Baseline characteristics and incidence of acute pancreatitis
| Nondiabetic | Diabetic | P value Nondiabetic vs. diabetic | Exenatide | Sitagliptin | Diabetes control | P value | ||
|---|---|---|---|---|---|---|---|---|
| Exenatide vs. diabetes control | Sitagliptin vs. diabetes control | |||||||
| Patient characteristics | ||||||||
| No. of subjects | 748,041 | 38,615 | 6,545 | 15,826 | 16,244 | |||
| Age (years) | 51.4 ± 8.3 | 52.7 ± 7.5 | <0.0001 | 51.4 ± 8.0 | 53.1 ± 7.3 | 52.9 ± 7.4 | <0.0001 | NS |
| Female sex | 346,427 (46.3) | 17,662 (45.7) | <0.05 | 3,699 (56.5) | 7,011 (44.3) | 6,952 (42.8) | <0.0001 | <0.01 |
| Chronic disease score (1 year) | 16.8 ± 13.3 | 31.4 ± 16.8 | <0.0001 | 35.7 ± 17.8 | 31.2 ± 16.8 | 30.0 ± 16.0 | <0.0001 | <0.0001 |
| Medications (diabetes and lipid: ≥1 claims during wash-in) | ||||||||
| No. of classes of diabetes medications | 0 | 1.5 ± 0.7 | 1.7 ± 0.7 | 1.7 ± 0.7 | 1.3 ± 0.4 | <0.0001 | <0.0001 | |
| Sulfonylureas | 0 | 16,621 (43.0) | 3,220 (49.2) | 7,693 (48.6) | 5,708 (35.1) | <0.0001 | <0.0001 | |
| Metformin | 0 | 27,581 (71.4) | 5,335 (81.5) | 12,543 (79.3) | 9,703 (59.7) | <0.0001 | <0.0001 | |
| Thiazolidinediones | 0 | 14,627 (37.9) | 2,878 (44.0) | 6,751 (42.7) | 4,998 (30.8) | <0.0001 | <0.0001 | |
| Fibrates | 33,680 (4.5) | 4,032 (10.4) | <0.0001 | 719 (11.0) | 1,757 (11.1) | 1,556 (9.6) | 0.0014 | <0.0001 |
| Statins | 329,394 (44.0) | 21,746 (56.3) | <0.0001 | 3,791 (57.9) | 9,256 (58.5) | 8,699 (53.5) | <0.0001 | <0.0001 |
| Nicotinic acid | 16,694 (2.2) | 1,171 (3.0) | <0.0001 | 236 (3.6) | 524 (3.3) | 411 (2.5) | <0.0001 | <0.0001 |
| Bile acid sequestrant | 5,685 (0.8) | 289 (0.7) | NS | 58 (0.9) | 125 (0.8) | 106 (0.6) | NS | NS |
| Ezetimibe | 25,967 (3.5) | 1,838 (4.8) | <0.0001 | 329 (5.0) | 844 (5.3) | 665 (4.1) | <0.005 | <0.0001 |
| Risk factors (medications): ≥1 claim during wash-in | ||||||||
| Azathioprine | 1,077 (0.1) | 57 (0.1) | NS | 9 (0.1) | 27 (0.2) | 21 (0.1) | NS | NS |
| Glucocorticoids | 51,353 (6.9) | 2,373 (6.1) | <0.0001 | 410 (6.3) | 969 (6.1) | 994 (6.1) | NS | NS |
| Sulfonamides | 18,970 (2.5) | 1,482 (3.8) | <0.0001 | 295 (4.5) | 597 (3.8) | 590 (3.6) | <0.005 | NS |
| Nonsteroidal anti-inflammatory drugs | 61,387 (8.2) | 3,765 (9.7) | <0.0001 | 678 (10.4) | 1,498 (9.5) | 1,589 (9.8) | NS | NS |
| Mercaptopurine | 44 (0.01) | 16 (0.04) | <0.0001 | 2 (0.03) | 7 (0.04) | 7 (0.04) | NS | NS |
| Methyldopa | 689 (0.09) | 27 (0.07) | NS | 7 (0.11) | 8 (0.05) | 12 (0.07) | NS | NS |
| Tetracyclines | 21,073 (2.8) | 1,132 (2.9) | NS | 188 (2.8) | 466 (2.9) | 478 (2.9) | NS | NS |
| Risk factors (ICD-9): ≥1 claim during wash-in | ||||||||
| Pancreatic disease | 455 (0.06) | 53 (0.14) | <0.0001 | 4 (0.06) | 22 (0.14) | 27 (0.17) | NS | NS |
| Alcohol abuse | 1,881 (0.25) | 60 (0.16) | 0.0002 | 7 (0.11) | 20 (0.13) | 33 (0.20) | NS | NS |
| Biliary stone disease | 4,500 (0.60) | 323 (0.84) | <0.0001 | 54 (0.83) | 148 (0.94) | 121 (0.74) | NS | NS |
| Hypertriglyceridemia | 7,071 (0.95) | 661 (1.71) | <0.0001 | 135 (2.06) | 293 (1.85) | 233 (1.43) | <0.001 | <0.005 |
| Cholestatic liver disease | 2,253 (0.30) | 104 (0.27) | NS | 15 (0.23) | 46 (0.29) | 43 (0.26) | NS | NS |
| Pancreatitis | ||||||||
| Patient follow-up (years) | 1.2 ± 0.4 | 0.7 ± 0.5 | <0.0001 | 0.6 ± 0.5 | 0.8 ± 0.5 | 0.7 ± 0.5 | <0.0001 | <0.0001 |
| New acute pancreatitis | 1,746 (0.2) | 154 (0.4) | <0.0001 | 22 (0.3) | 67 (0.4) | 65 (0.4) | NS | NS |
| Incidence of new acute pancreatitis (cases/100,000 patient-years) | 190.5 | 563.9 | 569.9 | 554.4 | 571.9 | |||
Data are means ± SD or n (%).