Baseline characteristics of all study patients
| Characteristics | Modified ITT (n=6190) | ||||
| No CV event* (n=5534) | CV event* | P value (no CV event group vs CV event group)* | P value (during vs after)† | ||
| During administration† (n=448) | After discontinuation† (n=208) | ||||
| Treatment, n (%) | 0.5365 | 0.9958 | |||
| Febuxostat | 2763 (49.9) | 223 (49.8) | 112 (53.8) | ||
| Allopurinol | 2771 (50.1) | 225 (50.2) | 96 (46.2) | ||
| Median age, years (IQR) | 64.0 (58.0–70.0) | 66.0 (60.0–72.0) | 69.0 (62.0–75.0) | <0.0001 | 0.0054 |
| Age≥65, n (%) | 2704 (48.9) | 252 (56.4) | 140 (67.3) | <0.0001 | 0.0237 |
| Male, n (%) | 4627 (83.6) | 396 (88.4) | 173 (83.2) | 0.0283 | 0.1998 |
| Body mass index | 33.5±6.9 | 33.4±6.4 | 34.3±7.9 | 0.2502 | 0.2894 |
| Median duration of gout, years (IQR) | 7.8 (3.1–17.2) | 9.9 (3.4–20.8) | 5.4 (2.3–15.5) | 0.0025 | 0.0030 |
| Median number of gout flares (IQR) | 2.0 (1.0–4.0) | 3.0 (1.0–5.0) | 2.0 (1.0–4.0) | 0.0013 | 0.1545 |
| Median number of tophi (IQR) | 2.0 (1.0–4.0) | 2.0 (1.0–3.0) | 2.0 (2.0–5.0) | 0.0586 | 0.0434 |
| Baseline serum urate level, mean±SD | 8.7±1.7 | 9.0±1.7 | 9.4±1.8 | <0.0001 | 0.0104 |
| Cardiovascular risk factors and history, n (%) | |||||
| DM with small-vessel disease | 2175 (39.3) | 144 (32.1) | 87 (41.8) | 0.0077 | 0.0470 |
| Hypertension | 5091 (92.0) | 426 (95.1) | 198 (95.2) | 0.0175 | 1.0000 |
| Hyperlipidaemia | 4789 (86.5) | 407 (90.8) | 184 (88.5) | 0.0270 | 1.0000 |
| Myocardial infarction | 2072 (37.4) | 251 (56.0) | 105 (50.5) | <0.0001 | 0.5537 |
| Hospitalisation for unstable angina | 1473 (26.6) | 177 (39.5) | 74 (35.6) | <0.0001 | 1.0000 |
| Coronary revascularisation | 1955 (35.3) | 245 (54.7) | 111 (53.4) | <0.0001 | 1.0000 |
| Cerebral revascularisation | 102 (1.8) | 13 (2.9) | 8 (3.8) | 0.0450 | 1.0000 |
| Congestive heart failure | 1024 (18.5) | 152 (33.9) | 77 (37.0) | <0.0001 | 1.0000 |
| Stroke | 740 (13.4) | 96 (21.4) | 34 (16.3) | <0.0001 | 0.3858 |
| Peripheral vascular disease | 666 (12.0) | 73 (16.3) | 48 (23.1) | <0.0001 | 0.1114 |
P value by χ2 test, Fisher’s exact test, analysis of variance or Kruskal-Wallis test.
*, † Adjusted p value by χ2 test, Fisher’s exact test with Bonferroni adjustment method, Dwass, Steel, Critchlow–Fligner multiple comparison or Tukey’s multiple comparison method.
DM, diabetes mellitus; ITT, intention-to-treat; sUA, serum uric acid.