Table 2.
Major clinical parameters during the trial in 98 participants receiving LDBen and 98 participants receiving LDFeb*
| Baseline | Week 4 | Week 8 | Week 12 | |
|---|---|---|---|---|
| Completed follow‐up, no. (%) of patients | ||||
| LDBen | 98 (100) | 97 (99) | 96 (98) | 92 (94) |
| LDFeb | 98 (100) | 98 (100) | 96 (98) | 91 (93) |
| Serum urate, median (IQR) mg/dl | ||||
| LDBen | 8.70 (7.91–9.06) | 5.60 (5.26–6.34)†, ‡ | 5.74 (5.22–6.60)†, ‡ | 5.57 (5.08–6.46)†, ‡ |
| LDFeb | 8.77 (8.10–9.27) | 6.12 (5.55–7.16)‡ | 6.44 (5.84–7.21)‡ | 6.42 (5.77–7.03)‡ |
| Fasting glucose, mean ± SD mmoles/liter | ||||
| LDBen | 5.52 ± 0.68 | 5.35 ± 0.54†, ‡ | 5.34 ± 0.44†, ‡ | 5.39 ± 0.51 |
| LDFeb | 5.56 ± 0.63 | 5.65 ± 0.58 | 5.69 ± 0.59§ | 5.54 ± 0.58 |
| Cholesterol, mean ± SD mmoles/liter | ||||
| LDBen | 4.84 ± 0.82 | 4.80 ± 0.84 | 4.84 ± 0.86 | 4.80 ± 0.85 |
| LDFeb | 4.76 ± 1.17 | 4.77 ± 0.99 | 4.83 ± 0.93 | 4.85 ± 1.01 |
| Triglycerides, median (IQR) mmoles/liter | ||||
| LDBen | 1.69 (1.17–2.34) | 1.57 (1.19–1.99) | 1.56 (1.14–2.00)§ | 1.50 (1.19–2.11)‡ |
| LDFeb | 1.67 (1.25–2.52) | 1.74 (1.22–2.67) | 1.65 (1.17–2.44) | 1.77 (1.17–2.50) |
| AST, median (IQR) units/liter | ||||
| LDBen | 21.00 (18.00–24.25) | 20 (17–23)†, § | 21.00 (17.25–23.75) | 20.00 (16.25–23.00)† |
| LDFeb | 19 (17–24) | 22 (18–27)‡ | 21 (18–28)‡ | 22 (18–28)‡ |
| ALT, median (IQR) units/liter | ||||
| LDBen | 26.0 (20.0–37.5) | 24 (18–33)‡ | 25.00 (19.00–33.75) | 24 (17–33)‡, ¶ |
| LDFeb | 23.50 (16.75–36.00) | 27 (18–37)§ | 27.00 (18.00–40.75)§ | 28 (19–40) |
| Creatinine, median (IQR) μmoles/liter | ||||
| LDBen | 82 (76–93) | 79.5 (72.0–88.0)‡ | 84 (76–91) | 81 (75–89) |
| LDFeb | 85.00 (76.00–95.25) | 81.0 (74.0–90.5)‡ | 82.5 (75.0–90.0)§ | 83 (74–91) |
| eGFR, mean ± SD ml/minute/1.73 m2 | ||||
| LDBen | 96.30 ± 15.51 | 100.57 ± 19.96§ | 96.86 ± 15.00 | 98.39 ± 15.42 |
| LDFeb | 94.60 ± 15.09 | 97.33 ± 16.71‡ | 97.85 ± 15.58§ | 97.40 ± 15.87 |
*
IQR = interquartile range; AST = aspartate aminotransferase; ALT = alanine aminotransferase; eGFR = estimated glomerular filtration rate.
†
P < 0.01 for low‐dose benzbromarone (LDBen) compared to low‐dose febuxostat (LDFeb).
‡
P < 0.01 for baseline values compared to weeks 4, 8, and 12 in the LDBen group or LDFeb group.
§
P < 0.05 for baseline values compared to weeks 4, 8, and 12 in the LDBen group or LDFeb group.
¶
P < 0.05 for LDBen compared to LDFeb.