Table 1

Characteristics of regular low-dose aspirin users with low risk of GI complications and low-dose aspirin users with an increased risk of GI complications, based on HARM-WRESTLING recommendations

Patients with increased risk of GI complications
N=3.213
Patients with low risk of GI complications
N=9.130
p Value*
Risk factors for GI complications at first prescription of LDASA (%)
 >80 years old2.543 (79.1)NANA
 >70 years old and simultaneous use of NSAIDs, oral anticoagulants, glucocorticosteroids, SSRIs and/or spironolacton623 (19.4)NANA
>60 years old and history of an ulcer47 (1.5)NANA
Sex (%)
 Men1.283 (39.9)5.352 (58.6)<0.0001
 Age (years) (SD)82.6 (6.1)62.1 (10.8)<0.0001
LDASA plus PPI use (%)
 No user of PPI1.142 (35.5) 4.541 (49.8)<0.0001
 Regular user of PPI1.480 (46.1)2.724 (29.8)
 Irregular user of PPI 591 (18.4)1.865 (20.4)
Comorbidity (%)
GI tract
 GI complications664 (20.7)1.475 (16.2)<0.0001
 Duodenal ulcer24 (0.8)21 (0.2)<0.0001
 Peptic ulcer34 (1.1)11 (0.1)<0.0001
 Hiatus hernia29 (0.9)58 (0.6)0.13
 Heart burn75 (2.3)233 (2.6)0.52
 Haematemesis7 (0.2)10 (0.1)0.19
 Rectal bleeding50 (1.6)97 (1.1)0.04
Cardiovascular diseases
 Cardiovascular diseases‡1.584 (49.3)4.196 (46.0)0.002
  Acute myocardial infarction223 (6.9) 792 (8.7)0.003
  Heart failure432 (13.5)257 (2.8)<0.0001
  Atrial fibrillation237 (7.4)509 (5.6)0.0003
  Ischaemic heart disease with angina476 (14.8)1.328 (14.6)0.72
  Ischaemic heart disease without angina173 (5.4)638 (7.0)0.003
  Atherosclerosis176 (5.5)644 (7.1)0.003
 Cerebrovascular diseases‡756 (23.5) 1.480 (16.2)<0.0001
  Stroke362 (11.3)731 (8.0)<0.0001
  TIA326 (10.2)541 (5.9)<0.0001
 Hypertension1.307 (40.7)3.546 (38.8)0.08
 Diabetes mellitus 779 (24.3)1.960 (21.5)0.002
 Hypercholesterolaemia1.567 (48.8)6.374 (69.8)<0.0001
Comedication (%)†
 Other drugs for acid-related disorders196 (6.1)477 (5.2)0.07
 Drugs for functional GI disorders277 (8.6)544 (6.0)<0.0001
 Cardiac therapy 964 (30.0)2.152 (23.6)<0.0001
Antihypertensive agents2.748 (85.5)7.357 (80.6)<0.0001
  Antihypertensives55 (1.7)171 (1.9)0.58
  Diuretics1.594 (49.6)2.456 (26.9)<0.0001
  β-blocking agents1.728 (53.8)5.250 (57.5)0.0005
  Calcium channel blockers 825 (25.7)2.113 (23.1)0.005
  RAAS agents1.672 (52.0)4.616 (50.6)0.17
Peripheral vasodilators4 (0.1)11 (0.1)1.00
Vasoprotectives103 (3.2)232 (2.5)0.06
Lipid modifying agents1.557 (48.5)6.311 (69.1)<0.0001
Antidiabetics624 (19.4)1.604 (17.6)0.03
  • *p Values are corrected for multiple testing by using false discovery rate.

  • †Determined in the year before and after the first prescription of LDASA.

  • ‡Not all indications are included, only the major ones.

  • GI, gastrointestinal; LDASA, low-dose acetylsalicyclic acid; NSAIDs, non-steroidal anti-inflammatory drugs; PPIs, proton-pump inhibitors; RAAS, renin-angiotensin-aldosterone system; SSRIs, selective serotonin reuptake inhibitors; TIA, Transient ischaemic attack.