 (0.3–5.0) | 0.44 (0.3–0.6) | 0.62 (0.5–4.1) | 0.48 (0.4–1.8) |
| AST | ||||
| U/L | 125.0 (71–716) | 44.5 (41–54) | 99.5 (56–441)c | 44.0 (38–110) |
| µkat/L | 2.09 (1.2–12.0) | 0.74 (0.7–0.9) | 1.66 (0.9–7.4)c | 0.73 (0.6–1.8) |
| Ferritin | ||||
| µg/L (ng/mL) | 586.3 (253–48,740)d | 93.5 (42–123) | 1750.5 (481–3020)e | 62.1 (49–75) |
| Albumin, g/L | 29.0 (13–40) | 32.0 (27–37) | 20.0 (18–29) | 33.0 (20–37)f |
| Hemoglobin, g/L | 93.0 (1–103) | 115.5 (99–123) | 90.0 (81–131)d | 113.0 (103–129)f |
| Total cholesterol | ||||
| mg/dL | 139.2 (67–225)g | 112.1 (93–131)h | 125.7 (97–1063)i | 106.3 (85–205)f |
| mmol/L | 3.6 (2–6)g | 2.9 (2–3)h | 3.3 (3–28)i | 2.8 (2–5)f |
| LDL-C | ||||
| mg/dL | 109.4 (19–194)g | 64.2 (63–75)h | 119.0 (62–143)h | 76.6 (53–137)h |
| mmol/L | 2.8 (0.5–5)g | 1.7 (2–2)h | 3.1 (2–4)h | 2.0 (1–4)h |
| HDL-C | ||||
| mg/dL | 8.9 (0–10)g | 18.9 (13–19)h | 9.4 (8–12)f | 13.1 (13–29)h |
| mmol/L | 0.2 (0.0–0.3)g | 0.5 (0.3–0.5)h | 0.2 (0.2–0.3)f | 0.3 (0.3–0.8)h |
| Triglycerides | ||||
| mg/dL | 163.9 (31–218)g | 99.2 (90–237)h | 265.7 (71–424)g | 151.1 (133–195)h |
| mmol/L | 1.9 (0.4–3)g | 1.1 (1–3)h | 3.0 (0.8–5)g | 1.7 (2–2)h |
| Liver volume, MN | 3.4 (3–4)h | 1.6 (0.3–3)h,j | 3.2 (0.1–4)d | 1.9 (1–2)e |
| Spleen volume, MN | 7.0 (3–11)e | 2.6 (2–7)h,j | 5.8 (0.7–15)c | 4.0 (2–6)e |
ALT alanine aminotransferase, AST aspartate aminotransferase, HDL-C high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; MN, multiples of normal
aWeek 240 (month 60; last visit with n > 2)
bWeek 156 (month 39)
cn = 8
dn = 7
en = 2
fn = 4
gn = 5
hn = 3
in = 6
jWeek 120 (month 30; last visit with n > 1)