Background
Methods
Subjects
Hong Kong Diabetes Registry
Primary and secondary prevention
Clinical endpoints
Sample size estimation
Statistical analysis
Results
Demographics
Overall (n = 6,454) | Aspirin users (n = 1,619) | Non-aspirin users (n = 4,835) | p-value‡ | |
---|---|---|---|---|
Age, years | 58.0 ± 12.8 | 65.7 ± 10.2 | 55.4 ± 12.6 | < 0.001 |
Male, n (%) | 2,928 (45.4) | 819 (50.6) | 2,109 (43.6) | < 0.001 |
Duration of diabetes, years | 8.1 ± 6.9 | 11.4 ± 7.5 | 7.0 ± 6.3 | < 0.001 |
Smoking (current), n (%) | 1,033 (16.1) | 253 (15.7) | 780 (16.2) | < 0.001 |
Alcohol (current), n (%) | 517 (8.1) | 100 (6.2) | 417 (8.7) | < 0.001 |
Systolic blood pressure, mmHg | 136.2 ± 20.3 | 142.6 ± 21.7 | 134.1 ± 19.4 | < 0.001 |
Diastolic blood pressure, mmHg | 75.1 ± 10.6 | 75.1 ± 11.2 | 75.1 ± 10.3 | 0.848 |
Body weight, kg | 63.4 ± 12.3 | 63.3 ± 11.8 | 63.5 ± 12.5 | 0.583 |
Body mass index, kg/m2 | 25.2 ± 3.9 | 25.3 ± 3.7 | 25.2 ± 4.0 | 0.135 |
Waist circumference (cm): Males | 88.7 ± 9.6 | 90.1 ± 8.7 | 88.4 ± 9.8 | < 0.001 |
Females | 83.8 ± 10.0 | 85.5 ± 9.9 | 83.6 ± 9.9 | < 0.001 |
Glycosylated haemoglobin, % | 7.59 ± 1.69 | 7.72 ± 1.68 | 7.57 ± 1.69 | < 0.001 |
Fasting plasma glucose, mmol/L | 8.59 ± 3.10 | 8.57 ± 3.18 | 8.59 ± 3.09 | 0.046 |
Total cholesterol, mmol/L | 5.21 ± 1.05 | 5.09 ± 1.06 | 5.23 ± 1.05 | 0.167 |
LDL cholesterol, mmol/L | 3.19 ± 0.95 | 3.06 ± 0.97 | 3.21 ± 0.94 | 0.286 |
HDL cholesterol, mmol/L | 1.30 ± 0.38 | 1.26 ± 0.33 | 1.31 ± 0.39 | < 0.001 |
Serum triglycerides, mmol/L † | 1.45 (1.43, 1.47) | 1.58 (1.53, 1.64) | 1.43 (1.41, 1.45) | < 0.001 |
Serum creatinine, μmol/L † | 83.2 (82.4, 83.9) | 97.1 (95.0, 99.2) | 79.1 (78.3, 79.8) | < 0.001 |
Estimated GFR# | 74.6 (73.8, 75.3) | 58.6 (56.8, 60.5) | 77.6 (76.8, 78.5) | < 0.001 |
Spot urine ACR, mg/mmol † | 3.7 (3.6, 3.9) | 8.3 (7.4, 9.2) | 2.9 (2.7, 3.0) | < 0.001 |
Blood haemoglobin, g/dL | 13.7 ± 1.6 | 13.4 ± 1.7 | 13.8 ± 1.6 | < 0.001 |
Peripheral vascular disease, n (%) | 400 (6.2) | 223 (13.8) | 177 (3.7) | < 0.001 |
Lower extremity amputation, n (%) | 26 (0.4) | 13 (0.8) | 13 (0.3) | 0.003 |
Ischaemic heart disease, n (%) | 281 (4.4) | 240 (14.8) | 41 (0.8) | < 0.001 |
Myocardial infarction, n (%) | 67 (1) | 65 (4) | 2 (0) | < 0.001 |
Coronary revascularisation, n (%) | 77 (1.2) | 75 (4.6) | 2 (0) | < 0.001 |
Congestive heart failure, n (%) | 119 (1.8) | 85 (5.3) | 34 (0.7) | < 0.001 |
Stroke, n (%) | 256 (4) | 221 (13.7) | 35 (0.7) | < 0.001 |
Atrial fibrillation, n (%) | 70 (1.1) | 35 (2.2) | 35 (0.7) | < 0.001 |
Overall (n = 6,454) | Aspirin users (n = 1,619) | Non-aspirin users (n = 4,835) | p-value† | |
---|---|---|---|---|
Anti-diabetic drugs
| ||||
Insulin | 1,203 (18.6%) | 458 (28.3%) | 745 (15.4%) | < 0.001 |
Any oral agent | 4,301 (66.6%) | 1,128 (69.7%) | 3,173 (65.6%) | 0.003 |
Sulphonylurea | 3,461 (53.6%) | 928 (57.3%) | 2,533 (52.4%) | 0.001 |
Metformin | 3,189 (49.4%) | 839 (51.8%) | 2,350 (48.6%) | 0.025 |
Thiazolidinedione | 27 (0.4%) | 9 (0.6%) | 18 (0.4%) | 0.322 |
Anti-hypertensive drugs
| ||||
Any anti-hypertensive drugs | 3,103 (48.1%) | 1,135 (70.1%) | 1,968 (40.7%) | < 0.001 |
Number of anti-hypertensive drugs* | 0.8 ± 1.0 | 1.3 ± 1.1 | 0.6 ± 0.9 | < 0.001 |
Any RAS inhibitor | 1,632 (25.3%) | 615 (38%) | 1,017 (21%) | < 0.001 |
ACE inhibitor | 1,519 (23.5%) | 564 (34.8%) | 955 (19.8%) | < 0.001 |
AII antagonist | 123 (1.9%) | 57 (3.5%) | 66 (1.4%) | < 0.001 |
Thiazide or related diuretic | 162 (2.5%) | 61 (3.8%) | 101 (2.1%) | < 0.001 |
Loop diuretic | 217 (3.4%) | 129 (8%) | 88 (1.8%) | < 0.001 |
Beta-blocker | 756 (11.7%) | 386 (23.8%) | 370 (7.7%) | < 0.001 |
Alpha-blocker | 189 (2.9%) | 83 (5.1%) | 106 (2.2%) | < 0.001 |
Calcium channel blocker | 1,838 (28.5%) | 697 (43.1%) | 1,141 (23.6%) | < 0.001 |
Centrally-acting agent | 309 (4.8%) | 117 (7.2%) | 192 (4%) | < 0.001 |
Vasodilator | 19 (0.3%) | 12 (0.7%) | 7 (0.1%) | < 0.001 |
Other cardiovascular drugs
| ||||
Statin | 902 (14%) | 434 (26.8%) | 468 (9.7%) | < 0.001 |
Fibrate | 232 (3.6%) | 76 (4.7%) | 156 (3.2%) | 0.006 |
Digoxin | 65 (1%) | 33 (2%) | 32 (0.7%) | < 0.001 |
Anti-arrhythmic drug | 20 (0.3%) | 9 (0.6%) | 11 (0.2%) | 0.040 |
Oral anticoagulant | 59 (0.9%) | 9 (0.6%) | 50 (1%) | 0.080 |
Antiplatelet drug other than aspirin | 24 (0.4%) | 14 (0.9%) | 10 (0.2%) | < 0.001 |
Other drugs
| ||||
NSAID | 157 (2.4%) | 46 (2.8%) | 111 (2.3%) | 0.218 |
Oral corticosteroid | 83 (1.3%) | 19 (1.2%) | 64 (1.3%) | 0.643 |
Proton pump inhibitor | 25 (0.4%) | 10 (0.6%) | 15 (0.3%) | 0.085 |
Histamine H2-receptor antagonist | 191 (3%) | 87 (5.4%) | 104 (2.2%) | < 0.001 |
Misoprostol | 1 (0%) | 0 (0%) | 1 (0%) | 0.563 |
Clinical endpoint of vascular outcomes and major gastrointestinal bleeding
Overall | Aspirin users | Non-aspirin users | Hazard ratio* (95% CI) | p-value† | |
---|---|---|---|---|---|
Primary prevention cohort:
| n = 5,731 | n = 1,034 | n = 4,697 | - |
-
|
Primary composite endpoint | 398 (6.9%) | 138 (13.3%) | 260 (5.5%) | 2.07 (1.66 to 2.59) | < 0.001 |
Vascular death | 115 (2%) | 54 (5.2%) | 61 (1.3%) | 2.61 (1.70 to 4.01) | < 0.001 |
Non-fatal myocardial infarct | 67 (1.2%) | 27 (2.6%) | 40 (0.9%) | 2.05 (1.11 to 3.79) | 0.023 |
Non-fatal stroke | 251 (4.4%) | 71 (6.9%) | 180 (3.8%) | 1.52 (1.14 to 2.04)# | 0.005# |
Secondary prevention cohort:
| n = 723 | n = 585 | n = 138 | - | - |
Primary composite endpoint | 145 (20.1%) | 116 (19.8%) | 29 (21%) | 0.91 (0.60 to 1.37)# | NS |
Vascular death | 69 (9.5%) | 55 (9.4%) | 14 (10.1%) | 0.92 (0.51 to 1.69)# | NS |
Non-fatal myocardial infarct | 23 (3.2%) | 20 (3.4%) | 3 (2.2%) | 1.42 (0.42 to 4.85)# | NS |
Non-fatal stroke | 73 (10.1%) | 55 (9.4%) | 18 (13%) | 0.71 (0.42 to 1.23)# | NS |
Complete cohort:
| n = 6,454 | n = 1,619 | n = 4,835 | - | - |
Upper gastrointestinal bleeding | 138 (2.1%) | 70 (4.3%) | 68 (1.4%) | 2.19 (1.53 to 3.15) | < 0.001 |
Endoscopically-confirmed ulcer bleeding | 68 (1.1%) | 33 (2%) | 35 (0.7%) | 1.72 (1.02 to 2.91) | 0.043 |
Haemorrhagic stroke | 61 (0.9%) | 25 (1.5%) | 36 (0.7%) | 1.71 (1.00 to 2.95)# | 0.051# |