Table 1

Baseline characteristics of all study patients

CharacteristicsModified 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 (%)0.53650.9958
 Febuxostat2763 (49.9)223 (49.8)112 (53.8)
 Allopurinol2771 (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)<0.00010.0054
Age≥65, n (%)2704 (48.9)252 (56.4)140 (67.3)<0.00010.0237
Male, n (%)4627 (83.6)396 (88.4)173 (83.2)0.02830.1998
Body mass index33.5±6.933.4±6.434.3±7.90.25020.2894
Median duration of gout, years (IQR)7.8 (3.1–17.2)9.9 (3.4–20.8)5.4 (2.3–15.5)0.00250.0030
Median number of gout flares (IQR)2.0 (1.0–4.0)3.0 (1.0–5.0)2.0 (1.0–4.0)0.00130.1545
Median number of tophi (IQR)2.0 (1.0–4.0)2.0 (1.0–3.0)2.0 (2.0–5.0)0.05860.0434
Baseline serum urate level, mean±SD8.7±1.79.0±1.79.4±1.8<0.00010.0104
Cardiovascular risk factors and history, n (%)
 DM with small-vessel disease2175 (39.3)144 (32.1)87 (41.8)0.00770.0470
 Hypertension5091 (92.0)426 (95.1)198 (95.2)0.01751.0000
 Hyperlipidaemia4789 (86.5)407 (90.8)184 (88.5)0.02701.0000
 Myocardial infarction2072 (37.4)251 (56.0)105 (50.5)<0.00010.5537
 Hospitalisation for unstable angina1473 (26.6)177 (39.5)74 (35.6)<0.00011.0000
 Coronary revascularisation1955 (35.3)245 (54.7)111 (53.4)<0.00011.0000
 Cerebral revascularisation102 (1.8)13 (2.9)8 (3.8)0.04501.0000
 Congestive heart failure1024 (18.5)152 (33.9)77 (37.0)<0.00011.0000
 Stroke740 (13.4)96 (21.4)34 (16.3)<0.00010.3858
 Peripheral vascular disease666 (12.0)73 (16.3)48 (23.1)<0.00010.1114
  • 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.