Table 1.
Participant enrollment and baseline characteristics
| Total number of control= 470600 person-years | ||||
|---|---|---|---|---|
| Traditional NSAIDs (N=123,419 person years) | Coxibs (N=16,392 person years) | Unexposed (N=340,396 person years) | P-value | |
| Number of TB cases | 1407 | 206 | 3206 | N.A |
| Demographics | ||||
| Male sex (%) | 84623 (68.6) | 10420 (63.6) | 245077 (72.0) | <.0001 |
| Age mean (year) | 63.1±17.5 | 75.5±9.8 | 55.9±19.9 | <.0001 |
| Index year (%) | ||||
| 1999 | 8740 (7.1) | 0 | 24660 (7.2) | <.0001 |
| 2000 | 10496 (8.5) | 0 | 28004 (8.2) | |
| 2001 | 10168 (8.2) | 80 (0.5) | 26409 (7.8) | |
| 2002 | 11097 (8.9) | 990 (6.0) | 29178 (8.6) | |
| 2003 | 11271 (9.1) | 2104 (12.8) | 29385 (8.6) | |
| 2004 | 10658 (8.6) | 2463 (15.0) | 28264 (8.3) | |
| 2005 | 11368 (9.2) | 2122 (13.0) | 30022 (8.8) | |
| 2006 | 9328 (7.6) | 1143 (6.9) | 26013 (7.6) | |
| 2007 | 8046 (6.5) | 1091 (6.7) | 22810 (6.7) | |
| 2008 | 9164 (7.4) | 1429 (8.7) | 26625 (8.1) | |
| 2009 | 7438 (6.0) | 1452 (8.9) | 22080 (6.5) | |
| 2010 | 7942 (6.4) | 1704 (10.4) | 23837 (7.0) | |
| 2011 | 7585 (6.2) | 1814 (11.1) | 21827 (6.4) | |
| Area : urban region | 52030 (42.2) | 6788 (41.4) | 169458 (49.8) | <.0001 |
| Area : metro area | 31446 (25.5) | 3897 (23.8) | 85565 (25.1) | |
| Area : suburban area | 26117 (21.2) | 3531 (21.5) | 59604 (17.5) | |
| Area : countryside area | 13826 (11.2) | 2176 (13.3) | 25769 (7.6) | |
| Annual insurance premium | ||||
| Dependent | 10446 (8.6) | 2349 (14.6) | 28046 (8.3) | <.0001 |
| <666 USD | 37517 (30.7) | 6355 (39.5) | 90984 (26.9) | |
| 666-1331 USD | 52657 (43.2) | 5914 (36.8) | 139440 (41.3) | |
| >= 1331 USD | 21424 (17.6) | 1462 (9.1) | 79315 (23.5) | |
| Comorbidity score | ||||
| Baseline combined comorbidity score | 1.41±1.94 | 2.54±2.43 | 0.84±1.54 | <.0001 |
| Individual comorbidity | ||||
| Peripheral vascular disease | 9704 (7.9) | 2539 (15.8) | 13440 (4.0) | <.0001 |
| Congestive heart failure | 14689 (12.0) | 4049 (25.2) | 20203 (6.0) | <.0001 |
| Myocardial infarction/acute coronary syndromes | 3842 (3.2) | 947 (5.9) | 6008 (1.8) | <.0001 |
| Cerebrovascular disease | 25397 (20.8) | 6550 (40.7) | 40531 (12.0) | <.0001 |
| Dementia | 4412 (3.6) | 1439 (8.9) | 9242 (2.7) | <.0001 |
| Chronic pulmonary disease | 51073 (41.9) | 10138 (63.1) | 86738 (25.7) | <.0001 |
| Rheumatologic disease | 4587 (3.8) | 1231 (7.7) | 5615 (1.7) | <.0001 |
| Peptic ulcer disease | 51084 (41.9) | 10386 (64.6) | 84019 (24.9) | <.0001 |
| Mild liver disease | 39309 (32.2) | 6968 (43.3) | 68469 (20.3) | <.0001 |
| Diabetes without chronic complications | 26942 (22.1) | 5782 (35.9) | 45868 (13.6) | <.0001 |
| Diabetes with chronic complications | 8356 (6.9) | 2053 (12.8) | 13954 (4.1) | <.0001 |
| Hemiplegia or paraplegia | 5199 (4.3) | 1263 (7.9) | 9365 (2.8) | <.0001 |
| Renal disease | 11377 (9.3) | 2978 (18.5) | 16967 (5.0) | <.0001 |
| Any malignancy, including leukemia and lymphoma | 11991 (9.8) | 2900 (18.0) | 19535 (5.8) | <.0001 |
| Moderate or severe liver disease | 690 (0.6) | 157 (1.0) | 1252 (0.4) | <.0001 |
| Metastatic solid tumor | 1245 (1.0) | 271 (1.7) | 2041 (0.6) | <.0001 |
| AIDS/HIV | 84 (0.07) | 15 (0.09) | 154 (0.05) | 0.003 |
| Alcohol/drug use | 3425 (2.8) | 549 (3.4) | 6826 | <.0001 |
| Psychiatric disorder | 43667 (35.8) | 8652 (53.8) | 66012 (19.5) | <.0001 |
| Neurologic disorder | 7046 (5.8) | 2069 (12.9) | 12232 (3.6) | <.0001 |
| Obesity | 1194 (0.9) | 223 (1.4) | 1892 (0.6) | <.0001 |
| Other Cancer except Metastatic solid tumor | 36548 (29.9) | 7072 (43.9) | 68592 (20.3) | <.0001 |
| COPD | 37556 (30.8) | 8128 (50.6) | 58896 (17.4) | <.0001 |
| Silicosis | 218 (0.2) | 32 (0.2) | 258 (0.1) | <.0001 |
| Gastrointestinal or esophageal hemorrhage | 7319 (6.0) | 1865 (11.6) | 12848 (3.8) | <.0001 |
| Risk factors | ||||
| Pregnancy | 913 (0.8) | 49 (0.3) | 3171 (0.9) | <.0001 |
| bed-ridden status | 1561 (1.3) | 361 (2.3) | 2408 (0.7) | <.0001 |
| Solid organ transplantation such as renal or heart transplantation | 15 (0.01) | 2 (0.01) | 77 (0.02) | 0.04 |
| Malnutrition | 678 (0.6) | 129 (0.8) | 928 (0.3) | <.0001 |
| Postgastric surgery | 34 (0.03) | 7 (0.04) | 30 (0.01) | <.0001 |
| Healthcare service utilization in the previous year | ||||
| The number of outpatient department visits | 32.4±25.1 | 42.1±27.6 | 14.1±15.9 | <.0001 |
| The number of emergency department visits | 0.2±0.87 | 0.4±1.26 | 0.1±0.51 | <.0001 |
| The number of hospitalizations | 0.3±0.87 | 0.5±1.12 | 0.2±0.9 | <.0001 |
| Medication use | ||||
| Aspirin | 25603 (20.9) | 5118 (31.8) | 32912 (9.7) | <.0001 |
| Systemic immunosuppressive agents and biologics | 416 (0.3) | 284 (1.8) | 336 (0.1) | <.0001 |
| Systemic corticosteroids | 26268 (21.5) | 4526 (28.2) | 23802 (7.1) | <.0001 |
| DMARDs (disease modifying anti-rheumatic drugs) | 2165 (1.8) | 694 (4.3) | 2150 (0.6) | <.0001 |
| Statin | 9380 (7.7) | 2233 (13.9) | 14224 (4.2) | <.0001 |
| ACE inhibitors | 17324 (14.2) | 2925 (18.2) | 23278 (6.9) | <.0001 |
| Beta blockers | 21155 (17.3) | 3771 (23.5) | 27789 (8.2) | <.0001 |
| Loop diuretics | 8569 (7.0) | 2295 (14.3) | 9196 (2.7) | <.0001 |
| Angiotensin II antagonists | 12596 (10.3) | 3789 (23.6) | 19482 (5.8) | <.0001 |
| Digoxin | 2925 (2.4) | 690 (4.3) | 4265 (1.3) | <.0001 |
| Nitrates | 9178 (7.5) | 2133 (13.3) | 11539 (3.4) | <.0001 |
| Antipsychotics | 434 (0.4) | 129 (0.8) | 1190 (0.4) | 0.01 |
| Proton-pump inhibitors(PPI) | 5977 (4.9) | 1606 (9.9) | 8098 (2.4) | <.0001 |
| CA channel blocker | 33842 (27.7) | 7126 (44.3) | 47053 (13.9) | <.0001 |
| Acetaminophen | 63673 (52.2) | 8965 (55.8) | 78967 (23.4) | <.0001 |