Table 1. Baseline characteristics of cases with symptomatic UGI events (UGI bleeding and symptomatic ulcer) and matched controls by database.
| United Kingdom | The Netherlands | Italy | |||||||
|---|---|---|---|---|---|---|---|---|---|
| cases N=307 |
controls N=48,860 |
P- value |
cases N=17 |
controls N=374 |
P- value |
cases N=74 |
controls N=8,334 |
P-value | |
| n(%) | n(%) | n(%) | n(%) | n(%) | n(%) | ||||
| Age in yrs (mean±sd) * | 74.0 (10.9) | 71.2 (9.5) | NA | 75.0 (9.6) | 73.9 (9.7) | NA | 69.9 (10.4) | 68.5 (9.4) | NA |
| Age category: * | NA | NA | NA | ||||||
| 50 – 64 | 60 (19.5) | 12,222 (25.0) | 2 (11.8) | 63 (16.8) | 26 (35,1) | 3,385 (40.6) | |||
| 65 – 74 | 101 (32.9) | 18,422 (37.7) | 6 (35.3) | 119 (31.8) | 22 (29,7) | 2,534 (30.4) | |||
| ≥ 75 | 146 (47.6) | 18,216 (37.3) | 9 (52.9) | 192 (51.3) | 26 (35,1) | 2,415 (29.0) | |||
| Gender (n(%) male) * | 132 (43.0) | 13,544 (27.7) | NA | 5 (29.4) | 71 (19.0) | NA | 20 (27.0) | 1,668 (20.0) | NA |
| UGI risk factors: | |||||||||
| Age ≥ 65 yrs | 247 (80.5) | 36,638 (75.0) | 0.243 | 15 (88.2) | 311 (83.2) | - | 48 (64.9) | 4,949 (59.4) | 0.670 |
| Prior UGI event | 57 (18.6) | 2,634 (5.4) | 0.028 | 1 (5.9) | 4 (1.1) | 0.694 | 2 (2.7) | 101 (1.2) | 0.282 |
| Use of antiplatelets | 106 (34.5) | 11,647 (23.8) | 0.123 | 10 (58.8) | 86 (23.0) | 0.042 | 12 (16.2) | 329 (3.9) | 0.007 |
| Use of anticoagulants | 14 (4.6) | 676 (1.4) | 0.032 | 1 (5.9) | 14 (3.7) | 0.912 | 0 (0) | 36 (0.4) | - |
| Use of glucocorticoids | 18 (5.9) | 1,298 (2.7) | 0.289 | 0 (0) | 11 (2.9) | - | 3 (4.1) | 98 (1.2) | 0.143 |
| Number of UGI risk factors: * | NA | NA | NA | ||||||
| 0 | 36 (11.7) | 10,578 (21.6) | 2 (11.8) | 61 (16.3) | 24 (32.4) | 3,300 (39.6) | |||
| 1 | 131 (42.7) | 24,332 (49.8) | 4 (23.5) | 205 (54.8) | 35 (47.3) | 4,567 (54.8) | |||
| 2 | 112 (36.5) | 13,310 (27.2) | 10 (58.8) | 103 (27.5) | 15 (20.3) | 455 (5.5) | |||
| 3 | 25 (8.1) | 619 (1.3) | 1 (5.9) | 5 (1.3) | 0 (0) | 12 (0.1) | |||
| 4 | 3 (1) | 21 (0) | |||||||
| Other comorbidities: | |||||||||
| Dyspepsia | 14 (4.6) | 1,613 (3.3) | 0.222 | 1 (5.9) | 16 (4.3) | 0.555 | 2 (2.7) | 296 (3.6) | 0.770 |
| Smoking | 252 (82.1) | 39,153 (80.1) | 0.272 | 4 (23.5) | 54 (14.4) | 0.599 | 3 (4.1) | 278 (3.3) | 0.714 |
| Heart Failure | 31 (10.1) | 2,101 (4.3) | 0.158 | 0 (0) | 34 (9.1) | - | 1 (1.4) | 138 (1.7) | 0.487 |
| Diabetes mellitus | 63 (20.5) | 6,542 (13.4) | 0.062 | 2 (11.8) | 62 (16.6) | 0.525 | 13 (17.6) | 878 (10.5) | 0.151 |
| Concomitant use of other medication: | |||||||||
| SSRIs | 34 (11.1) | 3,071 (6.3) | <0.001 | 0 (0) | 14 (3.7) | - | 1 (1.4) | 29 (0.3) | 0.341 |
| Spironolactone | 5 (1.6) | 391 (0.8) | 0.423 | 0 (0) | 6 (1.6) | - | (0) | (0) | - |
| calcium channel blockers | 68 (22.1) | 7,619 (15.6) | 0.097 | 0 (0) | 45 (12.0) | - | (0) | (0) | 0.646 |
| Duration of episode#: | |||||||||
| < 1 month | 151 (49.2) | 25,888 (53.0) | 0.150 | 6 (35.3) | 254 (67.9) | 0.046 | 66 (89.2) | 7,111 (85.3) | 0.329 |
| 1-6 months | 106 (34.5) | 13,921 (28.5) | 0.036 | 8 (47.1) | 95 (25.4) | 0.025 | 7 (9.5) | 1,151 (13.8) | 0.440 |
| 6-12 months | 24 (7.8) | 4,095 (8.4) | 0.859 | 1 (5.9) | 14 (3.7) | 0.306 | 0 (0) | 48 (0.6) | - |
| < 12 months | 26 (8.5) | 4,956 (10.1) | 0.842 | 2 (11.8) | 11 (2.9) | 0.025 | 1 (1.4) | 24 (0.3) | 0.098 |
*
Matching variables: age, gender and number of individual UGI risk factors.
SSRIs, selective serotonin reuptake inhibitors.
NA, Not applicable; matching criteria.
#
Episodes of NSAID use were defined as consecutive NSAID prescriptions with intervening gaps not exceeding the duration of the previous NSAID prescription. The duration of an NSAID episode was calculated by dividing the prescribed quantity by daily dose regimen (United Kingdom/Netherlands) or the indication-specific defined daily dose (Italy). The end of an NSAID episode was defined as the end of the duration of the last NSAID prescription within that episode or the end of follow-up, whichever was earliest.