Characteristics of pancreatitis events among sitagliptin- and placebo-treated participants in the TECOS study
| Characteristic . | Sitagliptin(N = 25) . | Placebo(N = 17) . |
|---|---|---|
| Symptoms | ||
| Abdominal pain | 22 (88) | 17 (100) |
| Vomiting | 11 (44) | 5 (29) |
| Evidence of pancreatic inflammation | ||
| Elevated pancreatic enzymes | 15 (60) | 14 (82) |
| Amylase or lipase >3× upper limit of normal | 13 | 13 |
| In patients with chronic pancreatitis, amylase, or lipase >2× upper limit of normal | 2 | 1 |
| Documented by imaging | 18 (72) | 7 (41) |
| Investigator reported pancreatitis etiology | ||
| Known or suspected etiology* | 15 (60) | 8 (47) |
| Alcohol | 2 | 0 |
| Biliary | 9 | 3 |
| History of pancreatitis | 6 | 6 |
| Other | 1 | 1 |
| Unknown† | 10 (40) | 9 (53) |
| Severity indices | ||
| Severe pancreatitis | 4 (16) | 0 (0) |
| Evidence of organ failure‡ | 1 | 0 |
| Local complications on imaging | 4 | 0 |
| Pancreatic necrosis | 3 | 0 |
| Pancreatic abscess | 2 | 0 |
| Pancreatic pseudocyst | 1 | 0 |
| Pancreatitis resulting in death§ | 2 | 0 |
| Characteristic . | Sitagliptin(N = 25) . | Placebo(N = 17) . |
|---|---|---|
| Symptoms | ||
| Abdominal pain | 22 (88) | 17 (100) |
| Vomiting | 11 (44) | 5 (29) |
| Evidence of pancreatic inflammation | ||
| Elevated pancreatic enzymes | 15 (60) | 14 (82) |
| Amylase or lipase >3× upper limit of normal | 13 | 13 |
| In patients with chronic pancreatitis, amylase, or lipase >2× upper limit of normal | 2 | 1 |
| Documented by imaging | 18 (72) | 7 (41) |
| Investigator reported pancreatitis etiology | ||
| Known or suspected etiology* | 15 (60) | 8 (47) |
| Alcohol | 2 | 0 |
| Biliary | 9 | 3 |
| History of pancreatitis | 6 | 6 |
| Other | 1 | 1 |
| Unknown† | 10 (40) | 9 (53) |
| Severity indices | ||
| Severe pancreatitis | 4 (16) | 0 (0) |
| Evidence of organ failure‡ | 1 | 0 |
| Local complications on imaging | 4 | 0 |
| Pancreatic necrosis | 3 | 0 |
| Pancreatic abscess | 2 | 0 |
| Pancreatic pseudocyst | 1 | 0 |
| Pancreatitis resulting in death§ | 2 | 0 |
Data are n (%) or n.
*Investigator reported.
†Events where study drug was reported as a possible cause are included in the category for unknown.
‡The patient with evidence of organ failure had renal failure (serum creatinine >2 mg/dL after rehydration), pulmonary insufficiency (Pao2 <60 mmHg), and shock (systolic blood pressure <90 mmHg).
§The deaths resulting from pancreatitis occurred in one patient with a history of alcohol use and one with a known history of chronic biliary pancreatitis.