Table 2.
Baseline characteristics of women in Italian tamoxifen chemoprevention trial
|
Normal ALT at baseline
|
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|---|---|---|---|---|---|---|
|
Multiple elevations of ALT (≥1.5×ULN)
|
||||||
|
NAFLD
|
||||||
| Characteristic | High ALT at baseline | Normal ALT during follow up | Single elevation of ALT (≥1.5×ULN) | HBV/HCV/ANA(+) | Suspected* | Confirmed† |
| All participants | 321 | 4853 | 170 | 12 | 52 | 20 |
| Tamoxifen group | 160 | 2420 | 78 | 8 | 34 | 13 |
| Placebo group | 161 | 2433 | 92 | 4 | 18 | 7 |
| Median age (years): | ||||||
| All participants | 51 | 51 | 51 | 54 | 51 | 50 |
| Tamoxifen | 52 | 51 | 50 | 54 | 51 | 50 |
| Placebo | 50 | 52 | 51 | 54 | 51 | 49 |
| Median weight (kg): | ||||||
| All participants | 70 | 64 | 69 | 63 | 70 | 70 |
| Tamoxifen | 70 | 65 | 67 | 60 | 70 | 69 |
| Placebo | 67 | 64 | 70 | 73 | 71 | 72 |
| Median body mass index (kg/m2): | ||||||
| All participants | 27.0 | 25.0 | 27.1 | 26.0 | 28.1 | 27.3 |
| Tamoxifen | 27.6 | 25.0 | 26.6 | 26.0 | 28.2 | 28.0 |
| Placebo | 26.3 | 25.0 | 27.7 | 25.3 | 26.7 | 25.9 |
| Diabetes (No (%)): | ||||||
| All participants | 17 (5.3) | 89 (1.8) | 6 (3.5) | - | 3 (5.8) | 1 (5.0) |
| Tamoxifen | 11 (6.9) | 48 (2.0) | 2 (2.6) | - | 0 | 0 |
| Placebo | 6 (3.7) | 41 (1.7) | 4 (4.3) | - | 3 (16.7) | 1 (14.3) |
| Median cholesterol (mmol/l): | ||||||
| All participants | 5.8 | 5.9 | 5.8 | 6.2 | 6.2 | 6.5 |
| Tamoxifen | 5.7 | 5.9 | 5.7 | 6.2 | 6.0 | 6.4 |
| Placebo | 5.9 | 5.9 | 5.8 | 6.1 | 6.6 | 6.6 |
| Cholesterol 6.5-7.8 mmol/l (No (%)): | ||||||
| All participants | 75 (23.4) | 1202 (24.8) | 23 (13.5) | 4 (33.3) | 14 (26.9) | 7 (35.0) |
| Tamoxifen | 35 (21.9) | 607 (25.1) | 11 (14.1) | 3 (37.5) | 8 (23.5) | 5 (38.5) |
| Placebo | 40 (24.8) | 599 (24.6) | 12 (13.0) | 1 (25.0) | 6 (33.3) | 2 (28.6) |
| Cholesterol > 7.8 mmol/l (No (%)): | ||||||
| All participants | 13 (4.0) | 244 (5.0) | 11 (6.5) | - | 7 (13.5) | 3 (15.0) |
| Tamoxifen | 6 (3.8) | 120 (5.0) | 4 (5.1) | - | 3 (8.8) | 1 (7.7) |
| Placebo | 7 (4.3) | 124 (5.1) | 7 (7.6) | - | 4 (22.2) | 2 (28.6) |
| Hypertension‡ (No (%)): | ||||||
| All participants | 49 (15.3) | 623 (12.8) | 27 (15.9) | 2 (16.7) | 13 (25.0) | 5 (25.0) |
| Tamoxifen | 31 (19.4) | 300 (12.4) | 12 (15.4) | 1 (12.5) | 8 (23.5) | 4 (30.7) |
| Placebo | 18 (11.2) | 323 (13.3) | 15 (16.3) | 1 (25.0) | 5 (27.8) | 1 (14.3) |
ALT= alanine aminotransferase; HBV/HCV/ANA(+)=positive for hepatitis B/C virus or antinuclear antibody; NAFLD=non-alcoholic fatty liver disease; ULN=upper limit of normal.
*
Women with normal ALT at baseline, with two or more elevations of ALT ≥1.5×ULN during follow up over at least six months and with no evidence of hepatitis B or C virus infection.
†
Diagnosis of NAFLD confirmed by biopsy.
‡
Normalised by treatment.